April 26, 2018

FDA Files Injunction Against Oregon Dietary Supplement Maker

The FDA has filed a permanent injunction against the dietary supplement manufacturer James G. Cole, Inc., after the company’s “repeated distribution of unapproved drugs and adulterated dietary supplements in violation of the Federal Food, Drug, and Cosmetic Act.” The company is based in Hood River, Oregon.

GavelsMelinda K. Plaisier, the FDA’s associate commissioner for regulatory affairs, said in a statement, “This company has ignored the multiple warnings they have been issued by the FDA by continuing to make unsubstantiated drug claims about the products it sells and by failing to conform to the cGMP requirements for dietary supplements.” In addition, some of the supplements were not manufactured in accordance with the cGMP requirements for dietary supplements.

The company has claimed their supplements treat cancer, heart disease, rheumatoid arthritis, autism, Alzheimer’s, fibromyalgia, and high cholesterol. Federal law states that products offered for such uses are considered drugs.¬†The products include PCA, PCA-Rx, C-60, ACAL Resveratrol,¬†Cytomune, Anavone, Liver Rescue, and Probiotics marketed under the brand names Maxam Labs, Advanced Sports Nutrition, and Maxam Nutraceutics.

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