Page:United States Statutes at Large Volume 90 Part 1.djvu/461

 PUBLIC LAW 94-278—APR. 22, 1976 " (B) which— " (i) is intended for ingestion in tablet, capsule, or liquid form, or " ( i i) if not intended for ingestion in such a form, does not simulate and is not represented as conventional food and is not represented for use as a sole item of a meal or of the diet. " (2) For purposes of paragraph (1)(B)(i), a food shall be considered as intended for ingestion in liquid form only if it is formulated in a fluid carrier and it is intended for ingestion in daily quantities measured in drops or similar small units of measure. " (3) For purposes of paragraph (1) and of section 403(j) insofar as that section is applicable to food to which this section applies, the term 'special dietary use' as applied to food used by man means a particular use for which a food purports or is represented to he, used, including but not limited to the following: " (A) Supplying a special dietary need that exists by reason of a physical, physiological, pathological, or other condition, including but not limited to the condition of disease, convalescence, pregnancy, lactation, infancy, allergic hypersensitivity^ to food, underweight, overweight, or the need to control the intake of sodium. " (B) Supplying a vitamin, mineral, or other ingredient for use by m a n to supplement his diet by increasing the total dietary intake. " (C) Supplying a special dietary need by reason of being a food for use as the sole item of the diet.", (b) The Secretary of Health, Education, and Welfare shall amend any regulation promulgated under the Federal Food, D r u g, and Cosmetic Act which is inconsistent with section 411 of such Act (as added by subsection (a)) and such amendments shall be promulgated in accordance with section 553 of title 5, United States Code. SEC. 502. (a)(1) Section 403(a) of the Federal Food, D r u g, and Cosmetic Act (21 U.S.C. 3 4 3 (a)) is amended (A) by inserting " (1) " after "If", and (B) by inserting before the period at the end a comma and the following: "or (2) in the case of a food to which section 411 applies, its advertising is false or misleading in a material respect or its labeling is in violation of section 411(b)(2) ". (2)(A) Section 201(n) of such Act is amended by inserting "or advertising" after "labeling" each time it occurs. (B) Section 303 of such Act is amended by adding at the end the following new subsection: " (d) No person shall be subject to the penalties of subsection (a) of this section for a violation of section 301 involving misbranded food if the violation exists solely because the food is misbranded under section 403(a)(2) because of its advertising, and no person shall be subject to the penalties of subsection (b) of this section for such a violation unless the violation is committed with the intent to defraud or mislead.". (C) Section 304(a) of such Act (21 U.S.C. 3 3 4 (a)) is amended by a d d i n g after paragraph (2) the following new paragraph: " (3)(A) Except as provided in subparagraph (B), no libel for condemnation may be instituted under paragraph (1) or (2) against any food which— " (i) is misbranded under section 403(a)(2) because of its advertising, and " (ii) is being held for sale to the ultimate consumer in an establishment other than an establishment owned or operated by a manufacturer, packer, or distributor of the food.

90 STAT. 411

"Special dietary use." 21 USC 343.

21 USC 350 note. 21 USC 301. Ante, p. 410.

21 USC 321. 21 USC 333. Misbranded food, penalties, exemption. 21 USC 331.

Libel for condemnation. Supra.

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