This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape.
- FDA official proposes “common sense reform” for the dietary supplements industry. Addressing an online conference on dietary supplements on May 24, FDA official Cara Welch said the agency is hoping to modernize the 26-year-old Dietary Supplement Health and Education Act (DSHEA) in a way that would involve “common sense reform.” DSHEA was originally enacted in 1994 which, she noted, was before the rise of social media and online shopping; the supplements industry, she added, has changed dramatically since then. Welch said an initiative such as mandatory product listing for all supplements on the market “would not impose significant burdens on the industry.” Welch, who is the acting director of the FDA’s Office of Dietary Supplement Programs, said the agency “is not looking to throw out DSHEA and start fresh – rather, we are talking about building on the current framework.”
- USDA and CDC investigate Salmonella linked to chicken products. On June 2, the USDA’s Food Safety and Inspection Service announced it is investigating a cluster of Salmonella illnesses that may be linked to frozen, raw, breaded and pre-browned stuffed chicken products. The CDC is also participating in the investigation. Noting that the onset dates of the patients’ illnesses ranged from February 11 to May 7, 2021, the USDA issued a public health alert to remind consumers about the proper handling and cooking of raw poultry products – most of the patients reported that they had not followed proper cooking instructions in preparing the chicken. Instead, the items were prepared for less than the recommended time and without using a meat thermometer to confirm the recommended temperature of 165 degrees Fahrenheit. As of June 2, 2021, a total of 17 people infected with the outbreak strain of Salmonella enteritidis have been reported from six Midwest states.
- Nonprofits write to FDA seeking action against hazardous elements in vinegar. On May 24, Food & Water Watch and the Empire State Consumer Project, Inc. asked the FDA to take action establishing limits and warnings for arsenic and lead in vinegar products sold in US stores. These dangerous elements, the group said, are frequently found in balsamic vinegars and glazes imported from such countries as Spain, Greece and Italy. “Given the growing popularity of vinegars, especially balsamics, the dangerous nature of these contaminants, and the apparently extensive contamination, vinegars and reductions must be given particular attention in order to protect public health,” the groups said in their letter. “This is especially critical for pregnant women because both lead and arsenic can seriously damage the fetus. Exposure to arsenic in utero is associated with DNA damage and micronuclei in newborns.”
- Supreme Court declines to act on appeal of FDA’s vaping regulations. On June 7, the US Supreme Court decided not to hear an appeal filed by entities that are challenging the FDA’s decision to regulate electronic cigarettes and vape pens. The Court’s action is a win for the FDA and leaves in place its regulations as well as a 2020 ruling by the US Court of Appeals for the Fifth Circuit that had rejected the challenge. The challengers, a Mississippi vape shop and a vaping industry trade group, had sought to invoke the rarely used non-delegation doctrine, which says that if Congress did not give clear guidance to a regulatory agency, the agency’s actions are invalid. The appeals court had held that congressional delegation of authority to the Secretary of Health and Human Services to deem additional products subject to the Tobacco Control Act is not unconstitutional.
- Court rejects challenge to FDA ban on unpasteurized butter. In an opinion issued May 24, the US District Court for the District of Columbia rejected a challenge to the authority of the FDA to ban the sale and shipment in interstate commerce of butter that is not pasteurized. The opinion emphasized the FDA’s authority to act in the interest of furthering the public health. “Ultimately, the FDA’s decision to require the pasteurization of butter to prevent the spread of communicable diseases is ‘a scientific judgment within its area of expertise’ that is entitled to ‘a high level of deference,’” the court concluded. The case was filed by the Farm-to-Consumer Legal Defense Fund (FTCLDF) and one of its members, Mark McAfee of Organic Pastures Dairy.
- Illinois legislature passes bill to ensure healthful drinks as default in kids’ restaurant meals. On May 27, the Illinois legislature passed a bill that would provide that healthful beverages such as water, milk and 100 percent juice are the default drinks served with children’s meals in restaurants, rather than soda, lemonade, fruit punch and other sugary drinks. The bill, now awaiting signature by Governor JB Pritzker, makes Illinois the fourth state to pass such a bill, after California, Hawaii and Delaware. “The bill is an important step in addressing health inequities in our state,” said state Representative Elizabeth Hernandez, a sponsor of the bill. “It ensures that all children have the same healthy options in their kids’ meals.” Proponents of the bill said it would help reduce the occurrence of heart disease and Type 2 diabetes in the state.