Environmental Health

The Export Documents Project assists those who sell domestically produced food, drug, cosmetic, and medical device products internationally. Through label review and routine inspections, we evaluate firms and their products for compliance with applicable State and Federal laws. 

Export Documents are required by many foreign countries. These documents certify that a company is in substantial compliance with the State and Federal standards and are equivalent to products marketed domestically in the United States. Each issued certificate is signed and notarized by the Export Documents Project.

Export Document applications are evaluated pursuant to N.J.S.A. 24:2-9 and N.J.A.C. 8:21-1.10 et seq.

The Export Documents Project issues the following certificate types:

Certificates of Free Sale: Certifies that specific products are manufactured, distributed, and offered for sale in New Jersey; are labeled in compliance with the Food, Drug and Cosmetic Laws of New Jersey; and originate at a facility that received a satisfactorily evaluated inspection by PHFPP or the US Food and Drug Administration.

Good Manufacturing Practice Certificate: Certifies that a manufacturing or wholesale distribution facility is licensed/registered and inspected by PHFPP.

Product Good Manufacturing Practice Certificate: Certifies that specific products are manufactured or stored at a licensed/registered and inspected facility.

Health Certificate: Certifies that specific products are manufactured or stored at a licensed/registered and inspected facility and are fit for human consumption.

Export Certificate: Certifies that a manufacturing or wholesale distribution facility is licensed/registered and inspected by PHFPP and NJ Department of Health (DOH) does not take exception to the sale of specific products to any other state or country.

Sanitation Letter: Certifies that a manufacturing or wholesale distribution facility is licensed/registered and inspected by PHFPP, has met the sanitary requirements of DOH, and all products originating from the facility are sold in New Jersey and fit for human consumption.

• Apostilles and Notary Certifications: see NJ Division of Revenue and Enterprise Services
• Dairy Sanitary Certificate: see US Department of Agriculture
• Export Certificates for meat and poultry: see US Department of Agriculture
• Export Documents for alcohol and tobacco: see the Alcohol and Tobacco Tax and Trade Bureau
• Export Documents for products other than food, drugs, cosmetics, or medical devices: see the International Trade Administration
• Export Documents for products manufactured or stored outside New Jersey: contact the resident licensing agency
• The Food and Drug Administration issues food, drug, cosmetic, and medical device export documents for manufacturer or wholesale distribution businesses, located in any state, that are registered and inspected by FDA

Applicants must demonstrate compliance with all of the below criteria in order to qualify for an Export Document:

• The products for export are food, cosmetics, drugs, or medical devices
• The products for export are physically manufactured or stored for distribution in a licensed New Jersey facility
• The products for export are sold throughout New Jersey
• The products for export are not under embargo
• The products for export are labeled in compliance with 21 CFR 101 et seq
• The facility of product origin holds a current and valid license/registration with PHFPP as a wholesale food-cosmetic or drug-medical device establishment
• The facility of product origin has received a satisfactorily evaluated inspection by a representative of PHFPP or the US Food and Drug Administration

1. Complete form F-12: Application for Certificate of Free Sale in its entirety.
   
   Download form F-12
   
   
2. Submit an electronic payment and receive a payment confirmation email.
   
   Submit an electronic payment
   
   
3. Purchase and prepare a self-addressed return shipping label for USPS, UPS, or FedEx.
   
   
4. If your request includes a list of products, collect a full legible product label image for each product. PDF format is preferred.
   
   
5. Collect all required attachments as below:
   1. Completed F-12 application form
   2. A product label to correspond with each product to be included on the certificate(s)
   3. Electronic payment confirmation: electronic payments are the only acceptable payment method for email submission
   4. Electronic copy of self-addressed return postage: courier mail, such as FedEx or UPS, is required for online submission
      
      
6. Combine the application and all attachments into a single pdf document.
   1. If a cover letter is needed, utilize the body of the email.
   2. If the file size is too large, product labels may be submitted as a separate, single pdf document.
      
      
7. Submit all items as attachments via email to cfs@doh.nj.gov
   
   Email cfs@doh.nj.gov
   
   
8. You will receive an automatically generated email to confirm receipt. Processing time begins upon confirmation.
   1. If you do not receive an automatic response email after 1 hour, ensure the documents were sent to cfs@doh.nj.gov 
   2. Processing time begins upon your receipt of the automatic response email

Any inquiries regarding a request submitted electronically must be submitted in the same email chain as the original submission. Do not start a new email thread to inquire about your request.

Find answers to the most frequently asked questions about PHFPP Export Documents.

Frequently Asked Questions