Description
The Food and Drug Administration has prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (P.L. 104-121). This guidance document restates in plain language the legal requirements set forth in a regulation concerning labeling claims for dietary supplements. This is a Level 2 guidance document published for immediate implementation in accordance with FDA's good guidance practices (21 CFR 10.115). The regulations are binding and have the force and effect of law. However, this guidance document represents the agency's current thinking on this subject and does not, itself, create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.
Scope & Applicability
Product Classes
5Products for which batch/lot information is particularly important
evaluated by the Division of Anti-Infective Drug Products
agents used during labor and delivery
Defined in section 201(g) of the FD&C Act; Articles intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease; Product classification based on chemical action or specific intended uses like altering pH
Products containing dietary ingredients intended to supplement the diet; The final product category for which the NDI is intended.
Stakeholders
2layman using the drug safely
Target audience for the compliance guide
Regulatory Context
Attributes
2includes aging, menopause, and the menstrual cycle
Requirement for substantiation of claims
Related CFR Sections (2)
- 21CFR101.93§ 101.93 Certain types of statements for dietary supplements.
- 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 →
Related Warning Letters (10)
- 2025-09-30
CGMP/Dietary Supplement/Adulterated/Misbranded
Valentine Enterprises, Inc.
- 2025-09-30
CGMP/Dietary Supplement/Adulterated/Misbranded
Time Challenger Labs International, Inc.
- 2025-09-30
CGMP/Dietary Supplement/Adulterated/Misbranded
Vidaslim Co.
- 2025-09-30
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Hans Bakery Inc. d/b/a Andersen’s Bakery
- 2025-09-16
Unapproved New Drugs/Misbranded
Mericon Industries, Inc.
- 2025-06-24
CGMP/Dietary Supplement/Adulterated/Misbranded
M.O.M. Enterprises, LLC
- 2025-06-24
Food Labeling/Misbranded
Revolution Foods, PBC
- 2025-06-03
Unapproved New Drugs/Misbranded
Mother Earth Minerals, Inc.
- 2025-06-03
CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated
One Roof LLC
- 2025-06-03
CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
Anti L’Age
See Also (8)
- Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (Status: Final)
- Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements Due to COVID-19: Guidance for Industry (Status: Final)
- Draft Guidance for Industry: Considerations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding Requirement in 21 CFR part 112 or the Preventive Controls Requirements in part 117 or 507 (Status: Draft)
- Small Entity Compliance Guide: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (Status: Final)
- Small Entity Compliance Guide: What You Need to Know About Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (Status: Final)
- Small Entity Compliance Guide: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements (Status: Final)
- Guidance for Industry: Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration (Status: Final)
- Guidance for Industry: Temporary Permits for Interstate Shipment of Experimental Packs of Food Varying from the Requirements of Definitions and Standards of Identity (Status: Final)