Food and Beverage News and Trends - May 25, 2023
This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape.
FDA sets forth Small Entity Compliance Guide for a key rule. May 18, the FDA published a Small Entity Compliance Guide for its Food Traceability Rule under the Food Safety Modernization Act. The compliance guide sets forth the requirements of the Food Traceability regulation as it applies to small entities, including farms and small businesses, that must comply with the applicable recordkeeping requirements under the regulation. The Food Traceability Rule was issued in November 2022, and the compliance date for recordkeeping requirements is January 20, 2026. Under the FSMA, the FDA is required to establish recordkeeping requirements for facilities that manufacture, process, pack, or hold foods that it designates as high-risk – in order to facilitate the rapid and effective traceability of such foods. Please also see our alert FDA issues Food Traceability Rule: Key takeaways for industry.
FDA reopens comment period on labeling of plant-based milk. On May 1, the FDA decided to reopen the comment period for its proposed draft guidance on labeling of plant-based milk. This decision came at the request of several stakeholder groups – but comments already submitted to the FDA even now show a wide rift between dairy and plant-based companies about how best to describe non-dairy milk and its nutritional value. The agency extended the deadline for comments until July 31 at the behest of the Plant Based Products Association, the Good Food Institute, the International Dairy Institute, and other commenters, which argued that they needed more time to evaluate the data the FDA had used in making its proposal. The proposal, among other things, would permit companies that sell oat milk, almond milk, and similar products to continue to use the term “milk” as a descriptor.
Major seizure of kratom in Oklahoma. On May 2, the FDA, acting with the US Marshals Service, seized nearly 250,000 products containing kratom, as well as a tank of bulk liquid kratom and more than 1000 kilograms of bulk powder kratom. Kratom is an herbal extract with opiate-like qualities that comes from the leaves of an evergreen tree grown in Southeast Asia. The seized articles, manufactured by Botanic Tonics, LLC, of Broken Arrow, Oklahoma, and marketed under the brand name “Feel Free Plant Based Herbal Supplement,” have an estimated value of more than $3 million. The civil forfeiture complaint alleges that kratom is a dietary ingredient for which there is inadequate information to provide reasonable assurance that it does not present a significant or unreasonable risk of illness or injury. The complaint further states that dietary supplements containing kratom are to be considered adulterated under the Federal Food, Drug, and Cosmetic Act.
Environmental group asks USDA to prohibit “low-carbon” claims for beef. On April 27, the Environmental Working Group petitioned the USDA to prohibit claims that beef is “low-carbon.” Scott Faber, the group’s senior vice president for government affairs, said, “There is no such thing as low-carbon beef. No food choice results in more greenhouse gas emissions than beef.” The group’s petition requests that the USDA require food companies to disclose their carbon emissions on product labels, in much the same way that calorie counts and other nutritional information are now displayed. The group added that these emissions reports should be verified by an independent party. “Many of these claims are not verified by independent, qualified third parties, and experts agree that USDA lacks reliable measurement, monitoring, reporting, and verification protocols,” the group wrote in its letter to the USDA’s Food Safety and Inspection Service.
FDA is urged to set voluntary targets for reducing added sugars. On April 25, the Center for Science in the Public Interest and the New York City Department of Health and Mental Hygiene called on the FDA to set voluntary targets for reducing added sugars in foods and beverages. In a petition to the agency, the nonprofit group and the city department wrote that the American food supply is now dominated by products with excessive amounts of added sugars and that overconsumption of foods and beverages high in added sugars is linked to weight gain, type 2 diabetes, heart disease, and tooth decay. The FDA already has a similar program setting short-term voluntary targets for sodium reduction in various categories of processed foods, the petition noted. It contended that a parallel program to reduce added sugars is another needed strategy to improve Americans’ diets and advance population health.
CRN asks FDA to reconsider its stand on drug preclusion. On May 9, the Council for Responsible Nutrition, which represents makers of food supplements and functional foods, petitioned the FDA to reconsider its application of the so-called Drug Preclusion Clause, part of a law passed by Congress in 1994. The petition said the agency is interpreting the clause too strictly and is removing substances from the market as “drug precluded,” contrary to the intent of Congress. The petition said, “FDA has increasingly interpreted the relevant section over nearly three decades in a manner that overly advantages drugs at the expense of dietary supplements. The continued reading of the drug preclusion provision in deference to drug company interests runs contrary to the statute’s text, structure, history, and purpose.”
Legislators condemn food companies for adding sesame to their products. On May 2, a bipartisan group of legislators, led by Senator Ron Wyden (D-OR), severely criticized food companies that have recently started adding sesame ingredients to baked goods in the wake of a new federal law naming sesame as a major allergen. The legislators wrote to Eric Dell, president and CEO of the American Bakers Association, decrying what is now becoming common in the industry – the practice of adding sesame instead of making efforts to avoid sesame contamination in food manufacturing facilities. Since late last year, it has been reported that bakery companies have begun adding small amounts of sesame to their products to avoid new anti-allergy requirements that took effect on January 1, 2023. This practice allows businesses to list sesame as an ingredient, rather than having to undertake the difficult task of cleaning their manufacturing facilities to avoid cross-contamination. The letter said, “The dangerous practice of adding sesame to baked goods that have not previously contained the ingredient, often without notice, undermines the trust that people with food allergies place in the food industry.” Earlier this year, the Centers for Science in the Public Interest charged that it is illegal to add sesame to food products that never contained it before the labeling requirement went into effect. See that story.
New bill in Congress will try to remove confusion over food dates. On May 9, three members of Congress – Senator Richard Blumenthal (D-CT) and House members Chellie Pingree (D-ME) and Dan Newhouse (R-WA) reintroduced the Food Date Labeling Act, a bill designed to end consumer confusion around food date labeling and to ensure that Americans do not throw out usable food. “Our current food labeling practices are outdated, confusing, and completely arbitrary, resulting in around 90 percent of Americans prematurely throwing out perfectly safe food. This staggering waste takes a toll on families’ wallets, on the environment, and on the economy,” said Pingree. “By standardizing the food date labeling system and making labels less confusing for consumers, the bipartisan Food Date Labeling Act will help ensure food is being used and eaten, rather than being thrown out.”
Supreme Court rejects challenge to California’s Proposition 12. On May 11, a narrowly divided US Supreme Court rejected a challenge by the National Pork Producers Council and the American Farm Bureau Federation to California’s Proposition 12 law against animal confinement. The trade groups had contended that the California measure violates the US Constitution’s Commerce Clause, but the high court, in an opinion by Justice Neil Gorsuch for the 5-4 majority, upheld the lower federal courts and rejected this claim. Proposition 12 bans the sale of pork in California from farms anywhere in the country that confine pregnant pigs in “gestation crates” for almost their whole lives. Justice Gorsuch’s opinion rested on the fact that California’s import restriction applied equally to products from in-state and out-of-state pigs. In other words, California pork producers, however few of them there are, are held to the same gestation crate ban as out-of-state producers. There is thus no violation of the “dormant commerce clause.” As Gorsuch put it, “while the Constitution addresses many weighty issues, the type of pork chops California merchants may sell is not on the list.”
California moves to prohibit five chemicals in processed food and beverages. On May 15, the California Assembly approved AB 418, which aims to eliminate five toxic chemicals from processed foods and beverages. Should the bill become law, it would be the first time these chemicals – Red Dye No. 3, brominated vegetable oil, potassium bromate, propylparaben, and titanium dioxide – would be prohibited from use in foods anywhere in the US. Some media outlets have inaccurately reported that the bill would “ban Skittles” and other popular candies. Each of the five chemicals has been linked to cancer and developmental issues in children and to other adverse or negative health impacts, both short-term and long-term. Four of these chemicals are already banned outright in foods and beverages in the European Union; Red Dye No. 3 is allowed there only in candied cherries. The bill now moves to California’s Senate.
California Assembly advances date-labeling bill. On May 18, a bill to require that specific terms be used in date labels for food sold in California was approved by the Appropriations Committee of the California Assembly. The full Assembly will vote by June 2 to decide whether the bill moves on to the state Senate. The bill would require the use of the phrases “Best if used by” or “Best if used by or frozen by” to indicate quality, or “Use by” or “Use if frozen by” to indicate safety. Food companies would no longer be able to use consumer-facing “Sell by” dates. A key background of the bill and of similar efforts at the nationwide level is that the FDA has estimated that consumer confusion relating to food labels is the cause of up to 20 percent of food waste in America.
Oregon to ban polystyrene food containers. On May 8, Oregon became the tenth US state to ban polystyrene foam from food containers on the grounds that the plastic can leak into the food and cause cancer and nervous system damage. Starting in 2025, a new law signed by Governor Tina Kotek will prohibit the production, sale, and distribution of polystyrene foam cups and takeout food containers, as well as packing peanuts and food coolers made from the plastic, anywhere in Oregon. The bill also prohibits so-called “forever chemicals” in food packaging, and a second bill signed by Governor Kotek will make it legal for consumers to bring their own reusable takeout containers to restaurants. Also see our alerts EPA releases draft national strategy to prevent plastic pollution and Washington becomes latest state to tackle plastic pollution.
Launch of Global Food Institute. On May 23, José Andrés, renowned chef and founder of the disaster-response NGO World Central Kitchen, and George Washington University announced they are launching the Global Food Institute, which will focus on the intersection of food production and climate change. “The world we live in today is confronted by a wide range of complex crises, and the global food system sits at the heart of each of them,” Andres said. Christopher Alan Bracey, provost of George Washington University, said the institute 2will advocate for structural change in global food strategies and seek to develop “evidence-based actionable” solutions to disruptions in the food system through interdisciplinary research that "creates and improves food policy both domestically and globally.” The institute was created via a founding gift from Andrés and will be privately supported.
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