FDA Takes Legal Action Against Dietary Supplement Maker In Pennsylvania

Traditional Chinese Medicine as practiced in Pennsylvania.

The FDA has for the first time taken legal action against a dietary supplement manufacturer and owner, which has substituted ingredients and products and failed to note the changes on the final product labels. The U.S. Department of Justice, which filed the permanent injunction for the FDA, could prohibit the defendant from producing and distributing over 400 products for violating the Federal Food, Drug and Cosmetic Act.

It is the first time that the FDA is carrying out legal proceedings against a dietary supplement manufacturer of this size because of its failure to comply with the dietary supplement current Good Manufacturing Practice (cGMP) regulations, which require manufacturers to ensure quality in their dietary supplements by controlling all aspects of their processes and procedures. In 2007, the cGMPs came into effect for dietary supplements in a stepped process based on company size. The company did not meet the relevant cGMP requirements after 2010, when the its compliance date became effective.

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