Functional Foods Policy and Regulations

Currently there are no separate regulations for functional foods in the United States and other countries, except Japan. The regulations mentioned below relate to the labeling of conventional food and beverage products, which may apply to functional foods, if the product bears a claim, such as health and structure/function claims that describes the health benefits of the product.

United States
In the United States, the Federal Food, Drug, and Cosmetic Act does not provide a statutory definition of functional foods, therefore the FDA has not established a formal regulatory category for such foods. The 1990 Nutrition Labeling and Education Act authorized the Food and Drug Administration to develop regulations for the use of claims on health benefits on foods and dietary supplements, which are often communicated to the consumers through the label on the product, website, or advertising. Functional foods can be regulated as a conventional food, a dietary supplement, a food for special dietary use, a medical food, or a drug and often these distinctions are based depending on the intended use and nature of the claim(s) (e.g., nutrient information and nutrient content and health claims) made on the product. Nutrition and health claims are used to communicate the benefits of functional foods. The following food and dietary supplement related regulations may also apply to products marketed as functional foods.

Food Label

  • Labeling & nutrition guidance documents & regulatory information
    • FDA Food labeling guidance for industry
      • Nutrient content claims characterizes the level of a nutrient in the food.
      • Health claims characterizes the relationship of any substance to a disease or health-related condition.
      • Qualified health claims characterizes the relationship of any substance to a disease or health-related condition.  Qualified health claims are based on the totality of publicly available evidence but the scientific support does not have to be as strong as that for Significant Scientific Agreement, required for health claims.
      • Structure-function claims characterizes the mechanism by which a nutrient affects a structure or function of the body or a person’s well-being, provided that such statements are not disease claims.

Regulations in Other Countries

Australia and New Zealand

Brunei

Canada

China

European Union
In 2006, the EU adopted a regulation to harmonize across the EU the rules for the use of health or nutritional claims on food products based on nutrient profiles. The Regulation is intended to ensure that any claim made on a food label in the EU is clear and substantiated by scientific evidence.

India

Japan

Malaysia

Mexico

Philippines

Singapore

Standards, Reports, Resources from Non-Government Organizations

Disclaimer: Resources on this webpage are for informational purposes only and not for the purpose of providing legal advice.