- A high-level internal working group that FDA convened to explore potential regulatory pathways for cannabidiol (CBD) products announced by way of a January 26, 2023 statement that existing regulatory pathways
DIETARY SUPPLEMENTS
FDA Launches Dietary Supplement Ingredient Directory
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- Yesterday, FDA launched its new Dietary Supplement Ingredient Directory which contains a list of ingredients used in dietary supplements along with links to FDA’s actions and communications regarding the ingredients.
FDA Publishes List of 2023 Priority Guidance Topics
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- FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) routinely publish a list of possible new topics for guidance documents or revisions
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 Letter States that β-Nicotinamide Mononucleotide is Not Lawful Dietary Supplement
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- This past summer Inner Mongolia Kingdomway Pharmaceutical Limited (“Kingdom”) submitted a new dietary ingredient (NDI) notification to FDA for β-Nicotinamide Mononucleotide (NMN), a compound that has been touted for its
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 Finalizes NAC Enforcement Discretion Guidance
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- FDA issued final guidance regarding its decision to exercise enforcement discretion with respect to the sale and distribution of dietary supplements containing N-acetyl-L-cysteine (NAC). The final guidance is substantively identical
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Georgia Court Finds Dietary Supplement Labeling Claim within FDA’s Jurisdiction
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- On June 24, the Court of Appeals of Georgia held that Plaintiff Shawn Smith’s deceptive product labeling case raised questions best left to the FDA.
- By way of background, in
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Senate Committee Passes the FDA Safety and Landmark Advancements Act
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- On June 14, 2022, the Senate Health, Education, Labor, and Pensions (HELP) Committee passed the FDA Safety and Landmark Advancements (FDASLA) Act (S. 4348) which proposes various changes
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FDA Releases Draft Guidance on NAC Enforcement
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- On April 21, 2022 FDA announced the issuance of draft guidance on FDA’s policy regarding dietary supplements containing N-acetyl cysteine (NAC). The guidance details the agency’s intent to exercise enforcement
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