There are two exemptions that tend to apply. The first requires no filing, just that your records document you qualify if inspected. That exemption is for businesses selling less than $50,000 annually of foods or dietary supplements or less than $500,000 in total gross sales annually.

The second requires an annual registration of your qualification, which can be done on-line at the FDA website.This exemption applies to businesses with less than 100 full-time equivalent employees or those businesses producing less than 100,000 units of the product for sale annually.