- In a Warning Letter posted yesterday (but issued in April), FDA warned Gluten Free Remedies LLC that one of their dietary supplement products was adulterated because it declared sulbutiamine as
WARNING LETTER
FDA Issues FSVP-Related Warning Letters
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- FDA recently posted two warning letters issued to companies for failure to comply with the foreign supplier verification program (FSVP) requirements in Section 805 of the Federal Food, Drug, and
FDA Issues Pair of Warning Letters for Violation of FSVP Requirements
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- FDA issued two warnings letters this month for violations of the foreign supplier verification program (FSVP) requirements which are found in section 805 Federal Food, Drug, and Cosmetic Act (codified
FDA Issues Warning Letter to Manufacturer of Lead-Contaminated Apple Cinnamon Products
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- On August 9, 2024, FDA issued a warning letter to Austrofoods S.A.S., the Peruvian-based manufacturer that produced lead-contaminated apple cinnamon fruit puree pouches that were the subject of a recall
FDA Issues Warning Letter Related to Allergen Labeling Practices
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- Yesterday FDA announced that it had issued a warning letter to Bimbo Bakeries USA, Inc. for, among other things, including allergen labeling elements in certain product labels (e.g. “contains sesame”),
FDA and FTC Issue Six Warning Letters for Delta-8 THC Copycat Snacks
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- Delta-8 Tetrahydrocannabinol (Delta-8 THC) is an isomer of Delta-9 THC, the intoxicating component of certain cannabis plants. It is naturally occurring at very low levels in hemp and can be
FDA Issues Warning Letters to Companies Illegally Selling CBD Products
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- On November 21, 2022, FDA posted warning letters that had been issued to 11-11-11 Brands, Naturally Infused LLC, Newhere Inc dba CBDFX, Infusionz LLC, and CBD American Shaman, LLC for
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FDA Issues Warning Letters to 7 Dietary Supplement Companies for Drug Claims
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- On November 17, 2022, FDA posted warning letters to 7 companies for selling different dietary supplements with claims that caused the products to be “drugs” in violation of the Federal
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FDA Warns 4 Companies for Selling Tainted Honey-Based Products
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- On July 12, the FDA announced that it issued warning letters to four companies for illegally selling honey-based products that could pose a significant health risk to consumers due to
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FDA Issues Warning Letters to 11 Supplement Companies
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- On May 9, the FDA posted warning letters to 11 companies for selling adulterated dietary supplements that either contained new dietary ingredients (NDIs) for which the FDA had not received
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