Description
Office of Nutrition, Labeling and Dietary SupplementsFood Labeling and Standards Staff, HFS-820Center for Food Safety and Applied NutritionFood and Drug Administration5001 Campus DriveCollege Park, MD 20740(Tel) 240-402-2375
Scope & Applicability
Stakeholders
2Entities involved in the supply chain of APIs.
Entities encouraged to reduce sodium in foods; Primary industry members encouraged to reformulate products
Regulatory Context
Attributes
1RACC used to determine eligibility for nutrient claims
Related CFR Sections (4)
- 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 →
- 21CFR101.65§ 101.65 Implied nutrient content claims and related label statements.
(a) General requirements. An implied nutrient content claim can only be made on the label and in labeling of the food if:Read full regulation →
- 21CFR101.54§ 101.54 Nutrient content claims for “good source,” “high,” “more,” and “high potency.”
(a) General requirements. Except as provided in paragraph (e) of this section, a claim about the level of a nutrient in a food in relation to the Reference Daily Intake (RDI) established for that nutrient in § 101.9(c)(8)(iv) or Daily Reference Value (DRV) established for that nutrient in § 101.9(c)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 →
Related Warning Letters (2)
- 2021-07-28
Unapproved New Drugs/Misbranded
Nutrishus Brands, Inc.
- 2020-06-30
Unapproved New Drugs/Misbranded
Only Natural, Inc. dba Bio Nutrition, Inc.
See Also (8)
- Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" : Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- CPG Sec. 460.100 Hospital Pharmacies - Status as Drug Manufacturer (Status: Final)
- CPG Sec. 442.100 New Drugs - Export (Status: Final)
- CPG Sec. 400.325 Candy "Pills" Representation as Drug (Status: Final)
- CPG Sec. 450.400 Labeling and Distribution of OTC Drugs in Vending Machines (Status: Final)
- CPG Sec. 446.100 Regulatory Action Regarding Approved New Drugs and Antibiotic Drug Products Subjected to Additional Processing or other Manipulations (Status: Final)
- CPG Sec. 450.300 OTC Drugs - General Provisions and Administrative Procedures for Marketing Combination Products (Status: Final)
- CPG Sec. 400.500 Identical or Similar Product Names (Status: Final)