Recently, an importer sought help from our firm because FDA refused its shipment of an herbal supplement after FDA tested the product and alleged that the amount of a certain nutrient in the product was significantly lower than the amount declared on its Supplement Facts panel. The importer insisted to FDA that it must have erred in its analysis because an overseas lab had verified the product’s nutrient content. Nonetheless, FDA required the importer to export or destroy the entire shipment which had a retail value of over $100,000. Additionally, Customs assessed $50,000 in liquidated damages against the importer for failing to redeliver the goods into Customs custody within the appropriate time frame.
Overturning an FDA Refusal
Getting FDA to overturn a refusal is particularly challenging. Normally, arguments need to be presented to FDA during a set time period called the “detention period” which begins at the time the goods are detained. After the detention period expires, FDA may refuse to allow the goods into U.S. commerce. Then, to get the goods released, the importer must prove that FDA committed an error of fact, law, or procedure in refusing the shipment.
Fortunately, this importer came to us before it was too late. Even though it is far more difficult to overturn a refusal than it is to challenge FDA during the detention period, we were able to identify significant mistakes FDA made, including procedural errors, communication problems, and disregard of the importer’s rights. FDA could not deny the evidence we presented and ultimately released the merchandise. In addition, Customs agreed to our petition to withdraw the liquidated damages claim in its entirety.
Because we not only had expertise in FDA law but also had in-depth knowledge of FDA’s practices and procedures, we were able discover FDA’s mistakes. Moreover, extensive knowledge of the intersection of FDA and Customs law and procedures enabled us to save an additional $50,000 for the client. All importers should know their rights and know that FDA does often make mistakes. Don’t think that an FDA decision cannot be challenged. With the right expertise and diligent work, you can overcome an unfair FDA decision!
Want to learn more about how to overcome challenges like this? Pick up our free guide “FDA Challenges of Importing Dietary Supplements into the US.”
