Frequently Asked Questions

What Does it Cost?

It’s free to upload your documents and receive your estimate. We determine an exact cost for your export certificate based on the complexity of your product and packaging. Then, we will email you an explanation of the cost and provide you with a payment link, so that you can immediately submit your payment for faster processing.  You’re not committed to pay anything unless you want the export certificate. Payment is easy, as we accept all major credit cards, as well as PayPal or check.

Is There a Discount for Multiple Export Certificates?

Yes! We know that many companies produce a variety of products and we want to be your #1 resource for FDA compliance consulting. If you have more than 4 export certificates at a time we will create a special discount for you. We are especially committed to helping small businesses and startups so please don’t hesitate to upload all of your documents at once so that we can work with you on a great discount. Please indicate that you require 4 or more export certificates when you contact us.

Are Export Certificates Required? Do I really need one?

FDA does not require Export Certificates to export products, but increasingly importing countries and companies are requiring U.S. exports to supply a “certificate” for products regulated by the Food and Drug Administration (FDA).

What Information do I need to Submit Along With My Application?

Each export certificate will require information that is unique to the type of product and the specific certificate you require.

Some common information that will be needed is:

  • product information,
  • product regulatory review (if applicable),
  • licenses/documentation from foreign country,
  • any requirements/ specifications given by the foreign purchaser,
  • copies of packaging/labeling material for the product,
  • manufacturer information,
  • exporter information, and
  • distributor info.

How Long Does it Take To Get A Certificate?

It depends on the type of certificate – the simpler certificates (e.g. Certificate of Free Sale for Food) take 20 days for FDA to issue. Some of the more complicated certificates (like for drugs), can take between 6 – 8 weeks.

Do Export Certs expire?

An export certificates expires 24 months after being issued.

Is it an Actual Certificate (Hard Copy?)

You receive a paper certificate or a letter from FDA, depending on the type of certificate. Some certificates are notarized and others are not. Do not be fooled by other companies claiming to “legalize” your export certificate. The certificate provided from FDA, notarized or not, is what you need.

What do I do With My Completed Certificate?

Although it depends on your specific destination country and product you will likely need to present the certificate along with the exported products. Some countries may require that copies be kept on file with their department others may require that you provide a copy with each shipment. Effective communication with the specific countries customs agency will be imperative. Through our firm’s international offices, we can assist in communicating with the necessary agencies.

What if I’m Not Sure Which Export Certificate to Get?

We can assist companies in determining the exact type of certificate to obtain. Simply fill in the inquiry form with the product details and we can get the process started for you.

I’m not Quite Ready- Do You Provide Other Regulatory Services?

Yes! See About Us.

History of Export Certificates

FDA’s issuing certifications on exports is not a recent development — but before the enactment of the FDA Export Reform and Enhancement Act of 1996 (“EREA”), there were many restrictions on exports and FDA could only issue certificates for products legally marketable in the United States. EREA eased restrictions on exports and allowed for the FDA to provide certification for products not legally authorized for sale in the U.S., as long as they met certain specific requirements. This amendment increased the products that were eligible for certificates.

FFDCA requires FDA to issue certificates for food, human drugs and biologics, animal drugs, and devices that meet the applicable requirements of the Act and may be legally marketed in the United States. In addition to these certificates, FDA issues Export Certificates for other FDA-regulated products such as cosmetics or products that are legal in the importing country, but not the United States.