Under 21 U.S.C. 350b(a), the manufacturer or distributor of a dietary supplement
containing a new dietary ingredient that has not been present in the food supply as an
article used for food in a form in which the food has not been chemically altered must
submit to FDA, at least 75 days before the dietary ingredient is introduced or delivered for
introduction into interstate commerce, information that is the basis on which the
manufacturer or distributor has concluded that a dietary supplement containing such new
dietary ingredient will reasonably be expected to be safe. FDA reviews this information to
determine whether it provides an adequate basis for such a conclusion. Under section
350b(a)(2), there must be a history of use or other evidence of safety establishing that the
new dietary ingredient,when used under the conditions recommended or suggested in the
labeling of the dietary supplement will reasonably be expected to be safe. If this
requirementi s not met, the dietary supplementi s considered to be adulterated under
U.S.C. 342(f)(l)(B) because there is inadequate information to provide reasonable
assurance that the new dietary ingredient does not present a significant or unreasonable risk
of illness or injury.
FDA has carefully considered the information in your submission, and the agency has
concerns about the evidence on which you rely to support your conclusion that a dietary
supplement containing Piracetam will reasonably be expected to be safe.
Your product is excluded from the definition of "dietary supplement" under 21 U.S.C.
321(ff)(3)(B). Piracetam is an article authorized as an investigational new drug (IND) for
which substantial clinical investigations have been instituted in the United States, and the
existence of such investigations has been made public. The results of at least two clinical
studies conducted under authorized INDs were published in peer reviewed journals. In
addition, there is no evidence that Piracetam was marketed as a dietary supplement or a
food prior to the authorization to investigate Piracetam as a new drug. Therefore Piracetam
is excluded from the statutory definition of a dietary supplement under 21 US.C.
321(ff)(3)(B).
In summary, Piracetam is not a dietary supplement under the Federal Food, Drug, and
Cosmetic Act. Moreover, the product appears to be a drug under the Act and thus subject
to the regulatory requirements of drugs.