This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape.
- FDA actions may mean the start of a crackdown on false claims for dietary supplements. On February 11, the FDA took regulatory action against 17 companies that it said are illegally selling products claiming to treat or prevent Alzheimer's disease. The actions included 12 warning letters and five online advisory letters to the companies, involving at least 58 products, many of which are being sold as dietary supplements.The agency noted that the products, which are often sold on websites and social media platforms, may be ineffective and unsafe and could prevent a person from seeking appropriate diagnosis and treatment. The same week, the agency said it is launching a new initiative to combat misleading claims about the effectiveness of dietary supplements to treat disease. Its multi-pronged plan will include a rapid-response tool to warn consumers about unsafe products and an update to compliance policies regarding new dietary ingredient notifications, or NDIs. FDA Commissioner Scott Gottlieb said, "Simply put, health fraud scams prey on vulnerable populations, waste money and often delay proper medical care – and we will continue to take action to protect patients and caregivers from misleading, unproven products."
- Conservative groups challenge FDA for "overreach" on e-cigarettes. On February 4, a coalition of conservative and libertarian organizations sent a letter to FDA Commissioner Scott Gottlieb criticizing him for "regulatory panic and significant government overreach" in the regulation of e-cigarettes. Under Gottlieb, the FDA has taken major steps to curb the use of e-cigarettes by teenagers out of concern that a new generation may become addicted to tobacco. The coalition said that the FDA is ignoring the importance of the use of e-cigarettes to wean adults from tobacco use. It argued that the FDA's actions would hurt "an innovative industry that is helping American smokers quit." Gottlieb did not back down from his position in response to the letter, saying that if vaping by young Americans continues to increase, he may order e-cigarettes off the market entirely. See some of our earlier coverage of this story.
- New process of farm inspection aims to ensure safety of produce. Food Navigator magazine reported on February 8 that this spring the FDA will begin a new process of routine inspections of large domestic and international farms as part of the Produce Safety Rule established under the Food Safety and Modernization Act of 2011. The purpose of the inspections will be to better address foodborne illnesses linked to fresh produce. "Fresh produce is an important part of an overall healthy diet," said FDA Commissioner Scott Gottlieb. "The vast majority of produce we eat is generally safe, especially when you consider per capita consumption rates. Unfortunately, in too many cases, foodborne illnesses are still being linked to fresh produce." See some of our coverage of last year's outbreak of E. coli in romaine.
- Peaches, nectarines and plums are recalled for possible Listeria contamination. The FDA says a New York produce company has issued a recall for more than 3,000 cartons of peaches, nectarines and plums that may be contaminated with Listeria. Jac. Vandenberg Inc., based in Yonkers, New York, issued the recall on January 24, although no deaths or illnesses have been reported. The recall was ordered after a routine sampling program in the warehouse found evidence of contamination. The company's products are typically sold at Aldi, Walmart and Costco stores in the eastern United States.
- Efforts increase to prohibit using the term "meat" for plant-based or lab-grown products. The New York Times reported February 9 that beef and farming industry groups have recently persuaded legislators in more than a dozen states to introduce laws that would make it illegal to use the word "meat" to describe products that are created from plant-based ingredients or are grown in labs. These meat alternatives may look and taste like meat, but cattle ranchers want to make sure that the new competition can't label them as meat. Last year, Missouri became the first state to pass such a law. Its statute bars companies from "misrepresenting a product as meat that is not derived from harvested production livestock or poultry." The law has been challenged in court. See our earlier coverage of this issue.
- FDA will soon tackle "milk" definition as comment period ends. The comment period set by the FDA regarding the enforcement of the legal definition of milk closed January 28. The agency had been asked by the milk industry to crack down on the labeling of plant-based milks that are not derived from dairy sources. The industry refers to these products as "fake milk" and says that since they lack the nutritional profile of dairy milk, it is misleading to sell them as soy milk, almond milk and the like. The Good Food Institute, which represents plant-based milk producers, replied that "consumers have long understood that various compound terms such as 'soy milk' refer to distinct products that are not made from the lacteal secretions of mammals but, rather, from plants like soybeans. Terms such as 'soy cheese' and 'almond milk' have become well established through continued and wide-ranging use by consumers, producers and the government, including FDA."
- Will congressional action bring back whole milk in school lunches? In late January, Representatives Glenn “GT” Thompson (R-PA) andCollin Peterson (D-MN) introduced the Whole Milk for Healthy Kids Act of 2019, which would allow whole milk to be served with school lunches across America. Whole milk disappeared from school lunches in 2010, after Congress passed the Healthy, Hunger-Free Kids Act, which required that all milk in school lunches be nonfat or low-fat with the goal of reducing childhood obesity. The bill is beginning to gain support from dairy organizations. US Agriculture Secretary Sonny Perdue recently permitted the use of low-fat (1 percent) flavored milk in school lunches, and this bill would move further in that direction. Several recent studies have shown that whole milk is not as unhealthful as some nutrition advocates believe. Peterson is chair of the House Agriculture Committee.
- Modernization act for alcohol industry is reintroduced in US Senate. On February 6, Senators Ron Wyden (D-OR) and Roy Blunt (R-MO) announced they are reintroducing the Craft Beverage Modernization and Tax Reform Act (CBMTRA). The purpose of the bill is to establish reduced taxes and modernized regulations for vintners, cider makers, brewers and distillers. Representatives of all those industries lauded the bill, saying it will promote job growth in their industries. "By modernizing burdensome rules and taxes for craft beverage producers, this legislation will level the playing field and allow these innovators to further grow and thrive," Wyden said. A temporary version of the bill was passed in 2017 and expires this year.
- North Carolina may consider ending state-owned monopoly on spirits sales. A legislative report released February 11 in North Carolina has that state’s legislature considering whether to end its program under which state-owned stores have a monopoly on the sale of spirits. The report advised legislators on the pros and cons of changing the system. North Carolina is one of 17 states that directly control the sale and distribution of spirits. About 170 local alcohol boards operate more than 430 stores, which by law can't stay open past 9 pm or on Sundays. Beer and wine, meanwhile, are sold by licensed conventional retailers. The North Carolina Retail Merchants Association said in a statement that it's about time liquor was sold in regular stores in that state, as it is in the majority of US jurisdictions.
- Bud Light will disclose calories, ingredients and nutrition information. Although brewers are not legally required by the FDA to list the ingredients, calorie content and amount of fats, carbohydrates and proteins in their products, major beer makers voluntarily agreed to do so in 2016, with a target date of 2020. The first product that will actually bear such labels will be Bud Light, which will launch the labels this month. Bud Light's maker, Anheuser-Busch, chose to use a large black and white label, similar to the ones the FDA mandates on packaged foods.
- Will Mississippi allow direct sale of wine within its borders? A Biloxi, Mississippi radio outlet reported on February 5 that Mississippi may soon decide to permit the direct sale and shipment of wine to its residents by wineries or direct-sale companies. Mississippi is now one of a handful of states that do not permit this. Bills allowing direct shipment have been introduced in both houses of the state legislature, but local liquor stores are lobbying against them. The state attorney general is currently suing four direct-sale mail-order companies for shipping wine into the state.
Kentucky takes key step to permit wine shipments into the state. On February 15, the Kentucky state Senate passed a bill that would, for the first time, permit residents of that state to receive shipments of wine to their homes. Kentucky, like Mississippi, is one of the few states that do not permit such shipments. The bill passed the state Senate by a 29-5 margin and will now go to the state’s House. Under the bill, each person in Kentucky could be shipped up to 24 cases of wine annually. State Senate Majority Floor Leader Damon Thayer said he supports the bill because he knows that Kentuckians visiting California and other wine-producing states want the ability to ship wine back to their homes that isn’t sold at their local retail establishments.
- US appeals court grants injunction against city law on sugary-drink advertising. On January 31, the US Court of Appeals for the Ninth Circuit ruled that a San Francisco ordinance requiring warning labels on billboard ads for sugary drinks violates the First Amendment and ordered a lower court to look at the ordinance again. Beverage makers, the 11-judge panel said, will likely succeed with their claims that the warning labels San Francisco requires infringe their free-speech rights. The ordinance, passed in 2015, requires advertisements on billboards and posters in the city to include a warning - covering at least 20 percent of the advertisement space - that drinking high-sugar beverages contributes to health problems, including obesity and diabetes. Notably, while this ruling is being hailed in some quarters as a victory for soda manufacturers, it is narrow. A spokesperson for the San Francisco city attorney noted, "This decision is solely about the size of the warning label. We're evaluating our next steps in light of this decision."
- Clarity begins to emerge concerning GMO labeling. The February 4 issue of Food Dive magazine explained which products will require disclosure under the USDA's newly completed rule implementing the federal law on the labeling of genetically modified organisms (GMOs). Specifically, items that contain highly refined ingredients don't have to be labeled; to require labeling, a product needs to have at least 5 percent bioengineered material. Meat, poultry and egg items don't require disclosure, nor do items that have meat, poultry or eggs as their major ingredient. The USDA will maintain a list of crops produced anywhere in the world that are definitively GMO. This list will help food manufacturers know which ingredients they need to disclose, but it is not exhaustive and will be updated periodically. The regulation gives manufacturers 18 months to update their labels after an ingredient is added to the list.
- Survey shows FDA-mandated nutrition label is a major source of consumer information. A survey published in Food Business News January 24 indicated that 69 percent of Americans look at the Nutrition Facts Label on a product before buying it and that 67 percent check the ingredient list. The survey was conducted by the International Food Information Council Foundation and the American Heart Association. Twenty-eight percent of respondents said it was easy for them to find healthy food, 61 percent said it was moderately easy and 11 percent said it was difficult. The Nutrition Facts Label is mandated by the FDA. Compliance dates for a new version of the label are now set at January 1, 2020, for manufacturers with sales above $10 million, and January 1, 2021, for manufacturers with sales less than $10 million.
- Looking at the Administration’s impact on food policy after two years. A detailed study in the February 14 issue of Food Processing magazine concludes that after two years of the Donald Trump Administration, its effects on food regulation have been “a series of surprises, for just about everybody, including the food and beverage industry.” The article concludes that “when it comes to food, observers say that the policy of the [Food and Drug Administration] and other federal agencies under Trump has been surprisingly consistent with previous administrations.” The article points to two regulations, both of which began under the Barack Obama Administration and continued under Trump. These are the Agriculture Department’s initiative to require labeling of GMOs and the FDA’s efforts to revise the Nutrition Facts panel. Both regulations are scheduled to be implemented on January 1, 2020.