Small Business Exemption - Simplified Version

Small Business Exemption - Simplified Version of the criteria found in:

21 Code of Federal Regulations (CFR) 101.9 (a) Nutrition information relating to food shall be provided for all products intended for human consumption and offered for sale unless an exemption is provided for the product in paragraph (j) of this section.

CAUTION/WARNING - ANY NUTRIENT CONTENT CLAIM OR HEALTH CLAIM MADE ON BEHALF OF THE PRODUCT VOIDS ALL EXEMPTIONS AND A NUTRITIONAL STATEMENT BECOMES MANDATORY.

Food manufacturers may claim a renewable 12-month exemption from the Nutrition Facts portion of required food labels if they satisfy the following criteria:

1. Food labels, labeling, and/or advertising bear no nutrition or nutrient content claims or other nutrition information, and no health claims.

2. Food offered for sale by a person who makes direct sales to consumers (e.g., a retailer) who has annual gross sales not more than $500,000 to consumers; or annual gross food sales to consumers of not more than $50,000.

3. Or, Low volume food products as defined below:
   1. From May 8, 1995, to May 7, 1996, employed fewer than 200 full-time equivalent employees (FTE's) and fewer than 200,000 units of that product sold in United States;

   2. All other food products, if for the preceding 12 months, employed fewer than 100 FTE's and fewer than 100,000 units of that product were sold in the United States;

   3. Food product not sold in last 12 month period, fewer than 100,000 units of such product are reasonably expected to be sold in the United States, during the year.

4. And, The company provides the FDA with notice of products that meet above criteria,

5. Except that if the person in not an importer and has fewer than 10 FTE's does not have to file a notice for any food product with annual sales of fewer than 10,000 total units.