FDA Warning Letters 33786

FDA Warning Letters

WASHINGTON--The Food and Drug Administration (FDA) issued several warning letters in the past month for companies allegedly making claims outside of the allowance of the Dietary Supplement Health & Education Act (DSHEA).

Integrity Nutraceuticals, an ingredient supplier, received an FDA warning letter concerning claims made on its Web site for several of its products, including Cinnulin PF, gamma oryzanol, chitosan, 5-methyl-7-methoxyisoflavone and grape seed extract. The agency alleges the claims are promoted with therapeutic claims, which position the ingredients as drugs rather than dietary supplements. FDA also took the firm to task for its stock of 4-androstenedione, which the company stated was a dietary supplement ingredient. FDA took action several months ago stating the agency considers andro a new dietary ingredient (NDI), for which it has received no notification; as such, the ingredient is considered adulterated and unsafe.

FDA investigated claims made online by Berkeley Premium Nutraceuticals for its products Rovicid, Rogisen and Enzyte. In addition to questioning the use of therapeutic claims, which would position the products as drugs, the agency tested the products and found the tablet weight for Rovicid and Enzyte was significantly lower than the label contents would suggest, making the products misbranded. FDA further questioned Berkeley's promotion of its Prulato product for treating benign prostatic hyperplasia (BPH), and its statement that its facility has been certified by FDA.

Grimmer Enterprises received a warning letter regarding purported drug claims made for an American ginseng product, including use of ginseng to treat cardiovascular disease, diabetes, impotence and cancer. In addition, analysis of the ginseng capsules showed pesticide residues for which no tolerance levels have been established, making the product adulterated.