- On October 24, FDA released a revised draft guidance document titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions
FDA Concludes that New Regulatory Frameworks for Foods and Supplements Containing Cannabidiol are Needed, Will Work with Congress
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- Yesterday, Janet Woodcock, M.D., the Principle Deputy Commissioner for the Office of the FDA Commissioner, released a statement regarding the Agency’s approach towards cannabidiol (CBD) and its application in the
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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FDA Confirms N-acetyl-L-cysteine (NAC) is Excluded From the Dietary Supplement Definition and Leaves Open Potential Rulemaking to Allow the use of NAC in Dietary Supplements
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- We previously reported on FDA’s November 24, 2021 tentative response denying requests in two citizens petitions (June 1, 2021 Council for Responsible Nutrition (CRN) petition and August 18, 2021 Natural
FDA Seeks Information on N-acetyl-L-cysteine (NAC)
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- N-acetyl-L-cysteine (NAC) is widely available as a dietary supplement and is also used to treat acetaminophen (Tylenol) poisoning and other conditions, such as lung collapse. In July 2020, the U.S.
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FDA & FTC Issue Warning Letters to 10 Companies
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- On September 9, 2021, the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) jointly issued warning letters to 10 companies for illegally selling dietary supplements claiming to treat
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FDA Warns Companies over Unapproved Fertility Claims
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- On May 26, FDA published a constituent update informing the public that it has issued warning letters to five companies for marketing dietary supplements that claim to cure, treat, mitigate,
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FDA Warnings Against Supplements for Depression
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- FDA will evaluate claims and other information on a dietary supplement’s website to establish the product’s “intended use.” In general, a dietary supplement is allowed to make claims about having
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CSPI Urges FDA to Take Further Action on Tianeptine Products
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- On August 25, 2020, the Center for Science in the Public Interest (CSPI) sent a letter urging FDA to take further enforcement against manufacturers, distributors, and retailers that sell products
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