A product is exempt from nutrition labeling if no nutrition information is declared on the label or labeling, if no nutrient content claim or health claim is made and if the manufacturer/packer or distributor meets one or more of the following provisions:
- Small Business Exemption based on value of gross sales (Note: after May 8, 1995, this exemption based on value of gross sales will apply only to retailers).
- For foreign firms importing foods, this exemption is based on the total amount of sales to consumers in the United States. The product is exempt from nutrition labeling if the firm whose name appears on the label has annual gross sales of food to consumers of not more than $50,000; or has total annual gross sales to consumers of not more than $500,000 [101.9(j)(1)] .
Small Business Exemption for low volume food products based on the average number of full time equivalent employees (FTE’s) and approximate units (of sale) of food products sold in the United States. The following is provided for your information, but only those products listed with the Office of Food Labeling are eligible for the exemption, (NOTE: a firm with less than 10 employees and less than 10,000 units does not have to apply to FDA for an exemption).
For products marketed prior to May 8, 1994, there are the following provisions:
- the effective date is delayed until May 8, 1995 providing that the firm had fewer than 300 FTE’s and less than 600,000 units of the product sold between 5/8/93 and 5/7/94.
- the effective date is further delayed from May 8, 1995 until May 8, 1996 providing that the firm had fewer than 300 FTE’s and less than 400,000 units of the product sold between 5/8/94 and 5/7/95.
- the effective date is further delayed from May 8, 1996 until May 8, 1997 providing the firm had fewer than 200 FTE’s and less than 200,000 units of the product were sold between 5/8/95 and 5/7/96.
- the effective date is delayed after May 8, 1997 providing the firm had fewer than 100 FTE’s and less than 100,000 units were sold in the previous year.
- Products initially marketed after May 8, 1994 are exempt providing the firm has fewer than 100 FTE’s and less than 100,000 units are projected for marketing in the first 12 months.
Foods served or sold in restaurants are exempt unless a claim is made on a label available to the consumer, (e.g., fat free salad dressing)[101.9(j)(2)(i)].
Foods served and sold for immediate consumption (e.g., schools, cafeterias, trains, airplanes, and retail stores, such as bakeries and deli’s), where there are facilities for immediate consumption[101.9(j)(2)(ii)].
