§2206 — Title 21 Food and Drugs | U.S. Code

Summary

If a business must get a permit or register with the Treasury under federal alcohol laws and it must also register because it makes, processes, packs, or holds alcoholic drinks, then the rules in this Act do not apply to that business for those alcohol-related activities. That exception is subject to the changes in sections 102, 206, 207, 302, 304, 402, 403, and 404 of the Act. The exception does not cover regular (non-alcohol) food unless the food is prepackaged so no one touches it and it makes up no more than 5 percent of the facility’s sales. Except for those limited cases, foods that are not alcoholic beverages are covered by the Act.

Title 21, §2206

Food and Drugs — Source: USLM XML via OLRC

(a)Except as provided by section 102, 206, 207, 302, 304, 402, 403, and 404 of this Act, and the amendments made by such sections, nothing in this Act, or the amendments made by this Act, shall be construed to apply to a facility that—

(1)under the Federal Alcohol Administration Act (27 U.S.C. 201 et seq.) or chapter 51 of subtitle E of the Internal Revenue Code of 1986 (26 U.S.C. 5001 et seq.) is required to obtain a permit or to register with the Secretary of the Treasury as a condition of doing business in the United States; and

(2)under section 350d of this title is required to register as a facility because such facility is engaged in manufacturing, processing, packing, or holding 1 or more alcoholic beverages, with respect to the activities of such facility that relate to the manufacturing, processing, packing, or holding of alcoholic beverages.

(b)Subsection (a) shall not apply to a facility engaged in the receipt and distribution of any non-alcohol food, except that such paragraph shall apply to a facility described in such paragraph that receives and distributes non-alcohol food, provided such food is received and distributed—

(1)in a prepackaged form that prevents any direct human contact with such food; and

(2)in amounts that constitute not more than 5 percent of the overall sales of such facility, as determined by the Secretary of the Treasury.

(c)Except as provided in subsections (a) and (b), this section shall not be construed to exempt any food, other than alcoholic beverages, as defined in section 214 11 See References in Text note below. of the Federal Alcohol Administration Act (27 U.S.C. 214), from the requirements of this Act (including the amendments made by this Act).

Notes & Related Subsidiaries

Editorial Notes

References in Text

This Act, referred to in subsecs. (a) and (c), is Pub. L. 111–353, Jan. 4, 2011, 124 Stat. 3885, known as the FDA Food Safety Modernization Act, which enacted this chapter and sections 350g to 350l–1, 379j–31, 384a to 384d, 399c, and 399d of this title, section 7625 of Title 7, Agriculture, and section 280g–16 of Title 42, The Public Health and Welfare, amended section 331, 333, 334, 350b to 350d, 350f, 374, 381, 393, and 399 of this title and section 247b–20 of Title 42, and enacted provisions set out as notes under section 331, 334, 342, 350b, 350d, 350e, 350g to 350j, 350l, and 381 of this title. section 102, 206, 207, 302, 304, 402, 403, and 404 of the Act enacted section 350l, 350l–1, 384b, 399d, 2251, and 2252 of this title, amended section 331, 333, 334, 350d, and 381 of this title, and enacted provisions set out as notes under section 334, 350d, 350l, and 381 of this title. For complete classification of this Act to the Code, see

Short Title

note set out under section 2201 of this title and Tables. The Federal Alcohol Administration Act, referred to in subsecs. (a)(1) and (c), is act Aug. 29, 1935, ch. 814, 49 Stat. 977, which is classified generally to subchapter I (§ 201 et seq.) of chapter 8 of Title 27, Intoxicating Liquors. section 214 of the Act probably means section 203 of the Act, which is classified to section 214 of Title 27 and defines “alcoholic beverage”. For complete classification of this Act to the Code, see section 201 of Title 27 and Tables. The Internal Revenue Code of 1986, referred to in subsec. (a)(1), is classified generally to Title 26, Internal Revenue Code.

§2206 Alcohol-related Facilities