- The Dietary Supplement Health and Education Act of 1994 (DSHEA) amended the Food, Drug, and Cosmetic Act to create the current regulatory framework for dietary supplements. At the time the
DIETARY INGREDIENTS
Stakeholder Comments Reflect Discontent with FDA’s Draft Guidance for Quantitative Labeling of Supplements Containing Live Microbials
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- FDA’s regulation on nutrition labeling of dietary supplements requires that dietary ingredients for which a Reference Daily Intake (RDI) or Daily Reference Value (DRV) has not been established must be
FDA Renews Cautions Against Consumption of Kratom Following Conclusion of Salmonella Investigation
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- Kratom is a botanical substance that grows naturally in Southeast Asia. FDA classifies kratom as an opioid, noting that it is addictive and has been linked to severe health consequences
FDA oversees destruction and recall of kratom products
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- On February 21, FDA issued a press release announcing the voluntary destruction and recall of a large volume of kratom-containing dietary supplements manufactured and distributed nationwide under the brand names
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FDA Announces October Meeting on Pre-DSHEA List
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- Manufacturers or distributors of new dietary ingredients (NDIs) must submit a pre-market notification called a new dietary ingredient notification (NDIN) to FDA at least 75 days before marketing a dietary
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Supplement Spotlight: FDA Revised NDI Draft Guidance Does Not Alleviate Industry’s Concerns
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As previously reported on this blog, FDA issued a revised Draft Guidance titled, “Dietary Supplements: New Dietary Ingredient [NDI] Notifications and Related Issues,” in August 2016. The Agency received…
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Supplement Spotlight: FDA Revises NDI Draft Guidance
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- The Dietary Supplement Health and Education Act (DSHEA) requires the manufacturer or distributor of a
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Supplement Registry Update
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Leading dietary supplement trade association makes strides in developing product registry.
- As previously covered on this blog, a leading dietary supplement trade association — the Council for Responsible Nutrition
Supplement Stimulant Spotlight
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FDA warns companies marketing dietary supplements that contain methylsynephrine.
- As previously covered on this blog, FDA has the authority to take enforcement action against unlawfully marketed and/or dangerous dietary ingredients
Supplement Label Roll Call
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- As previously covered on this blog, a leading dietary supplement trade association —