Tag: FDA
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...
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...
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...
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...
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...
AHPA Submits Comments to FDA on NDI Draft Guidance for Dietary Supplements
Silver Spring, MD—The American Herbal Products Association (AHPA) has submitted comments in response to FDA’s draft guidance on new dietary ingredient (NDI) filings and enforcement...
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...
CRN: 6 Issues with FDA’s NDI Draft Guidance for Dietary Supplements…
Washington, D.C.—The Council for Responsible Nutrition (CRN) has submitted comments in response to FDA’s draft guidance on new dietary ingredient (NDI) filings and enforcement discretion....
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...
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...
