• On April 29, 2021, the European Commission published a study considering the status of “new genomic techniques” (NGTs) under EU law. The study defined NGTs as techniques  for altering genetic material that have been developed since 2001 and considered the use of NGTs in plants, animals, and microorganisms in food, industrial, and pharmaceutical applications. The report concluded that the EU’s 2001 legislation on genetically modified organisms (GMOs) “is not fit for purpose for these innovative technologies” and that NGTs, such as CRISPR/Cas, have the potential to contribute to sustainable agriculture initiatives like the European Green Deal and the Farm to Fork Strategy.
  • The Council of the European Union commissioned the study following a controversial 2018 Court of Justice of the European Union (CJEU) ruling in Case C-528/16 that found organisms obtained by any technique that induces DNA mutagenesis are GMOs subject to the restrictions in its 2001 legislation. The ruling said that while techniques that have a long safety record can be exempt from the 2001 obligations, individual member states can decide for themselves whether to require these to be compliant with the law. Although the case did not directly address gene editing (which encompasses CRISPR/Cas), a distinct technology from mutagenesis, regulation over gene editing techniques was called into question.
  • The study clarifies that while organisms obtained through NGTs are subject to the 2001 GMO legislation, the current regulatory framework will stymie innovation, inhibit the EU from reaching its goals for a more resilient and sustainable food system, and put the EU at a competitive disadvantage. It explains that NGTs cover a diverse group of techniques and that a targeted regulatory framework considering the safety, risks, and uses of each technique will better serve the EU. While maintaining a cautionary tone, the report shed a more positive outlook on innovation in gene editing than past publications.
  • The Commission outlined its next steps in a letter to the Portuguese Presidency of the EU, which include initiation of a policy action on plants derived from targeted mutagenesis and cisgenesis and an accompanying impact assessment. It also stated that it will begin meeting with the European Parliament and stakeholders in meetings to gather opinions on proposed changes to the current regulatory framework. We will continue to monitor and report on developments.
  • On April 21, the Attorney General of Washington, DC, Karl A. Racine, filed a lawsuit against Beech-Nut Nutrition Company, one of the largest baby food manufacturers for “misleading parent-consumers about the health and safety of its products.” As stated in a press release, the DC Office of the Attorney General (OAG) alleged that Beech-Nut’s advertising violated the District’s consumer protection laws and misled parents that its baby food underwent the most stringent testing and was safe for babies when the food contained high levels of heavy metals. The OAG’s lawsuit seeks to stop Beech-Nut from engaging in these and similar violations, to obtain restitution damages for parent-consumers and their children, and to obtain civil penalties.
  • The OAG alleged that Beech-Nut violated DC’s Consumer Protection Procedures Act and harmed DC consumers by:
    • Misleading parents about the safety of its baby food;
    • Misrepresenting its testing practices; and
    • Falsely claiming to have high internal safety standards
  • As our readers know, the OAG’s lawsuit comes as a result of the congressional investigative report that found high levels of heavy metals in several brands of popular baby foods. Additionally, several baby food manufacturers have been hit with class action lawsuits that alleged consumer deception claims relating to the presence of heavy metals in baby foods. The FDA has responded with a plan, called Closer to Zero, to reduce exposure to toxic elements in baby foods.
  • Keller and Heckman will continue to monitor and report on any developments with the DC OAG lawsuit and other baby food-related lawsuits.
  • By way of background, on January 19, 2021, the Department of Health and Human Services (HHS) issued the final “Securing Updated and Necessary Statutory Evaluations Timely” (SUNSET) rule which would have amended nearly all of the approximately 18,000 HHS regulations to add self-executing expiration dates.
  • Specifically, the final rule stated that “subject to certain [undefined] exceptions,” all regulations in Titles 21, 42, and 45 of the CFR would expire on the later of the following dates: (1) five years after the effective date of the rule [originally March 22, 2021 and later delayed to March 22, 2022], (2) ten years after the regulation’s promulgation, or (3) ten years after HHS assessed and (if required) reviewed the regulation to determine if the regulation should be rescinded or modified to minimize its impacts on small entities. And, because over 17,000 of HHS’s rules are more than five years old, to avoid expiration, the SUNSET rule would require the vast majority of these rules to be assessed in a time and resource intensive process within five years of the effective date of the rule. The rule was purportedly issued to “enhance the Department’s implementation of section 3(a) the Regulatory Flexibility Act (RFA),” which requires agencies to periodically review rules which have or will have a significant economic impact on a substantial number of small entities.
  • As we have previously blogged about, various entities filed a lawsuit alleging that, among other things, the SUNSET rule violated the RFA and the Administrative Procedure Act (APA).
  • On April 21, 2021, in response to the lawsuit, HHS stated in a stipulation seeking to stay the case (filed jointly with Plaintiffs) that it “anticipates issuing, in the coming months, a notice of proposed rulemaking repealing the SUNSET Rule.” Keller and Heckman will continue to report on any developments in the repeal of the SUNSET rule.
  •  Since the enactment of the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), the label of a food that contains an ingredient that is or contains protein from a “major food allergen” must declare the presence of the allergen in the manner described by the law.  Until last week, there were eight major food allergens: milk, eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, designated by FALCPA in 2004 for special food allergy labeling because they account for over 90 percent of all documented food allergies in the U.S. and represents the foods most likely to result in severe or life-threatening reactions.
  • On April 23, 2021, President Biden signed into law the Food Allergy Safety, Treatment, Education and Research (FASTER) Act, making sesame the ninth allergen that must be declared in specific allergen labeling.  This change will apply to any food that is introduced or delivered for introduction into interstate commerce on or after January 1, 2023.  The new law (discussed here) also requires that FDA collect data on the prevalence of food allergies and prepare a report to Congress on the development of effective food allergy diagnostics, the prevention of food allergies, and the scientific criteria for defining a food or food ingredient as a “major food allergen.”  In this regard, while FDA has the authority to issue regulations requiring the disclosure of additives, such as spices and flavorings, that are, or contain, allergens other than the major food allergens, and a Citizen Petition was filed in November 2014, requesting that sesame be regulated similarly to other major allergens, by the end of last year, FDA had not yet moved beyond issuing a draft guidance, discussed here, for the voluntary disclosure of sesame as an allergen.
  • Consumer groups hope the FASTER Act of 2021 will lead to quicker expansion of the list of “major food allergens” the next time it becomes clear that an allergy is severe and prevalent in the U.S., and food that contains the allergen would not otherwise be required to disclose it as an ingredient.  According to a response from the Food Allergy Research & Education (FARE) organization, nearly 1.6 million Americans are allergic to sesame and will now be at less risk for death from accidental ingestion of food with sesame that was not listed on the food label.
  • On April 21, 2021, the U.S. Department of Agriculture (USDA) posted a request for comments seeking advice from industry on how to improve the flexibility and strength of food supply chain systems. The request comes in response to an Executive Order from President Biden issued on February 24, 2021 which directs several agencies, including USDA, to prepare a report that assesses the resilience of supply chains and critical manufacturing capacity to produce essential goods, products, and services. USDA notes it also hopes the comments it receives will help inform its thinking on how stimulus relief programs and spending on food can increase the durability of the U.S. food supply.
  • The notice states USDA is particularly interested in comments addressing local and regional food systems; new market opportunities, such as in value-added products; improving market competition and transparency and traceability of food products; and supporting food accessibility and security of low-income populations. USDA also seeks information regarding food manufacturing and processing, particularly on the geographic distribution of processing, access to transportation and export facilities, cold chain infrastructure and capacity, and access to packaging.
  • The President issued the executive order in consideration of food and agriculture supply chains that did not quickly adapt to changes in consumer demand early in the COVID-19 pandemic, resulting in massive food waste. While the pandemic highlighted major flaws in the supply chain and put a spotlight on food waste, the government has long been concerned with the high percentage of food waste in the United States.  As we reported in 2019, approximately 20% of the U.S. food supply is wasted each year, and approximately 40 million Americans are food insecure.
  • On April 20, 2021, the Center for Science in the Public Interest (CSPI) held the 2021 Virtual Sugary Drink Summit where consumer advocates gathered to address the need to reduce sugary drink consumption.  Representative Rosa DeLauro (D-CT), the current Chair of the House Appropriations Committee, presented at the CSPI event and announced that the “Sugar-Sweetened Beverages Tax (SWEET) Act—that would levy an excise tax on sugary drinks—could be introduced as soon as this week.  Representative DeLauro first introduced the SWEET Act to the 113th Congress in 2015.  In 2015, Representative DeLauro also championed the declaration of added sugars on the Nutrition Facts Panel found on packaged foods.
  • According to CSPI’s announcement, the SWEET Act would introduce a tiered tax system where cans or bottles of soda with less than 7.5 grams of sugars per 12 ounces would be exempt from the tax, but drinks with 7.5 grams to 30 grams per 12 ounces would be taxed at two cents per ounce.  Drinks with more than 30 grams of sugars per 12 ounces would be taxed at a rate of three cents per ounce.
  • CSPI stated that the SWEET Act would help decrease the consumption of sugary beverages to reduce the toll of soda-related diseases, such as heart disease, obesity, diabetes, and other health problems.  On April 23, CSPI will hold a SWEET Act Lobby Day where up to 500 participants will virtually lobby Congressional offices to address the need to reduce sugary drink consumption.
  • The Wisconsin State Assembly Committee on Agriculture recently approved two bills that would restrict terms such as “milk,” “cheese,” and “yogurt” to products derived from lactating hooved animals, regardless of whether the terms are qualified by phrases like “plant-based,” “vegan,” or “dairy free.” Assembly Bill (AB) 73 covers the labeling of dairy foods, and AB 74 discusses the labeling of milk products. Both passed the Assembly by executive action on April 7.
  • Both bills include a provision that states that “the prohibition in the bill applies only if at least 10 states out of a group of 15 states listed in the bill enact a prohibition similar to this bill by June 30, 2031.” In other words, the prohibition against use of such terms does not take effect unless at least 10 other named states enact a similar prohibition. The group of states is composed of Illinois, Indiana, Iowa, Kentucky, Maryland, Michigan, Minnesota, Missouri, North Dakota, North Carolina, Ohio, South Dakota, Tennessee, Virginia, and West Virginia.
  • The committee also passed a third bill, AB 75, that prohibits the labeling of a meat product as “meat” or a similar term unless the product is derived from an edible part of the flesh of an animal or any part of an insect, and does not include cultured animal tissue that is produced from animal cell cultures. In short, the bill prohibits cell cultured meat from being labeled as “meat.”
  • The bills’ sponsors allege that they drafted the bills because consumers are confused by plant-based milk, cheese, and meat labels. However, in a statement to FoodNavigator-USA, Michael Robbins of the Plant Based Foods Association (PBFA) argued that the bills are “anti-competitive, anti-free market” and “present a misguided attack on innovation and all food producers’ free speech rights to use words and phrases that consumers understand.”
  • The FDA is appealing a November 5, 2020 decision by the U.S. District Court for the Northern District of California which ordered the Agency to reconsider its 2015 approval of the genetically engineered (GE) AquAdvanage salmon.
  • In March 2016 a lawsuit was filed alleging that the FDA did not have jurisdiction to approve the GE salmon and, in the alternative, that the FDA unlawfully abused its authority by approving the GE salmon without appropriately considering its obligations under the National Environmental Policy Act (NEPA) and the Endangered Species Act (ESA). The jurisdictional claims were separately addressed in a December 19, 2019 opinion in which the Court held that the FDA could regulate the GE salmon as a drug because the Federal Food, Drug, and Cosmetic Act defines drugs in part as “articles (other than food) intended to affect the structure or any function of the body of man or other animals,” and the recombinant DNA (rDNA) that was used to create the GE salmon was a non-food article that was intended to stimulate growth.
  • However, in the November 2020, decision, the Court held that the FDA’s approval process did not meet the Agency’s statutory obligations under NEPA and ESA. Specifically, the Court held that NEPA required the FDA to consider the environmental harms that might result if the GE salmon were to escape and establish themselves in the wild. Instead, the FDA had only evaluated the likelihood of harm, concluding that it was very unlikely that the GE salmon would establish themselves in the wild, in part because the GE salmon were required to be raised away from natural bodies of water. The Court also noted that an evaluation of the potential harm was particularly important in this case because the likelihood of escape would increase as the company grew; while the FDA’s 2015 approval was specific to the two facilities named in the original application, FDA subsequently approved production at two additional facilities. In regard to ESA, the Court held that the FDA, having not considered the potential harm to wild salmon under NEPA, could not make a determination that the approval would have no effect on the endangered Gulf of Maine Atlantic salmon. As a result, FDA was required to review its decision, and per the mandates of ESA, consult with the National Marine Fisheries Service (NFMS) and the Fish and Wildlife Service (FWS) if it determined that the approval “may affect” an endangered species.
  • Despite finding the FDA’s approval unlawful, the Court held that the approval should not be vacated because the short-term risk to the environment was small and revocation of the approval would result in significant loss of property and animal life that would be wasteful if the FDA cured its errors on remand.
  • The FDA has filed the appeal but has not yet filed its appeal briefs and we will continue to monitor and report on this case as new developments occur.
  •  On April 16, 2021, the FDA issued an update on its investigation of an outbreak reported March 13, 2021 in Nevada of acute non-viral hepatitis of unknown cause, and associated with consumption of “Real Water” brand alkaline water.  According to the Centers for Disease Control and Prevention (CDC), which is also investigating the outbreak, acute non-viral hepatitis is inflammation of the liver from a cause other than a virus, such as drugs, alcohol, or toxins.
  • Thus far, five hospitalized pediatric patients from four households have recovered, as have two adults and three children from two of the four households, after experiencing less severe symptoms, including fever, vomiting, nausea, loss of appetite, and fatigue.  As the investigation continues, FDA is working to locate any remaining “Real Water” products, particularly products sold on-line, to ensure they are no longer available to consumers.  FDA recommends that consumers, including pets, avoid the recalled alkaline water products until more information is known about the cause of the illnesses.
  • Since FDA’s previous, March 31 update, which indicated a lack of cooperation from the firm, FDA has completed inspections at “Real Water” Inc.’s facilities and has received some requested records.  FDA is also sampling and analyzing Real Water products and will provide updates as the investigation continues.
  • The National Institute of Standards and Technology (NIST), housed within the U.S. Department of Commerce, has partnered with industry to further its efforts for improved testing methodologies in cannabis as part of the Cannabis Quality Assurance Program (CannaQAP). CV Sciences, Inc., a hemp oil manufacturer, and Alkemist Labs, a botanicals testing laboratory, announced this week that they will assist NIST in initial sourcing and testing of hemp products to work towards improved analytical tools to support legal, commerce, and safety claims on hemp derivatives, including cannabidiol (CBD).
  • As our readers know, while both marijuana and hemp come from the same plant, cannabis sativa L., federal law designates marijuana as cannabis plants containing 0.3% delta-9-tetrahydrocannabinol (THC) or more and hemp as those plants containing less than 0.3% THC. Because marijuana is classified as a controlled substance at the federal level and hemp is not, the legal and financial ramifications for imprecise testing and analysis of cannabis plants and associated products are a matter of extreme importance for regulatory authorities and market participants.
  • NIST is primarily responsible for developing measurement services programs to assist forensics laboratories in distinguishing hemp from marijuana and developing testing standards for related products.  CannaQAP is one component of this program and involves NIST collaboration with both forensic laboratories and commercial laboratories that focus on quality control for food and supplement ingredients, as well as regulators and researchers. Two CannaQAP exercises are in their initial stages, the results of which will help testing laboratories demonstrate and improve measurement comparability and quality of cannabis derivatives. The results of the exercises will be peer reviewed and made publicly available.