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21 U.S.C. § 350b — New dietary ingredients
Federal law — U.S. Code and appendices · legal_authorities
**(a) In general** A dietary supplement which contains a new dietary ingredient shall be deemed adulterated under [section 342(f) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section342/f&num=0&edition=prelim) unless it meets one of the following requirements:
(1) The dietary supplement contains only dietary ingredients which have been present in the food supply as an article used for food in a form in which the food has not been chemically altered.
(2) There is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides the Secretary with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.
The Secretary shall keep confidential any information provided under paragraph (2) for 90 days following its receipt. After the expiration of such 90 days, the Secretary shall place such information on public display, except matters in the information which are trade secrets or otherwise confidential, commercial information.
**(b) Petition** Any person may file with the Secretary a petition proposing the issuance of an order prescribing the conditions under which a new dietary ingredient under its intended conditions of use will reasonably be expected to be safe. The Secretary shall make a decision on such petition w
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Source file: Laws/federal/codes/united-states-code/title-21/section-350b-new-dietary-ingredients--839ee800b3.md
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Source location: Title 21, Chapter 9, § 350b; chapter-009-federal-food-drug-and-cosmetic-act.md
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**(a) In general** A dietary supplement which contains a new dietary ingredient shall be deemed adulterated under [section 342(f) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section342/f&num=0&edition=prelim) unless it meets one of the following requirements:
(1) The dietary supplement contains only dietary ingredients which have been present in the food supply as an article used for food in a form in which the food has not been chemically altered.
(2) There is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides the Secretary with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.
The Secretary shall keep confidential any information provided under paragraph (2) for 90 days following its receipt. After the expiration of such 90 days, the Secretary shall place such information on public display, except matters in the information which are trade secrets or otherwise confidential, commercial information.
**(b) Petition** Any person may file with the Secretary a petition proposing the issuance of an order prescribing the conditions under which a new dietary ingredient under its intended conditions of use will reasonably be expected to be safe. The Secretary shall make a decision on such petition within 180 days of the date the petition is filed with the Secretary. For purposes of chapter 7 of title 5, the decision of the Secretary shall be considered final agency action.
**(c) Notification**
(1) **In general** — If the Secretary determines that the information in a new dietary ingredient notification submitted under this section for an article purported to be a new dietary ingredient is inadequate to establish that a dietary supplement containing such article will reasonably be expected to be safe because the article may be, or may contain, an anabolic steroid or an analogue of an anabolic steroid, the Secretary shall notify the Drug Enforcement Administration of such determination. Such notification by the Secretary shall include, at a minimum, the name of the dietary supplement or article, the name of the person or persons who marketed the product or made the submission of information regarding the article to the Secretary under this section, and any contact information for such person or persons that the Secretary has.
(2) **Definitions** — For purposes of this subsection—
(A) the term “anabolic steroid” has the meaning given such term in [section 802(41) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section802/41&num=0&edition=prelim); and
(B) the term “analogue of an anabolic steroid” means a substance whose chemical structure is substantially similar to the chemical structure of an anabolic steroid.
**(d) “New dietary ingredient” defined** For purposes of this section, the term “new dietary ingredient” means a dietary ingredient that was not marketed in the United States before October 15, 1994 and does not include any dietary ingredient which was marketed in the United States before October 15, 1994.
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Federal law — U.S. Code and appendices · legal_authorities
The following acts and the causing thereof are prohibited:
**(a)** The introduction or delivery for introduction into interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded.
**(b)** The adulteration or misbranding of any food, drug, device, tobacco product, or cosmetic in interstate commerce.
**(c)** The receipt in interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise.
**(d)** The introduction or delivery for introduction into interstate commerce of any article in violation of section 344, 350d, 355,,11 So in original. 360bbb–3, or 364c of this title.
**(e)** The refusal to permit access to or copying of any record as required by section 350a, 350c, 350f(j), 350e, 354, 360bbb–3, 364a, 373, 374(a), 379aa, or 379aa–1 of this title; or the failure to establish or maintain any record, or make any report, required under section 350a, 350c(b), 350f, 350e, 354, 355(i) or (k), 360b(a)(4)(C), 360b(j), (l) or (m), 360ccc–1(i), 360e(f), 360i, 360bbb–3, 364a, 364g, 379aa, 379aa–1, 387i, or 387t of this title or the refusal to permit access to or verification or copying of any such required record; or the violation of any recordkeeping requirement under section 2223 22 See References in Text note below. of this title (except when such violation is committed by a farm).
**(f)** The refusal to permit entry or inspection as authorized by [section 374 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section374&num=0&edition=prelim).
**(g)** The manufacture within any Territory of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded.
*
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 331
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Federal law — U.S. Code and appendices · legal_authorities
Page 132
TITLE 21—FOOD AND DRUGS
§ 350b
301 et seq.), during the 90-day period beginning
on December 29, 2022, an individual may, with-
out prior notice to the Food and Drug Admin-
istration, import up to a 3-month supply of in-
fant formula for personal use from—
(A) Canada;
(B) any country in the European Union; or
(C) any other country that is determined
by the Secretary to be implementing and en-
forcing requirements for infant formula that
provide a similar assurance of safety and nu-
tritional adequacy as the requirements of
the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 301 et seq.).
(2) Limitations
Infant formula may be imported pursuant to
paragraph (1) only if the infant formula—
(A) is exclusively for personal use and will
not be commercialized or promoted; and
(B) does not present an unreasonable risk
to human health.
(3) Reporting of adverse events
If a health care provider becomes aware of
any adverse event which the health care pro-
vider reasonably suspects to be associated
with infant formula imported pursuant to
paragraph (1), the health care provider shall
report such adverse event to the Commis-
sioner of Food and Drugs.
(4) Public notice
The Secretary, acting through the Commis-
sioner of Food and Drugs, shall post on the
public website of the Food and Drug Adminis-
tration notice that—
(A) infant formula imported pursuant to
paragraph (1) may not have been manufac-
tured in a facility that has been inspected by
the Food and Drug Administration;
(B) the labeling of such infant formula
may not meet the standards and other re-
quirements applicable with respect to infant
formula under the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.); and
(C) the nutritional content of infant for-
mula imported pursuan
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 350b
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