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FDA Allows Longstanding MOU with AAFCO To Expire

On August 2, 2024, the Association of American Feed Control Officials (“AAFCO”) announced that its Memorandum of Understanding 225-07-7001 (the “MOU”) with the U.S. Food and Drug Administration (“FDA”) outlining the AAFCO...more

FDA Announces New Qualified Health Claim for Yogurt Products – With Limitations

Marketers of yogurt products may celebrate the latest approval by the Food and Drug Administration (“FDA”) of a new qualified health claim related to the consumption of yogurt and type 2 diabetes. However, producers of such...more

Caffeine’s Wake-Up Call: Navigating Legal Risks for Highly Caffeinated Beverage Products

In the bustling landscape of consumer goods, caffeinated beverages stand out as a daily staple for millions of Americans. A recent shift towards “clean caffeine” and caffeine alternatives has further energized consumer demand...more

FDA Releases Draft Guidance on Labeling of Plant Based Milk Alternatives

On February 22, 2023, the U.S. Food and Drug Administration (“FDA” or “Agency”) released draft guidance on labeling of plant-based milk alternatives (“PDMA”). This draft guidance is meant to clarify the FDA’s current view on...more

FDA Issues Warning Letters to Companies Whose Products Are Intended for Use with Food-Producing Animals

On May 26, 2022, the U.S. Food and Drug Administration (FDA) issued Warning Letters to four companies concerning the illegal sale of unapproved animal drugs containing cannabidiol (CBD) intended for use in food-producing...more

FDA Issues Final Guidance for Voluntary Recalls

Earlier this month, the U.S. Food and Drug Administration (“FDA”) completed guidance to help companies remove violative products from the market in a swift and effective manner. The guidance describes the precautionary steps...more

FDA Amends Yogurt Standard Of Identity

Starting in 2024, U.S. consumers are going to start seeing new formulations of yogurt on supermarket shelves. The U.S. Food and Drug Administration (FDA) has released an amended standard of identity for yogurt as part of its...more

Foods Soon To Bear Sesame Allergen Labels

Recently, President Biden signed the Food Allergy Safety, Treatment, Education and Research (FASTER) Act. The law adds sesame to the list of major allergens, requiring its disclosure on food labels as an allergen. Food...more

FDA Issues Action Plan To Reduce Heavy Metals In Foods

The U.S. Food and Drug Administration (FDA) recently released a new action plan designed to further reduce exposure to toxic elements, including heavy metals, from foods for infants and young children. This represents the...more

FDA Issues Warning Letters On Marketing And Sale Of OTC CBD Products

The U.S. Food and Drug Administration (FDA) issued Warning Letters this month to two companies concerning the marketing and sale of over-the-counter (OTC) drug products containing cannabidiol (CBD) as an inactive ingredient....more

FDA Reiterates Importance Of Allergen Labeling By Issuing Warning Letter Following Repeated Recalls

On December 16, 2020, the U.S. Food and Drug Administration (“FDA”) issued a corporate Warning Letter to Whole Foods Market (“Whole Foods”) following 32 recalls Whole Foods conducted over an approximate one year period for...more

Holiday Confusion For The Over-The-Counter Drug Industry: FDA Announces OTC Fee Schedule That HHS Quickly Withdraws

On December 29, 2020, the U.S. Food and Drug Administration (FDA) announced in a Federal Register notice the 2021 fee schedule for its Over-the-Counter Monograph Drug User Fee Program. That user fee program was an addition...more

The Trademark Trial And Appeal Board Rules U.S. Cheesemakers Can “Say, Gruyere!”

A recent decision of the Trademark Trial and Appeal Board (“TTAB”) highlights the overlap between trademark law and food regulatory law as well as the United States’ and Europe’s different approaches to Geographic Indications...more

FDA And OSHA Issue Employee Health And Food Safety Checklist For COVID-19

Last week, the U.S. Food and Drug Administration (FDA) and Occupational Safety and Health Administration (OSHA) issued a checklist to assist human and animal food operations during the COVID-19 public health emergency. The...more

FDA Finalizes Rule Related To Gluten-Free Labeling For Foods Containing Fermented Or Hydrolyzed Ingredients

The U.S. Food and Drug Administration issued a final rule, effective October 13, 2020, to establish compliance requirements for fermented and hydrolyzed foods, or foods that contain fermented or hydrolyzed ingredients, and...more

California’s OEHHA Proposes Regulation Requiring Warning For Acrylamide In Food

On August 4, 2020, the Office of Environmental Health Hazard Assessment (OEHHA) proposed to amend the Proposition 65 regulations. Proposition 65, also known as the Safe Drinking Water and Toxic Enforcement Act of 1986,...more

FDA Provides Updated Plan On Inspections During COVID-19

The U.S. Food and Drug Administration (FDA) announced updated plans for conducting routine inspections of domestic and foreign inspections during the COVID-19 public health emergency. In March, FDA announced that it was...more

FDA To Conduct Remote FSVP Inspections During COVID-19 Public Health Emergency

The U.S. Food and Drug Administration (FDA) has announced it will begin conducting remote inspections of importers under the Foreign Supplier Verification Program (FSVP) during the COVID-19 Public Health Emergency. FSVP...more

FDA And TTB Issue Additional Guidance On Hand Sanitizer Manufacturing, CARES Act Provides Tax Relief

The U.S. Food and Drug Administration (FDA) and Alcohol and Tobacco Tax and Trade Bureau (TTB) have issued new and updated guidance documents in addition to those previously published in order to address the decreased market...more

FDA Updates Recommendations On Social Distancing And Use Of PPE For Food Companies

Over the last several days, the U.S. Food and Drug Administration (FDA) has updated its recommendations for food manufacturers and food retailers during the COVID-19 public health emergency. While FDA continues to underscore...more

FDA Announces Guidance For Food Retailers During COVID-19 Pandemic

The U.S. Food and Drug Food and Drug Administration (FDA) has issued two guidance documents intended to assist restaurants and other retail food establishments during the COVID-19 public health emergency....more

Following FSIS Lead, FDA Announces Flexibility On Nutrition Labeling Requirements For Foodservice Products Diverted To Retail

The U.S. Food and Drug Administration (FDA) announced a new policy to provide flexibility for restaurants and food manufacturers that have products on hand that are not labeled for retail sale (i.e. labeled for foodservice)....more

FDA And TTB Issue Guidance To Increase Hand Sanitizer Production During COVID-19 Outbreak

The Food and Drug Administration and the Alcohol and Tobacco Tax and Trade Bureau (TTB) have both recently issued guidance documents to allow for the increased production of alcohol-based hand sanitizer during the COVID-19...more

FDA Issues Temporary Policy For Food Manufacturers And Importers In Light Of COVID-19 Outbreak

On March 17, 2020, the U.S. Food and Drug Administration (FDA) issued guidance to food manufacturers and importers in response to the COVID-19 pandemic. In the guidance, FDA stated it will temporarily not enforce supplier...more

FDA States CBD Is Not GRAS for Use In Food, Issues More Warning Letters

The U.S. Food and Drug Administration (FDA) issued a press release on the evening of Monday, November 25 concerning its recent enforcement actions and a regulatory decision concerning products that contain cannabidiol (CBD)....more

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