INADMISSIBILITY

Grounds. Waivers

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Drug

Under 21 USC 321(g)(1)

(A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the U.S., or official National Formulary, or any supplement to any of them; and

(B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and

(C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and

(D) articles intended for use as a component of any article specified in clause (A), (B), or (C).

A food or dietary supplement for which a claim, subject to sections 343(r)(1)(B) and 343(r)(3) of 21 USC, or sections 343(r)(1)(B) and 343(r)(5)(D) of 21 USC is made in accordance with the requirements of 21 USC 343(r) is not a drug solely because the label or the labeling contains such a claim.

A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with 21 USC 343(r)(6) is not a drug under clause (C) solely because the label or the labeling contains such a statement.

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