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

  • Nomination of new FDA chief advances in Senate. On December 3, a Senate committee forwarded the nomination of Dr. Stephen Hahn to be the next commissioner of the Food and Drug Administration. The Senate Committee on Health, Education, Labor and Pensions approved the nomination in an 18 to 5 vote, sending his nomination to the full Senate. Hahn is the chief medical officer at MD Anderson Cancer Center in Houston. His medical expertise is in radiation oncology, with specializations in lung cancer and sarcoma. Dr. Ned Sharpless, director of the National Cancer Institute, had served as acting FDA commissioner through November 1. Since Dr. Sharpless returned to his post at the institute, Dr. Brett Giroir, the assistant secretary of health, has been running the FDA.
  • Bill introduced on food contamination as FDA continues to investigate outbreak. On November 22, US Senator Kirsten Gillibrand (D-NY) introduced the Expanded Food Safety Investigation Act of 2019.  A similar bill is expected to be introduced in the House by Congresswoman Rosa DeLauro (D-CT), chair of the Congressional Food Safety Caucus, later this year. The bill authorizes the FDA to test for E. coli, Salmonella, and other pathogens on large animal farms in order to investigate outbreaks of food-related illness. These actions came in the wake of several outbreaks of E. coli in romaine lettuce – outbreaks that some believe may have been indirectly transmitted by farm animals. As of December 4, more than 100 people have been infected in a multistate outbreak of E. coli linked to romaine lettuce. The FDA and the CDC are investigating the outbreak. On November 22,  the CDC warned consumers against eating romaine  from California and called on restaurants not to serve it.
  • FDA will begin yearlong project to test romaine lettuce for bacteria. The FDA, on November 8, announced that it is conducting a one-year project to test romaine lettuce for Salmonella and E. coli bacteria. In recent years, romaine has been linked to several serious outbreaks of bacterial infection, including a current serious outbreak, and it’s not fully understood how the contamination has occurred. The agency will sample commodity romaine lettuce, in its natural state and prior to processing, and it will perform whole genome sequencing on whatever pathogens it detects. The project began in November 2019 and will continue through November 2020. Determining the genetics of the pathogens, the FDA said, will help it, the CDC, and state public health agencies develop targeted investigations into foodborne illness outbreaks.

  • GAO issues report calling on FDA to increase its scrutiny of imported seafood. On December 6, the Government Accountability Office − an independent, nonpartisan agency that works for Congress − issued a new report calling on the FDA to increase its scrutiny of the safety of imported seafood. Imports account for 90 percent of seafood consumption in the United States.  The GAO said that when the FDA finds an imported product may violate US laws, it can detain the product in port until the violation has been resolved—a process called an import alert.”  Before the product can be released from such an alert, the FDA should sample at least one shipment of the product. But, the GAO said, “We found that for 274 seafood products that FDA removed from import alerts between 2011 and 2018, FDA did not sample shipments for 95% of these products, and does not have a process to ensure it actually conducts such sampling.”   The GAO asked the FDA to improve its processes, time frames and performance goals in monitoring its effectiveness in checking on imported seafood.  In response, the FDA accepted all of the GAO’s recommendations.

  • Op-ed supports use of food standards of identity to provide information to consumers. Janet E. Collins, head of regulatory, government and industry affairs at Motif FoodWorks, wrote in an opinion article December 2 in Food Dive magazine that as consumer tastes evolve, so should the FDA’s standards of identity for foods. She said that when it comes to plant-based meat substitutes, the FDA should consider "ongoing innovation and food science" that have led to the emergence of many new nonmeat products in grocery stores. "In this crucial moment where FDA aims to promote innovation of healthier foods, it's essential that the agency consider these necessary technologies and changing consumer mindsets as it sets important guidance and regulations about plant-based alternatives − including what we call them," she wrote. She noted that the purpose of labeling restrictions is to inform consumers and that these restrictions should not be used to promote the interests of the meat industry.
  • FDA approves a new kind of chocolate. On November 22, the FDA announced that chocolate maker Barry Callebaut will be allowed for a 15-month period to label up to 60 million pounds of a pink-colored chocolate confection as "ruby chocolate." Ruby chocolate is a fourth type of chocolate and the newest to be marketed, after dark chocolate, milk chocolate and white chocolate. It was created by scientists at Barry Callebaut several decades ago, and the company recently discovered how to process cacao beans to obtain a marketable dark pink chocolate with a distinct berry-like taste. The temporary marketing order for ruby chocolate includes a lengthy definition of the substance, delineating how much cacao, milk fat and other solids and inclusions should be in it.

  • Meat substitutes are targeted by major PR campaign. The “meat wars” are escalating. On December 5, The New York Times published a feature story about a new marketing campaign undertaken by the Center for Consumer Freedom, a public relations firm whose financial supporters have included meat producers and others in the food industry. The group has been placing ads in major newspapers that raise health concerns about plant-based meat substitutes like the Impossible Burger and Beyond Burger. The ads slam the new products as “ultra-processed imitations” with many dubious ingredients. “What’s hiding in your plant-based meat?” asks one ad featuring a sad face made of two patties and a sausage. Impossible Foods, manufacturer of a popular plant-based burger, said the campaign is misleading and fear-mongering. The company says plant-based meat alternatives are better for consumers and better for the planet, requiring less land and water and producing fewer greenhouse gas emissions than meat from cattle.

  • Judge issues injunction against new Iowa ag-gag law. A federal judge in the Southern District of Iowa issued a preliminary injunction on December 2 against a so-called ag-gag statute passed by the Iowa legislature in early 2019. He prohibited the enforcement of the law while litigation brought by animal activists and the ACLU goes forward. The law makes it illegal to covertly take pictures or videos inside Iowa meatpacking plants and livestock facilities.  The challenge to this latest Iowa ag-gag law charges that it violates the First Amendment and criminalizes a free press.  A previous Iowa ag-gag statute, passed in 2012, was found unconstitutional by a federal judge. “Ag-gag laws threaten animals, food safety, workers’ rights and the environment, and federal courts have consistently ruled that they also violate the Constitution,” said Stephen Wells, executive director of the Animal Legal Defense Fund.

  • Michigan moves toward cage-free hens.  Michigan has become the fifth state to require by law that egg-laying hens be housed in cage-free systems. Lieutenant GovernorGarlin Gilchrist, acting in place of the governor, signed a bill on November 21 that will prohibit non-cage-free eggs from being sold in Michigan starting in 2025. The lieutenant governor said this will help maintain Michigan's standards for protecting animal welfare as among the strongest in the nation, while ensuring that egg producers will continue to thrive. The welfare of industrial chickens is a growing concern nationwide; for instance, McDonald's has announced that it will be 100 percent cage free by 2025. "Cage free" is distinct from "free range" – cage free hens are allowed to roam inside barns or large enclosures, while free-range hens may also roam outdoors.
  • Food packaging industry attempts to get rid of a common chemical. According to a November 25 article in Civil Eats magazine, the food packaging industry is attempting to move forward with a massive effort to eliminate a class of chemicals called PFAS, which have been long used in food packaging.  Two of the most widely studied of these compounds, perfluorooctane sulfonate (PFOS) and perfluorooctanoic acid (PFOA), sometimes dubbed "forever chemicals" since they don't easily break down, have been linked to a range of serious health problems in humans.  There are no legally enforceable limits for the use of PFAS at the federal level in the United States, but a citywide ban on them in San Francisco will go into effect on January 1, 2020, and the states of Maine and Washington recently banned their use in food packaging.  In June, the FDA announced, however, that it has no indication that the substances are a human health concern at the levels at which they are currently found in food.  See some of DLA Piper's earlier alerts on PFAS here.
  • CSPI urges action against dietary products marketed for fertility. On November 15, the nonprofit Center for Science in the Public Interest, after a lengthy investigation, filed petitions with the FDA and the Federal Trade Commission, asking the agencies to take enforcement action against manufacturers of dietary supplements marketed as fertility aids for women. The group identified 39 such products and concluded that none of their makers had provided reasonable scientific substantiation that they help women become pregnant. "Supplement manufacturers marketing fertility aids are making promises on which they can't deliver," said the group’s president, Dr. Peter G. Lurie. "They are selling false hope. They are preying on a vulnerable population. And they are diverting women away from treatments that actually have FDA approval and scientific evidence of effectiveness."
  • Minnesota is last "near beer" state. On November 1, Minnesota became the last state in the country to require that the alcohol content of beer sold at gas stations and supermarkets be capped at 3.2 percent alcohol and no higher. The Twin Cities Pioneer Press commented in a headline, "Here's to you, Minnesota. You're the last state in the nation with 3.2 beer." Calling the restriction antiquated, State Senator Karin Housley said the state's liquor laws "still reflect the era of Prohibition" and it is time to change the law. "Minnesota has a world class craft brewing scene and a booming market," she continued. "We should be encouraging growth in that area, not stifling it. I'm looking forward to having a robust debate on this issue during the upcoming legislative session."
  • Connecticut revamps laws on sale of beer and wine on premises. Effective January 1, 2020, Connecticut breweries will be able to sell beer and house-made wine on site, and something similar will hold true for wineries, which will be able to go into the brewing business and sell beer on site. This is the result of the passage of a new bill in the Connecticut legislature that will streamline regulatory permits to allow such craft producers to apply for and hold multiple permits. These permits could include the manufacture of wine, beer, spirits and cider under one roof. The new law will also permit beer manufacturers to sell nine gallons a day to a person for off-premises consumption. That is an increase from the previous maximum of nine liters.

  • Coalition hopes to bring permanent tax reform to beverage industry. A broad-based coalition set aside December 5 as a “Day of Action” on behalf of the craft beverage industry. The coalition includes beverage trade associations such as the Beer Institute, Brewers Association, Distilled Spirits Council of the United States, American Craft Spirits Association, Wine Institute, WineAmerica, the United States Association of Cider Makers and American Mead Makers Association. The purpose of the day was to lobby Congress concerning the pending Craft Beverage Modernization and Tax Reform Act, proposed legislation that would grant permanent status to tax reforms enacted on a temporary basis in 2017 that affect brewers, winemakers, distillers, cider makers and importers of beverage alcohol. The bill has 324 cosponsors in the House and 74 in the Senate.

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