FDA IMPORT & EXPORT COMPLIANCE

The United States Customs and Border Protection (CBP) is primary responsible for administering the laws concerning imports to and exports from the United States.  However, the FDA is responsible for determining whether food, drugs, cosmetics, medical devices, biologics, or tobacco products offered for importation are in compliance with or in violation of the acts enforced by FDA.  When importing an FDA-regulated product, importers must be in compliance with the rules and regulations of both the FDA and CBP.

At Gaitan Law Group, we regularly counsel importers and exporters of FDA-regulated products, including:

• Import requirements and procedures
• Preparation and filing of Prior Notice for food, beverage and dietary supplement imports
• Responding to a Notice of FDA Action when the FDA takes action against an entry line (i.e. “sample collected” or “intended for sampling”, “detained”, or “refused”
• Preparing reconditioning proposals for detained imported product(s) that can be brought into compliance
• Drafting petitions to reduce liquidated damages and penalties assessed by CBP for failure to redeliver or export goods
• Petitioning the FDA for removal from Import Alert
• Requesting export certificates from the FDA

RESPONDING TO NOTICE OF FDA ACTION

When a food, drug, medical device or cosmetic product is offered for import to the U.S.  the FDA district office is notified of the entry by CBP via the Operational and Administrative System for Import Support (OASIS) – the FDA’s electronic entry system.  Upon reviewing the entry documents the FDA will determine whether a physical examination of the imported goods is needed, in which case it will issue a “Notice of FDA Action” indicating which items are pending FDA review.

Importers that receive a Notice of FDA Action frequently seek the advise of experienced professionals like our FDA import and export attorneys.  Our attorneys are accustomed to and adept at working within FDA’s strict response times for responding to the Notice of FDA Action.  Whether a product is held for sampling or detained, our FDA import and export attorneys bring the experienced perspective necessary to achieve the most desirable results. We regularly work with clients to identify the best options in each case, whether it be reconditioning the goods (FDA Form 766), private lab testing,  requesting a refusal, or otherwise we skillfully work with the FDA compliance officer handling an entry to resolve the FDA’s concerns regarding the subject goods.

REMOVAL FROM FDA IMPORT ALERT

When an FDA District office determines that an imported product is adulterated or misbranded, they may make a recommendation for detention without physical examination to the FDA’s Division of Import Operations (DIOP).   If DIOP determines that detention without physical examination ((DWPE, aka automatic detention) is appropriate, a country, firm or product will be placed on Import Alert, and will appear on the Import Alert’s “Red List.” Once on Import Alert, all future importations will be immediately detained by the FDA on the presumption that the goods are adulterated or misbranded.

There are numerous Import Alerts, ranging in scope and impact, from some that affect entire countries or regions, to more specific ones affecting importer companies and products.  The most active Import Alerts are:

• 99-19:  Salmonella in food products
• 53-06:  Illegal/undeclared colors in cosmetics
• 45-02:  Illegal/undeclared colors in foods
• 16-81:  Salmonella in seafood and other food products
• 66-41:  Unapproved new drugs
• 89-08:  Medical device lacking the appropriate FDA clearance

Whether a firm or product is placed on Import Alert as a result of an FDA site inspection or as a result of a non-compliant import entry, Gaitan Law Group successfully counsels firms on the requirements for removal from Import Alert.  We understand that removal from Import Alert can only be achieved through clear and convincing evidence that the conditions giving rise to the misbranding, adulteration, or other violation have been resolved so that future entries will be compliant.  Thus, we work with clients to identify the root of the problem, and play an instrumental role in counseling them on procedural changes and improvements that are necessary to achieve continued compliance with the FDA rules and regulations.

Clients who have been placed on Import Alert, rely on our attorneys for such services as:preparing an adequate Corrective Action Plan (CAP); reviewing existing written Hazard Analysis and Critical Control Points (HACCP), Hazard Analysis and Risk-Based Preventive Controls (HARP), Standard Operating Procedures (SOP), and Current Good Manufacturing Practices (cGMP) in order to identify deficiencies; and drafting compelling petitions for removal from Import Alert.

FDA EXPORT CERTIFICATES

Firms exporting FDA regulated products from the United States are often asked by foreign customers or governments to provide a “certificate” from the FDA certifying the product’s regulatory or marketing status.  FDA export certificates offer an additional assurance that a food, drug, medical device or cosmetic meets FDA’s stringent regulatory requirements and can be marketed in the United States. Review of an FDA Export Certificate is sometimes a required part of the process to register or import a product into another country.

Our Import and Export attorneys advise domestic and foreign clients on the benefits of export certificates and help firms obtain the appropriate export certificate for their specific product and needs.  Our lawyers assist food, drug, medical device and cosmetic firms obtain the following export certificates:

• Certificate of Free Sale (Certificate of Export for Seafood) for food, including dietary supplements, and cosmetic products
• Health Certificates for Food/Feed currently required primarily by the European Union (EU)  and often contain language pertaining to “compliance” of the particular product/consignment with foreign regulations
• Specified Risk Materials of Bovine, Ovine and Caprine Origin Certificate is used for the export of gelatin and addresses concerns of transmissible spongiform encephalopathies
• Certificate of a Pharmaceutical Product conforms to the format established by the World Health Organization (WHO) and is used by the importing country when considering whether to license the product in question for sale in that country
• Non-clinical Research Use Only Certificate is for the export of a product, material, or component, for non-clinical research use only
• Certificate to Foreign Government is for the export of human drugs and biologics, animal drugs, and medical devices that can be legally marketed in the United States
• Certificate of Exportability is for the export of human drugs and biologics, animal drugs, and medical devices that cannot be legally marketed in the United States, but meet the requirements of sections 801(e) or 802 of the Act and may be legally exported

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