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

  • FDA publishes guidance for menu-labeling rule. On November 7, the FDA published additional guidance for compliance with its menu-labeling rule, whose effective date has been delayed twice and which will go into effect in May 2018. "I'm fully committed to implementing these provisions on the timetable we've already announced," FDA Commissioner Scott Gottlieb wrote in a statement. "But I'm equally committed to making sure we implement these provisions in a way that is practical, efficient and sustainable." For example, pizza chains had complained about be required to identify calorie counts for each of millions of possible topping combinations. According to the guidance, a company can post a base number of calories for a pizza and then post calorie counts for the toppings separately. The FDA's approach is being praised by the restaurant industry and consumer groups. Phil Lempert, who reports on food and agriculture issues for Forbes, wrote, "This positive move by the administration, in light of other food and agriculture regulations that it has dismantled, is a breath of fresh air and exemplifies 'doing the right thing.'"
  • CSPI organizes opposition to delay of Nutrition Facts panel. The nonprofit Center for Science in the Public Interest says it has helped to spur more than 40,000 comments from consumers against the FDA's decision to delay the Nutrition Facts panel update by 18 months. In all, nearly 290,000 comments have been submitted on the proposed rule. The deadline for commenting on the delay was November 1. Larger companies will need to start using the new label in 2020, and smaller companies will need to start using it in 2021. "We hope the agency listens to the tens of thousands of Americans who oppose the delay, and not the complaining companies who find it inconvenient to comply in a timely manner with these sensible and science-based regulations," the CSPI said on November 1.
  • WHO: stop feeding antibiotics to livestock. The World Health Organization has issued guidelines urging farmers and the food industry around the world to stop feeding antibiotics to healthy animals and calling for global coordination to fight antibiotic-resistant microbes. Earlier this fall, WHO warned that the practice of routinely feeding antibiotics to livestock contributes significantly to the problem of multi-drug-resistant superbugs. "The new WHO recommendations aim to help preserve the effectiveness of antibiotics that are important for human medicine by reducing their unnecessary use in animals," the organization said. "In some countries, approximately 80% of total consumption of medically important antibiotics is in the animal sector, largely for growth promotion in healthy animals." In January 2017, the FDA issued voluntary rules asking the US meat industry to stop using antibiotics to promote animal growth, but the rules left a loophole: producers may feed healthy animals small doses of antibiotics to prevent possible disease outbreaks. The WHO guidelines, issued November 7, are being seen as a rebuke to that loophole. Dr Tedros Adhanom Ghebreyesus, Director-General of WHO, stated, "Strong, sustained action across all sectors is vital if we are to turn back the tide of antimicrobial resistance and keep the world safe."
  • Study concludes that Philadelphia's soda tax is working. A study presented November 1 at an "Obesity Week" conference in Washington, DC, concluded that Philadelphia's tax on sugary beverages is working as planned. The study, by public health expert Sara Bleich, concluded that sales of those beverages have declined substantially in Philadelphia since the tax went into effect in 2016 but that Philadelphia grocery store sales in general did not decline. Nancy Brown, the CEO of the American Heart Association, said, "Philadelphia's tax is working exactly as intended and exposes industry's erroneous claims that are meant only to protect their profits at the expense of public health."
  • FDA cracks down on marijuana derivative. In four warning letters sent to dietary supplement companies October 31, the FDA appeared to be toughening its stance against the use of CBD, or cannabidiol, in supplements. CBD is a non-narcotic derivative of the marijuana plant. A British company has filed a new drug application for two CBD-based drugs, and the agency wrote in all four letters that because "substantial clinical investigations" are going on for these drugs, it is unlawful to introduce the chemical into interstate commerce. This conclusion was based on the FDA's finding that the companies were describing the CBD products as dietary supplements but marketing them as drugs.
  • Contamination found in Hawaii's black market marijuana. A testing lab in Hawaii has found that more than half the samples of black market medical marijuana it tested this summer were contaminated. The state-certified lab discovered mold, yeast, pesticides and even E. coli and Salmonella in the samples, reports Hawaii News Now. Hawaii only began allowing sales of medical marijuana through legal dispensaries this summer – the first one opened in August. In obtaining certification, the lab, Steep Hill Hawaii, needed to test large volumes of marijuana to demonstrate to the state Department of Health that its equipment was working properly. At that time, "the dispensaries weren't open so we had to go to the black market," said lab owner Michael Covington. "A lot of times we ran across contamination in people's samples." Hawaii has the strictest medical cannabis guidelines and regulations in the nation, but many medical marijuana users there are turning to the black market, where prices are lower and there are no limitations on volume.
  • FDA Commissioner speaks out against kratom. Kratom, an herb related to coffee and marketed as a safe dietary supplement to treat a wide range of conditions, has become a popular treatment for symptoms of opioid withdrawal. But, in the wake of reports of 36 deaths associated with its use, as well as a tenfold rise in calls to poison control centers about the substance, FDA Commissioner Scott Gottlieb issued a statement on November 14 about the "deadly risks" associated with using kratom. "It's very troubling to the FDA that patients believe they can use kratom to treat opioid withdrawal symptoms," he said. "There is no reliable evidence to support the use of kratom as a treatment for opioid use disorder." Kratom, Mitragyna speciosa, is banned in several Asia Pacific countries and several US states but is openly marketed online. The Washington Post reports that Gottlieb suggests manufacturers interested in proving kratom's safety and effectiveness should go through the agency's regular drug-approval process. Meanwhile, the Post said, the FDA is working to prevent kratom from entering the country and has seized and destroyed a number of shipments. "We've learned a tragic lesson from the opioid crisis: that we must pay early attention to the potential for new products to cause addiction and we must take strong, decisive measures to intervene," Gottlieb said.
  • Farmers must now adapt to new food safety rules. A feature article in Food Dive magazine published November 6 points out that under the Food Safety Modernization Act, America's 2.1 million farmers will, starting in January, need to comply with federal food safety standards for the first time. The requirements for biological soil additions, access to fields by animals, and worker health and hygiene training and access rules will be enforced for most produce farms in January 2018, with compliance dates for water-contamination issues entering into force in January 2022. According to some studies, as much as 46 percent of food contamination can come from produce, with leafy greens a particular culprit. Many farmers are unaware of how much their day-to-day practices will have to change. Consultant Will Daniels told the magazine, "It's a mixed bag of emotion and response and concern, or welcoming the regulation as creating kind of an even playing field for everybody."
  • Groups condemn delay in produce safety rule. On November 13, two nonprofits – the Center for Science in the Public Interest and the Center for Food Safety – condemned the Trump Administration for delaying the effective date of the Produce Safety Rule, which would require microbial testing of water for E. coli bacteria. The rule, mandated by the 2011 Food Safety Modernization Act, is intended to keep produce free of fecal contamination. Under the current plan, it will not go into effect until sometime between 2018 and 2022, depending on a number of factors, including the size of the farm. The organizations said that the delay could lead to as many as 730,000 additional cases of foodborne illness. "Americans deserve to know that their produce wasn't grown or rinsed in water contaminated with animal feces," said CSPI deputy director for legislative affairs Sarah Sorscher. "Testing water that is used to grow and harvest produce for E. coli will save both lives and money."
  • USDA delays effectiveness of an organic farm rule. On November 9, the USDA decided to delay until May 14, 2018 the effective date of a rule that would increase the animal-welfare protections provided for "organic" livestock. The department said that a 1990 law that created the federal organic program called for additional regulatory standards "for the care" of organic livestock, but said that important questions remain about the costs and benefits of additional regulation. The additional safeguards for animal welfare, USDA said, "should be limited to health care practices similar to those specified by Congress rather than as reflecting a stand-alone concern for animal welfare." Organizations of farmers who voluntarily participate in the federal organic program expressed disappointment in the delay. One of them, the Organic Trade Association, had already sued the USDA over the issue in September.