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Weekly News Briefs: New Chapter, NJ Labs, and More

NJ Labs reports on FDA warning letters NJ Labs reported FDA warning letters that will be issued to companies that have failed to validate that their...
adverse event reporting dietary supplements safety

Insights on Adverse Event Reporting from the Dietary Supplements Regulatory Summit

Washington, D.C.—The 7th annual Dietary Supplements Regulatory Summit, held in Washington D.C. and virtually on July 21, 2022, hosted briefings from the Food and...
nac n-acetylcysteine dietary supplement

FDA Issues Final Guidance on “Enforcement Discretion” of NAC

This article has been updated with comments from the industry. Washington, D.C.—The Food and Drug Administration (FDA) has issued Guidance for Industry: Policy Regarding N-acetyl-L-cysteine. The...
questions about dietary supplements, quality

NPA: Study on Adulterated Supplements “Reaffirms FDA’s Performance Failures Gaps”

Washington, D.C.—As WholeFoods Magazine has reported, a new report published in the Journal of the American Medical Association (JAMA; vol. 328, no. 4) suggests...
Courtesy of CHPA

Claims & Labeling: 5 Key Takeaways from the Dietary Supplements Regulatory Summit

Washington, D.C.—The 7th annual Dietary Supplements Regulatory Summit, held in Washington D.C. and virtually on July 21, 2022, hosted briefings from the Food and...
Multicolor vitamins and supplements on bright paper background. Concept for a healthy dietary supplementation. Close up.

AHPA Submits Comments to FDA on NDI Draft Guidance for Dietary Supplements

Silver Spring, MD—The American Herbal Products Association (AHPA) has submitted comments in response to FDA’s draft guidance on new dietary ingredient (NDI) filings and enforcement...
dietary supplements

Study Points to FDA Shortcomings in Policing Adulterated Supplements

Washington, D.C.—FDA warning letters are falling short when it comes to deterring bad actors from selling dietary supplements adulterated with novel and unapproved stimulants...
dietary nutritional supplements

CRN: 6 Issues with FDA’s NDI Draft Guidance for Dietary Supplements…

Washington, D.C.—The Council for Responsible Nutrition (CRN) has submitted comments in response to FDA’s draft guidance on new dietary ingredient (NDI) filings and enforcement discretion....
hand holding craft envelope with text WARNING on blue background, concept

4 Kratom Companies Sent FDA Warning Letters

Silver Spring, MD—On June 30, 2022, the Food and Drug Administration (FDA) issued warning letters, jointly with the Federal Trade Commission (FTC), to four...
Multicolor vitamins and supplements on bright paper background. Concept for a healthy dietary supplementation. Close up.

Senate HELP FDA Authorization Bill Passes Committee; Industry Groups “Strongly Concerned”

Washington, D.C.—Earlier this year, the Senate Health, Education, Labor, and Pensions (HELP) Committee released a discussion draft of legislation to reauthorize FDA user fees...