This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape.

  • FDA, USDA addressing their regulatory responsibilities for cell-cultured meat. FDA Commissioner Scott Gottlieb and Agriculture Secretary Sonny Perdue announced during a joint FDA-USDA public meeting that they are working on an expedited basis to divide regulatory responsibilities for cell-cultured meat between their agencies. The announcement came during the two agencies' October 23 – 24 public meeting held to discuss the issue of regulatory jurisdiction over cell-cultured meat products. Consumer advocates, food researchers, officials of startup companies and representatives of traditional meat companies were among those taking part. Representatives of the traditional meat industry continued to press for USDA regulation of the new cell-cultured meat. Consumer representatives, such as Sarah Sorscher of the Center for Science in the Public Interest, raised specific regulatory issues, such as how to deal with the likelihood that, in the absence of proper labeling, some consumers may eat cell-cultured meat without cooking it.
  • Walmart food safety exec joins FDA. Frank Yiannis, Vice President of Food Safety for Walmart, will join FDA as deputy commissioner for foods and veterinary medicine. Yiannis is highly respected in the food sector. In September, while still at Walmart, he announced that Walmart produce departments will soon feature technology allowing customers to scan their produce to see every step it took from the moment it was harvested. They will be able to do that because Walmart will, in January, begin requiring suppliers who provide leafy greens to the company to upload supply chain data to the blockchain through the IBM Food Trust Network – a requirement that arose in response to the massive outbreak of E.coli in romaine. On his Twitter feed last week, Yiannis said, "It's a brand new day & I am humbled and honored to be joining the FDA." He stated, "Being 'responsible' for food safety is better than being held 'accountable' for food safety. Do the right thing."
  • North Carolina opens investigation of major e-cigarette company. On October 15, the attorney general of North Carolina announced that he has opened an investigation into Juul, a wildly popular brand of e-cigarettes. Attorney General Josh Stein sent the Juul company a civil investigative demand to ask for more information about Juul's marketing practices, retailers, contact with resellers, efforts to verify age before purchase and any youth education and awareness programs it may be conducting. Just a few weeks ago, the FDA conducted an inspection of the company's corporate headquarters in San Francisco, seizing thousands of documents, many of which relate to the company's sales and marketing practices. "The use of e-cigarettes among young people is increasing at staggering rates," Stein said. "I am extremely concerned about the way Juul has marketed its product to young people, who face increased risk for addiction and exposure to health problems." Juul's non-tobacco food-type flavorings, like others in the industry, have drawn considerable flak from regulators, who say that these flavors are what makes them appealing to teen-agers.
  • FDA says it will redefine "healthy." The FDA has announced that in March 2019 it will issue a proposed rule to update the way the term "healthy" may be used on food labels. In its fall Unified Agenda, the agency said, "FDA is proposing to redefine healthy to make it more consistent with current public health recommendations, including those captured in recent changes to the Nutrition Facts label." The current definition has been particularly criticized for the way it limits fats. While it is unclear what changes the proposed rules will contain, the FDA is saying the rule will focus more on dietary patterns, to help Americans avoid chronic illnesses such as heart disease, cancer and stroke, the leading causes of death and disability in the US.
  • FDA will extend crackdown on trans fats. Next summer, the FDA will release a rule aiming to extend its ban on trans fats across the entire food supply. In 2015, the agency revoked the GRAS (Generally Recognized as Safe) designation for partially hydrogenated oils (PHOs), the main source of artificial trans fats in foods, and companies were given about three years to remove the chemical from their products. June 18, 2018 was the last day on which manufacturers could add PHOs to their food products. However, to allow an orderly marketplace transition, the agency said it would allow foods processed before the June cutoff until January 1, 2020 to work their way through the system. The proposed FDA rule, which will likely be released in June 2019, aims to put an end to all use of PHOs in American food manufacturing. Commissioner Gottlieb, said the goal of the rulemaking is "to further reduce deaths from coronary heart disease."
  • Nonprofits sue FDA for failing to designate "high-risk" foods. On October 15, two nonprofit groups, the Center for Food Safety and the Center for Environmental Health, sued the FDA, alleging that the agency has failed to designate and establish reporting requirements for producers of foods that are considered to be "high risk" for outbreaks of foodborne illness. The groups said the FDA was not complying with its responsibilities under the Food Safety Modernization Act. The lawsuit says that Congress required the FDA to designate such high-risk foods by January 2012 and by 2013 to propose recordkeeping requirements for facilities that handle such foods. Yet, according to the lawsuit, it has not designated any such foods. "A statute without its implementing regulations is an empty vessel. FDA's failure to so implement FSMA leaves all Americans vulnerable to foodborne illness," the complaint said. The case was filed in the US District Court for the Northern District of California.
  • FDA will review and revoke some official standards of identity. On October 17, as part of its formal Unified Agenda for fall 2018, the FDA announced it will revoke what it called "outdated standards of identity" for certain foods in order to stimulate innovation in the food industry. The agency said it is beginning this process with the standards of identity for French salad dressing and frozen cherry pie. "This is a down payment on a comprehensive effort to modernize food standards to reduce regulatory burden and remove old-fashioned barriers to innovation," said FDA Commissioner Scott Gottlieb in an official blog post. A standard of identity is a formal regulatory definition that sets forth the ingredients a product must contain, the ingredients it may contain but need not contain, and any manufacturing requirements. In the case of frozen cherry pie, for example, the federal definition requires that at least 25 percent of the pie, by weight, must consist of cherries.
  • Nutrition group urges FDA to curb misleading claims for processed foods. The Academy of Nutrition and Dietetics has urged the FDA to review claims by manufacturers that a product is "made with real fruit" and to closely examine products whose labels show "misleading images of whole fruits and vegetables when only minuscule amounts are in a serving" and products that are given names like "veggie sticks" and "fruit snacks" when they have little nutritive value. The group, which represents 104,000 dietitians and nutritionists, took this position October 11 in a comment it posted concerning the FDA's Comprehensive Multi-Year Nutrition Innovation Strategy. "Consumers should not be misled that processed foods touting images of fruits and vegetables are actually adequate dietary substitutes for fresh fruits and vegetables. For this reason, it is critical that the FDA's initiative should seek to correct misleading or inaccurate labeling claims and should not enable unhealthy foods to unfairly compete with fresh fruits and vegetables, which occupy too little space in Americans' diets," the group said.
  • Survey shows a low level of public confusion over nondairy "milk" products. As the FDA considers the regulatory status of nondairy "milks" from plant sources, a new online survey released October 13 by the International Food Information Council Foundation shows a low level of consumer confusion on the issue. According to the survey, about three-quarters of Americans understand that plant-based "milk" products do not actually contain cow's milk (75 percent for soymilk and almond milk, 74 percent for coconut milk, 73 percent for rice milk and 72 percent for cashew milk). Fewer than 10 percent believe that any of those products contains cow's milk, while the remainder say they don't know (20 percent for cashew milk and rice milk, 18 percent for coconut milk, and 16 percent for soymilk and almond milk). The survey results come in the midst of the FDA's 60-day comment period asking the public how they use plant-based dairy alternatives and how they understand the meaning of terms such as "milk" and "cheese" for products not made with cow's milk. FDA Commissioner Scott Gottlieb said earlier this year that the agency is considering restricting makers of plant-based beverages from using the word "milk" on product labels.