Dietary Supplement GMP

This comment examines the FDA's proposed rule on current good manufacturing practice in manufacturing, packing, or holding dietary ingredients and dietary


The Food and Drug Administration is proposing current good manufacturing practice regulations for dietary ingredients and dietary supplements 

Stated Purpose:

To ensure consumer's access to safe dietary supplements

Summary of RSP Comment:

The FDA uses consumer survey results indicating that they do not view dietary supplements as safe and believe there is need for increased federal oversight in the production of the supplements. These survey results are conditional on the respondents actually using dietary supplements, suggesting that there is a disconnect between what consumers do and what they say. The FDA ignores this apparent inconsistency and uses the survey results as pretext for expanding its role in the dietary supplement market.

Further, FDA discounts the viability of private oversight methods such as third-party certification of a producer's manufacturing process. Despite the FDA's admission that some certification organizations have begun to offer these services and consumers are likely to be willing to pay for the benefits provided by them, FDA asserts that private certification will not provide sufficient safeguards.In its cost benefit analyses, the FDA compares its regulatory regime to one in which private certification does not exist.

Lastly, the FDA ignores the possibility of state and local regulation because of its concern that state regulators will use their authority for protectionist purposes. Such a possibility is entirely precluded under Interstate Commerce jurisprudence, and, as such, should not serve as a bar to considering the option of regulation by lower levels of government.