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CRN Reacts to FDA’s NDI Enforcement Discretion Draft Guidance

On May 19, the U.S. Food and Drug Administration has released a draft guidance outlining a proposed policy to give companies an opportunity to submit late...
Multivitamin pills on a clay plate, on a vintage wooden table, with a sprig of mint

Mandatory Product Listing Proposal Included in Draft Legislation; NPA Weighs In

Washington, D.C.—The Senate Health, Education, Labor, and Pensions (HELP) Committee has released a discussion draft of its legislation to reauthorize FDA user fees for...

FDA Retracts Warning Letter to Glanbia Performance Nutrition

Silver Spring, MD—On May 9, 2022, the Food and Drug Administration (FDA) announced that it had issued warning letters to 11 companies for selling adulterated...
hand holding craft envelope with text WARNING on blue background, concept

FDA Warns Companies on Adulterated Dietary Supplements

Update (May 10, 2022, 3:20 pm ET): FDA's original announcement on May 9, 2022, as reported in an earlier version of this article, listed Glanbia Performance...
hemp with a bottle of hemp oil (cannabidiol cbd) on a table

FDA Sends Warning Letters to CBD, Delta-8 THC Companies

Washington, D.C.—The U.S. Food and Drug Administration (FDA) announced that it has issued warning letters to five companies for selling products labeled as containing...
dietary supplements

Dietary Supplement Listing Act of 2022 Introduced; Industry Divided

Washington, D.C.—The Dietary Supplement Listing Act of 2022 has been introduced by Senators Richard Durbin (D-IL) and Mike Braun (R-IN) with the intent of...
nac n-acetylcysteine dietary supplement

FDA Issuing Enforcement Discretion Guidance on NAC

Washington, D.C.—The U.S. Food and Drug Administration (FDA) announced in a Constituent Update that it is issuing  “Policy Regarding N-acetyl-L-cysteine: Draft Guidance for Industry”...
nac n-acetylcysteine dietary supplement

FDA Response on NAC Sets “Dangerous Precedent”

Washington, D.C.—In July 2020, the U.S. Food and Drug Administration (FDA) sent warning letters to seven supplement companies selling products containing N-acetyl-L-cysteine (NAC), claiming ...

FDA Shares “5 Things to Know” about Delta-8 THC

Silver Spring, MD—The Food and Drug Administration (FDA) has issued an updated consumer update titled 5 Things to Know about Delta-8 Tetrahydrocannabinol – Delta-8...
dietary nutritional supplements

Industry Reacts to FDA FY 2023 Budget Request; Proposal to Modernize Dietary Supplement Regulation

The U.S. Food and Drug Administration (FDA) announced that its request for a total budget of $8.4 billion as part of the President’s fiscal...