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by danneu
4978 days ago
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That's not true. What you defined is a drug. Accordingly, these ·products are drugs, under
section 201(g)(1)(C) of the Act, 21 U.S.C. § 321(g)(1)(C),
because they are not foods and they are intended to affect
the structure or any function of the body. Moreover, these
products are new drugs as defined by section 201(p) of the
Act, 21 U.S.C. § 321(p), because they are not generally
recognized as safe and effective for use under the
conditions prescribed, recommended, or suggested in
their labeling.
And you bet the FDA cares. Under sections 301(d) and 505(a) of the Act,
21 U.S.C. § 331(d) and 355(a), a new drug may not
be introduced or delivered for introduction into
interstate commerce unless an FDA approved application
is in effect for it.
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