FDA & International Compliance (Import/Export Regulations)

Our Lawyers and Consultants Assist U.S. and International Companies with FDA Import/Export Compliance

The U.S. Food and Drug Administration (FDA) regulates many types of products manufactured and sold in the United States. As it makes clear, “[a]ll products regulated by the Food and Drug Administration must meet the same requirements, whether imported from abroad or produced domestically.” Regarding products produced domestically, this is true whether these products are intended for sale in the United States or for export.

We assist companies in the U.S. and around the world with all aspects of international FDA compliance. This includes import and export compliance. Our lawyers and consultants work closely with our clients to help them implement compliant practices and protocols in all aspects of their operations, and we assist our clients with generating and storing the documentation they need to affirmatively demonstrate import/export compliance to the FDA when necessary.

Our International FDA Compliance Services

There are numerous aspects to international FDA compliance for both importers and exporters. The FDA has also adopted regulations that are specific to “import for export,” and while products imported for export may be exempt from the FDA’s approval requirements, companies that import unapproved products for export must still ensure that they meet all applicable regulatory requirements.

Our international FDA compliance services include:

FDA Import Compliance

All products imported to the United States that are subject to the FDA’s oversight are subject to inspection and review before being admitted into U.S. commerce. As the FDA explains: “All products offered for entry into the United States . . . must be declared to U.S. Customs and Border Protection (CBP) [and] CBP refers all FDA-regulated products to the FDA for review. . . . All imported shipments of FDA-regulated products are reviewed by the FDA and must comply with the same standards as domestic products.”

Companies on both sides of the importing process have a role in (and a responsibility for) managing FDA compliance. We assist foreign manufacturers, domestic importers and distributors, customs brokers, entry filers, and other entities with all aspects of FDA import compliance, including (but not limited to):

• Ensuring that foreign-manufactured products meet all applicable FDA requirements
• Preparing import shipments for CPB and FDA review
• Managing the entry review process
• Managing certification and testing prior to entry
• Responding to entry refusals (including refusals based on alleged adulteration and misbranding)

By taking a comprehensive and proactive approach to FDA import compliance, we help our clients in the U.S. and abroad minimize the costs of bringing FDA-regulated products to market in the United States. We also help our clients minimize their risk of facing FDA audits and inspections; and, when our clients face FDA scrutiny, we help them affirmatively demonstrate compliance (and proactively resolve issues as necessary) so that the FDA’s scrutiny is no more disruptive than necessary.

FDA Export Compliance

Domestic companies that export FDA-regulated products abroad also need to implement and manage effective international FDA compliance programs. Even when a company manufactures products solely for export, the company must still comply with all relevant provisions of the Food, Drug, and Cosmetic Act (FD&C Act) and all pertinent FDA regulations.

Additionally, as noted by the FDA, “[f]irms exporting products from the U.S. are often asked by foreign customers or foreign governments to supply a certification relating to products subject to the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. §§321-397, and other statutes FDA administers.” In addition to assisting U.S. exporters with FDA compliance, we also assist with these certifications, and we are able to assist U.S. exporters with obtaining local customs brokers and local counsel in foreign jurisdictions as necessary.

FDA “Import for Export” Compliance

“Import for export,” or “IFE,” refers to the practice of importing FDA-regulated products into the U.S. from foreign jurisdictions strictly for the purpose of exporting these products to other countries. Even though these products do not directly enter the U.S. stream of commerce, they are nonetheless subject to the FDA’s oversight.

But since these products do not directly enter the U.S. stream of commerce, they are not subject to the same requirements as FDA-regulated products sold in the United States. Under Section 801(d)(3) of the FD&C Act, IFE products are exempt from refusal on the basis of FDA non-compliance if they are strictly coming to the U.S. for further processing and export. Even so, IFE compliance is far from straightforward, and companies relying on the FD&C Act’s IFE exemption must ensure that they are meeting all applicable statutory and regulatory requirements.

Notably, these requirements differ for different types of FDA-regulated products. For example, while the FDA notes that drugs, medical devices, food and color additives, and dietary supplements generally qualify for the IFE exemption, it also notes that “[b]lood, blood components, plasma, and source leukocytes have IFE requirements that differ from those for drugs and other biological products.” Products in this category only qualify for the IFE exemption if either: (i) they comply with Section 351(a) of the Public Health Services Act (PHSA); or, (ii) the FDA’s Center for Biologics Evaluation and Research (CBER) permits import for export “under appropriate circumstances and conditions.” Additionally, the IFE exemption generally cannot be used for finished food products and other products specified as non-exempt under the FD&C Act or FDA regulations.

Industries We Serve

At Oberheiden P.C., our lawyers and consultants work with companies in all FDA-regulated industries. We have extensive experience advising companies both in the U.S. and abroad. This includes (but is not limited to) advising companies involved in the U.S. importation and exportation of products such as:

• Biologics
• Cosmetics
• Dietary supplements
• Drugs
• Food and color additives
• Medical devices
• Radiation-emitting electronic devices
• Tobacco products
• Veterinary products

Our clients range from small companies in the United States to large multi-national conglomerates. Our lawyers and consultants work with these clients at all stages of the product lifecycle for FDA-regulated products, from testing and quality control through export to the United States and to other countries around the world. Regardless of your company’s needs, we can provide an efficient and custom-tailored solution, and we can provide the advice and insights you need to manage FDA import, export, or IFE compliance with confidence.

Put our highly experienced team on your side

Dr. Nick Oberheiden

Founder

Attorney-at-Law

Lynette S. Byrd

Former DOJ Trial Attorney

Partner

Brian J. Kuester

Former U.S. Attorney

Hon. Kevin McCarthy

55th Speaker, U.S. House of Representatives (ret.)

Government Consultant

Mike Pompeo

Of Counsel

Former U.S. Secretary of State

John W. Sellers

Former Senior DOJ Trial Attorney

Linda Julin McNamara

Federal Appeals Attorney

Nicholas B. Johnson

Former Prosecutor

Roger Bach

Former Special Agent (DOJ)

Chris J. Quick

Former Special Agent (FBI & IRS-CI)

Michael S. Koslow

Former Supervisory Special Agent (DOD-OIG)

Ray Yuen

Former Supervisory Special Agent (FBI)

FAQs: FDA Import, Export, and IFE Compliance

Schedule an Appointment with an FDA Import/Export Compliance Lawyer at Oberheiden P.C.

If you need to know more about the rules that apply to importing or exporting FDA-regulated products, we invite you to get in touch. To speak with a senior international FDA compliance lawyer at Oberheiden P.C. in confidence, please call 888-680-1745 or tell us how we can reach you online today.