More FDA warning letters for website claims and cGMP violations


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More FDA warning letters for website claims and cGMP violations
The US Food and Drug Administration has issued warning letters to two dietary supplement companies, as the agency maintains its vigilance of website claims and cGMP compliance.

The first letter, sent to Draper, Utah-based Juve International LLC and dated April 2, 2013, addresses claims made on the company’s website.

A legal alert from the American Herbal Products Association (AHPA) explained: “FDA states that Juve International's website claims its Juve Juices' ingredients lower blood pressure, reduce cholesterol, fight infection, prevent strokes, reduce risk of certain cancers, and the like, all found by FDA to be disease claims. Therefore, Juve Juice is a drug, and an unapproved one at that, warns FDA.”

Please click here to read the full warning letter​.

Private label distributor requirements

FDA also sent a letter to Cuddy, PA-based Entrenet Nutritionals Inc. for cGMP violations following an inspection of the company’s Cuddy facility on betweem October 12 and November 1, 2012.

In addition, the Agency stated that “therapeutic claims on your product labels establish that the products are drugs because they are intended for use in the cure, mitigation, treatment or prevention of disease.”

FDA also alleges that some products are misbranded as dietary supplements.

An AHPA legal alert explains: “Dietary supplement distributors (own label) must be aware that FDA is imposing cGMP requirements on this class of trade even though they do not manufacture product.

“This warning letter to Entrenet spells out requirements FDA sees for this company. The company is also warned over disease claims and improper labeling that cause some products to be misbranded.”

The letter, dated May 8, 2013, can be read here​.


The warning letters follow similar letters to other companies. To read our recent round-up of important warning letters, please click here​.   

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