Monday, May 20, 2019
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.