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Small Business Exemption Notification Program

CFSAN Constituent Update - Fruit Basket
CFSAN Constituent Update - CFSAN FDA

May 23, 2007

On May 7, 2007, the Food and Drug Administration (FDA) launched a new web-based submission process for small businesses to file an annual notice of exemption from the nutrition labeling requirements. The new process will make it easier for businesses to update their information. In addition, firms eligible for the exemption will receive an electronic reminder when it is time to resubmit their nutrition labeling small business exemption notice.

The Federal Food, Drug, and Cosmetic Act requires packaged foods and dietary supplements to bear nutrition labeling unless they qualify for an exemption. One exemption, for low-volume products, applies if the person claiming the exemption employs fewer than an average of 100 full-time equivalent employees and fewer than 100,000 units of that product are sold in the United States in a 12-month period. To qualify for this exemption the person must file a notice annually with FDA. Note that low volume products that bear nutrition claims do not qualify for an exemption of this type.

Another type of exemption applies to retailers with annual gross sales of not more than $500,000, or with annual gross sales of foods or dietary supplements to consumers of not more than $50,000. For these exemptions, a notice does not need to be filed with the Food and Drug Administration (FDA).

Additional information about nutrition labeling small business exemptions and eligibility for these exemptions is available online (See: Small Business Nutrition Labeling Exemption). Firms that wish to submit an exemption notice using the Internet can go to the web-based submission form to request an account or to update an existing account.

FDA will still continue to accept notices filed by mail, or fax.