Regulatory Requirements
    1. “Food for Specified Health Use” Requirements (FOSHU)
    2. “Health Foods” are Unregulated
    Marketplace Implications and Consumer Impact
    1. It is Questionable Whether Most FOSHU-Approved Products are Truly Benefitting the Health of Consumers
    2. The Establishment of the FOSHU System has not Eliminated Misleading Claims for Functional Foods
    • The FOSHU approval system, though faulty, should be made mandatory for all functional foods
    • The fat, cholesterol, sodium and sugar content of FOSHU-approved foods should be limited
    • Standards for FOSHU approvals should be tightened
    • Consumption of conventional foods should be encouraged



    Regulatory Requirements
    1. Regulation of Ingredient Safety
    2. Regulation of Product Claims
      1. Health Claims for Foods and Dietary Supplements Positioned as Functional Foods
      2. Health Claims for Foods for Special Dietary Use and Medical Foods
      3. Structure/Function Claims for Foods and Dietary Supplements
    Marketplace Implications and Consumer Impact
    1. Some Foods and Supplements are Sold with FDA-Approved Health Claims
    2. Functional Foods are Often Sold on the Basis of Structure/Function Claims in Order to Avoid FDA-Approval Requirements that Apply to Health Claims
    3. Some Companies are Selling Functional Foods as Dietary Supplements to Avoid FDA Regulation
    4. Some Functional Foods are Sold as Medical Foods to Avoid FDA Regulation
    5. Companies Limit Health Claims to Advertising to Avoid FDA Scrutiny
    • The FDA should prohibit companies from marketing functional foods as dietary supplements
    • The FDA should close the loophole that allows unapproved health claims on the labels of medical foods
    • Functional ingredients in food should be generally recognized as safe or regulated as food additives
    • The FDA should consider requiring that the labels of functional foods indicate recommended dosages and provide related instructions for use
    • Health claims for functional food should be approved pursuant to the Nutrition Labeling and Education Act
    • The FDA should issue regulations controlling structure/function claims for foods
    • The Federal Trade Commission should update its Enforcement Policy Statement on Food Advertising to clarify that health claims for functional foods will be considered non-deceptive only if they meet requirements set forth by the FDA



    Regulatory Requirements
    1. Legal Requirements
    2. Self-Regulation
    Marketplace Implications and Consumer Impact
    1. Unsupported Claims Continue to be Made
    2. Some Claims are Made for Products with Unhealthful Ingredients
    • The European Union should issue a directive for health claims for foods
    • The Food Standards Agency should be empowered to implement requirements for health claims
    • Many elements of the code proposed by the JHCI should be made mandatory
    • The labels of functional foods should declare the amount of the functional ingredients and other relevant information
    • Mandatory nutrition labeling should be required on all foods



This report was prepared by Ilene Ringel Heller (CSPI), Yoko Taniguchi (JOF) and Tim Lobstein (Food Commission UK). The report was edited by Bruce Silverglade and Michael Jacobson. A special thank you goes to Jack Winkler, Director of Food & Health Research (UK).

Copyright © 1999 by the International Association of Consumer Food Organizations