This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape.
First Ukrainian grain shipment since Russian invasion. The first shipment of grain to leave the port of Odessa since the start of the Ukraine war is en route to Lebanon, and it is expected that 16 more vessels will also set sail in the coming days. The Sierra Leone-flagged cargo ship Razoni, carrying 26,000 metric tons of corn, stopped in Turkey to be inspected by a Russian and Ukrainian team, part of the formalities of the landmark deal brokered in July by Turkey and the United Nations. UN Secretary General Antonio Guterres called the shipment “an important starting point. It must be the first of many commercial ships bringing relief and stability to global food markets.” Meanwhile, as the 2022 harvest season begins, officials in Ukraine are rushing to move the backlog of 20 million tons of grain harvested in 2021 that have been trapped in Odessa warehouses since the start of the war. The UN’s World Food Program notes that as many as 50 million people in 45 countries around the world are on the brink of famine, a burgeoning crisis exacerbated by wars and extreme weather.
FDA chief says major review of agency’s food program is under way. In congressional testimony July 20, FDA Commissioner Robert Califf said the agency has initiated a complete top-to-bottom review of its regulation of the US food supply, “including its structure, function, leadership, authorities and funding.” He noted that hiring and retaining staff for the food program has long been a concern and that he is grateful that the user fee reauthorization bills now pending in the House and Senate “recognize the great need to get the right staff on board quickly” as the agency “seeks to anticipate and respond to supply shortages.” In a statement, Califf announced that the agency is partnering with the Reagan-Udall Foundation, a congressionally mandated nonprofit that supports the FDA’s mission, to complete the review. A report and recommendation will be issued within 60 days. Califf also noted that the US food supply is safe and that FDA staff has succeeded in bringing nutritious food options to the American public.
FDA pledges to begin rulemaking concerning controversial supplement ingredient. The FDA appears to be moving ahead with a proposed rule to allow NAC (N-acetyl cysteine) as a dietary ingredient for use in supplements, according to a newly published guidance from the agency. This rulemaking would be dependent on a finding by the FDA that the ingredient does not have any safety concerns. NAC is a derivative of the amino acid L-cysteine and occurs naturally in some foods, such as garlic. Even though NAC has been used in supplements since the 1990s, the FDA said in 2020 that it is not a legal dietary ingredient because of its prior use as a drug. The industry then filed citizens’ petitions asserting that the FDA’s position was not justified under the law, and the agency responded on August 1 that it will complete a proposed rulemaking concerning the ingredient and will exercise enforcement discretion and not move forward against companies that use NAC in their supplements.
Canada enacts supplemental food labelling regulations. Health Canada has announced new regulations for supplemented foods that require manufacturers to put a standardized Supplemented Food Facts Table on the packaging. This label includes information on the amount of each supplemental ingredient added and information for consumers on cautions and directions for use. New regulations also impose restrictions on the type of foods that can be supplemented. Manufacturers and distributors are no longer required to obtain a Temporary Marketing Authorization (TMA) to sell a supplemented food. Supplemented foods that are already on the market with a TMA or for which a company has submitted an application for a TMA before July 21 that is subsequently approved by Health Canada will have until January 1, 2026, to comply with these new regulations, the public health department said in its announcement. New supplemented foods (without a TMA) will need to comply immediately.
Formal food safety strategy for berries. The FDA announced on July 26 that it is developing a formal food safety prevention strategy to enhance the safety of fresh and frozen berries and to prevent contamination. The strategy is being developed in response to a history of hepatitis A and norovirus outbreaks linked to the consumption of both fresh and frozen berries. In the United States, there recently have been four hepatitis A outbreaks and three norovirus outbreaks linked to fresh strawberries, including a current outbreak linked to fresh organic strawberries. Much like the ongoing prevention work that the FDA does for other agricultural commodities, such as leafy greens, tahini, and imported specialty mushrooms, the food safety prevention strategy for berries will be informed by the findings of surveillance sampling. In August, the agency plans to resume its project of collecting and testing frozen berries, which had been paused at the start of the COVID-19 pandemic.
FDA bans import of enoki mushrooms from Korea because of Listeria. On July 20, the FDA announced it has banned the import of all enoki mushrooms from Korea. The agency’s Import Divisions are authorized to detain, without physical examination, any enoki mushrooms from the Republic of Korea because of possible Listeria contamination. In fiscal year 2021, 43 percent of enoki mushrooms from Korea sampled by the agency were contaminated with Listeria. After a listeria outbreak in 2020, the FDA began implementing an Imported Specialty Mushroom Prevention Strategy, with a focus on enoki mushrooms, to protect public health and prevent future outbreaks.
Canadian Food Inspection Agency issues recall because ingredient not declared on the label.The CFIA has issued a recall of chicken wiener products distributed by Maple Lodge Farms because an ingredient in the products was not disclosed on the label. Zabiha Halal brand Original Chicken Wieners and Maple Lodge Farm Original Chicken Wieners, sold in 450-gram packages with best-before dates from June 30, 2022 to September 28, 2022, as well as 1-kg packages of Zabiha Halal brand Corn Dogs with best-before dates ranging from May 6, 2023 to June 14, 2023 are included in the recall. These products include pea protein, which was not disclosed on the product label ingredient list.
USDA formally declares Salmonella an adulterant in raw chicken products. On August 1, the USDA’s Food Safety and Inspection Service (FSIS) announced it will soon formally declare Salmonella to be an adulterant in breaded and stuffed raw chicken products. “Food safety is at the heart of everything FSIS does,” said Agriculture Secretary Tom Vilsack. “That mission will guide us as this important first step launches a broader initiative to reduce Salmonella illnesses associated with poultry in the U.S.” By making this declaration, FSIS will be able to ensure that highly contaminated products that could make people sick are not sold to consumers. Since 1998, breaded and stuffed raw chicken products have been associated with up to 14 outbreaks and approximately 200 illnesses. The problem is that some of these products appear cooked, but they are actually heat-treated only to set the batter or breading, and the product contains raw poultry.
Supplements industry says FDA amnesty may not work as planned. In May, the FDA announced it will exercise enforcement discretion, in a limited time and under limited circumstances, not to take action against supplement companies that had not filed a required NDI (New Dietary Ingredient) notification with the agency. On July 19, the Council for Responsible Nutrition, which represents dietary supplement industry companies, said persistent problems with the FDA’s recent NDI Draft Guidance means that few companies will likely file new notifications during the recently announced amnesty window. The Council said many sticking points and uncertainties remain in the amnesty proposal, and the industry is still striving to understand these issues; as a result, few companies are likely to take the FDA up on its offer. The Council said the FDA needs to work more closely with industry to fix this problem.
Blue Bell CEO’s motion is rejected, and his criminal trial begins. The criminal trial of Paul Kruse, former CEO and part owner of Blue Bell Creameries, began on August 1 in the US District Court for the Western District of Texas. Kruse is accused of attempting to cover up a deadly Listeria outbreak in 2015 arising from Blue Bell products. On July 27, the court ruled that Kruse would not be permitted to narrow the charges against him. He is charged with felony conspiracy and wire fraud for allegedly concealing from customers, for months, that the company knew its products were contaminated with Listeria. In a related case, Blue Bell pleaded guilty in 2020 to misdemeanor charges of distributing adulterated food products. The Texas-based ice cream maker paid a criminal fine of $17.3 million, plus an additional $2.1 million to settle civil False Claims Act allegations. Kruse’s trial is expected to last three to four weeks.
Court approves settlement of class action against Anheuser Busch. On July 19, the US District Court for the Western District of Missouri approved a settlement of a class action against Anheuser Busch LLC in which consumers had claimed they were deceived by the company’s packaging of its Lime-A-Rita Sparkling Margarita and other “Ritas” products sold by the company. The plaintiffs alleged that the “Sparkling Margarita” drinks contain no tequila, that the “Mojito” drinks contain no rum, and that the “Sangria” and “Rosé” drinks contain no wine. In the settlement, Anheuser-Busch also agreed to add the words “Malt Beverage” to the drinks’ packaging. The settlement permits purchasers of certain “Ritas” brand alcoholic drinks since January 1, 2018, to recover $21.25 per household with proof of purchase, or $9.75 without proof.