August 2018

Reader Q+A

I understand that a small start-up business gets some exemptions from labeling regulations. Is that correct? What are the exemptions?

Yes, FDA does provide a nutrition labeling exemption for small companies that meet very specific qualifications. However, please be advised that if you make any nutrient content or health claims on your label or labeling, the small business exemption will not apply. Please also know that even when the nutrition labeling exemption is taken, all other label components must comply fully with FDA’s other mandatory food labeling regulations. 

Specifically, small manufacturers with fewer than 100 full time people and fewer than 100,000 units sold annually in the U.S. are eligible for the small business exemption from nutrition labeling. Such manufacturers must file a notice annually with the FDA to obtain this exemption. 

Additionally, very small domestic manufacturers, packers and distributors (not importers) with fewer than 10 full time employees who sell fewer than 10,000 units annually in the U.S. are exempt from nutrition labeling. This particular exemption does not require a notice with FDA.

For retailers: nutrition labeling is not required on food products if the retailer has total annual gross sales of $500,000 or less, or total annual food gross sales of $50,000. A small business exemption notice does not have to be filed with FDA.