The Food and Drug Administration (FDA) has the responsibility under the Federal Food, Drug and Cosmetics (FD&C) Act to stop any adulterated or mislabeled food products from entering the United States. Foreign companies that attempt to ship to the United States products not in compliance with FDA’s laws and regulations often get listed on an FDA Import Alert.

Companies located as close as Mexico and Canada, and as far away as China and Australia are on FDA Import Alert lists because their products were found to contain illegal pesticide residues, contaminants, salmonella, or other hazards to consumers. Even products from certain Italian suppliers such as cheese, fish, honey, and confectionary products are on the FDA Import Alert List. Once listed, any future shipments of the same product from the same foreign company will automatically be detained without physical examination (DWPE), and not allowed to proceed into the commerce of the United States unless time consuming and expensive laboratory analysis for that particular, refused shipment is conducted in the United States by specific laboratories, and the negative laboratory report is accepted by the FDA.

To get off an FDA Import Alert, a company must prepare and submit a persuasive petition to FDA’s Division of Import Operations (DIO) that the problem has been permanently remedied. Petitions to the DIO are usually done through an attorney familiar with the policies and procedures of the FDA. Chapter 9 (Import Operations and Actions) of the FDA’s Regulatory Procedures Manual provides some guidance on “Removal  From Detention Without Physical Examination”.  FDA decisions to remove a product, manufacturer, packer, shipper, grower, country, or importer from DWPE should be based on evidence establishing that the conditions that gave rise to the appearance of a violation have been resolved, and the FDA has confidence that future entries will be in compliance with U.S. law.  The most important point to keep in mind – and to avoid potential delays in the review of a petition – is that all requisite documentary information must been initially submitted with the petition.  A minimum of five (5) consecutive non-violative commercial shipments of that product is required from that manufacturer, supplier, country, etc.  Each of the five (5) shipments should include a U.S. Customs and Border Protection entry number, date of entry, and port of entry.

In many cases, not only must documentation of compliance for at least five consecutive, commercial-size shipments be submitted to the FDA, but also documentation that the manufacturer or supplier of the product has eliminated the source of contamination or adulteration that caused the product to be listed. The FDA may require a foreign establishment inspection which demonstrates the company has adequately addressed its violative conditions before removal from DWPE.  The Petition for Removal from Import Alert is submitted electronically to the FDA, should always be accompanied by a cover letter addressed to the FDA, a letter of authorization from the company to the submitting attorney, and include numerous exhibits of supporting evidence. The supporting evidence is typically one or more of the following:

• Third-party laboratory analyses
• Manufacturing or processing records
• FDA establishment inspections
• Proof of registration and/or listing
• Proof of certification by a foreign government or certified body
• Evidence that labeling violations have been corrected
• Evidence that the product is in compliance

The FDA will promptly respond by email to acknowledge the receipt of the Petition. The file is then assigned to an FDA analyst who will review the submission. Too often, such Petitions are rejected because they did not contain the information required by the FDA. That delays the entire process as a new Petition must be submitted, and the Petitioner will have to wait until the next FDA analyst is available. Hopefully, when properly submitted the first time, it is analyzed, and a letter from the FDA granting the request for removal from the FDA Import Alert is granted and would be immediately effective.

Please call or email me with any questions or comments at PQuinter@Gunster.com or mobile (954) 270-1864. Mr. Quinter has been recognized by “Best Lawyers in America” legal directory in the area of FDA Law from 2009 to 2023. He is also one of very few attorneys to be heralded by the Chambers Global legal directory as one of the best attorneys in the area of International Trade in 2020, 2021, and 2022.

We have prepared a Blog series on U.S. Market Entry for Italian Enterprises, in which we share our thoughts and experiences on the challenges and opportunities arising from the attempt to enter and grow in the United States and expand globally from there.

The U.S. marketplace is the pinnacle of business growth and investment opportunity; competitive, fast-moving, and dynamic, yet the most accessible in the world. In many respects, the U.S. remains the most attractive and largest global investment destination, far outstripping other nations in foreign direct investment dollars. Foreign investment in the U.S. provides access to the vast American marketplace, its deep talent pool, a stable and innovative business environment, and intelligent and rich investment finance and capital sources.

The U.S. offers a business ecosystem unmatched in the world, comprised of world-class universities, flexible labor markets, deep, talented labor pools, and a highly developed judicial system protective of foreign investment and intellectual property. Moreover, its financial markets and stock exchanges provide a vast array of sophisticated financial products and capital sources, with unlimited venture capital and private equity sources. And finally, it serves as an excellent gateway to expanding business in Canada, Mexico, and Latin America.

The series encompasses a broad spectrum of U.S. market entry modalities. These modalities are discussed in the context of the level of risk and reward that each modality presents to the Italian enterprise. Beginning with a simple U.S. representative or branch office and ending with foreign direct investment upon U.S. soil, the level of risk increases exponentially as capital is brought onshore and permanently invested in a direct foreign investment project. Yet, with greater risk comes greater rewards for successful U.S. market penetration. Presenting this series through the lens of escalating levels of risk provides the Italian enterprise with the proper strategic insight into assessing the merits of these different market entry modalities.

Our firm intimately understands the different risk levels in cross-border entry for Italian enterprises as we have counseled and participated in each market entry modality. Our legal, tax and business services seek to reduce and effectively manage project and investment risk, and we stand ready to assist your market entry plans.

Please click on the following link to download the complete guide: www.mqrassociati.com/en/global-business/united-states-market-entry-for-italian-enterprises/