• A class action lawsuit has been filed against Rachel Ray’s Nutrish dog food brand, alleging that “natural” claims were false and misleading under state consumer protection laws, based on testing that showed the presence of glyphosate residues.
  • Glyphosate, commonly known as Roundup®, is an EPA-approved herbicide that is used on food crops, including crops that have been genetically modified to be resistant to glyphosate (e.g., canola, corn, soy, sugar beet, and wheat).
  • While many human foods (e.g., granola bars, cereal, green tea, oatmeal, honey) have been the subject of lawsuits challenging natural claims based on glyphosate residues, other consumer products have not faced as many challenges for natural claims.  The lawsuit against Nutrish could be a harbinger of more challenges for “natural” claims in the pet food sector, where such claims have proliferated in recent years.
  • On July 31 and August 1, 2018, the U.S. Food and Drug Administration (FDA) participated in a meeting of the Leafy Greens Food Safety Task Force that was formed in response to the outbreak of E. coli O157:H7 associated with romaine lettuce from Yuma, Arizona that occurred earlier this year. During the meeting, FDA shared preliminary hypotheses about possible outbreak causes and the actions necessary to prevent a future occurrence. FDA has previously mentioned that samples of canal water in Yuma tested positive for the outbreak strain of E. coli, and that the contaminated water coming into contact with the produce was a viable explanation for the cause of the outbreak. FDA also discussed that the location of the canal is situated close to a Concentrated Animal Feeding Operation (CAFO) and can hold in excess of 100,000 head of cattle at any one time, and that FDA traceback information showed a clustering of romaine lettuce farms nearby.
  • According to foodsafetynews.com, the Task Force suggested tripling the industry-imposed 400-foot buffer zone to separate leafy greens growing fields from animal feedlots. Members of the California and Arizona Leafy Greens Marketing Agreement are accepting comments on the setback suggestion before making a final decision on required buffer zone size. This suggestion demonstrates the produce industry’s interest to have preventive measures in place before the next growing season.
  • On August 6, the FDA publicly released a statement about the CAFO hypothesis, and added that their experts are continuing to work on examining potential links between the CAFO, adjacent water, and geologic and others facts that may explain the contamination and its relationship to the outbreak. FDA will detail its findings in an environmental assessment report, though the exact release date of the report was not given.
  • As our readers may remember, we’ve previously discussed the outbreak, which was declared officially over on June 28. As a result of the outbreak, five people died and more than 200 others across 36 states were confirmed with infections.
  • The 2016 National Bioengineered Food Disclosure Standards (NBFDS) Act directs the U.S. Department of Agriculture (USDA) to develop regulations and standards to create mandatory disclosure requirements for bioengineered (BE) foods by July 2018. The Center for Food Safety (CFS) and the Center for Environmental Health (CEH) filed a lawsuit in the Northern California U.S. District Court on August 1 citing USDA’s failure to meet that deadline. Agriculture Secretary Sonny Perdue; Bruce Summers, Administrator, USDA’s Agricultural Marketing Service; and USDA are named as plaintiffs in the suit. The nongovernment organizations (NGOs) filed the lawsuit in order to obtain a mandated schedule of when the implementing rules will be published, CFS stated in a press release.
  • This is not the first time CFS has sued USDA in connection with the NBFDS. The Center sued USDA in September 2017 for not releasing the results of a study on possible technical challenges to obtaining BE information through electronic or digital disclosure methods that was mandated by the Act. CFS dropped that lawsuit after USDA released the study results (See our Dec. 1, 2017 blog for more details). Last month, CFS sued USDA for denying its Freedom of Information request (FOIA) to obtain documents surrounding the Department’s decision on how to label BE foods. More information on that suit can be found on CFS’s website.
  • The comment period on USDA’s proposed requirements to implement the NBFDS closed on July 3. (See our July 6 blog to view a summary of the comments received.) We will continue to monitor developments on the NBFDS.
  • Blue crab is among several species known to be susceptible to illegal, unreported, and unregulated (IUU) fishing and seafood fraud.  As reported on this blog, the National Oceanic and Atmospheric Administration’s (NOAA) has established a Seafood Import Monitoring Program (SIMP) with regulations that took effect January 1, 2018, requiring importers to document that the catch is legally and sustainably caught.  SIMP was implemented in response to longstanding concerns over rampant seafood fraud.
  • A recent article in the Washington Post, An unsavory scam? Company accused of diluting Chesapeake blue crab meat with imported crab, illustrates the limitations of SIMP in preventing seafood fraud perpetrated in the United States.  According to the article, federal prosecutors have alleged that between 2012 and 2015, Casey’s Seafood Processing sold over 398,000 pounds of crab meat labeled as Chesapeake blue crab from the United States, but intentionally mixed in cheaper species of crab from foreign countries that were not identified on the label.  This economic adulteration was uncovered in a search of the Newport News, VA seafood processing facility after a tip from an informant that Casey’s Seafood Processing was attempting to undercut market prices for the scarce and highly regulated Chesapeake blue crabs.  The dilution of the Chesapeake blue crab meat with other species was verified using DNA analysis of the mislabeled crab meat.
  • The species used to perpetrate this instance of Chesapeake blue crab meat labeling fraud were not subject to SIMP.  Moreover, SIMP has no provision that would reach the actions of plants such as Casey’s Seafood Processing operating in the U.S. even if the Chesapeake blue crab meat had been diluted with crab meat covered under SIMP.  Charges in the case were brought against the plant’s owner, James R. Casey, under the Lacey Act, a federal law from 1900 that, among other things, prohibits selling wildlife such as crab meat that is mislabeled under the Federal, Food, Drug and Cosmetic Act.
  • In a July 31, 2018 press release, FDA Commissioner Scott Gottlieb announced upcoming efforts by FDA to implement “good antimicrobial stewardship practices.”  FDA’s Center for Veterinary Medicine (CVM) has already taken steps to support judicious use in animals of antimicrobials important for treating human disease.
  • FDA will soon publish a five-year blueprint to further address antimicrobial resistance in animals.  The three key goals of this blueprint will be:
    • “Aligning antimicrobial drug product use with the principles of antimicrobial stewardship;
    • Supporting efforts to foster better stewardship of antimicrobials in veterinary settings; and
    • Enhancing the monitoring of antimicrobial resistance and antimicrobial drug use in animals.”
  • Some specific issues FDA will address include setting durations of use for medically important antimicrobials and bringing all dosage forms of medically important antimicrobials under veterinary oversight.   FDA will address use of antimicrobials in companion animals and it expects to publish a list of all medically important antimicrobials that do not have a defined duration of use on their labels.  Finally, FDA notes that it will improve the collection and sharing of data on use and resistance of antimicrobials.
  • Interested parties will have an opportunity to participate in FDA’s development of its antimicrobial policies via comment on the blueprint or associated guidance.
  • The U.S. District Court for the Central District of California has granted a motion for summary judgment in favor of Odwalla, in Wilson v. Odwalla Inc. et al. (Case Number 2:17-cv-02763).  Odwalla, which is owned by Coca-Cola, had been subjected to class action challenge based on a “no added sugar” claim on 100% juice products.
  • In March 2017, Plaintiffs alleged that the “no added sugar” claim violated state consumer protection and false advertising laws, in addition to the Federal Food, Drug, and Cosmetic Act.  The court disagreed, basing its decision on a letter obtained through the Freedom of Information Act (FOIA), in which an FDA official (Douglas Balentine, Director of the Office of Nutrition and Food Labeling at the Center for Food Safety and Applied Nutrition) interpreted the meaning of 21 CFR 101.60 (“Nutrient content claims for the calorie content of foods”), paragraph (c)(2)(iv).  That paragraph prohibits “no sugar added” claims unless “the food that it resembles and for which it substitutes normally contains added sugars.”
  • Both parties presented arguments that the court found reasonable, but the judge determined that the FDA letter, interpreting Section 101.60(c)(2)(iv) as permitting juice with no added sugar to be considered a substitute for juice with added sugar and similar sugar-sweetened beverages, was entitled to deference. 
  • On July 26, 2018, FDA posted its first Warning Letter citing Kerry, Inc. for alleged violations of the Hazard Analysis and Risk-Based Preventive Controls (HARPC) and Current Good Manufacturing Practice (CGMPs) provisions at 21 CFR Part 117. While FDA has cited violations of the revised CGMP regulations in prior Warning Letters, this appears to be the first Warning Letter that addresses violations of the HARPC requirements.
  • Based on the results of the inspection and analytical results from positive Salmonella environmental samples, FDA determined that the cereal produced at the facility is adulterated under Section 402(a)(4) of the Food, Drug and Cosmetic Act because it was prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health. Kerry’s own tests returned repeated positive results for Salmonella but it continued to produce and ship cereal. It is important to note that failure to comply with CGMP and HARPC requirements does not result in adulteration per se, but it is a prohibited act.  FDA cited the following CGMP and HARPC violations:
  1. “Your hazard analysis did not identify a known or reasonably foreseeable hazard for each type of food manufactured, processed, packed, or held at your facility to determine whether there are any hazards requiring a preventive control as required by 21 CFR 117.130(a)(1).”
  2. “You are required to identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 or misbranded under section 403(w) of the Act (21 U.S.C. §§ 342 or 343(w)) to comply with 21 CFR § 117.135(a)(1).”
  3. “You did not implement written corrective action procedures that must be taken if preventive controls are not properly implemented to comply with 21 CFR 117.150(a)(1) and (d).”
  4. “You did not verify that your sanitation preventive controls are consistently implemented and are effectively and significantly minimizing or preventing a hazard with environmental monitoring as required by 21 CFR § 117.165(a).”
  • FDA’s Warning Letter signals that FDA will continue to focus on violations of the CGMP and HARPC provisions.  We will continue to monitor and report on FDA’s enforcement activities as they relate to HARPC and other food safety related issues.
  • The European Court of Justice has ruled that all techniques that induce DNA mutagenesis result in products that can be regulated as genetically modified organisms.  GMO regulation had previously been limited to products of genetic engineering where DNA from a separate organism was introduced into the target organism’s genome.  Newly developed gene editing techniques exploit the discovery of Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) to cut strands of DNA with molecular “scissors” so that a new DNA sequence can be inserted.  But, these gene editing techniques can also be used to induce mutations by removing select sequences of a plant’s DNA, or by inducing disruption of a DNA sequence at a targeted location to facilitate the opportunity for the organism’s own repair mechanism to give rise to a useful mutation.  Significantly, these latter two applications do not involve the insertion of any foreign DNA.  But, as a result of the European Court of Justice decision, all organisms obtained by mutagenesis, even if the mutation actually arises from induced errors in natural repair mechanisms, whether the mutation site is targeted by gene editing or random (e.g., radiation induced), are genetically modified organisms which are subject to regulation.
  • In a statement, the Court of Justice said it “takes the view, first of all, that organisms obtained by mutagenesis are GMOs within the meaning of the GMO Directive in so far as the techniques and methods of mutagenesis alter the genetic material of an organism in a way that does not occur naturally.” While the ruling exempted crops produced through mutagenesis techniques which have been “conventionally used in a number of applications and have a long safety record,” ultimately, under this ruling, crops or livestock that have undergone gene editing through new mutagenesis techniques that have emerged since the adoption of the GMO Directive would need to be labeled as genetically modified.  In response, U.S. Secretary of Agriculture Sonny Perdue issued a statement criticizing the ruling. The statement reads, in part, “[g]overnment policies should encourage scientific innovation without creating unnecessary barriers or unjustifiably stigmatizing new technologies. Unfortunately, this week’s ECJ ruling is a setback in this regard in that it narrowly considers newer genome editing methods to be within the scope of the European Union’s regressive and outdated regulations governing genetically modified organisms.” The statement concludes that “USDA will re-double its efforts to work with partners globally towards science and risk-based regulatory approaches.”
  • The Court of Justice’s ruling comes as USDA’s Agricultural Marketing Service (AMS) works to implement the National Bioengineered Food Disclosure Standard (NBFDS). The comment period for the proposed rule closed on July 3, 2018, and the agency is now working to publish a final rule. As previously covered on this blog, the proposed rule defines “bioengineered food” as, “…a food that contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques and for which the modification could not otherwise be obtained through conventional breeding or found in nature.”  In the preamble to the proposed rule, USDA AMS notes that the proposed list concept for BE labeling would provide the vehicle through which AMS could evaluate whether foods resulting from particular technologies meet the definition of “bioengineered food.” Following AMS’s publication of the proposed rule, on June 14, 2018, USDA’s Animal and Plant Health Inspection Service announced that under its biotechnology regulations, it was not planning to regulate gene-edited plants as it does plants with foreign genes inserted with recombinant DNA. Whether this position extends to labeling of BE food remains to be seen.

Keller and Heckman will continue to monitor developments on the domestic and foreign treatment of novel DNA techniques as well as the implementation of the National Bioengineered Food Disclosure Standard.

Statement from FDA Commissioner Scott Gottlieb, M.D., on the process FDA is undertaking for reviewing and modernizing the agency’s standards of identity for dairy products (FDA Statement)

  • As reported on this blog, FDA held a public meeting on July 26, 2018 to discuss the FDA’s Nutrition Innovation Strategy (NIS), which promotes public health through efforts to empower consumers to make better and more informed decisions about their diets and health, foster the development of healthier food options, and expand the opportunities to use nutrition to reduce morbidity and mortality due to chronic disease. FDA’s plans to possibly limit use of the term ‘milk’ in labeling plant-based products were a prominent feature of the NIS meeting.
  • A Press Release from FDA Commissioner Dr. Scott Gottlieb immediately following the NIS meeting characterizes it as the first step in the process of modernizing FDA’s standards of identity by gathering stakeholder feedback. While focusing on milk, Dr. Gottlieb’s statement also mentions the need for potentially updating nearly 300 other standards of identity as well.
  • FDA’s next step – possibly coming by late summer or early fall – will be to release a specific set of questions pertaining to consumer awareness and understanding of the use of milk and other dairy terms on plant-based alternatives. Depending upon the feedback received, FDA could then potentially revisit its policy of not enforcing the standard of identity for milk as it pertains to plant-based beverages.
  • In a March 29 speech at the National Food Policy Conference, FDA Comissioner Dr. Scott Gottlieb announced the Nutrition Innovation Strategy (NIS).  Commissioner Gottlieb hopes to improve public health by: (1) empowering consumers to make better and more informed decisions about their diets, (2) encourage the development of healthier foods, and (3) expand the use of nutrition to reduce the instances and impact of chronic disease.  As part of NIS, Dr. Gottlieb announced a plan to limit the use of the term “milk” to “the lacteal secretion” of mammals.
  • On June 26, FDA announced a public meeting to discuss the implementation of NIS.  The meeting was held on July 26 (see agenda) and included remarks by Dr. Gottlieb, a presentation of consumer trends in the marketplace, and discussions regarding standards of identity, ingredient lists, nutrition facts, and label claims.
  • Some highlights from the meeting:
    • In the Opening Remarks, Dr. Gottlieb reiterated and elaborated on his concerns regarding plant-based products using the term “milk” (or other dairy related terms) as part of their name.
    • In the Consumer Trends in the Marketplace discussion, it was noted that there is a growing preference for minimally processed foods.
    • In the Evolving Food Landscape and Industry Innovation Panel there continued discussion on the need for a reworking of standards of identity to enable innovation of healthier food options that would still fall within the standard.
    • In the morning Claims and Statements Used on Food Labels / Icon for “Healthy” breakout session there was a discussion regarding “healthy” claims.  In this discussion there was a general consensus that a major hurdle in properly implementing healthy icons and in making health claims is consumer understanding.  There is still a wide diversion of opinions on what constitutes a “healthy” food and this undoubtedly contributes to continued consumer confusion.  Many participants seemed to agree that increased consumer education regarding existing label requirements would help.
  • Keller and Heckman will be publishing a client alert summarizing the remainder of the meeting.