Way, John. It’s amazing how life can be running along great one day, you’re bothering no one, loving others, minding your own business, enjoying your work and then one crooked cop can railroad you. This cop who screwed me over–Robert Bifano– failed to arrest a suicidal AWOL soldier a few years ago and the guy went on to kill his wife and then shot himself. Bifano got sued for his ineptitude.
Your product is not generally recognized as safe and effective for the referenced uses and, therefore, the product is a “new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
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