This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape.
- FDA issues serving size guidance for new Nutrition Facts labels. The FDA has issued final guidance on what constitutes a “serving size” of food for the purposes of compliance with the agency’s revised Nutrition Facts labels. Among other things, the rules define, in consonance with established law, a “serving” or “serving size” as “the amount of food customarily consumed on one eating occasion.” Although the Nutrition Facts regulations took effect on January 1, the agency has announced that it does not intend to take any enforcement action with respect to them for the first six months of this year. In addition, the FDA will use its enforcement discretion concerning manufacturers of single-ingredient sugars like honey and maple syrup, as well as for makers of some cranberry products, and will not enforce the rules against them until July 1, 2021.
- FDA adds a new fiber to its list of those that qualify as having health benefits. On January 10, the FDA said it intends to propose that glucomannan be classified as a substance that meets the agency’s definition of dietary fiber because it has been shown to help reduce blood cholesterol. Glucomannan is found in the tuber or root of the elephant yam, also known as the konjac plant. In 2016, the agency stated a definition for dietary fiber for the first time, declaring that dietary fiber is defined as any naturally occurring fibers that are “intrinsic and intact” in plants as well as some synthetic nondigestible carbohydrates that the FDA has determined have physiological effects that benefit human health. There are now 17 nondigestible substances that the FDA classifies as dietary fiber and that help reduce blood cholesterol.
- FDA report shows that antibiotic use in animals increased in 2018 but is at low level historically. The FDA has released its annual report on the nationwide use of antimicrobial products in food-producing animals. The report, released on December 10, covers calendar year 2018 and shows that domestic sales and distribution of medically important antimicrobials for use in food-producing animals increased nine percent between 2017 and 2018. However, the agency also pointed out that 2018 is the second-lowest year on record for sales and that sales of such products in 2018 were down 21 percent since 2009, the first year of such reporting. The agency wants to slow the use of antibiotics and thus slow the growth of antimicrobial resistance in order to preserve the current uses of antimicrobials as effective treatments for disease in human beings and animals. The nonprofit Center for Science in the Public Interest said in a statement that the report “sends a disappointing message” and that “work to foster responsible antibiotics use is by no means finished.”
- Appeals court holds that FDA can regulate e-cigarettes. On December 10, the US Court of Appeals for the DC Circuit ruled unanimously that the FDA can regulate e-cigarettes in the same way that it regulates conventional cigarettes. The case was not about any proposed ban on any vaping devices. Rather, the issue was whether the FDA has the authority to treat e-cigarettes as “tobacco products” and to subject them to the same type of rules and regulations as regular cigarettes. The case was the first to decide this issue. The court noted the “relatively unknown and potentially grave risks of e-cigarettes to all users and their extraordinary allure to middle and high school students” as a factor in its decision. The case was brought by the e-cigarette maker Nicopure and the Right to Be Smoke-Free Coalition. They claimed that the FDA, in trying to regulate e-cigarettes, was violating the Tobacco Control Act, the First Amendment and the Administrative Procedure Act.
FDA declares romaine lettuce outbreak over as its investigation continues. On January 15, the FDA announced that its investigation has found that all outbreaks of E. coli contamination in romaine lettuce from Salinas, California, are over and that consumers no longer need to avoid this lettuce. The FDA added that its investigation of the outbreaks is continuing. “We are doing everything possible to find the source or sources of contamination. The investigation into how this contamination occurred is important, so romaine growers can implement measures that will prevent future contamination and illnesses, the FDA said. The investigation narrowed the source of the contamination down to about 10 fields in the lower Salinas Valley, but still has not found the precise cause of the outbreak.
USDA loosens regulations on school lunch nutrition. On January 17, the USDA issued new rules concerning the nutritional content of school lunches across America. The changes would reduce the amount of fruit that schools are required to offer students for breakfast from one cup to a half cup. They would also allow more “flexibility” in the vegetables served in schools. Cafeterias would still be required to offer students five cups of vegetables per week, but that calculation could now include up to three and a half cups of white potatoes, instead of the previous limit of two cups. Nutrition-oriented and public health groups took issue with the changes, which would modify a program that is identified with former First Lady Michelle Obama; many noted that the rules were announced on the former First Lady’s birthday. Karen Tumulty, a columnist for the Washington Post, said that President Donald Trump’s USDA has “picked the wrong food fight” and that “the potato lobby appears to be one of the real forces at work” regarding the new regulations. USDA officials said that the move was designed to limit food waste.
- Nonprofits sue USDA over new pork inspection program. On January 13, the Center for Food Safety and Food & Water Watch filed a lawsuit against the USDA concerning the department’s new rules for the inspection of swine in slaughterhouses. The nonprofit groups claim in their lawsuit that the rules “vitiate” the system, “effectively turning it over to the slaughter companies themselves.” The lawsuit, filed in the US District Court for the Northern District of California, objects to the new rules on health and safety grounds. It says that the department “approved these dangerous regulatory rollbacks, despite the fact that contaminated pork may cause as many as 1.5 million cases of foodborne illnesses, 7,000 hospitalizations, and 200 deaths in the United States each year.” It seeks an injunction against the new inspection program on the grounds that it violates the Federal Meat Inspection Act and other federal laws.
- Arkansas judge upholds challenge to law targeting nonmeat products. US District Judge Kristine Baker of the Eastern District of Arkansas granted a preliminary injunction December 10 against a new Arkansas state law, passed in March, that prohibits manufacturers of plant-based meat imitation products from using terms like “sausage,” “burger,” or “meat” on their labels. The judge ruled that the statute was likely to violate the First Amendment’s guarantee of freedom of speech. The state argued that the law is intended to prevent consumer confusion about what these products are made of, but the judge rejected this argument, saying that with all the qualifiers and other language on the packages, consumers would not actually believe that nonmeat sausage actually contained animal-based sausage. The statute has not yet been enforced. See some of our earlier coverage of the “meat wars” here and here.
Borden files for bankruptcy. On January 6, Borden Dairy Co. became the latest US dairy company to file for bankruptcy protection, following a similar move by Dean Foods in November. With 3,300 employees in 12 plants across the country, Borden produces nearly 5,000 gallons of milk a year, for groceries and institutions. Although the US dairy industry is the largest in the world, it faces strong pressure from changing consumer habits: Americans drink 40 percent less milk than they did in 1975. Borden noted in its court filings that in the last 18 months alone, more than 2,700 US dairy farms have ceased operations.
Appeals court strikes down Missouri alcohol advertising rules on free-speech grounds. On January 8, the US Court of Appeals for the Eighth Circuit struck down, on First Amendment grounds, a provision of Missouri law that the state interprets to prohibit manufacturers or distributors of alcohol from engaging in retail advertising. It also struck down on similar grounds two state regulations that restrict advertising by alcohol retailers of discounted or below-cost prices for alcoholic drinks. The court said that the law on its face does not address free speech, but “its practical operation restricts speech based on content and speaker identity” because it “imposes content-based restrictions by limiting what producers and distributors can say in their advertisements.” It noted that the two regulations, although they were asserted by the state to be appropriate measures to combat underage drinking and over-consumption of alcohol, were not suitably tailored for these purposes and thus would not pass muster under the First Amendment. The case was brought by the Missouri Broadcasters Association and was heavily supported by the American Civil Liberties Union of Missouri and free speech advocates.
- Appeals court rejects claim concerning labeling of Diet Dr Pepper. On December 30, the US Court of Appeals for the Ninth Circuit ruled unanimously that the parent company of Dr Pepper did not intentionally mislead consumers and induce them to believe that consumption of the beverage would result in weight loss or healthy weight management. The appeals court found that the company did not violate California’s consumer fraud laws. Consumer Shana Becerra had said in her lawsuit that the company’s use of the word “diet” on its labels was misleading because studies show that aspartame, the artificial sweetener in the product, is likely to cause weight gain and has no weight loss benefit. This was the latest in a series of similar court rulings that have upheld the principle that calling a beverage a “diet” drink does not make misleading health or nutritional claims. “No reasonable consumer would assume that Diet Dr Pepper’s use of the term ‘diet’ promises weight loss or management,” wrote Judge Jay Bybee for the appeals court. “The use of ‘diet’ in a soft drink’s brand name is understood as a relative claim about the calorie content of that soft drink compared to the same brand’s ‘regular’ (full-caloric) option.”
- Congress extends tax break that benefits the nation’s alcohol industries. On December 17, Congress made brewers, winemakers and spirits producers happy by voting to extend a tax break that was due to expire at the end of 2019. The tax break was, however, extended for one year rather than made permanent as the industry had requested. Its renewal for a year was part of a $1.4 trillion spending package that Congress passed and sent to President Donald Trump just before members left town for the holidays. Trade groups had estimated that if the break were not renewed, industry members would face a tax increase of nearly 400 percent. Craft brewers were said to be the ones who would benefit most from the extension, but the entire industry stood to gain from it.
- Salad vegetables were apparent source of current bacterial outbreak. On December 9, the Centers for Disease Control and Prevention warned consumers not to eat Fresh Express’s Sunflower Crisp chopped salad kit. The centers announced that their investigation had found that the product contained a harmful type of E. coli bacteria. Eight people in three states – Minnesota, Wisconsin and North Dakota – have been infected, and the product is also the probable source of an outbreak in Canada in which 16 people in five provinces have been ill. No deaths have been reported in either country. Salad vegetables, especially romaine lettuce, have been a major source of food-borne illness in the last couple of years, and the Food and Drug Administration has undertaken a major probe.