Tag Archives FDA

At a speaking engagement, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb reportedly expressed that the agency’s standards of identity for milk have not been enforced. According to the standard of identity, milk is “the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows,” a definition that does not include non-dairy beverages produced from almonds, soy, rice or coconuts that are labeled as milk. Admitting that “an almond doesn’t lactate,” Gottlieb reportedly indicated that FDA will begin collecting public comments before determining its approach to the issue.

The U.S. Food and Drug Administration (FDA) has sent a warning letter to Roorda Dairy advising that an investigation of its premises revealed cattle sold for food that tested positive for unapproved antibiotics. The agency purportedly tested muscle tissue and found antibiotics used contrary to the approved label use and found no evidence of veterinary supervision. FDA’s approach to antibiotics in cattle use has been criticized, including a March 2018 New York Times report on the agency’s distinction between antibiotics for growth, which is not allowed, and antibiotics for disease prevention, which is acceptable under FDA standards. In 2017, the World Health Organization recommended ending the routine use of antibiotics in healthy animals.

As part of a proposal to reorganize several federal agencies, the Trump administration has recommended that food-safety regulatory oversight be shifted to the U.S. Department of Agriculture (USDA), combining the agency's Food Safety and Inspection Service (FSIS) with the current food purview of the Food and Drug Administration (FDA). According to the proposal, the Government Accountability Office found that the existing approach "has caused inconsistent oversight, ineffective coordination, and inefficient use of resources" and recommends "merging Federal food safety functions as a potential solution to this fragmentation." For example, the administration suggests, "[W]hile FSIS has regulatory responsibility for the safety of liquid eggs, FDA has regulatory responsibility for the safety of eggs while they are inside of their shells; FDA regulates cheese pizza, but if there is pepperoni on top, it falls under the jurisdiction of FSIS; FDA regulates closed-faced meat sandwiches, while FSIS regulates open-faced meat sandwiches." The proposed USDA agency, the…

The U.S. Food and Drug Administration (FDA) has released draft guidance on intentional adulteration of the food supply. The guidance aims to help manufacturers develop and implement plans to protect their products by providing details on the components of a food defense plan, including vulnerability assessments, mitigation strategies and training requirements. Large businesses must have a plan by July 26, 2019, with enforcement dates in 2020 and 2021 for small or very small businesses. FDA also indicated that it will issue two further installments of draft guidance on intentional adulteration focusing on vulnerability assessments and corrective actions. "The likelihood of an incident at a particular facility is low, but the intentional adulteration of the U.S. food supply represents a very serious threat – one that could have devastating public health consequences," FDA Commissioner Scott Gottlieb said in a statement. "The goal of this draft guidance, in its entirety, is to…

The U.S. Food and Drug Administration will host a public meeting on cultured meat, poultry and seafood on July 12, 2018. In a press release, FDA Commissioner Scott Gottlieb asserted that the agency governs "both substances used in the manufacture of these products of animal cell culture technology and the products themselves that will be used for food" and grouped cultured meats with other "rapidly evolving areas of technological innovation" such as genetically engineered foods and microbial, algal and fungal cells generated and used as direct food ingredients. "The FDA remains committed to using our expertise in relevant scientific areas to evaluate the safety of emerging food technologies, such as foods generated by animal cell culture technology," according to Gottlieb's statement. "But as we mentioned, in addition to leveraging the existing expertise of our staff, we’re also investing in making sure we are considering all the unique attributes and challenges…

A California federal court has dismissed a consumer’s putative class action against AdvancePierre Foods, Inc. alleging the company both physically and financially harmed her by selling her a microwavable sandwich made with partially hydrogenated oil (PHO). Hawkins v. AdvancePierre Foods, Inc., No. 15-2309 (S.D. Cal., order entered November 8, 2016). The court agreed with AdvancePierre’s argument that the U.S. Food and Drug Administration’s June 2015 final determination removing PHO’s status as a material generally recognized as safe for use in food implemented a June 2018 deadline for compliance to avoid allowing consumers to obtain damages for the use of PHO in the meantime. Under the Consolidated Appropriations Act of 2016 (CAA), “No partially hydrogenated oils as defined in the [Final Determination] shall be deemed unsafe . . . and no food that is introduced into interstate commerce that bears or contains a partially hydrogenated oil shall be deemed adulterated . .…

A Delaware cheese company and two individual defendants have pled guilty to a misdemeanor violation of the federal Food, Drug, and Cosmetic Act for distributing adulterated ricotta, queso fresco and fresh cheese curds in several neighboring states. U.S. v. Roos Foods, Inc., No. 16-0013 (D. Del., information filed January 22, 2016). Roos’ cheese was connected to a 2014 outbreak of Listeria that caused five adults and three newborns to contract listeriosis. The criminal information alleged the company produced the cheese in unsanitary conditions, including the “[f]ailure to clean food-contact surfaces as frequently as necessary to protect against contamination of food” and “failure to store raw materials or ingredients in a manner that protects against contamination.” In their agreement with the U.S. Food and Drug Administration (FDA), the defendants agreed to an injunction preventing them from processing or distributing food products until they undergo an FDA inspection and facility testing by…

Shook Partner Jim Muehlberger and Associate Iain Kennedy have co-authored an article for Law360 about slack-fill regulation and litigation. They note that although some product packaging uses unused space within a bottle or bag for functional purposes—transportation or theft protection, for example—companies have increasingly been targeted for litigation under the Fair Packaging and Labeling Act or U.S. Food and Drug Administration regulations. “All of the legitimate explanations in the world have not deterred some in the plaintiffs’ bar, who have seized upon slack-fill litigation as the newest product packaging and labeling class action du jour,” Muehlberger and Kennedy write. The article summarizes the litigation landscape, including existing putative class actions challenging potato chip, eye drop and deodorant packaging, and notes that plaintiffs usually allege some combination of misrepresentation, fraud, unjust enrichment, breach of warranties and consumer-protection statutory claims. Muehlberger and Kennedy offer ideas for minimizing slack-fill litigation risk, including considering…

Citing stakeholder concerns over insufficient time to develop meaningful submissions, the U.S. Food and Drug Administration (FDA) has extended by 90 days the period in which to submit comments about the agency’s risk assessment titled, “Multicriteria-Based Ranking Model for Risk Management of Animal Drug Residues in Milk and Milk Products.” FDA seeks suggestions for improving the specific criteria, scoring and weighting scheme; selection of animal drugs evaluated; and transparency of the risk assessment. Electronic or written submissions are now due by October 27, 2015. See Federal Register, July 30, 2015.   Issue 573

The Center for Science in the Public Interest (CSPI) has filed a citizen petition with the U.S. Food and Drug Administration (FDA) seeking a rule that would require sesame seeds and sesame products to be disclosed on food labels in the same way that allergens, such as milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soy, are disclosed. CSPI asks that sesame be added to FDA’s list of allergens in its “Statement of Policy for Labeling and Preventing Cross-contact of Common Food Allergens” “to address both labeling and cross contact issues related to food manufacturing practices.” The petition includes letters from parents of purported sesame-allergic children “explaining why better labeling is so important for their families.” They claim that reactions to sesame have been severe and life-threatening. See CSPI News Release, November 18, 2014.

Close