Description
The purpose of this guidance is to advise firms that manufacture, market, or distribute dietary supplements of our intent to exercise enforcement discretion with respect to the declaration of live microbial quantity in colony forming units (CFUs), in addition to the quantitative amount by weight declaration required by regulation, within the Supplement Facts label of dietary supplements containing live microbials, provided that certain conditions are met.
Scope & Applicability
Product Classes
2Guidance does not apply to these products.
Products containing dietary ingredients intended to supplement the diet; The final product category for which the NDI is intended.
Stakeholders
1Entity responsible for submitting NDINs
Regulatory Context
Attributes
4Actual or ideal body weight used for dosing.
Determined based on stability data; Established through stability testing; also called dating period.; Established through formal stability studies; Establishing the period during which a drug product is expected to remain within specifications; Period for drug products; The period during which a drug product is expected to remain within specifications; Duration product remains within acceptance criteria; Period during which product remains within specifications; Established for intermediates pu
Required unit of measure for weight
Numerical criteria for generic E. coli
Related CFR Sections (4)
- 21CFR101.36§ 101.36 Nutrition labeling of dietary supplements.
(a) The label of a dietary supplement that is offered for sale shall bear nutrition labeling in accordance with this regulation unless an exemption is provided for the product in paragraph (h) of this section.Read full regulation →
- 21CFR101.9§ 101.9 Nutrition labeling of food.
(a) Nutrition information relating to food shall be provided for all products intended for human consumption and offered for sale unless an exemption is provided for the product in paragraph (j) of this section.Read full regulation →
- 21CFR101.13§ 101.13 Nutrient content claims—general principles.
(a) This section and the regulations in subpart D of this part apply to foods that are intended for human consumption and that are offered for sale, including conventional foods and dietary supplements.Read full regulation →
- 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.
- 2024-11-05
CGMP/Dietary Supplement/Adulterated
Top Health Manufacturing, LLC
- 2024-07-23
New Drugs/Dietary Supplements/Food Labeling/Misbranded
Formulation Technology, Inc.
- 2023-09-05
Unapproved New Drugs/Misbranded
Osmosis, LLC
- 2023-08-29
CGMP/Dietary Supplement/Adulterated/Misbranded
Cosmax NBT USA
- 2023-02-07
CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
Quality Supplement Manufacturing, Inc.
- 2023-01-31
CGMP/Dietary Supplement/Misbranded
Adept Life Science, LLC
- 2023-01-24
Dietary Supplement/Misbranded
Evimeria El Aztecano, Inc.
- 2020-10-20
Unapproved New Drugs/Misbranded
Prollergy Corporation/Ready Set Food
- 2020-09-01
CGMP/Dietary Supplement/Adulterated/Misbranded
Revival Products, Inc.
See Also (8)
- Guidance for Industry: Guide for Developing and Using Data Bases for Nutrition Labeling (Status: Final)
- Draft Guidance for Industry and FDA Staff: Whole Grain Label Statements (Status: Draft)
- Guidance for Industry: Food Labeling Guide (Status: Final)
- Guidance for Industry: Questions and Answers Regarding Food Allergen Labeling (Edition 5) (Status: Final)
- Small Entity Compliance Guide: Revision of the Nutrition and Supplement Facts Labels (Status: Final)
- Guidance for Industry: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, Dual-Column Labeling, and Miscellaneous Topics (Status: Final)
- Guidance for Industry: Nutrition and Supplement Facts Labels Questions and Answers Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals (Status: Final)
- Guidance for Industry: Converting Units of Measure for Folate, Niacin, and Vitamins A, D, and E on the Nutrition and Supplement Facts Labels (Status: Final)