- We previously reported on FDA’s March 16, 2018 warning letter to Bhavani Fruits and Vegetables LLC for “serious violations” of Current Good Manufacturing Practice (CGMP) requirements under 21 CFR Part
FDA ENFORCEMENT
11th Circuit Rules for Plaintiffs in Class Action Lawsuit Based on Economic Loss From Purchase of ‘Worthless’ Supplements Containing DMBA – an Impermissible NDI
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- We previously reported on a flurry of FDA enforcement actions in 2015 based on adulteration per se, which followed years of relative inaction in the dietary supplement marketing arena outside
FDA Will Seek to Remove Flavored E-Cigarettes from the Market
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- On September 11, 2019 President Trump, along with HHS Secretary Azar and FDA Commissioner Sharpless, announced that the Food and Drug Administration (FDA) intends to soon finalize a compliance policy
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FDA Calls on Papaya Industry to Take Action to Prevent Foodborne Illness Outbreaks
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- On August 26, the FDA issued a letter to all sectors of the papaya industry to take action to prevent future foodborne illness outbreaks. As noted in the letter, since
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As FDA Considers Revisions to the Regulatory Definition, a Federal Court Agrees That Consumers Are Not Misled by Coconut Milk Marketed as “Healthy”
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Danone Dodges Deceptive Ad Suit Over Coconut Milk (Subscription to Law360 required)
- The U.S. District Court for the Southern District of California on August 14, 2019 dismissed a proposed class
FDA Issues First Warning Letter to Food Importer Under FSVP
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- On August 13, FDA announced the issuance of the first warning letter to a U.S. food importer under the Food Safety Modernization Act’s (FSMA) Foreign Supplier Verification Program (FSVP). As
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FSVP Follow-up
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- With little fanfare, FDA issued a new Import Alert (IA 99-41) to prevent the importation of foods by importers who are not in compliance with the Foreign Supplier Verification
FDA Adds New Ingredients to Dietary Supplement Ingredient Advisory List
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- On June 25, Frank Yiannis, Deputy Commissioner, Food Policy and Response, Food and Drug Administration (FDA), announced via Twitter that FDA has added octopamine and N-Methyltyramine to the Dietary Supplement
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FDA Authorizes Qualified Health Claim for Foods and Supplements with EPA and DHA Omega-3 Fatty Acids
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- On June 19, 2019, FDA announced that it would not object to qualified health claims for foods and dietary supplements stating that the consumption of eicosapentaenoic acid (EPA) and docosahexaenoic
FDA Releases Report on Inspection and Environmental Sampling of Ice Cream Production Facilities for Harmful Bacteria
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- A large number of pathogen-related recalls of ice cream (16 over the three-year period of 2013, 2014, and 2015) and a deadly outbreak of listeriosis in 2015 that was linked