Food and Beverage News and Trends - May 17, 2024
This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape.
FDA clarifies it is the key regulator of genomically altered animals. On May 1, the FDA issued final guidance, “Heritable Intentional Genomic Alterations in Animals: Risk-Based Approach,” along with draft guidance, “Heritable Intentional Genomic Alterations in Animals: The Approval Process.” These guidance documents clarify that FDA, in consultation with USDA, will be the agency that leads the regulatory review of intentional genomic alterations in animals. The genomes of such animals have been changed via molecular technologies to enhance or alter a desirable trait. Among recent examples: Angus cattle with short hair, making them better able to cope with hotter climates; faster-growing salmon; pigs without the cellular-level alpha-gal molecule, which triggers a rare but dangerous allergy. The FDA’s action was lauded by the Center for Science in the Public Interest. Its president and executive director, Dr. Peter G. Lurie, stated, “The agency’s current proposal appears to appropriately balance the prerogatives to bring innovative products to market and promoting consumer safety. The FDA’s scientific expertise and human and animal health mandates make it the appropriate agency to maximize the benefits and minimize the risks of the next generation of genetically altered animals.”
Canada engages in review of Safe Food for Canadians Act and key regulations. The Canadian Minister of Agriculture and Agri-Food and the Minister of Health are reviewing the Safe Food for Canadians Act and seeking input from stakeholders. The Act has been in force since January 2019 and covers safety standards for food and beverage in Canada, including grade standards, labelling, and advertising, import/export and provincial trade, and inspection and licensing. The objective of the review is to examine the efficacy of the Act and the Regulations and to evaluate what changes may be warranted. Responses may be provided to the Canadian Food Inspection Agency until May 2024.
FDA to hold webinar on new agricultural water rule. FDA will host a webinar on May 20 to provide an overview of the final rule on pre-harvest agricultural water, including an opportunity for participants to ask questions. The final rule replaces certain pre-harvest agricultural water requirements for covered produce (other than sprouts) in the 2015 Produce Safety Rule with requirements for systems-based agricultural water assessments to determine and guide appropriate measures that minimize potential risks associated with pre-harvest agricultural water. Register for the webinar here, and see our earlier description of the rule here.
Processed egg products from Ukraine receive Canada’s Sanitary Certificate. The Canadian Food Inspection Agency has successfully negotiated a sanitary certificate for Ukrainian processed egg products. While the certificate came into effect on May 16, 2024, trade cannot commence until Canada’s Automated Import Reference System has been updated. Importers of processed egg products from Ukraine are required to hold a Safe Food for Canadians license to import and must abide by all applicable Canadian requirements.
In speech to foundation, FDA commissioner sets forth priorities for the year. On May 7, in an address to the Reagan-Udall Foundation, FDA Commissioner Robert Califf said his number one priority this year is to create a new, unified Human Foods Program under one leader at the FDA. He said that other major priorities for the agency in the food area are stepped-up oversight for food safety, supply chain security, and dietary supplements, as well as developing a better understanding of “ultraprocessed” foods. Califf said that there is “a lot of observational evidence” of a direct relationship between ingestion of a large quantity of ultraprocessed foods and negative consequences to human health such as weight gain and diabetes. Thus, he said, much more research on the issue needs to be done. Califf’s appearance before the foundation also included a town hall-style discussion.
Canada launches Food Guide Toolkit for Educators. The Government of Canada has launched a food guide toolkit for use by teachers, health promoters, and community leaders who work with children between the ages of 4-11. The goal of the toolkit is to help children explore foods, learn food skills, develop healthy eating habits, and understand Canada’s food guide at an early age. The toolkit itself includes sections on Canada’s food guide, equity considerations, creating a supportive environment, and food safety.
CSPI sues FDA over dangers of opiates in poppy seeds used in food. On May 8, the nonprofit Center for Science in the Public Interest brought suit against the FDA for its alleged failure to act on a 2021 regulatory petition seeking to protect consumers from contaminated poppy seeds. The seeds themselves contain no or negligible levels of opiates, but inadequate processing can contaminate the seeds with opiates. (Some Internet sellers market their poppy seeds as “unwashed” or “unprocessed” as a signal to opiate users.) CSPI said that its investigations have found 19 deaths and 20 nonfatal overdoses from consuming poppy seeds. The lawsuit calls on the US District Court for the District of Columbia to order the FDA, under the authority of the Administrative Procedure Act, to provide a definitive response within 60 days of the court’s decision.
CFIA approves importation of duck meat from Thailand. The CFIA has approved the importation of cooked chicken and duck meat from Thailand. A number of conditions for import have been imposed which are set out at this link.
Florida and Alabama ban sale of lab-grown meat. On May 1, Florida Governor Ron DeSantis signed a bill that would prohibit the sale of lab-grown (also known as cell-based) meat in that state. Among the stated purposes of the law: to encourage residents to eat beef raised in Florida, and to protect the poultry and beef industries. On May 9, a similar bill was signed into law in Alabama; the Alabama bill does allow institutions of higher-education and government departments to carry out research in the emerging field. Only two cell-based chicken products have been approved for the US market, but their availability is very limited: GOOD Meat’s product is available in Singapore and occasionally at the José Andrés restaurant China Chilcado in Washington, DC.
Avian flu update. As of this writing, the H5N1 strain of bird flu, also called HPAI (highly pathogenic avian influenza), has been found in cattle on 49 dairy farms in 9 US states. On May 10:
The Department of Health and Human Services announced it will invest $101 million through the CDC and FDA for H5N1 testing, prevention, and treatment. The announcement followed FDA Commissioner Robert M. Califf’s May 8 appearance before the Senate Appropriations Committee, in which he stated that the agency is taking steps to prepare for the possibility that H5N1 could jump to humans and is working with other federal and state agencies to scale up medical countermeasures such as biosecurity and vaccine research. He stressed to the committee that “we’ve got to have the funding” to ensure that such measures may move forward.
USDA Secretary Tom Vilsack announced a new federal government plan to spend millions to stem the spread of avian influenza in the nation’s dairy herds. “Our mission is to contain this as an animal health event,” Vilsak said. “Ultimately, we want to eliminate the virus in the industry and develop over time a vaccine to prevent another emergence of H5N1 in cattle.”
The USDA announced it will provide financial disaster aid to affected dairy farms to address such needs as ordering lab tests; providing personal protection equipment to workers, improving biosecurity; and heat-treating milk from infected cows before discarding it. Each affected farm may receive up to $28,000 in aid over the next three months.
The FDA confirmed that pasteurization of dairy products does kill the H5N1 virus, and a study by the USDA of beef available in retail outlets concluded that the nation’s beef supply is free of the pathogen. FDA also announced it is making an additional $8 million available to surveil the milk production system and to help its regulatory partners at the state level.
The Colorado Department of Public Health and Environment confirmed that approximately 70 dairy farm workers are being monitored for possible symptoms of avian flu. All were exposed at two Colorado dairies, and none have visible symptoms. Colorado recently adopted a new federal rule that mandates testing of lactating dairy cattle moving between states.
And on May 3, the Government of Canada provided an update on HPAI, confirming that it has expanded surveillance to manage the potential emergence of the virus in Canadian dairy herds. This expanded surveillance consists of such measures as requiring negative HPAI test results for lactating dairy cattle that are imported from the US; conducting enhanced testing of milk at the retail level to look for viral fragments of HPAI; and facilitating the voluntary testing of cows that are not presenting with clinical signs of HPAI to enhance industry biosecurity efforts. On May 14, the Canadian Broadcasting Corporation announced that federal tests in Canada on 142 retail milk samples had found no signs of the virus in milk.
Appeals court upholds judgment for KIND in class action over its labeling. On May 2, the US Court of Appeals for the Second Circuit upheld a District Court decision to grant summary judgment for KIND, LLC, a snack food company, in a class action against the company. The company had been sued by a group of plaintiffs who alleged that the phrase “All Natural” on the labels of KIND’s products was deceptive and misleading. The lower court rejected these arguments and granted summary judgment for KIND, and the appellate court panel of judges affirmed. The court said that the plaintiffs had failed to create a triable issue of fact both in their definition of “All Natural” and in their deposition testimony. “Plaintiffs’ testimony, even taken collectively, does not establish an objective definition of how a reasonable consumer acting reasonably understands the term ‘All Natural.’ To the contrary, it establishes how divergent consumers’ expectations can be.”
