CRITERIA NEEDED WITH REQUEST FOR CERTIFICATE OF FREE SALE FOR DIETARY SUPPLEMENT(S), INFANT FORMULA(S), & MEDICAL FOOD(S)
(Certificates are only issued for products manufactured in the United States.)

1. Letter requesting certificate of free sale.
2. List product or products.
3. List the country or countries certificate of free sale is going to.
4. State how many certificates you are requesting.
5. State whether you want all products together on each certificate, or one product on a separate certificate.
6. Original label or labels for each product. (Note: No photocopies unless product is distributed in BULK FORM ONLY; if labeling is in a foreign language, we need the label/labels in English; the labels must be flat, do not send round containers with label applied).
7. The cost per certificate is $10.00. You do not have to mail the $10.00; you will be billed.
8. Mail all submissions to:

   Certificate Program
   Food and Drug Administration
   Office of Nutritional Products, Labeling, and Dietary Supplements, HFS-810
   5100 Paint Branch Parkway
   College Park, MD 20740-3835

Note: There is no need to mail the request to anyone's attention as long as you have the office's certificate program mail code as listed above.

The Certificate of Free Sale is issued on official Department of Health and Human Services (DHHS) letterhead along with a DHHS seal, and cannot be notarized.

Current processing time is approximately 8 weeks.

If you have any questions please feel free to call (301) 436-2375 (or fax your question to (301)436-2639)) and ask to speak with someone concerning certificates of free sale.