Politico has published a report on the U.S. Food and Drug Administration (FDA) based on more than 50 interviews with current and former employees of the agency, including former FDA commissioners. "There is a remarkable level of consensus that the agency is simply not working," states the report. "Current and former officials and industry professionals used terms like 'ridiculous,' 'impossible,' 'broken,' 'byzantine' and 'a joke' to describe the state of food regulation at FDA." Subjects examined by the investigation include leadership issues within the food division of the agency, a lack of action on foodborne illnesses, the issue of heavy metals in baby food and delays on nutrition targets. Sen. Patty Murray (D-Wash.) sent a letter to Commissioner Robert Califf expressing concern over the findings of Politico's investigation. "This report highlighted several delays in regulatory action that have endangered the public health. Over a decade after the Food Safety Modernization…
Tag Archives FDA
The U.S. Food and Drug Administration (FDA) has issued draft guidance on how it will evaluate the public health importance of a food allergen not listed as a major food allergen. Topics in the guidance include (i) scientific factors FDA will consider; (ii) what types of information will be relevant to the labeling and production of food containing the allergen; and (iii) recommendations for identifying and analyzing evidence for the evaluation of a non-listed food allergen.
Shook Of Counsel John Johnson III will co-present "Food and Dietary Supplement Regulation Year-in-Review" on Wednesday, March 30, 2022, at the Food and Dietary Supplement Safety and Regulation Conference. The conference, which takes place March 30-31, will be presented virtually by the Food and Drug Law Institute. "This session will recap the most significant recent developments in food and dietary supplement regulation and enforcement, including updates on FDA and United States Department of Agriculture (USDA) inspections, FDA and Federal Trade Commission (FTC) warning letters and enforcement, and compliance challenges faced by manufacturers and retailers," according to the conference agenda. "Panelists will also discuss the extent to which federal regulation and enforcement may have impacted private litigation over the past year."
The U.S. Food and Drug Administration (FDA) has announced that it will conduct quantitative consumer research on the use of "voluntary symbols that could be used in the future to convey the nutrient content claim 'healthy.'" The agency is simultaneously "developing a proposed rule that would update when manufacturers may use the 'healthy' nutrient content claim on food packages." "Updating labeling and making it more accessible helps empower consumers," the constituent update states. "In particular, claims and symbols can help consumers better understand nutrition information and identify foods that contribute to a healthy eating pattern. Manufacturers may also reformulate products to improve their nutritional value so they can use the claim."
The U.S. Food and Drug Administration (FDA) has issued a final rule amending the acceptable qualities of food labeled as yogurt. Under the rule, the standards of identity for lowfat and nonfat yogurt will be combined with the general definition; in addition, the list of allowable ingredients has expanded to include additional substances such as agave. "Additionally, the final rule supports the many innovations that have already been made in the yogurt marketplace, including continuing to allow manufacturers to fortify yogurts, such as adding vitamins A and D, as long as they meet fortification requirements," according to the constituent update. "The rule also allows various styles or textures of yogurt as long as they meet requirements in the standard of identity."
The U.S. Food and Drug Administration (FDA) has issued guidance indicating that it will not enforce particular provisions implementing the Food Safety Modernization Act (FSMA). "In certain situations the FDA has determined it is appropriate to take time to consider options, including rulemaking, to address concerns raised by stakeholders, while continuing to protect public health," the constituent update states. "As we work on solutions, the agency does not intend to enforce these provisions as they currently apply to entities or activities addressed in the guidance." Affected rules include: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Animal Food; Foreign Supplier Verification Program; Produce Safety; and Intentional Adulteration.
The U.S. Food and Drug Administration has announced that it has "made a low-risk determination for the marketing of products, including food, from two genome-edited beef cattle and their offspring." The agency determined that the product does not raise any safety concerns and that the product developer is not expected to pursue FDA approval before marketing the product, which is produced from cattle with an intentional genomic alteration (IGA) ensuring a short-hair coat. "To date, the FDA has made low-risk determinations for enforcement discretion for many other IGAs in animals for non-food uses and also has approved applications for five IGAs: in groups of goat, chicken, salmon, rabbit and, most recently, in a line of pigs," the announcement notes. “Today’s decision underscores our commitment to using a risk and science-based, data-driven process that focuses on safety to the animals containing intentional genomic alterations and safety to the people who eat…
U.S. Representative Rosa DeLauro (D-Conn.) has written a letter to the Office of the Inspector General seeking "assistance in investigating whether the Food and Drug Administration (FDA) took prompt, appropriate, and effective action leading up to the recent recall involving powdered infant formula produced by Abbott Nutrition's Sturgis, Michigan plant." DeLauro indicates she is "concerned the agency acted too slowly in pulling potentially dangerous infant formula off store shelves, which may have resulted in additional illnesses and death." The letter notes that FDA alerted the public to a potential link between formula produced at the Sturgis location and Cronobacter sakazakii four months after the agency learned of the possible link. "The delay between the September inspection and the recall raises serious questions about the FDA's ability to adequately regulate the infant formula industry," the letter asserts. "It seems evident that the FDA could have acted sooner to prevent additional illnesses and deaths…
The Center for Food Safety and International Center for Technology Assessment have filed a rulemaking petition urging the U.S. Food and Drug Administration to regulate the use of nanotechnology in infant formula. "These new materials can have fundamentally different properties from their bulk material counterparts—properties that also create unique human health and environmental risks—which create new oversight challenges for the regulatory agencies charged with protecting public health and the environment," the petition states. "Of unique concern is the use of engineered nanomaterials in infant formulas sold throughout the United States." The actions the groups request include "rigorous screening or safety testing" of infant formula for "nanomaterials or other potentially toxic synthetic ingredients," a required delineation of all nanoparticle ingredients on the label of an infant formula product, and a declaration that any infant formula currently available that contains nanomaterials is adulterated and misbranded.
Following the Environmental Protection Agency's 2021 final rule revoking tolerances for residues of the pesticide chlorpyrifos in food, the U.S. Food and Drug Administration's (FDA's) Center for Food Safety and Applied Nutrition has issued guidance for industry on how the agency will enforce the rule, which sets the expiration date for the tolerances as February 28, 2022. The guidance document is issued in the form of questions and answers; questions include "After the tolerances expire, is food containing residues of chlorpyrifos considered adulterated under the [federal Food, Drug and Cosmetic Act]?," "As an example, how would FDA respond to rutabagas with chlorpyrifos residues before and after the showing date?" and "As an example, how would FDA respond to canned rutabagas with chlorpyrifos residues before and after the showing date?" "There are two stages to our enforcement approach after February 27, 2022: (1) in Stage 1, we generally intend to exercise…
