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

  • Califf testifies on his nomination as FDA chief. On January 12, Dr. Robert Califf testified before the full Senate Health, Labor, Education & Pensions Committee of the US Senate on his nomination as commissioner of the FDA. Dr. Califf, who would be the first permanent FDA commissioner in nearly a year, led the agency for a brief period during the Obama Administration. In his testimony, Dr. Califf said that, should he be approved, he will focus on three areas: emergency preparedness and response, drawing on lessons learned from the pandemic; consumer and patient protection –ensuring food safety and safe, effective medical products as well as addressing the nationwide opioid epidemic; and modernization and innovation – staying current on the latest advances to better guide industry and stakeholders “on everything from clinical trial development to best practices for protecting the safety of the US food supply.” Dr. Cahill concluded, “This is a once-in-a-generation time for public health, and the FDA must continue to play a vital role in protecting and promoting the health of all Americans by leveraging the acceleration in technology and biomedical knowledge.” Dr. Califf’s nomination is expected to be confirmed by the full Senate.
  • FDA launches RFR dashboard. On January 5, the FDA launched the interactive Reportable Food Registry (RFR) Data Dashboard, allowing any member of the public to easily view historical data from the registry. Congress established the RFR to help the FDA better track patterns of food and feed adulteration. The RFR accepts reports from public health officials and from food companies but not from the public and applies to all foods regulated by the FDA, except for infant formula and dietary supplements. The RFR is regarded as an essential tool for the food industry. The RFR program helps the agency’s state and local partners determine when to issue health alerts and take other steps to remove harmful food from the market and fine-tune their enforcement efforts. See the dashboard here.
  • Nonprofit calls for expansion of FDA Medwatch program. In a December 20 blog post, the nonprofit Center for Science in the Public Interest (CSPI) called on the FDA to beef up its Medwatch program for reporting food issues such as allergies. The program permits consumers and health professionals to report problems with drugs, and it also applies to foods. But CSPI said the program is severely underutilized for foods and that the relevant forms ask questions that seem to apply primarily to drugs. “The FDA needs a better system for reporting adverse events related to foods so that the agency can monitor potentially serious risks, from food allergies to inadequate labeling to microbial contamination. FDA is working on a new and improved, food-specific adverse event reporting system, and CSPI is advocating that the agency makes this a priority,” the blog post said.
  • New disclosure rule on bioengineered food goes into effect. A federal law mandating a new consumer labeling standard for foods containing genetically modified organisms (GMOs) is now in effect as of January 1, 2022.The law, which refers to GMOs by using the term “bioengineered foods,” does not require labeling as such but does require some disclosure of GMO content in the form of text, a symbol, a QR code, or a note to receive a text message. Some consumer advocates and environmental groups are arguing that the new standard has serious loopholes. The USDA, which administers the new law, has ruled that “highly refined” ingredients are exempt from disclosure if they no longer contain detectable amounts of modified genetic material. This means that the law does not apply to many processed foods made with ingredients derived from GMO crops. Furthermore, disclosure is not necessary if the proportion of GMO ingredients is less than 5 percent. The law will have a limited effect for another reason – very few foods now on the market are sold in a bioengineered form, among them some types of apples, canola oil, corn, eggplants, papayas, pineapples, potatoes, and salmon. Most fruits, vegetables, grains, seeds, and beans now sold in the US do not have a genetically modified version.
  • Study indicates that new GMO disclosure law may not affect consumers’ choices. Inspired by the GMO disclosure law, a new study by Cornell University faculty members Aaron Adalja and Jura Liaukonyte and two other researchers asks whether under such a law, consumers’ choices are likely to change. The study examined sales data from cereal products in Vermont after the state enacted its own GMO labeling law. That short-lived state law went into effect in July 2016 and was invalidated at the end of that year by the federal GMO labeling law that took effect in January 2022. The findings from the Cornell study showed that consumers' purchase rate of products made with GMOs did not change in a significant manner when the labeling law took effect.
  • Calorie labeling on restaurant menus prompts offerings of lower-calorie items, study finds. A study published on December 31, 2021 in the JAMA Network Open journal indicates that restaurant menu items that were introduced after FDA’s menu labeling law and related mandatory calorie labeling went into effect in 2018 contain about 25 percent fewer calories on average compared with dishes introduced before mandatory labeling. As part of the Affordable Care Act, restaurant chains with 20 or more locations in the United States must now post the calorie content of prepared foods on menus alongside the price of the item. The lead scientist for the article, Anna Grummon of the Harvard T.H. Chan School of Public Health, said, “The nationwide rollout of these calorie labels appeared to prompt restaurants to introduce lower-calorie items to their menus.” Earlier research has shown that people reduce their caloric intake slightly when ordering from restaurant menus that list calories.
  • Ground beef recalled because of possible E. coli contamination. On January 6, the USDA announced that Interstate Meat Distributors, a meat processing company, has recalled 28,365 pounds of ground beef because of possible E. coli contamination. The recall occurred after tests conducted by Consumer Reports found a dangerous strain of E. coli called O157:H7 in a package of Kroger-branded meat that was sold by Interstate. No illnesses have been reported from the beef. The beef that was recalled was sold at Albertsons, Fred Meyer, Walmart, and WinCo supermarkets and was shipped to stores in seven states -- Arizona, California, Nevada, Oregon, Utah, Washington, and Wyoming.
  • Waffle company sued in class action because protein claims are allegedly misleading. On January 1, a class action complaint was filed in the US District Court for the Northern District of California against Van’s International Foods, Inc., the maker of Power Grains Protein Original Waffles, on the grounds that much of the protein claimed for the product is not actually usable by human beings. The complaint says that a serving of the waffles is claimed by the manufacturer to contain 10 grams of plant-based protein. The plaintiffs contend that a consumer would “reasonably expect that each product will actually provide the amount of protein per serving claimed on the front of the product package.” However, not all proteins are capable of being processed by the human body, and the waffles have an FDA amino acid score of 0.4 to 0.5, meaning that only about 40 to 50 percent of their proteins can be processed by the body. Thus, the complaint asserts, the labeling of the product is misleading.
  • New plant-based food packaging fights mold and harmful bacteria. Scientists from Nanyang Technological University, Singapore and Harvard T.H. Chan School of Public Health have developed a biodegradable food packaging material that can eliminate harmful bacteria. The researchers say the new technology, which is also waterproof, is able to extend the shelf life of fresh fruit by up to three days compared to traditional plastic packaging. It may be used for an array of other foods, such as fish and meats. The main component of the packaging is zein, a corn protein that is a waste byproduct of ethanol manufacturing; other components of the packaging, such as cellulose, are also derived from plants, and the material is infused with antimicrobial compounds such as thyme oil which are also plant-based. The packaging releases antimicrobials only when bacteria or high humidity is present. The new material eliminates the need for plastic packaging, prolongs shelf life, and reduces spoilage - all critical, global-level food security issues. Philip Demokritou, who co-led the study and is Director of Nanotechnology and Nanotoxicology Center and Co-director of the NTU-Harvard Initiative on Sustainable Nanotechnology, said, “One of the most efficient ways to enhance food safety and reduce spoilage and waste is to develop efficient biodegradable non-toxic food packaging materials.”