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FDA Issues More Warning Letters

Phase 2

The U.S. Food and Drug Administration (FDA) has sent out more warning letters to dietary supplement companies who are not following cGMP (good manufacturing practices) and label claims. ATS Labs, in Spring, TX, was sent a warning letter citing cGMP violations earlier in February. These violations cause the company’s products: Support, Liver Food, Test PSI, Lipo Blast, CFI, Dilate, Winalean, Pro Flex, Lady Lean and Weapon-X PreWorkout Extreme to become adulterated. This is because they were alleged to be improperly prepared, packed or held under conditions that do not mean the cGMP standards. Some of the company’s products were also alleged to contain DMBA, “our products, CFI, Weapon-X Pre-Workout Extreme, and Lady Lean, are labeled and/or offered for sale as dietary supplements. The Supplement Facts panels of these products declare 4-amino-2-methylpentane citrate as a dietary ingredient. This ingredient is also called, among other names, 1 ,3-Dimethylbutylamine, DMBA, 2-amino 4-methylpentane, AMP citrate, and 4-methyl-2-pentanamine, and will be referred to in the rest of this letter as DMBA,” the letter from the FDA stated.

In January, Majopa Industries (Guayama, Puerto Rico) also received a letter regarding its Graviola Extract product for unsubstantiated claims on labels, and cites alleged cGMP violations, which caused the product to be adulterated, according to the letter.

In addition to ATS Labs and Majopa Industries, in early December, ChayaHerbal.com received its warning letter for alleged drug claims on the website that establish products: Chaya Capsules, Chaya Tea and Chaya and Aloe Tea, and Sacha Inchi Omega 3-6-9 because they make drug claims such as, “[R]educes vein and hemorrhoid inflammation … reduces cholesterol levels … lung decongestant and disinfectant, prevents anemia … prevents arthritis, cancer and diabetes among other diseases.”

For more information, visit www.fda.gov.