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Tuesday, May 20, 2014

Family Smoking Prevention and Tobacco Control Act/Food Drug and Cosmetic Act can not Regulate Nictone

As it turns out, upon reading the various acts you see the following:

See:

U.S. Code › Title 21 › Chapter 9 › Subchapter II › § 321
21 U.S. Code § 321 - section (g)1 -
(g)
(1) The term “drug” means
(A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and
[nicotine is listed in the National Formulary]

and

(rr)
(1) The term “tobacco product” means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).

(2) The term “tobacco product” does not mean
[ my underline ] an article that is a drug under subsection (g)(1), a device under subsection (h), or a combination product described in section 353 (g) of this title.

The Family Act amends (1) and (2) as

TITLE I—AUTHORITY OF THE FOOD
AND DRUG ADMINISTRATION
SEC. 101. AMENDMENT OF FEDERAL FOOD, DRUG, AND COSMETIC ACT.
(a) DEFINITION OF TOBACCO PRODUCTS
.—Section 201 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended
by adding at the end the following:
‘‘(rr)(1) The term ‘tobacco product’ means any product made
or derived from tobacco that is intended for human consumption,
including any component, part, or accessory of a tobacco product
(except for raw materials other than tobacco used in manufacturing
a component, part, or accessory of a tobacco product).
‘‘(2) The term ‘tobacco product’ does not mean an article that
is a drug under subsection (g)(1), a device under subsection (h),
or a combination product described in section 503(g).


So, as I originally postulated and as is confirmed here the "Family Smoking Prevention and Tobacco Control Act" would not seem to include the regulation of nicotine "derived" from tobacco because nicotine is something that already exists outside of the tobacco plant, i.e., just like water or chloropyll.

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