Certificate of Free Sale

A Certificate of Free Sale (COFS), required by Indiana HB 1169, Section 49, is evidence that goods, including food items, are (1) legally sold or distributed in the open market freely without restriction; and (2) approved by the regulatory authorities in the United States.

Indiana prepares certificates for Indiana firms only. Firms must have a current registration with the Indiana Food Protection Division and an inspection report within the past five years of the request that indicates the firm is in “good standing”.

Indiana firms include: Manufacturer, processor, packager, distributor, or warehouser that is registered with the Indiana Department of Health Food Protection Wholesale Division and:

COFS are available in the English language only. The standard certificate heading is Certificate of Free Sale. You may also request that the wording Health Certificate is added. Certificates are valid for 1 year from the notarized date.

Exceptions:

• Drug products, baby formula or dietary supplements
  • Contact the U.S. Food and Drug Administration (FDA). FDA also processes certificates for food, food additives, seafood, cosmetics, human or animal drugs, biologics and medical devices. Instructions for obtaining a certificate can be found on the FDA website.
  • FDA Food Export Guidance
  • FDA Food Export Certificates
• Animal feed
  • Contact the Indiana Office of the State Chemist (OISC)
• Exports to China
  • All export certificates for products shipped to China must be prepared by FDA. For more details on China’s requirements, additional information on the U.S. competent authority for certain products that are under the FDA’s authority or the USDA’s Food Safety and Inspection Service’s authority, or both and for step-by-step instructions on how to apply to the ELM, visit Food Export Library and Online Applications for Export Lists. For more information, contact the FDA Export Certification Team at CFSANExportCertification@fda.hhs.gov.

Order Certificate of Free Sale

The online ordering system allows Indiana firms to place an order, upload required documentation and use a credit card to pay for the order. You will receive updates regarding your order to the email address you provide with your request.

Please note: this process includes a verification step to ensure that only businesses with a current, satisfactory inspection history are eligible to request a COFS.

The ordering process is as follows:

1. First-time users will fill in and submit the "User Information" form in the portal.

2. After submitting the user information form, first-time users will need to contact the Food Protection Division at 317-493-0217 or by email to complete the account set-up and have their facility added to their account. Users will receive an email once set-up is complete.

3. Once the account is set up, users can login to the portal, complete the "Certificate of Free Sale (COFS) Request Form, and submit payment.

Orders may take up to 4 weeks to process but can take longer if a facility inspection is required before issuance.

Please be advised that all requests for drug and cosmetic facilities are processed by the FDA from the Food Export Certificates portal. Food based establishments may also use the FDA portal in place of the Indiana State Certificate of Free Sale if it is preferred. In order to expedite shipping, provide a shipping label with valid business information by email within 24 hours of submitting the request.