Certificate of Free Sale
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
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.
- Letter requesting certificate of free sale.
- List product or products.
- List the country or countries certificate of free sale is going
- State how many certificates you are requesting.
- State whether you want all products together on each
certificate, or one product on a separate certificate.
- 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
- The cost per certificate is $10.00. You do not have to mail the
$10.00; you will be billed.
- Mail all submissions to:
Food and Drug Administration
Office of Nutritional Products, Labeling, and Dietary
5100 Paint Branch Parkway
College Park, MD 20740-3835
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.