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Our Services

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Services Provided to Clients of Becker & Poliakoff, P.A.

The new Food Safety Modernization Act (FSMA) amends the Bioterrorism Act and places new restrictions on all companies involved in any way with the food supply into the United States whether the company is located in the United States or anywhere else in the world.

Becker & Poliakoff’s Customs and International Trade Department is led by Jennifer Diaz, a Board Certified International Trade Attorney, considered an expert in International law by the Florida Bar. Becker & Poliakoff’s Customs and International Trade Department provides assists clients with FSMA and also provides a customizable menu of FDA services for both domestic and foreign companies. Assistance includes pre-compliance (assisting to successfully bring your product to market in the U.S.) as well as assistance with FDA enforcement actions. We provide FDA assistance for food, dietary supplements and alcoholic beverages; over-the-counter drugs; cosmetic and medical device companies.

Pre-compliance assistance is to assure the product is marketable in the U.S. Pre-compliance services include product and label review, biennial registration and U.S. Agent services for foreign food facilities registration with the FDA, and registrations with the FDA. Examples of enforcement actions by the FDA may include Notices of FDA Action detaining goods upon entry causing time delays, being placed on the FDA’s Import Alert (“red light”) list, warning letters, FDA’s inspections, and liquidated damages claims issued by U.S. Customs and Border Protection (“CBP”) for an underlying FDA violation.

Becker & Poliakoff, P.A. is a Florida, U.S. based law firm with extensive experience in international trade, and specifically in working with U.S. Government agencies including the U.S. Food and Drug Administration (FDA), U.S. Customs and Border Protection (CBP), and others. The attorneys of Becker & Poliakoff, P.A. help importers of FDA regulated products comply with the requirements of the new Food Safety Modernization Act (FSMA). We provide the following FDA services:

  • 1) Timely and properly registering domestic and foreign facilities with the FDA to obtain an FDA Registration Number.

  • 2) Appointment of the law firm of Becker & Poliakoff, P.A. as the United States agent for the facility or facilities. NOTE: All non-U.S. companies must appoint a United States agent when registering with the FDA. The U.S. Agent is responsible for being readily available to respond to FDA communications. FDA will communicate with the designated U.S. Agent, to schedule inspections and require an immediate response. The U.S. Agent is a person or entity located within, or that maintains an office, in the United States and acts as your domestic representative in all communications with the FDA.

  • 3) Advise on timely and properly completing the first Prior Notice Submission Form. We will be available to assist with subsequent Submission Forms at a small fee for each such additional form where our assistance is requested.

  • 4) Advise on records required to be maintained as ordered by the FDA.

  • 5) Advise on label review to assure your product complies with FDA requirements.

  • 6) We are available to promptly communicate with officials from CBP as well as the FDA. We can assist with questions or problems that may arise in connection with any food shipments to the United States which have been examined, delayed, detained, or refused entry into the United States. Examples include assistance in:

    • a. Adequately responding to Notices of FDA Action received by FDA when goods are detained causing time delays,

    • b. Petitioning FDA to request removal from FDA’s Import Alert (“red light”) list,

    • c. Responding to a Warning Letter received by FDA,

    • d. Preparing for an FDA inspection,

    • e. Responding to a liquidated damages claim issued by U.S. Customs and Border Protection (“CBP”) for an underlying FDA violation.

  • 7) Provide access to a FREE blog to provide you with timely updates about new FDA and Customs policies and issues that impact your business.

Additional services Becker & Poliakoff, P.A. provides include:

International Transactions, Corporate and Tax

  • 1. U.S. Corporate Formation

  • 2. Foreign Sales Agencies and Distributorships

  • 3. Foreign Joint Ventures, Branches & Subsidiaries

  • 4. International Mergers & Acquisitions

  • 5. International Franchising

  • 6. Intellectual Property & Technology

    • Trademark and Copyright Registration and Recordation with Customs

    • Patent Registration

  • 7. Inbound & Outbound Transactions

  • 8. Foreign Corrupt Practices Act Issues

CBP Regulations

  • 1. Compliance Audits

  • 2. Import Manuals

  • 3. Classification of Merchandise

  • 4. Valuation of Merchandise

  • 5. Determination of Country of Origin

  • 6. Free Trade Agreement Compliance

  • 7. Bonded Warehouses Applications

  • 8. Centralized Examination Stations (CES)

  • 9. Foreign Trade Zone (FTZ) Applications

  • 10. Detentions of Merchandise

  • 11. Seizures and Forfeitures

  • 12. Penalties and Liquidated Damages

  • 13. Prior Disclosures

Export Controls

  • 1. Compliance Audits

  • 2. Export Manuals

  • 3. Export Licensing

  • 4. Shippers Export Declarations/ AES

  • 5. Voluntary Disclosures

  • 6. Seizures

  • 7. Penalty Mitigation

Please visit www.bplegal.com for additional information about our qualifications and experience.

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