Table 1     
Functional Foods: An International Comparison of Health Claims Regulation
JapanUnited StatesUnited Kingdom
I. FOSHU System
(Food for Specified Health Use):

Health claims permitted for specific products upon approval of application. Application must include scientific documentation demonstrating the medical or nutritional basis for a health claim and ingredient safety information.
Products may state for example, “suitable for individuals with high blood pressure,” but must also carry disclaimer that the product does not prevent or cure hypertension.

I. Food, Drug, and Cosmetic Act
permits two types of claims:

1) Health claims linking a nutrient to a particular disease or health-related condition, e.g., diets rich in calcium may reduce the risk of osteoporosis. Health claims must be pre-approved by the FDA. They may also be based on an authoritative statement from another government agency with scientific expertise so long as FDA does not object within a 120-day period after the company notifies FDA of its intent to make a claim.

2) Structure/function claims linking a substance to an effect on a structure or function of the body, e.g., calcium builds strong bones. There is no pre-approval requirement for structure/function claims.

I. Food Safety Act: prohibits medicinal claims -- claims to treat a disease or restore, correct or modify physiological functions.

Health maintenance claims that do not specifically refer to a disease may be lawful. There is no pre-market approval requirement. Enforcement is carried out by local trading standards officers and self-regulating bodies.

II. Key Problems:

To escape FOSHU approval requirements, many companies sell products without express health claims. The Japan Health Food & Nutrition Food Association offers its own seal of approval which may confuse consumers. The FOSHU system should be strengthened to control the sale of all functional food products.

II. Key Problems:

Some U.S. products are attempting to escape regulation by being marketed as dietary supplements or medical foods.

Consumers may be confused by health claims which require FDA approval and structure/function claims which do not require FDA approval.

II. Key Problems:

No specific law applies to claims for functional foods.


Voluntary codes have not proven to be effective means to prevent misleading claims.