2014 Year-End FDA Compliance and Enforcement Update – Food and Dietary Supplements

March 2, 2015

In 2014, food safety spurred significant rulemaking, enforcement activity, and litigation by regulators and lawmakers at both the federal and state levels.  The U.S. Food and Drug Administration ("FDA") and the U.S. Department of Justice ("DOJ") enforced current good manufacturing practice ("cGMP") regulations and marketing requirements against food and dietary supplement companies, while the U.S. Federal Trade Commission ("FTC") took action against both established manufacturers and small supplement businesses for allegedly deceptive advertising practices. 

The FDA engaged in substantial rulemaking pursuant to the Food Safety Modernization Act ("FSMA"), finalizing its rule addressing recordkeeping requirements for food manufacturers, revising four previously issued proposed rules, and issuing a proposed rule on sanitary transport requirements, which could provide for many changes in how food is stored and transported.  In addition to FSMA-related rulemaking activity, the FDA issued guidance on nanotechnology relating to food and dietary supplement products and guidance on distinguishing beverages from liquid dietary supplements.  The agency also reopened comment on the final guidance document that would impose regulatory requirements applicable to clinical studies of drug products to certain studies of food or dietary supplements. 

Finally, the past year heralded significant developments in food labeling.  Legislation addressing labeling of food containing genetically modified organisms ("GMOs") was proposed at both federal and state levels.  One of the state laws is scheduled to take effect in 2016, subject to the result of constitutional challenge currently in federal court.  While the FDA declined to weigh in on whether foods containing bioengineered ingredients could be labeled as "natural," it proposed revisions to the "Nutrition Facts" portion of food labels and other labeling changes that, if implemented, could mark the most significant changes to food labeling requirements in 20 years.  

This update discusses the following key developments from 2014 relating to the regulation of food and dietary supplements:[1] 

  • Section I – Federal enforcement activity against human food and dietary supplement manufacturers;
  • Section II – Trends in Warning Letters and FDA Form 483 observations;
  • Section III – FDA activities surrounding implementation of the FSMA;
  • Section IV – Newly issued draft and final guidance affecting the food and dietary supplement industries; and
  • Section V– Key labeling developments. 

I.   2014 Enforcement Activity in the Food and Dietary Supplement Industries

The FDA and DOJ demonstrated how seriously they take food safety through aggressive prosecution of individual officers and employees of companies responsible for contaminated food.  In addition, federal agencies sought to shut down manufacturers in the cheese, seafood, and dietary supplement industries who failed to comply with cGMP or Hazard Analysis and Critical Control Point ("HACCP") requirements, showing the willingness to take significant action against companies that do not adequately remediate issues identified in Warning Letters and FDA Form 483 observations.  In most cases, the courts mandated that these companies expend resources on third-party expert consultants to bring their facilities into compliance before they are eligible to resume operations.  The FTC also brought several actions against food and dietary supplement manufacturers for making allegedly false and misleading marketing claims.

            A.   Criminal Prosecutions

In perhaps the highest profile food-related enforcement action to conclude in 2014, a jury returned guilty verdicts against two former officials of, and one broker for, the Peanut Corporation of America ("PCA") for introducing misbranded and adulterated food into the market, among other charges related to the sale of salmonella-tainted peanuts and peanut products.[2]  In 2009, FDA investigators found a number of deficiencies related to the company’s cleaning program and procedures that FDA officials described as "clearly a violation of good manufacturing practices."[3]  Expert evidence at trial showed that tainted food led to a 2009 outbreak with over 700 reported cases of salmonella poisoning; the epidemiological projections of the Centers for Disease Control ("CDC") totaled more than 22,000 cases.[4]  The government also presented evidence that company officials fabricated certificates of analysis for various shipments of peanut products that showed PCA’s products were free of pathogens, when either no testing had occurred or the testing had in fact revealed pathogens.  Commenting on the verdict, Attorney General Eric Holder stated that "[a]ll Americans must be able to rely on the safety of the food they purchase.  And any individual or company who puts the health of consumers at risk by criminally selling tainted food will be caught, prosecuted, and held accountable to the fullest extent of the law."[5]

Earlier in 2014, the U.S. Attorney’s Office for the District of Colorado announced that Eric and Ryan Jensen, the owners of Jensen Farms, had been sentenced to five years of probation including six months of home detention, and ordered to pay $150,000 in restitution for introducing adulterated food into interstate commerce.[6]  According to the CDC, cantaloupe from Jensen Farms that were contaminated with Listeria monocytogenes ("L. mono") resulted in at least 33 deaths and 147 hospitalizations.[7] 

The DOJ also pursued individual criminal charges against Barry Steinlight, the owner of the dietary supplement company Raw Deal.  In December 2014, Mr. Steinlight pleaded guilty to conspiracy to commit wire fraud relating to a scheme to sell diluted and adulterated dietary supplements.[8]  Mr. Steinlight was accused of secretly adding fillers to his dietary supplement products, falsely certifying that his products were kosher and organic, and giving falsified documents to the FDA.  He agreed to forfeit more than $1 million in profits stemming from the scheme; sentencing will commence on March 30, 2015.[9]

            B.   Actions Based on Noncompliance with cGMP Regulations for Human Food and HACCP Requirements

Food and dietary supplement producers must comply with cGMP regulations relating to the facilities, controls, equipment, and methods used in manufacturing those products.  Juice and seafood processors are also subject to HACCP regulations that require the development and implementation of HACCP plans to identify hazards that may potentially affect their products and methods of controlling or preventing those hazards.  Compliance with cGMPs is the focus of many FDA inspections and subsequently the focus of FDA Form 483 observations, Warning Letter citations, and enforcement action.

            1.   Cheese Producers

On August 8, 2014, the DOJ filed suit against S. Serra Cheese Company and its owners to prevent the distribution of allegedly adulterated Italian cheeses.[10]  The DOJ alleged that these cheeses were manufactured in unsanitary conditions and that the company’s procedures were inadequate to ensure product safety, as evidenced by the identification of two potentially dangerous types of bacteria during 2013 inspections of S. Serra’s manufacturing facility.[11]  The inspections allegedly uncovered strains of E. coli and L. innocua that, while non-pathogenic, indicated that the facility was unsanitary, contaminated, and could support the growth of life-threatening bacteria.[12]  With respect to failures to comply with cGMPs, the complaint alleges that the facility was not constructed in a manner that permitted the floors to be adequately cleaned and maintained in good repair, and that the company failed to store raw materials and to clean and sanitize equipment in a manner that protected against contamination.[13]

The United States entered a consent decree with another cheese producer, Finger Lakes Farmstead Cheese Company, LLC and its owner after FDA allegedly identified L. mono in the company’s finished cheese products and in its manufacturing facility.[14]  An earlier inspection of the facility had resulted in a Warning Letter citing violations of cGMP regulations, and findings of L. mono throughout the facility, and findings of generic E. coli in a finished product sample.[15]  Under the consent decree, the company cannot resume operations until it hires an independent laboratory and sanitation expert, trains employees, destroys all inventory and other food items in the facility, and develops a Listeria control plan.[16] 

Showcasing the other administrative enforcement avenues at its disposal, in March 2014, the FDA suspended cheese maker Roos Foods’s facility registration in response to an L. mono outbreak that infected eight individuals between August and November 2013.[17]  An investigation led by local and state public health and regulatory agencies, the CDC, and the FDA concluded that cheese products made by Roos Foods were the likely source of the outbreak.[18]  Roos Foods had voluntarily recalled all lots, sizes, and types of cheese distributed under several brands, as well as several other dairy products.[19]  But during a two-week inspection in early 2014, the FDA also cited cGMP violations related to water dripping from the ceiling onto cheese processing equipment, food residue found on equipment, openings in milk storage tanks, and uncleanable surfaces on processing and storage equipment.[20]  The agency stated that it will "vacate the suspension order and reinstate Roos Foods’s facility registration when [it] determines that food manufactured, processed, packed, or held at the facility no longer has a reasonable probability of causing severe adverse health consequences or death to humans."[21]

            2.   Seafood Products

Manufacturers of seafood products also were an enforcement target in 2014.  In April, the U.S. District Court for the Eastern District of New York entered an injunction against New York City Fish, Inc., a Brooklyn fish processing plant.[22]  The FDA had issued a Warning Letter to New York City Fish in 2010, citing the presence of L. mono in its facility and other unsanitary conditions;[23] when it entered the injunction, the district court noted that the defendants had violated the Federal Food, Drug, and Cosmetic Act ("FDCA") previously and that there was no certainty that they would refrain from continuing to violate the law.[24]  The injunction prohibits the plant from operating until independent experts develop a Listeria monitoring program and provide a comprehensive inspection of the facilities.[25] 

Other seafood manufacturers faced FDA enforcement action as well.  In March, Jensen’s Old Fashioned Smokehouse Inc., a smoked fish processor, was ordered to stop all food operations after the FDA found the presence of L. mono in environmental samples collected during a recent inspection of the facility.[26]  The company was operating under a consent decree issued in 2011, which required it to comply with HACCP and other requirements.[27]  Another seafood product manufacturer, Los Angeles-based Neptune Manufacturing, Inc., and its owners agreed in a consent decree to a permanent injunction requiring them to stop all manufacturing and distribution until their operations comply with the FDCA.[28]  According to the FDA’s press release, over the course of seven inspections that occurred since 2006, the FDA found L. mono on four occasions and found a failure to control for Clostridium botulinum, a rare bacterium causing botulism, on three occasions.[29] 

            3.   Other Producers

Pursuant to a consent decree of permanent injunction entered by the U.S. District Court for the District of Hawaii on December 11, 2014, the owner of RZM Food Factory agreed to cease processing and distribution until the facility could demonstrate compliance with FDA food safety requirements.[30]  Although the FDA had received no reports of people becoming ill from consuming RZM Food Factory’s products, the agency had "repeatedly advised RZM Food Factory of unsanitary conditions at the facility."[31]  The contamination issue was critical because the facility prepared, packed, and held various kinds of sprouts, which are consumed raw, and other ready-to-eat foods.[32]  Before resuming processing and distribution, RZM Food Factory must retain a third-party sanitation expert and develop a remediation program.[33]

In November 2014, the DOJ also sought to enjoin ready-to-eat sandwich manufacturer, Scotty’s Incorporated (doing business as Bruce Enterprises and Bruce’s Fresh Products), from distributing adulterated sandwiches.[34]  The complaint alleged that the company, among other failures, did not have a written HACCP plan in place for handling seafood used in the company’s ready-to-eat tuna sandwiches.[35]  According to the DOJ’s press release, Scotty’s Incorporated was previously warned to develop a HACCP plan, but still had not done so when FDA inspections occurred in early 2014.  The inspections additionally revealed a lack of sanitation control records.  Commenting on the case, Acting Assistant Attorney General Joyce R. Branda commented that "[t]he Department of Justice will take all appropriate measures to protect the safety of the seafood consumers eat."[36]

            C.   Failure to Comply with Dietary Supplement cGMPs and Marketing Requirements

In 2014, federal district courts enjoined the operations of several dietary supplement manufacturers following the FDA’s conclusion that the supplements were adulterated as a result of being prepared, packed, or held under substandard conditions without systems in place to confirm compliance with cGMP requirements and product specifications.

  • GM Manufacturing.  On June 20, 2014, a Central District of California court entered a permanent injunction against GM Manufacturing ("GMM").[37]  The FDA alleged that GMM manufactured and distributed adulterated dietary supplements, and failed to keep the plant clean and sanitized.[38]  The injunction prohibits GMM from manufacturing, preparing, or distributing dietary supplements until an expert inspects the facilities, certifies that no deficiencies remain, and the FDA re-inspects the facilities.[39]  GMM also must recall and destroy all supplements manufactured or distributed since February 13, 2012.[40]
  • Mira Health Products, Ltd.  On July 1, 2014, an Eastern District of New York court entered a consent decree of permanent injunction against Mira Health Products, Ltd. and two officers.  Based on its inspection of Mira’s facilities, the FDA alleged there were no systems in place to ensure that the dietary supplements were not contaminated or deteriorated.[41]  The consent decree requires Mira to cease all operations until the FDA determines that Mira’s manufacturing practices conform to the law.[42]
  • Triceutical, Inc.  On July 8, 2014, an Eastern District of New York court entered a consent decree of permanent injunction against Triceutical, Inc. and its president.[43]  The FDA alleged that it had inspected Triceutical’s manufacturing facility and found no systems in place to prevent product contamination or deterioration.[44]  Triceutical agreed to cease all operations until the FDA determines that Triceutical’s manufacturing processes comply with the law.[45]  
  • APS Pharmaco.  On July 23, 2014, the Eastern District of New York entered a consent decree permanently enjoining APS Pharmaco and its president from circulating its allegedly adulterated dietary supplements.[46]  The FDA claimed that the company violated the FDCA by failing to ensure that its products met specifications.  In particular, a series of FDA inspections found that APS Pharmaco did not examine and test all of the ingredients contained in its product.  Under the injunction, APS Pharmaco must recall all products sold since January 1, 2014, and cease operations until the FDA determines that APS Pharmaco’s practices comply with the law.[47]
  • BioAnue Laboratories.  On July 23, 2014, a Middle District of Georgia court issued an order enjoining dietary supplement manufacturer BioAnue from selling its products.[48]  In addition to past FDA findings of noncompliance with cGMPs for dietary supplements, the agency also asserted that certain products marketed as dietary supplements by the company were actually unapproved new drugs because they were promoted for the treatment of cancer, HIV/AIDS, and diabetes, among other conditions.[49]  The terms of the injunction prevent BioAnue from resuming manufacture or distribution until it hires independent experts to ensure that its manufacturing and labeling are compliant with the law.[50]
  • SciLabs Nutraceuticals Inc.  On November 13, 2014, the DOJ announced a consent decree of permanent injunction against dietary supplement contract manufacturer SciLabs Nutraceuticals Inc. and its CEO for failing to comply with applicable cGMPs.[51]  The complaint, filed in the Central District of California, alleged that FDA inspections in 2012, 2013, and 2014 found that the company failed to conduct appropriate tests to verify the identity of every dietary ingredient, to establish product specifications for finished batches, and to document equipment use, maintenance, cleaning, and sanitization properly.[52]  The consent decree requires SciLabs to cease all operations and requires that the FDA determine that SciLabs’s manufacturing practices comply with the law before defendants can resume manufacturing dietary supplements distributed under the brand name "All Science."[53]

            D.   FTC Enforcement

The FTC shares jurisdiction with the FDA over representations made by food and dietary supplement manufacturers about their products.  Pursuant to a 1971 Memorandum of Understanding between the two agencies, the FTC has primary jurisdiction over regulation of food advertising, while the FDA has primary jurisdiction over regulation of food labeling.[54] 

During 2014, the FTC stepped up its scrutiny of health-related claims, taking action against weight-loss products and asserting narrow interpretations of what constitutes "reliable scientific evidence."  In November 2014, an FTC official named false or unsubstantiated health claims as an ongoing FTC priority with respect to deceptive advertising practices.[55]  In 2015, FTC will continue its enforcement efforts with respect to deceptive weight-loss claims, "[g]iven the continuing onslaught of miracle pills and potions claiming dramatic weight loss and slimming," and pursue investigations "in the pipeline" that focus on cognitive benefit claims.[56]  Several notable 2014 FTC actions are described below.

            1.   Weight-Loss Claims

At the start of 2014, the FTC announced "Operation Failed Resolution," a crackdown on claims that products will lead to easy weight loss.[57]  Over the course of the year, the FTC announced multiple weight-loss product settlements, most of which required the defendants to substantiate any future weight-loss claims with at least two adequate and well-controlled human studies.[58]  In one case, the FTC won contempt sanctions (including incarceration) against two individuals who allegedly made unsubstantiated diet claims and then failed to comply in a reasonable manner with a court order mandating recall of their products.[59]  The FTC announced its second settlement of the year related to Human Chorionic Gonadotropin weight-loss products in December, and is poised to continue this enforcement focus in 2015.[60] 

            2.   Requirements for Medical Foods

The FTC also flexed its advertising authority over medical foods.  In February 2014, the FTC won a judgment against Wellness Support Network, Inc. and two individuals for making allegedly deceptive claims that their products controlled blood sugar and were effective in managing diabetes and insulin resistance.[61]  The defendants had argued that these products were medical foods intended for dietary management of diabetes under a physician’s supervision and thus were not subject to FTC advertising requirements for conventional foods and dietary supplements.[62]  The FDCA defines "medical food" as a food "formulated to be consumed . . . under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation."[63]  Under the FDCA, medical foods are exempt from certain labeling requirements for nutritional information, nutrient content claims, and health-related claims applicable to conventional foods and dietary supplements.[64]  In analyzing the case, however, the Northern District of California court focused on the FTC’s deceptive advertising framework rather than FDA regulation of medical foods.[65]  Without reaching the question of whether the products were actually medical foods, the court held that FDA regulatory standards applicable to the defendants’ product did not affect the FTC’s claims.[66]

            3.   Defining the Contours of "Competent and Reliable Scientific Evidence"

The FTC applies a standard of "competent and reliable scientific evidence" to claims regarding the benefits of dietary supplements,[67] but the precise requirements regarding what will satisfy that standard remain unsettled.  During 2014, the FTC moved for an order to show cause why Bayer Corporation ("Bayer") should not be held in contempt for an alleged violation of a 2007 consent decree between Bayer and the FTC that prohibited Bayer from making representations about the health benefits of dietary supplements without "competent and reliable scientific evidence."[68]  Relying on expert testimony to define what constitutes "competent and reliable scientific evidence,"[69] the FTC alleged that Bayer’s advertising for its Phillips’ Colon Health probiotics supplement product lacked substantiation.  In FTC proceedings prior to the filing, Bayer produced approximately one hundred papers as support for its claims, which related to the health benefits of probiotics (e.g., the reduction of gastrointestinal symptoms).[70]  Relying on expert testimony, the FTC argued that none of the papers provided adequate support because reliable scientific evidence required "human clinical trials that (1) are randomized, placebo-controlled, and double-blind; (2) use the specific product for which the claims are made; (3) are performed in the population at which the claims are directed; and (4) use validated methods and appropriate statistical methods to assess ‘outcomes’ . . . ."[71]  The FTC rejected the use of other types of research, such as animal studies or studies of similar, but not fully equivalent, products.  The court granted the order to show cause but has expressly taken no position on whether Bayer violated the 2007 consent decree.[72]  Bayer has responded, attacking the FTC’s proposed standard as inconsistent with applicable law and the views of medical experts;[73] the case remains pending.

The FTC’s efforts to establish a narrow definition of reliable scientific evidence took a blow in Basic Research, LLC v. FTC, however.  In Basic Research, the FTC alleged violations of a 2006 consent order that prohibited Basic Research from making unsubstantiated advertising claims relating to weight loss for two dietary supplements:  Akävar and Relacore.[74]  The FTC’s expert opined that the studies Basic Research relied upon to substantiate its claims for Akävar failed to meet an "ideal" standard of a clinically significant result obtained in a randomized, double-blind, placebo-controlled clinical trial and published in a peer-reviewed journal.[75]  With respect to Relacore, the expert opined that 34 studies cited by Basic Research’s experts should be disregarded, including all animal studies.[76]  After reviewing expert reports on both sides, the court concluded that the consent order did not require Basic Research to support all claims with "uncontroverted evidence"; instead, Basic Research had "to possess competent and reliable evidence that substantiates its claims."[77]  As a result, the FTC was required to "do more than present an expert who simply disagrees with the scientific literature upon which Basic Research relied."[78]  Moreover, the court observed that while it would be inappropriate to extrapolate automatically from animal studies to humans, it would also be wrong to disregard all animal studies and all studies that only addressed a part of the question, without explaining why inferences and correlations could not be drawn from them.[79]  Rejecting the views of the FTC’s expert, the court found that Basic Research had presented reliable scientific evidence supporting its advertising claims and granted its motion for summary judgment.[80] 

            4.   Alleged Misrepresentation of FDA Authorization to Make a Health Claim

The FTC also launched litigation proceedings against Gerber Products Co. ("Gerber") for allegedly making unsubstantiated health claims, which were similar to those the FDA had rejected.[81]  Gerber had sought FDA approval for a health claim that a key ingredient in its formula (partially hydrolyzed whey protein) reduced the risk of food allergies in infants.[82]  The FDA rejected that request, stating that there was no credible evidence to support it.[83]  Gerber later requested permission to use a health claim that the same formula component reduced the risk of atopic dermatitis.  The FDA found the scientific evidence to be uncertain but agreed to use its enforcement discretion to permit the claim, provided that Gerber include language indicating that the evidence for the claim was limited.[84]  In its complaint, the FTC alleged that Gerber’s advertising included broader claims about allergy prevention than were submitted to the FDA, as well as a gold badge stating, "1st and Only Meets FDA Qualified Health Claim."[85]  The FTC asserted that the gold badge converted the FDA’s offer of limited enforcement discretion into a statement implying that the product "qualified for or received approval for a health claim."[86]  Gerber filed an answer on January 5, 2015, arguing that the FTC’s claims fall within the primary jurisdiction of the FDA.[87]

II.   Observations and Warning Letters

The FDA’s inspectional (Form 483) observations and enforcement correspondence, described below, highlight the most common pitfalls and areas of regulatory scrutiny in 2014.  Although these communications from the FDA are not welcome news for manufacturers, they provide a valuable opportunity to examine and reinvigorate internal compliance practices and to respond directly to the FDA’s concerns.  A manufacturer’s robust response at this critical stage can stem the tide of further enforcement action, significant business disruptions, and other serious consequences that we saw in 2014.    

            A.   Common FDA Form 483 Observations

The most common FDA Form 483 observations cited during food and dietary supplement inspections in fiscal year 2014 are summarized below.[88]  There has been little fluctuation in the most common observations for conventional foods from year to year, with the top two observations remaining unchanged since 2009:  (1) lack of effective measures to exclude pests from processing areas or to protect against contamination of food by pests, and (2) failure to monitor sanitation conditions and practices with sufficient frequency.  The most frequently cited dietary supplement cGMP regulations have varied more over that time period; in 2014, the leading issue cited was the failure to establish product specifications for the identity, purity, strength, or composition of a finished dietary supplement product.[89]

Top Food 483 Observations - FY 2014

Top Dietary Supplement cGMP 483 Observations – FY 2014

Source: U.S. Food & Drug Admin., FY 2014 Inspectional Observation Summaries[90]

            B.   Warning Letters

In 2014, the FDA issued 58 Warning Letters relating to dietary supplements and 252 Warning Letters involving conventional foods.[91] 

2014 Warning Letters

Source: U.S. Food & Drug Admin.[92]

While many of those Warning Letters cited cGMP violations similar to the FDA Form 483 observations cited above, the FDA’s Center for Food Safety and Applied Nutrition and various district offices also cited other violations, such as improperly marketing products as dietary supplements when those products were actually new drugs.[93]  

III.   FSMA Implementation

Since its enactment, implementing the FSMA has driven extensive FDA rulemaking and guidance activity—2014 was no different.  In addition to outlining its operational strategy for prospective FSMA implementation, the agency released a new proposed rule, revised four previously issued proposed rules, and released a final rule on recordkeeping requirements with interpretive guidance documents.

            A.   FDA Releases FSMA Operational Strategy

The FDA released an operational strategy for FSMA implementation in 2014, which describes internal agency changes as well as the roles it anticipates partner agencies, and other public and private parties, will play in the U.S. food safety system.[94]  According to FDA representatives, the operational strategy conveys the agency’s current "high-level" thinking on implementation of the final FSMA rules on the ground.[95] 

The FDA plans to develop a nationally integrated food safety system including data systems that would facilitate information sharing among federal, state, and local agencies.  Adopting a risk-based approach, the FDA also proposed to modernize inspection and enforcement approaches based on a prevention model, third-party audits, and incentives for regulatory compliance.  Although the FDA may expand its surveillance methods, including use of sampling techniques and screening, it anticipates "reduced scrutiny of firms with records of demonstrated good performance."[96]   

With respect to produce safety standards, the FDA acknowledged that it lacks the resources to inspect farms with a frequency that would assure regulatory compliance.  The FDA plans to collaborate with the U.S. Department of Agriculture ("USDA") and other partner agencies on produce safety issues and will rely on public and private resources, such as USDA audits, marketing agreements, and commercial purchaser audits to monitor compliance.  The FDA also plans to shift more responsibility to importers for the safety of produce from foreign suppliers rather than relying on border detection of food safety issues; the FDA will reconfigure border and field examination activities to complement its foreign supplier verification programs. 

            B.   Draft Approach for Designating High-Risk Foods

The FSMA requires the FDA to designate high-risk foods that must comply with additional recordkeeping requirements.[97]  On February 4, 2014, notice of "FDA’s Draft Approach for Designating High Risk Foods as Required by Section 204 of FSMA" was published in the Federal Register.[98]  The FDA’s proposed risk model would include scoring components based on a comprehensive list of representative food-hazard pairs (i.e., characteristics of foods and their known or reasonably foreseeable hazards).  Ultimately, based on total risk scores for foods/food categories, the FDA would create a preliminary high-risk food list.[99]  The FDA requested comment and industry data both generally and with respect to certain specific areas, such as food categorization schemes and the weight that certain statutory criteria should be assigned in the risk model.[100]  The agency also requested data regarding contaminants and manufacturing control measures for representative foods in each food category.[101]  Companies that manufacture high-risk foods will have to implement procedures for adherence to FDA’s increased recordkeeping requirements when those requirements are determined.  It is likely that the FDA’s high-risk food list, when developed, will be used to prioritize the frequency of FDA inspections. 

            C.   New FSMA Proposed Rules

As the FDA continues to implement the FSMA through rulemaking and guidance development, it will work under a new set of rulemaking deadlines set forth in a consent decree entered in February 2014.[102]  The new schedule is the product of a settlement reached between the FDA and the Center for Food Safety and the Center for Environmental Health, which sued the agency for failing to promulgate seven final rules by the deadlines set forth in the FSMA.[103]  The stipulated deadlines require that the FDA issue final rules as follows: 

C. New FSMA Proposed Rules

Source:  Center for Food Safety v. Hamburg, No. 12-cv-04529-PJH (N.D. Cal. Feb. 20, 2014).

While the FDA may seek an extension of these deadlines for good cause, such an extension will require either agreement from the plaintiffs or permission from the court.  As described below, the agency already took significant steps toward completion of the seven final rules last year.

            1.   Proposed Rule: Sanitary Transportation of Human and Animal Food

In February 2014, the FDA published the seventh (and last) proposed rule pursuant to the FSMA:  "Sanitary Transportation of Human and Animal Food."[104]  The proposed rule seeks to prevent unsanitary food transport practices to minimize food safety risk during transport.[105]  Those subject to the proposed rule would include shippers, receivers, and carriers that transport food in the United States by motor or rail.  It would also apply to foreign persons who ship food to the United States by international freight container and arrange transfer of that container onto a motor or rail vehicle in the United States that is intended for sale in the United States.[106]  Exemptions are included for shippers, receivers, or carriers with less than $500,000 total annual sales, raw agricultural commodities transported by farms, live food animals, and fully packaged shelf-stable foods.[107]

The proposed rule focuses on requirements for the design of vehicles and equipment used in food transportation.  The FDA also attempted to demonstrate flexibility, stating that the transportation industry could "continue to use best practices [it has developed] concerning cleaning, inspection, maintenance, loading, unloading, and operation of vehicles and transportation equipment."[108]  If implemented, the proposed rule would require many changes with respect to how food is stored and transported.  In the comments submitted on the proposed rule, some industry stakeholders questioned its requirements, such as those relating to temperature monitoring, which would add substantial cost to implement.[109]  It remains to be seen whether the agency will modify the final rule based on these comments. 

            2.   Proposed Supplemental Rules

In September 2014, the FDA also published revisions to four proposed rules originally issued in 2013 in response to the agency’s outreach efforts and public comments.  The FDA explained that the changes were intended to make the proposed rules more "flexible, practical, and targeted."[110]  Some notable aspects of those changes are detailed below. 

                                    a.   Preventive Controls for Human Food 

This proposed supplemental rule revised the definition of "farm" to exempt from food facility registration requirements those farms that pack or hold raw agricultural commodities for another farm with different ownership.  These farms generally would be covered instead under the proposed supplemental produce safety rule.[111]  "Very small businesses" with less than $1 million in total annual human food sales are also exempt from the rule’s requirements.[112]  

In its revisions to the original proposed rule, the FDA attempted to clarify the procedures that it would follow prior to withdrawing an exemption for a qualified facility for food safety reasons.[113]  In addition, the proposed supplemental rule added language regarding requirements for product testing, environmental monitoring, and supplier controls.  A supplier controls program would be required when a receiving facility identifies a significant hazard related to the raw material or ingredient supplied through its hazard analysis and that hazard is not controlled by the receiving facility or its customers.[114]  With respect to product testing and environmental monitoring, the FDA specifically requested comment as to whether the final rule should require facilities to conduct product testing or environmental monitoring to verify implementation and effectiveness of preventive controls in certain circumstances.[115] 

                                    b.   Preventive Controls for Animal Food 

The FDA acknowledged in the preamble to this proposed supplemental rule that its original proposal on cGMPs for animal food was largely based on existing cGMP regulations for human food.[116]  Thus, the revisions are designed to be more flexible, taking into account the wide variety of animal food facilities.[117]  In most circumstances, food facilities compliant with cGMPs for human food would not be required to also comply with animal food cGMPs when supplying a by-product for animal food, with the exception of proposed cGMPs related to holding and distributing certain human food by-products.[118] 

The proposed supplemental rule specifically sought comment as to (1) whether animal food facilities should be required to conduct product testing and environmental monitoring to verify the implementation and effectiveness of preventive controls, (2) whether feed mills associated with vertically integrated farms should be subject to the proposed rule, and (3) whether the final rule should address hazards introduced intentionally for economic reasons.[119]  Similar to the supplemental proposed rule on preventive controls for human food, the revised proposal for animal food included clarification of procedures that the agency would follow when withdrawing an exemption for a qualified facility.[120]

                                    c.   Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption 

In its proposed supplemental rule regarding produce standards, the FDA clarified that the proposed rule would not apply to farms or farm mixed-type facilities with average annual produce sales under $25,000.[121]  In addition, the definition of "farm" will now include facilities that pack or hold raw agricultural commodities that another farm grows or harvests.[122]  The FDA also proposed and requested comment on several changes affecting agricultural water:  the microbial quality standard for water applied to produce (other than sprouts) during growing activities, testing frequency, and use of third-party testing data.[123]  As with the other proposed supplemental rules, the FDA’s revisions describe the procedures the agency would follow when withdrawing a farm’s exemption for food safety reasons.[124]

                                    d.   Foreign Supplier Verification Programs 

The FDA described its revisions to the proposed rule on Foreign Supplier Verification Programs ("FSVPs") as intended to provide the food industry with greater flexibility to determine appropriate verification measures based on risk.[125]  Under the supplemental proposed rule, the FDA would require importers to conduct a more comprehensive hazard analysis considering a variety of factors:  the nature of hazards in the foods at issue, the entity that will be controlling the hazard, the foreign supplier’s food safety procedures and practices, the foreign supplier’s compliance with U.S. food safety regulations, and the foreign supplier’s food safety history.[126]  The FDA also revised its original proposal for supplier verification activities to require annual onsite audits of a foreign supplier when there is reason to believe that a hazard will result in serious injury or death.[127]  Importers will have the flexibility to use one or more of four supplier verification activities prior to initially importing from a given supplier.[128]  Very small importers with less than $1 million in annual food sales are exempt from the proposed supplemental rule’s requirements for FSVPs.[129] 

            D.   Final Rule on the Establishment, Maintenance, and Availability of Records

In April 2014, the FDA issued a final rule describing recordkeeping requirements,[130] along with two guidance documents explaining those new requirements.[131]  The FSMA revised section 414 of the FDCA to expand the FDA’s records access authority.[132]  Section 414 now broadly requires any person who manufactures, processes, packs, distributes, receives, holds, or imports "an article of food [or] any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner" to allow the FDA to access and copy certain records when the agency reasonably believes that (1) the article of food is adulterated and presents a threat of serious adverse health consequences or death or (2) "there is a reasonable probability that the use of or exposure to" the article of food "will cause serious adverse health consequences or death . . . ."[133]  The FDA’s guidance states that the agency is most likely to request access to records under sections 414(a) and 704(a) of the FDCA when it becomes aware of:

  • Reportable food reports, as defined in 21 U.S.C. § 350f(a)(2);
  • Foodborne outbreaks;
  • Epidemiological evidence indicating food as the cause of illness or death;
  • Product recalls;
  • Adverse event reports; or
  • Consumer complaints.[134]

The FDA’s guidance also provides examples of the records the agency would be permitted to access, which include:  manufacturing records, raw materials receipt records, product distribution and inventory records, test records, recall records, reportable food records, customer distribution lists, and complaint and adverse event records.[135]  Entities subject to the records requirements should review the final rule and related guidance to assure that they have plans in place to handle such requests.

            E.   Recent Developments

As the FDA implements FSMA, Congress and the executive branch are proposing sweeping reforms to the federal framework for food safety.  In January 2015, Senator Dick Durbin (D-IL) and Representative Rosa DeLauro (D-CT) introduced the Safe Food Act of 2015, which would create an independent "Food Safety Administration" with authority over activities such as labeling, inspection, and enforcement.[136]  President Obama’s fiscal year 2016 budget, released on February 2, 2015, includes a similar proposal.  Citing confusion caused by "[f]ractured oversight and disparate regulatory approaches," the President’s budget calls for the creation of a single new agency within the Department of Health and Human Services that would incorporate "the food safety related components of the FDA" and the USDA’s Food Safety and Inspection Service.[137]  This new agency would have primary responsibility for food safety inspections, enforcement, and outbreak response.[138]  While Senator Durbin and Representative DeLauro have introduced comparable legislation several times in the past,[139] the inclusion of this issue in President Obama’s new budget adds important momentum to the proposals for a significant overhaul of the federal food system.  In 2015, we expect continuing debate on the federal government’s role in and regulatory approach to ensuring the safety of the food supply.

IV.   Guidance for the Food and Dietary Supplement Industries

            A.   Nanotechnology

In June 2014, the FDA released three final guidance documents and one draft guidance document related to nanotechnology, two of which apply to human foods including dietary supplements.  While the FDA acknowledged that nanotechnology products may have different properties from conventionally manufactured products, the agency will not automatically consider nanotechnology products to be either benign or harmful.[140]  Instead, the FDA plans to assess nanotechnology products in the same manner it assesses any other product.[141]

            1.   Final Guidance: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology

This guidance document outlines the agency’s general approach to regulation of products (including foods and dietary supplements) that involve the application of nanotechnology.[142]  According to the guidance, the FDA will consider two factors when determining whether an FDA-regulated product involves nanotechnology: 

  • Whether a material or end product is engineered to have at least one external dimension, or an internal or surface structure, in the nanoscale range (approximately 1 nm to 100 nm); [and]
  • Whether a material or end product is engineered to exhibit properties or phenomena, including physical or chemical properties or biological effects, that are attributable to its dimension(s), even if these dimensions fall outside the nanoscale range, up to one micrometer (1,000 nm).[143]

The FDA concludes that "[a]n affirmative finding to either of [these two questions] . . . might suggest the need for particular attention to the product by FDA and/or industry for potential implications for safety, effectiveness, public health impact, or regulatory status of the product."[144]  For the time being, the FDA is addressing issues including the safety, effectiveness, and regulatory status of nanotechnology products on a case-by-case basis.[145]

            2.   Final Guidance: Assessing the Effect of Significant Manufacturing Process Changes

Included in the FDA’s slate of nanotechnology guidance was a second document applicable to food manufacturing, titled "Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives."[146]  The discussion of nanotechnology in this guidance focused on changes (particularly those resulting from intentional alteration of particle size distribution) made to substances that are already used in foods.[147] 

When a significant manufacturing process change affects the safety and/or regulatory status of a food substance, the manufacturer may need to make a new regulatory submission to establish that the new process is safe and lawful.[148]  The final guidance does not concretely define a "significant manufacturing process change" but does set forth recommended factors for assessing whether a change is significant:

  • Ascertain changes made to the identity of the food substance/food contact substance as a result of the manufacturing process change;
  • Conduct a safety assessment for the use of the food substance/food contact substance, considering any impact of the process change on the identity of the food substance;
  • Consider whether the use of the food substance/food contact substance is authorized under a food additive or color additive regulation, is within the scope of an effective food contact notification or Generally Recognized as Safe ("GRAS") affirmation or identification, or whether the GRAS status of the use of the food substance would be affected;
  • Consult with the FDA regarding the conclusions reached about the impact of the significant manufacturing change on safety and/or regulatory status; and
  • Make any appropriate regulatory submissions.[149]

In addition, the FDA provides examples of significant changes:  a change in one or more starting materials; a change in the concentration of starting materials; a change in catalyst; a change in the source microorganism used for a food substance derived from fermentation of a microorganism; and a change in food manufacturing or ingredient technology, such as the use of nanotechnology.[150]

            B.   Distinguishing Beverages from Liquid Dietary Supplements

Responding to an observed increase in the marketing of liquid products with varying ingredients and intended uses, in January 2014, the FDA issued final guidance describing the factors that distinguish liquid dietary supplements from liquid conventional foods (beverages).[151]  The guidance presents important insights into the FDA’s approach to manufacturers of these products:  (1) liquid products that make labeling claims inconsistent with their product category may be misbranded, and (2) dietary supplements are subject to separate cGMP regulations from foods. 

The guidance document explains that labeling and advertising may contain the most obvious representations about a product’s use.  For example, statements suggesting that a liquid product is intended to "rehydrate" would suggest that the product is a beverage.[152]  In addition, the FDA considers the following factors to be potentially important for distinguishing beverages from liquid dietary supplements:  product name, packaging, serving size, recommended daily intake, other recommended conditions of use, composition, marketing practices, and product representations made outside labeling and advertising.[153]  Examples of how these factors may influence the determination of whether a product is a beverage or liquid dietary supplement are included in the final guidance.[154] 

The FDA is already taking enforcement action based on this distinction between liquid dietary supplement and beverage:  in January 2015, the agency issued a Warning Letter to NYSW Beverage Brands, Inc., asserting that certain of the company’s product labels represented that the products were for use as conventional foods and that the products were packaged in a similar manner to beverages like vitamin waters.[155]  According to the Warning Letter, if the products at issue are labeled as dietary supplements, they would be misbranded if also represented for use as conventional foods.[156] 

The FDA also issued a brief final guidance document, titled "Guidance for Industry:  Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements," to "remind" manufacturers of the applicable FDA requirements for substances added to foods and that the same requirements apply to substances added to dietary supplements that are not dietary ingredients.[157]  In particular, the FDA expressed concern regarding ingredients not previously used in conventional foods that "are now being added to beverages . . .  at levels in excess of their traditional use level . . . ."[158]  This FDA "reminder" signals an area of continuing agency scrutiny and enforcement action.

            C.   IND Requirements for Food and Dietary Supplement Studies

In 2013, the FDA issued final guidance regarding the applicability of investigational new drug application ("IND") requirements to human research studies (the "IND Guidance").[159]  The IND Guidance emphasizes the intent of a clinical study as the determining factor when deciding if an IND is necessary.[160]  With respect to dietary supplements, an IND is not required if the study "is intended only to evaluate the dietary supplement’s effect on the structure or function of the body . . . ."[161]  If the study is intended to evaluate the dietary supplement’s ability to diagnose, cure, mitigate, treat, or prevent disease, however, the FDA believes that an IND is required.[162]  The analysis for clinical studies involving foods is similar, except that food labeling may bear an authorized health claim related to disease risk reduction without being considered a drug.[163]  While these distinctions are somewhat vague, the IND Guidance would result in a significant broadening of the IND requirements to encompass various food and dietary supplement studies, and the study sponsors could become enforcement targets if they conducted these studies without an IND.

In February 2014, the FDA published a notice reopening comment on the IND Guidance with respect to the portions that discuss cosmetic, food, and dietary supplement studies.[164]  During the reopened comment period, multiple industry stakeholders objected to the policies laid out in the IND Guidance on the grounds that the agency lacks authorization under the FDCA to require INDs for research involving foods, dietary supplements, and cosmetics, and that the agency violated the Administrative Procedure Act by announcing the new IND policy in a guidance document.[165]  The FDA is reviewing these comments.  

V.   Labeling Developments

            A.   Proposed Rules on Food Labeling

The well-known Nutrition Facts label has remained nearly unchanged since its introduction in 1993, except for the addition of trans fats to the label in 2006.[166]  In 2014, however, the FDA proposed two significant rules modifying the Nutrition Facts label used on food packages in the United States. 

            1.   Revision of the Nutrition and Supplement Facts Labels 

To reflect updated information regarding consumer behavior, consumption patterns, and current public health conditions, the FDA indicated a number of changes to the Nutrition Facts label in a proposed rule published on March 3, 2014,[167] that included:

  • The inclusion of "Added Sugars" as a required element on the label;
  • Updated daily values for various nutrients, including sodium, dietary fiber, and Vitamin D;
  • Adopting a definition of "dietary fiber" based on the Institute of Medicine’s definition of "total fiber";
  • Changes to the list of "nutrients of public health significance" that must be included on the label: Potassium and Vitamin D would become mandatory, while Vitamins A and C would become optional, and Calcium and iron would remain mandatory;
  • Removing "Calories from Fat" from the label, while retaining the "Total Fat," "Saturated Fat," and "Trans Fat" requirements; and
  • Design changes, including increased emphasis on the total calories and the number of servings per container.

The addition of "Added Sugars" to the Nutrition Facts label is a contentious issue that is of particular interest to the industry.  The controversial subject of added sugars has been widely discussed since the issue was first raised in a petition by the Center for Science in the Public Interest ("CSPI") in 1999.[168]  While the FDA argues that added sugars contribute to excess calorie consumption and reduced consumption of nutrient-dense foods, opponents of the proposal view the proposed requirement as difficult to implement and likely to cause consumer confusion, as there are no chemical differences between added sugars and sugars intrinsic to the food.  Because there is no analytical test capable of distinguishing added sugars from intrinsic sugars in a food when the added sugars undergo fermentation, the FDA has proposed that manufacturers keep records of how much sugar they add to foods.  The proposed rule would mandate that manufacturers have written documentation available during an inspection to confirm the amount of declared added sugar on a food’s label, alone or in combination with naturally occurring sugars, when the added sugars are subject to fermentation.[169]

            2.   Serving Size Revisions

The FDA also published a second proposed rule on food labeling with respect to serving sizes.[170]  The serving sizes currently used to calculate Nutrition Facts are based on a series of Reference Amounts Customarily Consumed ("RACCs") derived from studies of typical food consumption.  The FDA proposes updating the RACCs (and accordingly the serving sizes) for a variety of foods to reflect changes in food consumption patterns over the past twenty years.[171]  For the most part, the FDA proposes to update the RACCs where typical consumption has increased or decreased by at least 25%.[172]

The proposed rule also requires that some packages currently labeled as containing multiple servings be treated as single-serving containers.[173]  Under the new rule, packages containing up to 200% of the RACC would be labeled as single servings, and packages containing 200%– 400% of the RACC would contain dual-column labels with nutrition facts for the RACC and for the entire package.[174] 

The impact of the proposed rule will vary heavily depending on the food item.  Some products will be required to display nutrition information based on substantially larger quantities (for example, the RACC used for ice cream will double)[175] but in some cases the serving size will actually drop.  Significantly, changes in RACC are likely to affect a food’s eligibility for health or nutrient content claims, such as "low calorie" or "reduced fat."  According to FDA regulations, a product must meet the requirements for a nutrient content or health claim based on the RACC amount.[176]  A food may meet the requirements to qualify for a nutrient content claim at the current RACC, but exceed the nutrient amount allowed for that claim at the new RACC.  While the FDA acknowledged the impact of RACC changes on product claims, it reasoned that "such changes may be appropriate in light of the changes in the amounts of food being customarily consumed."[177]  If the proposed RACC changes are implemented, a manufacturer whose product no longer qualifies for making a health or nutrient content claim under the new RACC would need to reformulate its product to meet the claim requirements, or remove the claim from the product’s labeling.

If finalized, the labeling changes described above may require significant label redesigns and claim strategies on the part of manufacturers.  On December 9, 2014, the FDA announced that January 1, 2018, will be the uniform compliance date for food labeling regulations that are issued in calendar years 2015 and 2016.[178]

            B.   Final and Draft Guidance on Certain Labeling Requirements

In addition to proposing revisions to food labeling requirements, the FDA also issued draft and final guidance related to allergen labeling requirements and labeling requirements specific to certain foods.

            1.   Draft Guidance: Food Allergen Labeling Exemption Petitions and Notifications

In May 2014, the FDA issued draft guidance regarding the process by which food manufacturers may obtain an exemption from food allergen labeling requirements.[179]  The Food Allergen Labeling and Consumer Protection Act amendments to the FDCA deem foods misbranded unless they declare each major food allergen on the product label.[180]  But the FDCA also provides that manufacturers can request an exemption from this requirement, via notification or petition, for an ingredient that contains an allergenic protein.[181]  To request an exemption based on scientific evidence demonstrating that the ingredient at issue "does not cause an allergic response that poses a risk to human health," manufacturers must submit a petition.[182]  Notifications may be used to request an exemption on the basis of scientific evidence showing that the ingredient "does not contain allergenic protein" or that the FDA previously determined under section 409 of the FDCA that the ingredient "does not cause an allergic response that poses a risk to human health."[183]  Because the FDA has seen few requests for exemption under the petition or notification procedure,[184] it issued the draft guidance to clarify the process by providing recommendations for the content of petition and notification submissions, including requirements for clinical testing used to provide data for petitions.  In an appendix to the draft guidance, the FDA indicates that data from animal testing will, in many cases, be insufficient to test human allergenicity.[185] 

            2.   Product-Specific Guidance for the Land of Beer and Honey

The FDA also took steps to clarify labeling requirements for certain beers and honey in 2014. 

                                    a.   Final Guidance:  Labeling of Certain Beers 

Alcoholic beverages meet the definition of a "food" under the FDCA.[186]  Generally, however, the Alcohol and Tobacco Tax and Trade Bureau ("TTB") is responsible for regulating labeling of alcoholic beverages, including malt beverages.  In December, the FDA released final guidance that requires certain bottled and packaged beers that the TTB determined did not meet the Federal Alcohol Administration Act’s definition of "malt beverages" to adhere to the labeling requirements of the FDCA and the Fair Packaging and Labeling Act.[187]  The FDA previously exercised enforcement discretion with respect to the labeling of such beers until January 1, 2012 to provide time for manufacturers to make necessary label changes, but the guidance clarifies that the agency now expects all labeling for those products to be in compliance with applicable laws and regulations.[188]

                                    b.   Draft Guidance: Proper Labeling of Honey and Honey Products

To address honey and honey product labeling issues related to a previously denied citizen petition that requested the FDA to adopt a U.S. standard of identity for honey, the FDA issued draft guidance in April 2014.[189]  The draft guidance provides a definition of honey adopted from public domain materials and describes how different honey products should be named, clarifying that foods consisting of honey and a sweetener such as sugar cannot be labeled as only "honey."[190]  In circumstances where a honey product includes both honey and another sweetener, the FDA asserts that it could take enforcement action against that honey product as adulterated under section 402(b)(1) of the FDCA because the sweetener has been substituted for a "valuable constituent" in the product.[191]  In addition, the FDA stated that this type of product could be adulterated under section 402(b)(4) on the theory that the sweetener was added to the honey to increase its bulk or weight.[192]  Products labeled as "honey" without disclosing other ingredients could also be misbranded.[193]

            C.   GMO Labeling Initiatives

While the FDA does not require special labeling of foods containing GMOs,[194] there was substantial state-level activity on this issue in 2014, with over half of the states considering GMO labeling measures in some manner.[195]  While food activists seeking GMO disclosures successfully brought the issue to the fore in the 2014 election cycle, proposed federal legislation and a constitutional challenge to state legislation led to continued uncertainty regarding implementation of GMO labeling initiatives.

            1.   State Legislative Activity

Vermont passed legislation requiring labeling for all foods containing GMOs sold at retail within the state, starting in July 2016.[196]  Although GMO legislation had previously passed in two other states (Maine and Connecticut),[197] the Vermont law is the first GMO law that takes effect without a trigger provision that depends on the passage of legislation in other states.  Industry associations have challenged the Vermont law in court on First Amendment grounds, arguing that the GMO labeling requirement "compels manufacturers to use their labels to convey an opinion with which they disagree, namely, that consumers should assign significance to the fact that a product contains an ingredient derived from a genetically engineered plant."[198]  Those associations also asserted that federal statutes, including the FDCA, preempted Vermont’s legislation.[199]  As it may be a bellwether for other states considering similar legislation in the near future, the Vermont case will be an important one to watch in 2015.

Although only Vermont, Maine, and Connecticut have enacted GMO labeling requirements, legislation has been proposed in dozens of states.  Two ballot initiatives that would have required GMO labeling were defeated in the November 2014 elections:  one in Oregon (narrowly) and one in Colorado (by a substantial margin).[200]  Unless preempted by new developments at the federal level, state efforts to mandate GMO labeling will likely continue into 2015 and beyond. 

            2.   Federal Legislative Activity

In April 2014, Representative Mike Pompeo (R-KS) proposed federal legislation that would foreclose the possibility of state-level labeling requirements for GMOs.  The proposed Safe and Accurate Food Labeling Act of 2014 (H.R. 4432) would make the FDA’s consultation process for new genetically modified foods mandatory, but it would not impose labeling requirements on genetically modified foods at the federal level and would prohibit states from imposing their own mandatory labeling requirements.[201]  The proposed Safe and Accurate Food Labeling Act of 2014 was directly in conflict with the proposed Genetically Engineered Food Right-to-Know Act, which would have imposed mandatory GMO labeling requirements at the federal level.[202]  Neither bill passed during the 113th Congress, but the Genetically Engineered Food Right-to-Know Act was reintroduced in February 2015.[203]  The future of federal legislation in this area remains uncertain. 

Federal legislation addressing the question of GMO labeling would be significant.  State-level legislative activity in this area is poised to create a patchwork of regulations, forcing  manufacturers to create different packaging and labeling for use in different states and to manage their supply chains accordingly (or to use GMO labeling even where not mandatory in order to simplify compliance).

            D.   The FDA Declines to Define "Natural"

In 2013, three federal district courts issued orders referring to the FDA the question of whether food products that contain bioengineered ingredients—in particular corn and corn derivatives grown from genetically modified seeds—could be labeled as "Natural," "All Natural," or "100% Natural."[204]  On January 7, 2014, the FDA declined to make that determination.[205]  In its letter to the federal district judges, the FDA referenced its 1993 statement that it would maintain its policy of defining food products as "natural" when "nothing artificial or synthetic" has been included in, or has been added to, a food that would not normally be expected to be in the food.[206]  The FDA further explained that if it chose to change or elaborate on this definition, it would not do so in the context of private litigation, but through its formal rulemaking process.[207]  The FDA recognized that defining the term "natural" would impact many interests and would have implications beyond bioengineered ingredients.[208]  Moreover, the FDA asserted that it would have to consider "relevant science; consumer preferences, perceptions, and beliefs; the vast array of modern food production technologies in addition to genetic engineering . . . ; and any strictures flowing from the First Amendment."[209]  Finally, the FDA suggested that it was not planning to initiate rulemaking proceedings to define "natural" in the near future, stating that other "food public health and safety matters are largely occupying the [FDA’s] limited resources . . . ."[210]

Given the FDA’s decision not to define "natural," the district courts that preside over the "natural" challenges are less likely to invoke the primary jurisdiction doctrine, under which a court will stay or dismiss an action with issues that have been placed within the special competence of an administrative body such as the FDA.  But here, "deference to the FDA would likely be unfruitful due to the agency’s long-standing reluctance to officially define the term ‘natural.’"[211] 

The proposed Safe and Accurate Food Labeling Act of 2014 (H.R. 4432), discussed above, would require the FDA to issue regulations defining "natural" within two years of the bill’s passage.[212]  As introduced, the bill would not require the FDA to define "natural" in a particular way, such as prohibiting its use on foods that contain bioengineered ingredients. 

VI.   Conclusion

During 2014, federal agencies demonstrated their commitment to aggressive enforcement of food safety requirements, up to and including criminal prosecution.  The FDA, Congress, and state legislatures also proposed critical changes to the regulation of food and dietary supplements, including extensive new proposals for food safety programs and labeling.  We will continue to monitor and report on these developments, as there is no sign of abatement in 2015.

   [1]   Because the Federal Food, Drug, and Cosmetic Act definition of a "food" includes, for most purposes, dietary supplements, the implications of enforcement and regulatory activity for one product category often affect the other.  21 U.S.C. § 321(ff).

   [2]   Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, Peanut Corporation of America Former Officials and Broker Convicted on Criminal Charges related to Salmonella-Tainted Products (Sept. 29, 2014), http://www.justice.gov/opa/pr/peanut-corporation-america-former-officials-and-broker-convicted-criminal-charges-related

   [3]   Mary McVean, Violations cited in Georgia peanut butter factory, L.A. Times, Jan. 28, 2009, http://articles.latimes.com/2009/jan/28/science/sci-peanut28.

   [4]   Press Release, supra note 2.

   [5]   Id. (quoting Eric Holder, Attorney General, U.S. Dep’t of Justice).

   [6]   Press Release, U.S. Attorney’s Office, District of Colo., U.S. Dep’t of Justice, Statements Regarding the Sentencing of Eric and Ryan Jensen (Jan. 28, 2014), http://www.justice.gov/usao/co/news/2014/jan/1-28-14.html

   [7]   Press Release, U.S. Attorney’s Office, District of Colo., Eric And Ryan Jensen Plead Guilty To All Counts Of Introducing Tainted Cantaloupe Into Interstate Commerce  (Oct. 22, 2013), http://www.justice.gov/usao/co/news/2013/oct/10-22-13.html.

   [8]   See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, Owner of Dietary Supplement Company Pleads Guilty to Multi-Million Dollar Scheme to Adulterate Dietary Supplements (Dec. 17, 2014), http://www.justice.gov/opa/pr/owner-dietary-supplement-company-pleads-guilty-multi-million-dollar-scheme-adulterate-dietary.

   [9]   Id.

  [10]   See Press Release, U.S. Dep’t of Justice, Office of Pub. Affairs, United States Files Enforcement Action Against Michigan Cheese Company and Owners to Stop Distribution of Adulterated Cheese Products (Aug. 8, 2014), http://www.justice.gov/opa/pr/united-states-files-enforcement-action-against-michigan-cheese-company-and-owners-stop.

  [11]   See id.

  [12]   See id.

  [13]   See id.

  [14]   Press Release, U.S. Food & Drug Admin., United States Enters Consent Decree with New York Cheese Producer Due to Listeria Contamination (Apr. 29, 2014), http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm395339.htm

  [15]   Warning Letter from Ronald M. Pace, Dist. Dir., Pub. Health. Serv., U.S. Food & Drug Admin. to Finger Lakes Farmstead Cheese Company LLC (Oct. 23, 2012), http://www.fda.gov/iceci/enforcementactions/warningletters/2012/ucm325714.htm.

  [16]   Press Release, supra note 14.

  [17]   See Multistate Outbreak of Listeriosis Linked to Roos Foods Dairy Products (Final Update), CDC (Apr. 18, 2014) http://www.cdc.gov/listeria/outbreaks/cheese-02-14/; see also FDA Investigates presence of Listeria in some Hispanic-style Cheeses, FDA (Apr. 18, 2014), http://www.fda.gov/Food/RecallsOutbreaksEmergencies/Outbreaks/ucm386726.htm.

  [18]   See Multistate Outbreak, supra note 17.

  [19]   See FDA Investigates, supra note 17.

  [20]   See Notice of Opportunity for Hearing (NOOH) – Roos Foods Inc. 3/11/14 (Mar. 11, 2014), http://www.fda.gov/RegulatoryInformation/FOI/ElectronicReadingRoom/ucm388921.htm.

  [21]   See FDA Investigates, supra note 17.

  [22]   Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, Brooklyn Fish Processors Ordered to Comply with Sanitation Remedies (Apr. 10, 2014), http://www.justice.gov/opa/pr/brooklyn-fish-processors-ordered-comply-sanitation-remedies

  [23]   Warning Letter from Ronald M. Pace, Dist. Dir., Pub. Health Serv., Food & Drug Admin. to NY Fish Inc. (Mar. 10, 2010), http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm205204.htm#.

  [24]   See Press Release, supra note 22.

  [25]   See id.

  [26]   Press Release, U.S. Food & Drug Admin., FDA Orders Wash.-based Smoked Seafood Manufacturer to Cease Operations (Mar. 28, 2014), http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm391011.htm.

  [27]   Consent Decree of Permanent Injunction, United States v. Jensen’s Old-Fashioned Smokehouse Inc., No. 01-0122 (W.D. Wash. Jan. 30, 2001).

  [28]   Press Release, U.S. Food & Drug Admin., California Seafood Company to Halt Production Until FDA Documents Correction of Unsanitary Practices (Dec. 4, 2014), http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm425684.htm.

  [29]   Id.

  [30]   Press Release, U.S. Food & Drug Admin., RZM Food Factory to Cease Operations for Repeated Food Safety Violations (Dec. 12, 2014), http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm426683.htm.

  [31]   Id. (quoting Melinda K. Plaisier, Assoc. Comm’r for Regulatory Affairs, U.S. Food & Drug. Admin.).

  [32]   Id.

  [33]   Id.

  [34]   Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, United States Files Enforcement Action Against Michigan Sandwich Company and Co-Owner to Stop Distribution of Adulterated Products (Nov. 21, 2014), http://www.justice.gov/opa/pr/united-states-files-enforcement-action-against-michigan-sandwich-company-and-co-owner-stop

  [35]   Id.

  [36]   Id.

  [37]   Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, District Court Enters Permanent Injunction Against California-Based Firm and Individuals to Prevent Distribution of Adulterated Dietary Supplements (June 23, 2014), http://www.justice.gov/opa/pr/district-court-enters-permanent-injunction-against-california-based-firm-and-individuals.

  [38]   Id.

  [39]   Id.

  [40]   See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, District Court Enters Permanent Injunction Against California-Based Firm and Individuals to Prevent Distribution of Adulterated Dietary Supplements (June 23, 2014), http://www.justice.gov/opa/pr/district-court-enters-permanent-injunction-against-california-based-firm-and-individuals.

  [41]   See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, U.S. Files Complaint and Consent Decree Against Mira Health and Senior Officers (July 1, 2014), http://www.justice.gov/opa/pr/us-files-complaint-and-consent-decree-against-mira-health-and-senior-officers.

  [42]   See id.

  [43]   See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, District Court Enters Permanent Injunction Against Joint King Dietary Supplement Maker to Prevent Distribution of Adulterated Supplements (July 9, 2014), http://www.justice.gov/opa/pr/district-court-enters-permanent-injunction-against-joint-king-dietary-supplement-maker.

  [44]   Id.

  [45]   Id.

  [46]   See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, District Court Enters Permanent Injunction Against New York Dietary Supplement Maker to Prevent Distribution of Adulterated Supplements (July 24, 2014), http://www.justice.gov/opa/pr/district-court-enters-permanent-injunction-against-new-york-dietary-supplement-maker-prevent.

  [47]   Id.

  [48]   Press Release, U.S. Food & Drug Admin., FDA takes Action Against Georgia Dietary Supplement Manufacturer (Aug. 25, 2014), http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm411390.htm.

  [49]   Id.

  [50]   Id.

  [51]   See Press Release, U.S. Dep’t of Justice, Office of Public Affairs, District Court Enters Permanent Injunction Against California Dietary Supplement Company and Chief Executive Officer to Stop Distribution of Adulterated Products (Nov. 13, 2014), http://www.justice.gov/opa/pr/district-court-enters-permanent-injunction-against-california-dietary-supplement-company-and.

  [52]   See id.

  [53]   See id.

  [54]   Memorandum of Understanding Between the Fed. Trade Comm’n and the Food and Drug Admin. (MOU 225-71-8003) (May 14, 1971), available here.    

  [55]   Jessica Rich, Dir. Bureau of Consumer Protection, Fed. Trade Comm’n, Keynote Address at the Brand Activation Association Marketing Law Conference: From Health Claims to Big Data: FTC Advertising and Privacy Priorities for Today’s Marketplace (Nov. 6, 2014), available at http://www.ftc.gov/system/files/documents/public_statements/597921/110714baa_speech.pdf.

  [56]   See id. 

  [57]   Press Release, Fed. Trade Comm’n, Sensa and Three Other Marketers of Fad Weight-Loss Products Settle FTC Charges in Crackdown on Deceptive Advertising (Jan. 7, 2014), http://www.ftc.gov/news-events/press-releases/2014/01/sensa-three-other-marketers-fad-weight-loss-products-settle-ftc.

  [58]   See, e.g., Press Release, Fed. Trade Comm’n, Federal Trade Commission Continues Crackdown on Fad Weight-Loss Products (Dec. 11, 2014), http://www.ftc.gov/news-events/press-releases/2014/12/federal-trade-commission-continues-crackdown-fad-weight-loss; Press Release, Fed. Trade Comm’n, FTC Approves Final Orders Banning Marketer Behind ‘Fat Burner’ Diet Pills from Making or Selling Weight-Loss Products (Oct. 24, 2014), http://www.ftc.gov/news-events/press-releases/2014/10/ftc-approves-final-orders-banning-marketer-behind-fat-burner-diet; Press Release, Fed. Trade Comm’n, Green Coffee Bean Manufacturer Settles FTC Charges of Pushing its Product Based on Results of "Seriously Flawed" Weight-Loss Study (Sept. 8, 2014), http://www.ftc.gov/news-events/press-releases/2014/09/green-coffee-bean-manufacturer-settles-ftc-charges-pushing-its; Press Release, Fed. Trade Comm’n, Marketers of ‘Fat Burning’ and ‘Calorie Blocking’ Diet Pills to Pay $500,000 for Making Deceptive Weight Loss Claims (July 25, 2014), http://www.ftc.gov/news-events/press-releases/2014/07/marketers-fat-burning-calorie-blocking-diet-pills-pay-500000.

  [59]   See Order, Fed. Trade Comm’n v. Nat’l Urological Grp., Inc., No. 04-3294 (N.D. Ga. Sept. 2, 2014).

  [60]   See Press Release, Fed. Trade Comm’n, Federal Trade Commission Continues Crackdown on Fad Weight-Loss Products (Dec. 11, 2014), http://www.ftc.gov/news-events/press-releases/2014/12/federal-trade-commission-continues-crackdown-fad-weight-loss.

  [61]   Order re Summary Judgment Motions, Fed. Trade Comm’n v. Wellness Support Network, Inc., No. 10-04879 (N.D. Cal. Feb. 19, 2014).

  [62]   Defendants’ Motion for Summary Judgment at 10, Fed. Trade Comm’n v. Wellness Support Network, Inc., No. 10-04879 (Dec. 6, 2013).

  [63]   21 U.S.C. § 360ee(b)(3).

  [64]   21 U.S.C. §§  343(q)(5)(A)(iv), 343(r)(5)(A).

  [65]   See Order re Summary Judgment Motions, Fed. Trade Comm’n v. Wellness Support Network, Inc., No. 10-04879 (N.D. Cal. Feb. 19, 2014)

  [66]   Id.

  [67]   In re Novartis Corp., 127 F.T.C. 580, 725 (1999).

  [68]   Brief in Support of Motion for Order to Show Cause Why Defendant Should not be Held in Contempt, United States v. Bayer Corp., No. 07-00001 (D.N.J. Sept. 12, 2014).

  [69]   See id

  [70]   Id. at 3. 

  [71]   Id. at 16.

  [72]   See Order, United States v. Bayer Corp., No. 07-00001 (D.N.J. Oct. 23, 2014). 

  [73]   Defendant’s Brief Showing Cause Why it Should Not be Held in Civil Contempt, United States v. Bayer Corp., No. 07-00001 (D.N.J. Dec. 23. 2014). 

  [74]   Memorandum Decision and Order at 21, Basic Research, LLC v. Fed. Trade Comm’n, No. 09-00779 (D. Utah Nov. 25, 2014).

  [75]   Id. at 7, 13.

  [76]   Id. at 25.

  [77]   Id. at 21 (quoting Fed. Trade Comm’n v. Garden of Life, Inc., 845 F. Supp. 2d 1328 (S.D. Fla. 2012), vacated in part & remanded in part on other grounds, 516 F. App’x 852 (11th Cir. 2013)).   

  [78]   Id. at 21.

  [79]   Id. at 25-26.

  [80]   See id.

  [81]   Complaint for Permanent Injunction and Other Equitable Relief, Fed. Trade Comm’n v. Gerber Prods. Co., No. 14-06771 (D.N.J. Oct. 30, 2014).

  [82]   Id. at 7.

  [83]   Id.

  [84]   Id. at 8.

  [85]   Id. at 6.

  [86]   Id. at 10.

  [87]   Answer, Fed. Trade Comm’n v. Gerber Prods. Co., No. 14-06771 (D.N.J. Jan. 5, 2015).

  [88]   FY 2014 Inspectional Observation Summaries, FDA, http://www.fda.gov/ICECI/Inspections/ucm424098.htm (last updated Nov. 28, 2014).

  [89]   Compare FY 2014 Inspectional Observation Summaries, FDA, http://www.fda.gov/ICECI/Inspections/ucm424098.htm (last updated Nov. 28, 2014) with FY 2013 Inspectional Observation Summaries, FDA, http://www.fda.gov/ICECI/Inspections/ucm381526.htm (last updated May 15, 2014), FY 2012 Inspectional Observation Summaries, FDA, http://www.fda.gov/ICECI/Inspections/ucm326984.htm (last updated Nov. 16, 2012), FY 2011 Inspectional Observation Summaries, FDA, http://www.fda.gov/ICECI/Inspections/ucm327135.htm (last updated Nov. 16, 2012), FY 2010 Inspectional Observation Summaries, FDA, http://www.fda.gov/ICECI/Inspections/ucm255532.htm (last updated Nov. 16, 2012), and FY 2009 Inspectional Observation Summaries, FDA, http://www.fda.gov/ICECI/Inspections/ucm255534.htm (last updated Nov. 16, 2012).

  [90]   FY 2014 Inspectional Observation Summaries, FDA, http://www.fda.gov/ICECI/Inspections/ucm424098.htm (last updated Nov. 28, 2014).

  [91]   The number of Warning Letters for conventional foods, includes approximately 89 Warning Letters that the FDA categorized as relating to findings of "Illegal Drug Residue."  Under the FDCA, a food is adulterated if it bears or  contains "a new animal drug (or conversion product thereof) that is unsafe within the meaning of [21 U.S.C. § 360b]."  21 U.S.C. § 342(a)(2)(C)(ii). 

  [92]   Inspections, Compliance, Enforcement, and Criminal Investigations: Warning Letters, FDA, http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm (last accessed Jan. 31, 2015).  These calculations are derived from a review of Warning Letters issued in 2014 that are available on the FDA’s website and from the FDA’s categorization of Warning Letters by subject.  Warning Letters alleging that products were improperly marketed as dietary supplements were counted in the "dietary supplement" category.

  [93]   See, e.g., Warning Letter from Reynald R. Rodriguez, Jr., Dallas District Dir., U.S. Food & Drug Admin., to Citrus Fit Weight Loss and Detox Products, LLC (Oct. 15, 2014), available at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm419450.htm.

  [94]   Operational Strategy for Implementing the FDA Food Safety Modernization Act (FSMA), May 2, 2014, FDA, http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm395105.htm (last updated Aug. 5, 2014). 

  [95]   Michael R. Taylor and Howard Sklamberg, We’re Reinventing Ourselves to Keep Your Food Safe, FDA Voice (May 2, 2014), http://blogs.fda.gov/fdavoice/index.php/2014/05/were-reinventing-ourselves-to-keep-your-food-safe/?source=govdelivery&utm_medium=email&utm_source=govdelivery.

  [96]   Operational Strategy, supra note 94. 

  [97]   21 U.S.C. § 2223(d). 

  [98]   Designation of High-Risk Foods for Tracing; Request for Comments and for Scientific Data and Information, 79 Fed. Reg. 6,596 (Feb. 4, 2014); FDA’s Draft Approach for Designating High-Risk Foods as Required by Section 204 of FSMA (Feb. 2014), http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM380212.pdf.

  [99]   79 Fed. Reg. at 6,597.

[100]   Id. 

[101]   Id.

[102]   Consent Decree at 4-5, Ctr. for Food Safety v. Hamburg, No. 12-cv-04529-PJH (N.D. Cal. Feb. 20, 2014).

[103]   Hank Schultz, FDA agrees to new deadlines on FSMA final rules, Food Navigator (Feb. 24, 2014), http://www.foodnavigator-usa.com/Regulation/FDA-agrees-to-new-deadlines-on-FSMA-final-rules.

[104]   Sanitary Transportation of Human and Animal Food, 79 Fed. Reg. 7,006 (Feb. 5, 2014).

[105]   Id. at 7,006.

[106]   Id. at 7,010.

[107]   Id. at 7,006.

[108]   Id.

[109]   Jay Sjerven, Transportation Proposal Under Scrutiny, Food Business News (Aug. 14, 2014).

[110]   Constituent Update:  FDA Seeks to Make FSMA Proposals More Flexible, Targeted, FDA, (Sept. 19, 2014), http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm415132.htm

[111]   Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food, 79 Fed. Reg. 58,524, 58,525 (Sept. 29, 2014).

[112]   See 79 Fed. Reg. at 58,555.

[113]   Id. at 58,552-553.

[114]   Id. at 58,526.

[115]   Id.

[116]   Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals, 79 Fed. Reg. 58,476, 58,477 (Sept. 29, 2014).

[117]   Id. 

[118]   Id.

[119]   Id. at 54,477-478, 58,483.

[120]   Id. at 58,480, 58,500-501.

[121]   Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, 79 Fed. Reg. 58,434 (Sept. 29, 2014).

[122]   Id. at 58,439-440.

[123]   Id. at 58,440-441.

[124]   Id. at 58,464-467.

[125]   Foreign Supplier Verification Programs for Importers of Food for Humans and Animals, 79 Fed. Reg. 58,574, 58,575 (Sept. 29, 2014). 

[126]   Id.

[127]   Id. at 58,585.

[128]   Id. at 58,584-585.

[129]   Id.at 58,588.

[130]   Establishment, Maintenance, and Availability of Records:  Amendment to Record Availability Requirements, 79 Fed. Reg. 18,799 (Apr. 4, 2014).

[131]   U.S. Food & Drug Admin., Guidance for Industry: FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, and Cosmetic Act (Apr. 2014), http://www.fda.gov/downloads/Food/GuidanceRegulation/UCM292797.pdf [hereinafter Records Access Authority Guidance]; U.S. Food & Drug Admin., Guidance for Industry:  What You Need to Know About Establishment, Maintenance, and Availability of Records—Small Entity Compliance Guide (Apr. 2014), . 

[132]   See Establishment, Maintenance, and Availability of Records:  Amendment to Record Availability Requirements, 77 Fed. Reg. 10,658, 10,658 (Feb. 23, 2012) (preamble to interim final rule).

[133]   21 U.S.C. § 350c(a). 

[134]   Records Access Authority Guidance, supra note 131, at 5.

[135]   Id. at 7.

[136]    Safe Food Act of 2015, S. 287, 115th Cong. (2015).

[137]      Office of Mgmt. & Budget, Fiscal Year 2016 Budget of the U.S. Government 82 (2015).

[138]      Id.

[139]      Maryn McKenna, Is It Time for a Single Food Agency?, Nat’l Geographic: the Plate (Feb. 5, 2015), http://theplate.nationalgeographic.com/2015/02/05/budget-one-agency/

[140]   Id. at 4.

[141]   See U.S. Food & Drug Admin., Guidance for Industry: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology (June 2014), http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM401695.pdf [hereinafter Nanotechnology Guidance]; U.S. Food & Drug Admin., Guidance for Industry:  Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Ingredients that Are Color Additives (June 2014), here [hereinafter Manufacturing Process Change Guidance]. 

[142]   See Nanotechnology  Guidance, supra note 141.

[143]   Id. at 4, 6.

[144]   Id. at 10.

[145]   Id. at 4-6.

[146]   Manufacturing Process Change Guidance, supra note 141. 

[147]   Id. at 5, 14.

[148]   Id. at 16.

[149]   Id. at 17-20.

[150]   Id. at 16.

[151]   See U.S. Food & Drug Admin., Guidance for Industry:  Distinguishing Liquid Dietary Supplements from Beverages (Jan. 2014), [hereinafter Liquid Dietary Supplement Guidance]. 

[152]   Id. at 2-3.

[153]   Id. at 3-5.

[154]   Id.

[155]   Warning Letter from Ronald M. Pace, District Dir., N.Y. District, U.S. Food & Drug Admin., to NYSW Beverage Brands, Inc. (Jan. 7, 2015), available at  http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm429530.htm.

[156]   Id.

[157]   See U.S. Food & Drug Admin., Guidance for Industry:  Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements (Jan. 2014).

[158]   Liquid Dietary Supplement Guidance, supra note 151, at 6.

[159]   U.S. Food & Drug Admin., Guidance for Clinical Investigators, Sponsors, and Institutional Review Boards on Investigational New Drug Applications—Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application (Sept. 2013), http://www.fda.gov/downloads/Drugs/Guidances/UCM229175.pdf.

[160]   Id. at 4.

[161]   Id. at 12. 

[162]   Id. at 12.  In this context, a "’disease’ is damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., cardiovascular disease), or a state of health leading to such dysfunctioning (e.g., hypertension); except that diseases resulting from essential nutrient deficiencies (e.g., scurvy, pellagra) are not included in this definition."  21 CFR § 101.93(g)(1).

[163]   Id. at 13.

[164]   Guidance for Clinical Investigators, Sponsors, and Institutional Review Boards on Investigational New Drug Applications—Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application; Reopening of the Comment Period, 79 Fed. Reg. 7,204 (Feb. 6, 2014).

[165]   See, e.g., Comment from Grocery Manufacturers Association (GMA), Docket No. FDA-2010-D-0503-0036 (Apr. 7, 2014), http://www.regulations.gov/#!documentDetail;D=FDA-2010-D-0503-0036; Comment from Mars, Inc., Docket No. FDA-2010-D-0503-0047 (Apr. 7, 2014), http://www.regulations.gov/#!documentDetail;D=FDA-2010-D-0503-0047

[166]   U.S. Food and Drug Admin., Guidance for Industry:  Food Labeling:  Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims Small Entity Compliance Guide (Aug. 2003), here.

[167]   Food Labeling:  Revision of the Nutrition and Supplement Facts Labels; Proposed Rule, 79 Fed. Reg. 11,880 (Mar. 3, 2014). 

[168]   Food Labeling:  Added Sugars; Availability of Citizen Petition, 65 Fed. Reg. 39,414 (June 26, 2000) (CSPI petition); Food Labeling:  Revision of the Nutrition and Supplement Facts Labels, 79 Fed. Reg. 11,879 (Mar. 3, 2014) (2014 proposed rule including discussion of public comments on the CSPI petition).

[169]   79 Fed. Reg. at 11,882.

[170]   Food Labeling:  Serving Sizes of Foods That Can Reasonably Be Consumed at One-Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments, 79 Fed. Reg. 11,990 (Mar. 3, 2014).

[171]   Id. at 11,994.

[172]   Id.

[173]   Id. at 12,000-001.

[174]   Id.

[175]   Id. at 12,012.

[176]   21 C.F.R. § 101.12(g).

[177]   79 Fed. Reg. at 12,007.

[178]   Uniform Compliance Date for Food Labeling Regulations, 79 Fed. Reg. 73,201 (Dec. 10, 2014).

[179]   U.S. Food & Drug Admin., Draft Guidance for Industry:  Food Allergen Labeling Exemption Petitions and Notifications (May 8, 2014), here [hereinafter Draft Food Allergen Guidance]. 

[180]   21 U.S.C. 343(w).

[181]   Id.

[182]   Id.

[183]   Draft Food Allergen Guidance, supra note 179, at 4.

[184]   Inventory of Notifications Received under 21 U.S.C. 343(w)(7) for Exemptions from Food Allergen Labeling, FDA, here (last updated Aug. 15, 2013); Inventory of Petitions Received under 21 U.S.C. 343(w)(6) for Exemptions from Food Allergen Labeling, FDA, here  (last updated Aug. 15, 2013). 

[185]   Draft Food Allergen Guidance, supra note 179, at 18.

[186]   21 U.S.C. § 321(f).

[187]   U.S. Food & Drug Admin., Guidance for Industry:  Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration (Dec. 2014), here

[188]   Id. at 6.

[189]   U.S. Food & Drug Admin., Draft Guidance for Industry:  Proper Labeling of Honey and Honey Products (Apr. 2014). 

[190]   Id. at 5-6.

[191]   Id. at 7-8.

[192]   Id.

[193]   Id.

[194]   Genetically engineered foods are subject to the FDA’s general food safety regulations, and the FDA encourages a voluntary consultation process on safety and nutritional issues before new genetically engineered foods are brought to market.  Genetically engineered organisms are also subject to other forms of oversight, such as Department of Agriculture and Environmental Protection Agency regulations, and (for animals) the FDA’s animal drug regulations.

[195]   Ned Potter, GMO Labeling: How to End the Fight, Forbes (Nov. 7, 2014, 11:00 AM), http://www.forbes.com/sites/forbesleadershipforum/2014/11/07/gmo-labeling-how-to-end-the-fight/.

[196]   Labeling of Food Produced with Genetic Engineering, Vt. Stat. Ann. tit. 9, § 3043 (West 2016). 

[197]   Mandatory labeling of genetically-engineered food, seed, or seed stock. Applicability. Civil penalty. Regulations., Conn. Gen. Stat. Ann. § 21a-92c (West 2013); Disclosure requirements for genetically engineered food, Me. Rev. Stat. tit. 22, § 2593 (2014).

[198]   Complaint ¶ 43, Grocery Mfrs. Ass’n, v. Sorrel, No. 5:14-cv-117 (D. Vt. June 12, 2014).

[199]   Id. at ¶ 85.

[200]   Measure 92:  Requires food manufacturers, retailers to label "genetically engineered" foods as such; state, citizens may enforce, Oregon Secretary of State (Nov. 4, 2012), http://www.oregonvotes.gov/doc/history/nov42014/92.pdf; Colorado Election Results, Secretary of State Scott Gessler, http://results.enr.clarityelections.com/CO/53335/149718/Web01/en/summary.html (last updated Dec. 4, 2014).

[201]   Genetically modified foods found to be materially different from the conventional varieties would require labeling, but genetic modifications would not intrinsically constitute a material difference.

[202]   Versions of the Genetically Engineered Food Right-to-Know Act have been introduced multiple times, including in a pair of 2013 bills (S. 809 and H.R.1699) introduced by Senator Barbara Boxer (D-CA) and Representative Peter DeFazio (D-OR).

[203]   Press Release, Barbara Boxer, U.S. Senator, California, Boxer, Blumenthal, DeFazio Introduce Bill to Require Labeling of Genetically Engineered Foods (Feb. 12, 2015), http://www.boxer.senate.gov/press/release/boxer-blumenthal-defazio-introduce-bill-to-require-labeling-of-genetically-engineered-foods/.

[204]   Order Granting Motion to Dismiss in Part (Dkt. No. 37) and for Referral to the United States Food and Drug Administration, Cox v. Gruma Corp., No. 4:12-cv-6502-YGR (N.D. Cal. July 11, 2013); Order Granting in Part and Denying in Part Defendant’s Motion to Dismiss Second Amended Class Action Complaint and Staying Matter, Barnes v. Campbell Soup Co., No. 3:12-cv-05185-JSW (N.D. Cal. July 25,2013); Order, In re General Mills, Inc. Kix Cereal Litigation, No. 2:12-cv-00249-KM-MCA (D.N.J. Nov. 1, 2013).

[205]   Letter from U.S. Food & Drug Admin. to Judges Yvonne Gonzalez Rogers, Jeffrey S. White, and Kevin McNulty (Jan. 6, 2014).

[206]   Id. at 2 (quoting Food Labeling:  Nutrient Content Claims, General Principles, Petitions, Definition of Terms; Definitions of Nutrient Content Claims for the Fat, Fatty Acid, and Cholesterol Content of Food, 58 Fed. Reg. 2,302, 2,407 (1993)).

[207]   Id.

[208]   Id.

[209]   Id.

[210]   Id.

[211]   Gedalia v. Whole Foods Mkt. Servs., Inc., No. 4:13-CV-3517, 2014 WL 5315030, at *4 (S.D. Tex. Sept. 30, 2014); see Ault v. J.M. Smucker Co., No. 13 CIV. 3409 PAC, 2014 WL 1998235, at *4 (S.D.N.Y. May 15, 2014) ("The FDA’s refusal to consider the question demonstrates that resort to the agency at this time would be unavailing and therefore weighs against applying the primary jurisdiction doctrine.") (internal quotation marks and citation omitted).

[212]   Safe and Accurate Food Labeling Act of 2014, H.R. 4432, 113th Cong. (Apr. 9, 2014). 

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