FDA Holds Dietary Supplement Distributor, Not Contract Manufacturers, “Ultimately” Responsible for GMP Failings

September 9, 2011

FDA's warning letter was issued to Confidence Inc. on July 7.

In a warning letter issued to Confidence Inc. on July 7, FDA admonished the company for failing to meet Good Manufacturing Practices (GMP), stating that as the product distributor, the company, and not its contract manufacturers, is ultimately responsible for meeting regulations.

“As an own-label dietary supplement distributor that contracts with other manufacturers to manufacture dietary supplements that your firm releases for distribution under your firm’s name, FDA considers you to be a manufacturer of such dietary supplements. As such, you have ultimate responsibility for the dietary supplements that you introduce or deliver for introduction into interstate commerce,” FDA’s letter states.

The letter points out the following GMP infringements of 21 CFR Part 111:

  • Failing to establish specifications for each component used in the manufacture of the supplements

  • Not establishing specifications for dietary supplement labels

  • Failing to establish and maintain written procedures for quality-control operations

  • Failing to establish written procedures for the company’s holding and distributing operations

  • Not collecting and maintaining reserve samples of each lot packaged

In addition, the letter cites the company and its website for making drug claims.

Nutritional Outlook thanks Harry Rice, PhD, for the tip.