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Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act

FinalHuman Foods Program01/05/2009

Description

OMB Control No. 0910-0626Expiration Date: 08/31/2011See additional PRA statements inSection IIIof this guidance

Scope & Applicability

Product Classes

2

Conventional Food

Food marketed for general consumption, distinct from dietary supplements.; Comparison point for intake levels

Dietary Supplement

Products containing dietary ingredients intended to supplement the diet; The final product category for which the NDI is intended.

Stakeholders

1

Manufacturer

Entity responsible for submitting NDINs

Regulatory Context

Attributes

1

Competent and reliable scientific evidence

The standard applied to evaluate the substantiation of claims.

View on FDA.gov

Related CFR Sections (2)

21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →
21CFR101.93§ 101.93 Certain types of statements for dietary supplements.
(a)Read full regulation →

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See Also (8)