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

Summary

The law says the government cannot set maximum strength limits on vitamins or minerals in certain special dietary foods. The government also cannot call a vitamin or mineral a drug just because it is stronger than officials think is useful. The government cannot limit how many vitamins, minerals, or other food ingredients can be combined in those products. These limits do not apply when the product is marketed to treat or manage a specific disease or disorder, or is meant for children under 12, or for pregnant or breastfeeding women. If a product lists all its ingredients correctly, it cannot be labeled as misbranded just because ads mention ingredients that are not vitamins or minerals. Non-dietary ingredients can only be listed as part of the full ingredient list and must follow labeling rules. Officials must make exceptions if listing everything is impractical or would be unfair. This applies to human foods made for special dietary use that contain vitamins or minerals and that are meant to be taken as tablets, capsules, powders, softgels/gelcaps, or liquids measured in drops or other small daily amounts. It also covers foods not sold as ordinary foods and not sold as the only item of a meal or diet. "Special dietary use" means a food made to meet a particular need, such as needs caused by disease, recovery, pregnancy, breastfeeding, infancy, food allergies, being underweight or overweight, controlling sodium, adding vitamins or minerals to the diet, or serving as the only food in a diet.

Title 21, §350

Food and Drugs — Source: USLM XML via OLRC

(a)(1)Except as provided in paragraph (2)—

(A)the Secretary may not establish, under section 321(n), 341, or 343 of this title, maximum limits on the potency of any synthetic or natural vitamin or mineral within a food to which this section applies;

(B)the Secretary may not classify any natural or synthetic vitamin or mineral (or combination thereof) as a drug solely because it exceeds the level of potency which the Secretary determines is nutritionally rational or useful;

(C)the Secretary may not limit, under section 321(n), 341, or 343 of this title, the combination or number of any synthetic or natural—

(i)vitamin,

(ii)mineral, or

(iii)other ingredient of food,

(2)Paragraph (1) shall not apply in the case of a vitamin, mineral, other ingredient of food, or food, which is represented for use by individuals in the treatment or management of specific diseases or disorders, by children, or by pregnant or lactating women. For purposes of this subparagraph,11 So in original. Probably should be “paragraph”. the term “children” means individuals who are under the age of twelve years.

(b)(1)A food to which this section applies shall not be deemed under section 343 of this title to be misbranded solely because its label bears, in accordance with section 343(i)(2) of this title, all the ingredients in the food or its advertising contains references to ingredients in the food which are not vitamins or minerals.

(2)The labeling for any food to which this section applies may not list its ingredients which are not dietary supplement ingredients described in section 321(ff) of this title (i) except as a part of a list of all the ingredients of such food, and (ii) unless such ingredients are listed in accordance with applicable regulations under section 343 of this title. To the extent that compliance with clause (i) of this subparagraph is impracticable or results in deception or unfair competition, exemptions shall be established by regulations promulgated by the Secretary.

(c)(1)For purposes of this section, the term “food to which this section applies” means a food for humans which is a food for special dietary use—

(A)which is or contains any natural or synthetic vitamin or mineral, and

(B)which—

(i)is intended for ingestion in tablet, capsule, powder, softgel, gelcap, or liquid form, or

(ii)if not intended for ingestion in such a form, 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 343(j) of this title 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 be 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 man 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.

Notes & Related Subsidiaries

Editorial Notes

Amendments

1994—Subsec. (b)(2). Pub. L. 103–417, § 7(d), redesignated subpar. (A) as par. (2), substituted “dietary supplement ingredients described in section 321(ff) of this title” for “vitamins or minerals”, and struck out former subpar. (B), which read as follows: “Notwithstanding the provisions of subparagraph (A), the labeling and advertising for any food to which this section applies may not give prominence to or emphasize ingredients which are not— “(i) vitamins, “(ii) minerals, or “(iii) represented as a source of vitamins or minerals.” Subsec. (c)(1)(B)(i). Pub. L. 103–417, § 3(c)(1), inserted “powder, softgel, gelcap,” after “capsule,”. Subsec. (c)(1)(B)(ii). Pub. L. 103–417, § 3(c)(2), struck out “does not simulate and” after “in such a form,”.

Statutory Notes and Related Subsidiaries

Effective Date

of 1994 AmendmentFor provision that dietary supplements may be labeled after Oct. 25, 1994, in accordance with

Amendments

made by section 7(d) of Pub. L. 103–417, and shall be so labeled after Dec. 31, 1996, see section 7(e) of Pub. L. 103–417, set out as a note under section 343 of this title. Amendment of Inconsistent

Regulations

by Secretary Pub. L. 94–278, title V, § 501(b), Apr. 22, 1976, 90 Stat. 411, as amended by Pub. L. 96–88, title V, § 509(b), Oct. 17, 1979, 93 Stat. 695, provided that: “The Secretary of Health and Human Services shall amend any regulation promulgated under the Federal Food, Drug, and Cosmetic Act [this chapter] which is inconsistent with section 411 of such Act [section 350 of this title] (as added by subsection (a)) and such

Amendments

shall be promulgated in accordance with section 553 of title 5, United States Code.”

§350 Vitamins and Minerals

Summary

Title 21, §350

Notes & Related Subsidiaries

Editorial Notes

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Statutory Notes and Related Subsidiaries

Effective Date

Amendments

Regulations

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