News & Analysis as of

Dietary Supplements Food and Drug Administration (FDA) Compliance

Morrison & Foerster LLP

New Dietary Ingredient Notifications: FDA Addresses Common Pitfalls and Shares New Educational Tools

On June 11, 2025, the U.S. Food and Drug Administration (FDA) released educational videos and a new fact sheet to facilitate compliance with the agency’s New Dietary Ingredient Notification (NDIN) review process. Under the...more

Akin Gump Strauss Hauer & Feld LLP

FDA Adds a Dose of Clarity to the NDIN Process

Recently, the U.S. Food and Drug Administration (FDA) released two educational videos and a supplemental fact sheet to guide dietary supplement manufacturers and distributors through the New Dietary Ingredient Notification...more

Gardner Law

New Draft FDA Guidance for Dietary Supplement Master Files

Gardner Law on

FDA has developed a new set of requirements for documenting the safety of dietary supplement ingredients. Manufacturers are able to market products with new ingredients without preapproval as long as they can prove they are...more

McDermott Will & Emery

After Almost 25 Years, FTC Issues New Health Products Compliance Guidance

McDermott Will & Emery on

The Federal Trade Commission (FTC) announced its Health Products Compliance Guidance on December 20, 2022. The 2022 guidance updates and replaces the FTC’s 1998 guidance, Dietary Supplements: An Advertising Guide for...more

Hinch Newman LLP

Advertising Law Alert: FTC Announces New Health Products Compliance Guidance

Hinch Newman LLP on

In December 2022, the the Federal Trade Commission published new guidance regarding representations about the benefits and safety of health-related products: Health Products Compliance Guidance. Federal Trade Commission...more

Venable LLP

FTC Announces Health Products Compliance Guidance

Venable LLP on

On December 20th, 2022, the Federal Trade Commission published new guidance regarding claims about the benefits and safety of health-related products: Health Products Compliance Guidance. This guidance replaces the...more

Goodwin

Common Bioresearch Monitoring Violations: Updates from FY 2021 to Now

Goodwin on

The Bioresearch Monitoring Program (BIMO), run by the U.S. Food and Drug Administration (FDA), oversees the conduct of on-site inspections and data audits of FDA-regulated research in support of new product development and...more

American Conference Institute (ACI)

[Webinar] What New Dietary Ingredient Master Files Mean for Innovation & Compliance - May 27th, 1:00 pm - 2:00 pm EST

FDA first raised the concept of Master Files for dietary supplements in its 2016 revised NDI Guidance. The agency views master files as a tool to promote better compliance with NDI notification requirements. Ingredient...more

Morgan Lewis

FDA Rule Prohibits Certain Nutrient Content Claims for Omega-3 Fatty Acids

Morgan Lewis on

The final rule prohibits label claims of food products, including dietary supplements, that are “high in,” “rich in,” or an “excellent source of” DHA or EPA and allows some nutrient content claims for ALA. On April 28,...more

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