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Dietary Supplements

Third-Party Audit Results ‘Definitely The Direction’ For FDA Supplement Facility Inspection Planning

“There's a lot of third-party audit information out there. Could we take that and apply it into our inspectional planning process?” says Office of Dietary Supplement Programs Director Cara Welch.

US FDA Makes Enforcement Discretion Official For Accepted Supplement Label Disclaimer Practice

“We have rarely, if ever, enforced this requirement” FDA says announcing enforcement discretion regarding requirement for disclaimer about supplement structure/function and other label claims to be printed on every panel of a product’s package.

No Sale For Supplement Direct Sellers’ Ad Claims In Industry Self-Regulation Group’s Reviews

Urban Retreat didn’t cooperate with Direct Selling Self-Regulatory Council’s review or “indicate any intent to comply with” recommendations to discontinue claims for its Balance Capsules. LoveBiome responded sufficiently to merit a DSSRC recommendation to pull three health claims.

Supplement Registration And Pre-DSHEA Lists: Key Missing Tools Limiting US Pre-Market Review

FDA looks to Congress for authority to require registration for all supplements available for sale in US for public-facing product listing but no authority can produce list of dietary ingredients available pre-DSHEA.

C&D Pulls Curtain Down On Gummy Vitamin Gambit With Sale To Piping Rock Health

Decision on vitafusion and L’il Critters business planned by end of year, but Piping Rock Health provided incentive for C&D to opt for divestiture.

Two Strikes And Firms Selling 7-OH Supplements Will Be Out Of Options To Avoid US Enforcement

Enforcements at facilities in Missouri operated by Shaman Botanicals and Relax Relief Rejuvenate Trading were preceded by administrative detention orders, FDA’s first use of the authority since its reorganization in October 2024.

In Challenge To Age-Restricted Sales, CRN Argues Court ‘Diluted Constitutional Protections’

CRN’s attorneys ask Second Circuit for en banc review of a three-judge panel’s denial of its appeal of 2024 decision in district court rejecting motion for preliminary injunction against enforcement of New York state law age-restricting sales of weight loss and muscle building supplements.

As US FDA Turns: Can Makary, Prasad And Pazdur Make It Work?

FDA leadership drama continues after Richard Pazdur was elevated to drug center director. Can Pazdur, CBER Director Vinay Prasad and Commissioner Martin Makary get along?

Industry’s Battle Against Age-Restricting Supplement Sales Spreads To Michigan

Lawmakers in IL, MA and NJ as well as MI consider proposals as firms marketing weight loss and bodybuilding supplements in New York already are subject to first-ever state law limiting sales of products to consumers 18 and older.

Prebiotic Ingredient Firm Comet Forecasts Trail Of GLP-1 Popularity Driving Gut Health Concern

Canadian firm states in 2026 forecast that its research, including consumer surveys and sales data, shows a majority of consumers, 65%, are not only familiar with the benefits of prebiotics but also interested in the ingredients, 55%.

Hemp’s Preclusion For Use As Dietary Ingredient In US Continues Even With THC Concerns Resolved

Regardless of THC level and even though the US hemp product marketplace is growing, FDA regulations prohibit the botanical’s use as a dietary ingredient or food additive because it’s been studied or approved for use as a drug in the US.

Get To Know: Responsibility For Quality Compelled Designs For Health To Make Its Own Supplements

After using supplements from third-party providers for personalized nutrition programs it offered to patients at wellness clinics it operated, Designs for Health has shifted to focus entirely on providing supplements to healthcare practitioners.