Structure-Function Claims – FDA Compliance Made Easy

District Court sides with Industry on Dietary Supplement Substantiation

Dietary Supplements, Disease Claims, Drugs, Enforcement, FDA, Structure-Function Claims, SubstantiationFDA, FTC

A U.S. District judge New Jersey has ruled in United States v. Bayer Corporation that Bayer will not be held in contempt for alleged violations of a 2007 consent decree regarding the marketing of its Phillip’s Colon Health (PCH) product. …

Food & Drug (FDA) Attorney Katherine Giannamore Interviewed on Complexities of Marketing Cosmetics

Cosmetics, Disease Claims, Drugs, Enforcement, FDA, Labeling, Structure-Function Claims, Warning LettersFDA

On March 31, 2015, Attorney Katherine Giannamore, of The Law Office of Katherine Giannamore, P.A., was interviewed by Ryan Nelson of “The Rose Sheet” about the challenges that companies face when marketing cosmetic products. “The Rose Sheet” is one of …

FDA Warns of Marketing Cosmetics with Drug Claims

Cosmetics, Disease Claims, Drug, Drugs, Enforcement, FDA, Labeling, Structure-Function Claims, Warning LettersFDA

The difference between a product being marketed as a cosmetic and marketed as a drug can be a very thin line. However, the differences in regulation between the two are stark. The Federal Food Drug and Cosmetic Act (The Act) …

Dietary Supplement Company Prohibited from Operations After Ignoring FDA Warning Letter

CGMP, dietary supplement marketing, Dietary Supplements, Disease Claims, Drugs, Enforcement, FDA, Labeling, manufacturing practices, permanent injunction, Structure-Function Claims, Warning LettersFDA

On August 8, 2014, the U.S. Food and Drug Administration (“FDA”) obtained a court order from the United States District Court for the Middle District of Georgia against a dietary supplement manufacturer. The Order prohibits the manufacturer from selling dietary …

FDA Issues Guidance on Distinguishing Liquid Dietary Supplements from Beverages

Beverages, Dietary Supplements, FDA, Food, GRAS, Labeling, Structure-Function ClaimsFDA

On January 16, 2014, the U.S. Food & Drug Administration (“FDA”) published a guidance document entitled “Distinguishing Liquid Dietary Supplements from Beverages” (“Guidance”). Found here, the Guidance is aimed at explaining to industry how dietary supplements and beverages differ. Beverages …

FDA Seeks Permanent Injunction against Oregon Dietary Supplement Company

CGMP, Dietary Supplements, Disease Claims, Structure-Function ClaimsFDA

On October 21, 2013, the U.S. Food and Drug Administration (“FDA”) announced that it is seeking a permanent injunction against James G. Cole, a dietary supplement manufacturer based in Oregon, along with the company’s president, James G. Cole, and general …

FDA Issues Warning Letters to Companies Marketing Illegal Diabetes Drugs

Dietary Supplements, Disease Claims, Drugs, Enforcement, FDA, Labeling, Structure-Function Claims, Warning LettersFDA

On July 23, 2013, the U.S. Food and Drug Administration (FDA) announced that it issued warning letters to 15 domestic and foreign companies that were deemed to be unlawfully marketing diabetes products in violation of the Federal Food, Drug, and …

FDA Warns Dietary Supplement Firms for Marketing Concussion Treatments

Dietary Supplements, Disease Claims, Drugs, Food, Labeling, Structure-Function Claims, Warning LettersFDA

On September 6, 2012, the U.S. Food and Drug Administration (“FDA”) issued warning letters to two dietary supplement companies in connection with promoting unapproved products as drugs. According to the FDA, the firms cited by the Agency, PruTect Rx and …