FDA Takes Action Against Dietary Supplement Maker James G. Cole, Inc.
The Food and Drug Administration has filed a complaint seeking a permanent injunction against James G. Cole, Inc., its president, James G. Cole, and its general manager, Julie D. Graves, to stop the company’s distribution of unapproved drugs and adulterated dietary supplements in violation of the Federal Food, Drug, and Cosmetic Act.
The complaint was filed by the U.S. Department of Justice in the U.S. District Court for the District of Oregon, Portland Division.
The injunction would stop the company from promoting and distributing its products until it complies with current good manufacturing practice (cGMP) requirements for dietary supplements, as well as remove all disease claims are removed from its websites, product labels and other products and websites under Cole’s custody and control.
The FDA says that James G. Cole, Inc.‘s dietary supplements and other products have been marketed as treatments for cancer, heart disease, rheumatoid arthritis, autism, Alzheimer’s, fibromyalgia and high cholesterol. Under federal law, products offered for such uses are considered to be drugs, and none of those uses have been approved by the FDA.
The products include PCA, PCA-Rx, C-60, ACAI Resveratrol, Cytomune, Anavone, Liver Rescue, Probiotics and several other products. They are marketed under the Maxam Labs, Advanced Sports Nutrition and Maxam Nutraceutics brands.
In addition, during facilities inspections conducted in 2012 and 2013, the FDA found that James G. Cole Inc. distributed dietary supplements that were not manufactured in accordance with the cGMP requirements. For example, the company did not establish an identity specification for each component and did not conduct at least one appropriate test to verify the identity of a dietary ingredient.