Food & Beverage Litigation & Regulatory Update

Category: FDA

  • FDA Issues Draft Nutrition and Calorie Labeling Guidance for Retail Venues

    The U.S. Food and Drug Administration has issued draft guidance for industry titled “A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods—Part II (Menu Labeling Requirements in Accordance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,…

  • FDA Cracks Down on Sales of Pure Powdered Caffeine

    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…

  • General Mills Trans Fat Case Stayed for FDA Guidance

    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…

  • FDA Warning Letter Targets Use of Stevia Leaf

    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,…

  • GMA Petitions FDA for Specific Uses of Trans Fat

    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…

  • FDA Issues Guidance About Nanomaterials in Food for Animals

    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…

  • FDA Extends Comment Period for Risk Assessment of Animal Drug Residues in Milk

    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…

  • Labeling Small Amounts of Nutrients, Dietary Ingredients Subject of FDA Draft Guidance

    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 §…