New FDA Automatic Destruction Rule

New FDA Automatic Destruction Rule

Under New Authority Re-Export Option May be Removed

An ominous sounding new rule goes into effect tomorrow (October 15, 2015). The rule is titled, “Administrative Destruction of Certain Drugs Refused Admission to the United States. Final rule.” This may be one scenario where the rule is as ominous as the title suggests.

Under the new FDA automatic destruction rule the FDA is given authority to automatically destroy a refused shipment. Notice will still be given in the typical form of a refusal notice. The notice will now be more specific to state that destruction is intended. As with all import refusals the notice will provide an opportunity to respond prior to destruction. Under the new FDA automatic destruction rule the Agency does not provide the party an option of re-exporting or destruction. Instead if the shipment is valued at under $2, 500 then the option of re-exporting is removed. The shipment is automatically destroyed.

The FDA automatic destruction new rule pertains to “certain drugs” which would seem to narrow the scope of its application. It is important to remember the FDA may determine classification during inspection. For example, a dietary supplement making disease or drug claims would be reclassified as a drug and subject to automatic destruction. Similarly a cosmetic could make structure/function claims or fail to comply with a monograph, like an acne product, and be subject to automatic destruction. Also look at animal products, such as “supplements” or topical therapeutic products. Animal products are either foods or drugs and such products would be at a high risk of automatic destruction under the new FDA automatic destruction rule.

The new FDA automatic destruction rule requires notice to the owner or consingee. This may result in notice going to the shipper, customs broker, or importer. Manufacturers could be left out of the communication loop. As we have emphasized before it is important when importing to establish clear channels of communication and to rely on a FDA Agent to ensure proper receipt of notices. The new FDA automatic destruction rule makes this particularly important.

 

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Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

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