With passage of the Bioterrorism Act of 2002, foreign companies that manufacture, process, pack, or hold food, nutraceuticals, dietary supplements, vitamins, minerals, natural products and their ingredients for consumption in the US must register with the US FDA (United States Food and Drug Administration).
Separately, the Food and Drug Administration Modernization Act of 1997 states that foreign companies engaged in the importation to the United States or the offering for import into the United States of all human drugs, animal drugs, biological products, and medical devices are required to register with the FDA and to identify a US Agent.
In order to register with the FDA, foreign companies must have a US Agent who lives or maintains a place of business in the US and is physically present in the US
It is recommended that foreign establishments appoint a third party as their US Agent.
In accordance with the FDA:
- The FDA will treat representations provided by the US Agent as those of the foreign company and consider information provided to the US Agent as the equivalent of providing the same information or documents to the foreign company.
- Only one individual may be designated as the "US Agent", but this does not preclude a foreign company from having multiple agents for other business purposes.
Dr. Louis M. Scarmoutzos is a highly qualified professional and US Agent who is accessible to the FDA 24 hours a day 7 days a week as required by the FDA.
Dr. Scarmoutzos and MVS Solutions will perform the required functions as US Agent for your non-U.S. establishment and will ensure that all of the regulatory responsibilities and interests of our clients will be handled promptly and with the utmost professionalism.
More details and information concerning The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) and the FDA's new Bioterrorism Regulations can be found on the the FDA website: Fact Sheet and Final Rule.
All inquiries for US Agent and advisory services are held in the strictest of confidence. Non-Disclosure Statements and Confidentiality Agreements will be provided upon request.
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