The U.S. Food and Drug Administration (FDA) has issued a final rule allowing “the safe use of mica-based pearlescent pigments prepared from titanium dioxide and mica as color additives in certain distilled spirits.” Mica-based pearlescent pigments are currently approved as color additives in many foods and beverages, including distilled spirits containing “not less than 18 percent and not more than 23 percent alcohol by volume.” Effective November 5, 2015, the new rule permits the use of these pigments at a level of up to 0.07 percent by weight in distilled spirits containing not less than 18 percent and not more than 25 percent alcohol by volume, while finding that “certification of mica-based pearlescent pigments prepared from titanium dioxide is not necessary for the protection on the public health.” “Regarding cumulative exposure from the current and petitioned uses of mica-based pearlescent pigments, we note that in our recent final rule that…
Category Archives Food and Drug Administration
Weeks after the U.S. Food and Drug Administration (FDA) sent Hampton Creek Foods a letter warning that its Just Mayo is misbranded because it does not contain eggs, emails obtained through the Freedom of Information Act reportedly indicate that the American Egg Board (AEB) and a public relations firm made a concerted effort to remove Just Mayo from the market. The emails reportedly detail the actions the group undertook, including a complaint to FDA, an attempt to convince Whole Foods to stop selling Just Mayo, aid to Unilever in its litigation against Hampton Creek, and payments to food bloggers who post about how “real and sustainable foods, like eggs,” fit into their lifestyles. Details about Unilever’s lawsuit against Hampton Creek appear in Issue 549 of this Update. Public health attorney Michele Simon posted the emails on her blog, alleging that AEB likely broke laws during its attempt to quash Hampton…
The U.S. Food and Drug Administration has issued draft guidance for industry titled “A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods—Part II (Menu Labeling Requirements in Accordance with 21 CFR 101.11.” When finalized, the guidance is intended to assist chain establishments with 20 or more locations (e.g., grocery stores, quick service restaurants, pizza delivery outlets, convenience stores, movie theaters, fast food restaurants) comply with menu-labeling requirements for standard menu items, including self-service offerings. See Federal Register, September 16, 2015. Issue 578
The U.S. Food and Drug Administration (FDA) has issued five warning letters to the distributors of pure powdered caffeine, citing two fatalities linked to caffeine toxicity as evidence that the products “are dangerous and present a significant or unreasonable risk of illness or injury to consumers.” Equating 1 teaspoon of pure caffeine to 25 cups of coffee, FDA also warns consumers not to purchase or use powdered caffeine as “it is nearly impossible to accurately measure pure powdered caffeine with common kitchen measuring tools and you can easily consume a lethal amount.” In particular, the agency plans to “aggressively monitor the marketplace” for pure powered caffeine being sold as a dietary supplement. The warning letters not only find the products adulterated under the Federal Food, Drug, and Cosmetic Act, but argue that labeling directs consumers to use difficult measurements such as one-sixteenth of a teaspoon. “Consumers are unlikely to have…
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…
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 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
