A California federal court has granted a stay awaiting guidance from the U.S. Food and Drug Administration (FDA) in a putative class action alleging that General Mills uses partially hydrogenated vegetable oils, which contain trans fat, in its baking mixes. Backus v. Gen. Mills, Inc., No. 15-1964 (N.D. Cal., order entered August 18, 2015). After finding that the plaintiff had standing because he alleged economic and immediate physical injury, the court turned to his claims of unlawful and unfair business practices under California law and held that they were plausibly alleged. The public nuisance and implied warranty of merchantability claims were insufficient, the court found, because the plaintiff failed to show a public harm distinct from his own injury and he failed to allege “that the baking mixes were unfit for even the most basic degree of ordinary use.” The court then granted General Mills’ motion to stay the continuing…
Category Archives U.S. Government and Regulatory Agencies
U.S. Sens. Dianne Feinstein (D-Calif.), Kirsten Gillibrand (D-N.Y.) and Elizabeth Warren (D-Mass.) have authored an August 17, 2015, letter expressing concern that the U.S. Department of Health and Human Services, U.S. Department of Agriculture and U.S. Department of Defense have not yet responded to an executive order establishing a Presidential Advisory Council on Combatting Antibiotic-Resistant Bacteria. According to the letter, which claims that food animal production accounts for 75 percent of “medically important antibiotics sold each year,” the appointed agencies have failed to provide a formal response or approve nominations for advisory council members. In particular, the senators ask that the final council include at least three experts from outside the food industry. “As noted in our December 2014 letter, representatives from industrial animal producers associations and the veterinary drug industry have publically voiced doubts about the need to reduce antibiotic use in animals and about the impact that the…
The U.S. Food and Drug Administration (FDA) has published a July 31, 2015, warning letter targeting the use of whole stevia leaf in food and beverages. Issued to Ten Ren Tea Co. of San Francisco, Ltd., the letter claims that tea products containing “Stevia leaf, tea bag cut” are adulterated under the Federal Food, Drug, and Cosmetic Act “because they bear or contain an unsafe food additive.” “Any substance added to a conventional food, such as your Ten Ren Chrysanthemum Tea and Hibiscus Spice Tea, must be used in accordance with a food additive regulation, unless the substance is the subject of a prior sanction or is generally recognized as safe (GRAS) among qualified experts for its use in foods [21 CFR 170.30(g)],” notes the agency, which has only permitted highly-refined stevia preparations in specific applications. “[W]e are not aware of any basis to conclude that Stevia leaf is GRAS…
The U.S. Department of Agriculture’s Office of the Under Secretary for Food Safety, National Oceanic and Atmospheric Administration and the U.S. Food and Drug Administration have announced a September 24, 2015, public meeting in College Park, Maryland, to discuss draft U.S. positions for consideration at the 34th Session of the Codex Committee on Fish and Fishery Products (CCFFP) slated for October 19-24 in Alesund, Norway. The CCFFP develops global standards for fresh, frozen (including quick frozen) or otherwise processed fish, crustaceans and molluscs. Agenda items at the September gathering will include draft codes of practice for processing of fish sauce and processing of fresh and quick-frozen raw scallops as well as proposed food additive provisions in standards for fish and fishery products. See Federal Register, July 30, 2015. Issue 575
The U.S. Department of Agriculture (USDA) is soliciting nominations for five open slots on the National Genetic Resources Advisory Council (NRGAC), a subcommittee of the National Agricultural Research, Extension, Education, and Economics Advisory Board. NRGAC members are charged with recommending policies for collecting, maintaining and utilizing genetic resources as well as considering approaches for their conservation. The agency is specifically looking for three candidates with scientific backgrounds (i.e., agricultural sciences, environmental sciences, natural resource sciences, health sciences, nutritional sciences) and two candidates representing the general public. The deadline for nominations is August 28, 2015. See Federal Register, August 10, 2015. Issue 575
The Grocery Manufacturers Association (GMA) has petitioned the U.S. Food and Drug Administration (FDA) “to approve specific low-level uses of partially hydrogenated oil (PHOs) in food products.” According to an August 5, 2015, press release, the petition seeks approval to use PHOs for color, flavor and texture when “important for the production of safe food products.” Because FDA revoked the generally recognized as safe (GRAS) status of trans fats on July 16, 2015, food manufacturers must now ask the agency to approve the ingredient for specific purposes. “Our food additive petition shows that the presence of trans fat from the proposed low-level uses of PHOs is as safe as the naturally occurring trans fat present in the normal diet,” said GMA Chief Science Officer Leon Bruner. “It’s important to know that food and beverage companies have already voluntarily lowered the amount of trans fat added to food products by more…
The U.S. Food and Drug Administration (FDA) has issued guidance for industry about the agency’s “current thinking regarding the use of nanomaterials or the application of nanotechnology in food for animals.” According to FDA, the recommendations are intended to assist industry and other stakeholders identify potential safety or regulatory status issues. See Federal Register, August 5, 2015. Issue 574
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 U.S. Food and Drug Administration (FDA) has issued draft guidance for industry about the agency’s current thinking regarding the disclosure of small amounts of nutrients and dietary ingredients on nutrition labeling. The document focuses on how the agency intends to use its enforcement discretion when a conflict occurs between compliance with § 101.9(c) and § 101.9(g) of Title 21 of the Code of Federal Regulations such that compliance with both sections is not possible. FDA is also considering whether to revise both sections and, if so, may reportedly amend or withdraw the draft guidance. Those wishing to submit comments on the draft guidance must do so by September 28, 2015. See Federal Register, July 30, 2015. Issue 573
The U.S. Food and Drug Administration (FDA) has told a California federal court that the agency will not issue guidance until 2016 about the use of “evaporated cane juice” (ECJ)—which plaintiffs nationwide assert is merely sugar—on food and beverage labeling. Swearingen v. Late July Snacks LLC, No. 13-4324 (N.D. Cal., agency letter filed July 13, 2015); Swearingen v. Healthy Beverage LLC, No. 13-4385 (N.D. Cal., agency letter filed July 13, 2015). The court issued an order in May 2015 requesting FDA to indicate whether the agency would issue guidance within 180 days. “FDA is actively working on a final guidance to address this issue,” Associate Commissioner for Policy Leslie Kux writes. “However, because of competing priorities, FDA cannot commit to issuing a decision within 180 days. . . . We have received a substantial number of comments and extensive amounts of supporting materials. FDA is obligated to review and consider…
