The United States Food and Drug Administration (FDA) has authority to put an importer, manufacturer, shipper, grower, geographic area of a country, or an entire country on a “detention without physical examination” (DWPE) list  (a/k/a the FDA’s ‘Black List’).  To check if a company you are doing business with is on such a list, check FDA’s Import Alert page.   You can search by country, company, etc.  If your company is on this list, any merchandise you attempt to import into the United States may be detained by the FDA as soon as it is offered for entry into the United States.  An importer will have to prove to the FDA that the merchandise should be allowed to enter the U.S., otherwise, it will be refused entry and must be exported or destroyed within 90 days.  The company/country, etc. will remain on this ‘Black List’ until sufficient information is presented to the FDA that proves the merchandise complies with the FDA requirement.

FDA’s Regulatory Procedures Manual provides guidance to those who wish to get off the ‘Black List’.  The specific method to use to get off the ‘Black List’ is directly related to why you were placed on the ‘Black List’ in the first place.  For example, if a food product was placed on the ‘Black List’ because it was deemed “adulterated” or “misbranded” by the FDA, a minimum of five consecutive non-violative commercial shipments must thereafter enter the U.S., and at least one of the five non-violative entries should be audited by the FDA to ensure compliance.  The five shipments must be over a reasonable time period, not one day.  Separately, a Petition must be filed with the FDA requesting that the importer be removed from the ‘Black List’.  The Petition must include the specific products being automatically detained, the Entry Numbers, and any other relevant documentation to detail steps taken to prevent entry into the U.S. of merchandise that violates the FDA’s many requirements.

It is wise to know whether you or your company are on the FDA ‘Black List’, to know the FDA requirements to get off the list as soon as possible, and to take action, so that you too, can get off the FDA ‘Black List’.

Jennifer Diaz is an attorney in the Customs and International Trade Department of Becker & Poliakoff. She concentrates her practice on assisting clients with issues relating to the import and export of merchandise to and from the United States. Contact Diaz at jdiaz@becker-poliakoff.com or 305-262-4433.

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Peter Quinter

• Recommended pre-shipment due diligence
• What importers and customs brokers need to know to timely and completely file entries
• How to overcome automatic detentions and the relationship between the CBP and the FDA for reviewing food and medical devices

The presenters include representatives from the FDA and expert compliance officers. Attendance is free for members of the Florida Customs Brokers and Forwarders Association, or just $45 for non-members. To download a registration form with more information, click here.

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Fellow supplement blogger Marc Ullman of Ullman, Shapiro & Ullman, posed the question to Eugene I. Lambert, Senior Counsel at Covington & Burling, whether FDA user fees, such as those paid by prescription drug manufacturers to increase the speed of review for new drug applications, could be used to provide FDA with more resources to increase inspections of food and dietary supplement ingredients at the border?

Lambert agreed that such an application of user fees may provide a benefit to food and dietary supplement manufacturers and marketers, and could provide the industry with a reason to once again consider whether user fees are a tool help accomplish industry goals that the current regulatory scheme fails to address.

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