FDA Guide: Compliance for Functional Claims in Dietary Supplements

# FDA Guide: Compliance for Functional Claims in Dietary Supplements

The United States Food and Drug Administration (FDA) has established clear guidelines for the use of claims in functional foods and dietary supplements. Understanding these categories is crucial for the compliant marketing of products in the USA.

Background

The regulation of claims for dietary supplements in the USA is based on the Dietary Supplement Health and Education Act (DSHEA) of 1994. Unlike pharmaceuticals, dietary supplements do not require prior FDA approval but must still meet strict requirements for claim substantiation.

Key Statements

• The FDA distinguishes three main types of claims: Nutrient Content Claims, Health Claims, and Structure-Function Claims
• All claims must be supported by "competent and reliable scientific evidence"
• Health Claims generally require FDA authorization
• Structure-Function Claims must be notified to the FDA within 30 days of market launch
• Violations can lead to warning letters, product recalls, and legal consequences

Implications for Manufacturers

For manufacturers serving the US market, correct classification and substantiation of claims is essential. Incorrect or insufficiently substantiated claims can not only lead to regulatory actions but also damage consumer trust and brand reputation.

Recommendations

• Correctly classify all your product claims according to FDA categories
• Ensure at least one well-controlled clinical human study is available
• Document the scientific substantiation of all claims comprehensively
• Timely notify the FDA of Structure-Function Claims
• Avoid disease-related statements for dietary supplements
• Train your marketing team in FDA compliance
• Have claims reviewed by legal experts before publication

Note: This article is for informational purposes only and does not constitute legal advice. Manufacturers should seek legal counsel for compliance questions.

Source: [FoodNavigator USA - Ensuring Compliance for Functional Claims](https://www.foodnavigator-usa.com/Article/2024/11/13/ensuring-compliance-for-functional-claims)