News & Analysis as of

Health Claims Manufacturers

Epstein Becker & Green

FDA Releases Updated Directory on Select Dietary Supplement Ingredients

Epstein Becker & Green on

Whether a consumer is taking calcium carbonate for strong bones, magnesium to fall asleep, or high-dose caffeine to stay awake, the U.S. Food and Drug Administration (FDA) does not approve dietary supplements for safety and...more

Searcy Denney Scarola Barnhart & Shipley

FDA: Blood Volume Expanders Present Severe Risks for Patients

On July 7, 2021, the U.S. Food and Drug Administration (FDA) issued new warnings regarding hydroxyethyl starch (HES) blood volume expanders. Specifically, the FDA is now requiring manufacturers to update the safety labels for...more

Faegre Drinker Biddle & Reath LLP

Preemption of Structure/Function Claims

Seen frequently on grocery items, and especially on dietary supplements, structure/function claims describe the role of a nutrient or ingredient in the structure or function of the human body. Examples include “Calcium builds...more

Womble Bond Dickinson

Insight into Medical Foods and the Scope of FDA Regulation

Womble Bond Dickinson on

The FDA has issued warning letters to manufacturers of products marketed as medical foods to treat a range of medical conditions, including fibromyalgia, autoimmune disorders, irritable bowel syndrome, arthritis, asthma,...more

Beveridge & Diamond PC

FDA and FTC Warn Dietary Supplement Manufacturers Against Making Fraudulent Anti-Coronavirus Claims

Beveridge & Diamond PC on

Beware of fraudulent claims that products will kill the coronavirus (officially, the Novel Coronavirus SARS-CoV-2) or cure the disease caused by that virus (Novel Coronavirus Disease 2019, abbreviated as COVID-19). The Food...more

BCLP

FDA Labeling Guidance: Making Structure/Function Claims for Dietary Supplements

BCLP on

Dietary supplement manufacturers seeking to explain and market their products must carefully craft statements on supplement labels to ensure compliance with the Food and Drug Administration’s (“FDA’s”) regulations regarding...more

Ward and Smith, P.A.

Federal Trade Commission Joins in Warning Companies About Unsupported CBD Health Claims

Ward and Smith, P.A. on

Much of the regulatory "attention" regarding cannabidiol ("CBD") has been, understandably, focused on the U.S. Food and Drug Administration ("FDA"). Indeed, the FDA was the first federal regulatory agency to publicly...more

Manatt, Phelps & Phillips, LLP

FTC Warns Companies on CBD-Infused Product Health Claims

The Federal Trade Commission warned three companies on Sept. 10 that they could not legally advertise that their CBD-infused products can “prevent, treat, or cure a human disease without competent and reliable scientific...more

Carlton Fields

CBD Health Claims Spur FDA Warning & Product Seizure Threats

Carlton Fields on

The 2018 Farm Bill gave cannabis businesses around the country a legal path to market and sell hemp and hemp-derived products. Despite the groundbreaking law, several regulatory uncertainties remain. The FDA has been a source...more

Bradley Arant Boult Cummings LLP

Labeling and Advertising Risks for CBD Companies - Cannabis Industry News Alert

Cannabidiol (CBD) – a non-psychoactive component of cannabis with numerous claimed health benefits – has steadily grown in popularity in recent years. This upward trajectory went into overdrive with the passage of the...more

Shook, Hardy & Bacon L.L.P.

Dietary Supplement & Cosmetics Legal Bulletin | October 2017

The use of beauty products is “an understudied source of environmental chemical exposures” with a disparate effect on women of color, George Washington University and Occidental College researchers argue. Ami R. Zota, et al.,...more

Carlton Fields

Claim Dismissed Against Brand For Deceptive Label, But Retailer May Still Pay - Eidelman v. Sun Prod. Corp., No. 16-cv-3914 (NSR)...

Carlton Fields on

A negligent misrepresentation claim against laundry detergent brand The Sun Products Corp., for an allegedly deceptive label was dismissed by a New York federal district judge, while an unjust enrichment claim against...more

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