new dietary ingredient notification
FDA Releases New Dietary Ingredient Final Guidance, Associations Respond
On March 5, the U.S. Food and Drug Administration (FDA) announced the availability of a final guidance for industry titled “Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry.” According to the FDA, the guidance is intended to help manufacturers and distributors of new dietary ingredients (NDIs) and dietary supplements prepare and ...
Industry Questions FDA Policy Notice on NDIs
On May 20, FDA’s (U.S. Food and Drug Administration) Center for Food Safety and Applied Nutrition (CFSAN) published a notice in the Federal Register announcing the availability of a draft guidance, “Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notification.” Under the new policy described in this draft ...
NPA Files Citizen’s Petition With FDA on Specific CBD Relief
On Feb. 22, in a Citizen’s Petition to the U.S. Food and Drug Administration (FDA), the Natural Products Association (NPA) requested the FDA either: Determine cannabidiol (CBD) is not excluded from the definition of a dietary supplement under 21 U.S.C. §321(ff)(3)(B) allowing the Commissioner the ability to exercise enforcement discretion in a specific and selective ...
AHPA Recommends FDA Implement Policies to Support Responsible Innovation
The American Herbal Products Association (AHPA) submitted extensive and specific policy recommendations on July 15 to the U.S. Food and Drug Administration (FDA) to support responsible dietary supplement innovation while preserving and strengthening FDA’s ability to efficiently and effectively protect the public from unsafe and unlawful products. AHPA submitted these recommendations to FDA in response to an ...
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