The United States Food and Drug Administration and Nafta

The North American Free Trade Agreement (NAFTA) helps safeguard the ability of the United States Food and Drug Administration to ensure food safety and quality within North America. NAFTA is an agreement between Canada, the US and Mexico that took effect on January 1, 1994, designed to increase the scope for the free flow trade and investment among these three countries. The US Food and Drug Administration (US FDA), which participated in the negotiation of NAFTA, has reviewed the US Food and Drug Administration standards for safety, purity and appropriate labeling of foods and has determined that these standards are consistent with the terms of the agreement. This is why no changes in US Food and Drug Administration standards are needed or proposed to implement NAFTA.

NAFTA does not change existing or future US Food and Drug Administration standards regarding pesticide use or pesticide and other chemical residue or contaminant standards for fresh or processed foods. NAFTA provisions safeguard the ability of the US Food Drug Administration to ensure food safety. In short, existing US Food and Drug Administration standards will continue to be applied to imported foods as well as domestically produced foods. This means that the U.S. will continue to prohibit any food shipments determined not to meet pesticide residue or other food safety requirements.

NAFTA has no effect on U.S. Food and Drug Administration laws and regulations in the area of safety, effectiveness, and appropriate labeling of human and animal drugs and medical devices. Any products coming into the U.S. must continue to meet all US FDA standards and requirements.

Additionally, NAFTA does not change or affect US Food Drug Administration laws and regulations with respect to US Food and Drug safety and appropriate labeling of dietary supplements imported in to the U.S. U.S. FDA and TWG

Within the auspices of the NAFTA, the three countries have developed a technical working group on pesticides called TWG. It serves as a focal point for all issues related to pesticides for these countries. TWG’s aim is to ensure that the countries can be assured of the legality and safety of foods produced in any of the NAFTA countries. US food and drug administration is providing trilateral cooperation between Mexico and Canada to enforce the TWG standards.

Article 723(6) makes explicit that any party challenging a U.S. Food and Drug Administration safety measure would have the burden of showing that the US Food and Drug measure is inconsistent with NAFTA. Whether any particular level of protection is “appropriate” is a social and political judgment that the agreement reserves for the government applying the measure (see Articles 712(2) and 724). As provided in Article 712, a sanitary measure is to be based on a risk assessment “as appropriate to the circumstances,” and is not to be maintained where there is no longer a scientific basis for it. US Food and Drug Administration standards are already based on risk assessments and have a scientific basis. These NAFTA requirements help assure that measures applied by the other parties will not unfairly exclude U.S. food exports.

Russell K. Statman, Esq., is a founder and Executive Director of FDA Registrar Corp., a firm providing registration, compliance assistance and U.S. Agent Services for the food and beverage, cosmetics and medical device industries. Mr. Statman is an attorney-at-law representing firms in FDA-regulated industries for the past eighteen years. Contact the author at: statman@fdaregistrar.com

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