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Dietary Supplement Distributors are Responsible for Contract Manufacturer’s CGMP Compliance

A dietary supplement distributor that uses a contract manufacturer to make its dietary supplement can be held liable for the contract manufacturer’s failure to comply with current good manufacturing practices (“CGMPs”).   Accordingly, distributors should ensure that their contract manufacturers follow CGMPs.

According to the CGMP final rule,  a company must only “comply with the CGMP requirements that apply to [its] operations related to manufacturing, packaging, labeling, and holding of dietary supplements.” , 72 Fed. Reg. 34751, 34790 (June 25, 2007).   To illustrate this point, FDA stated that it is the manufacturer’s responsibility to do component testing, not the packager or labeler’s responsibility, because the packager or labeler receives a finished dietary supplement, not components.  Id. at 34851.  This suggests that companies are only responsible for CGMP regulations applicable to their specific operations.  Under the example FDA gave, however, FDA said that the packager or labeler must still establish specifications to ensure that the received product is adequately identified and consistent with the purchase order.  Id.

Just as the packager or labeler is not off the hook entirely for operations performed by another company, neither are distributors.  The CGMP final rule states:

In cases where a distributor contracts with a manufacturer to manufacture a dietary supplement that the distributor then distributes under its own label, the distributor has an obligation to know what and how manufacturing activities are performed so that the distributor can make decisions related to whether the packaged and labeled product conforms to its established specifications and whether to approve and release the product for distribution.

Id. at 34790.

In sum, it is not only FDA’s duty to ensure that the dietary supplement industry is complying with CGMPs, it is also the duty of segments of the industry to ensure that other segments of the industry are complying.

Failure to self-police can result in harsh penalties.  If a distributor releases a dietary supplement for distribution that was not prepared, packed or held under conditions that meet CGMP regulations, the distributor violates the FDCA’s prohibition against the introduction into interstate commerce of any adulterated dietary supplement, and the distributor can be subjected to both civil and criminal penalties.   See 21 U.S.C. §§ 331(a), 333(a), 342(g).


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