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
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.
- Related Articles
- Related Q&A
- The United States Food and Drug Administration and Nafta
- Identifying Food Allergies - 8 Foods That Commonly Cause Allergies
- Canadian Drugs are Cheap, But are they Legal?
- Are Canadian Drugs Legal?
- Can You Buy Canadian Drugs Legally?
- Can You Be Arrested For Buying Canadian Drugs?
- Can Americans Buy Canadian Drugs Legally?
- Can U.S. Consumers Legally Buy Canadian Drugs?




Liability Lawyers Help Protect Consumers
By: P. Macneil | 02/07/2009In my experience, the general public has no idea how much the legal profession contributes to their safety, including as users and consumers of products.
Drug Testing, State Laws, Workers Compensation: Do It Right or Suffer the Consequences
By: Robert Elliott, J.D. | 01/07/2009State laws and drug testing in the workplace and workers compensation. Follow state laws to avoid problems.
Preliminary Name Searches versus Corporate Searches
By: Holly Crosgrey | 23/06/2009Explains what preliminary name searches are and why they are done with a comparison of the difference between a preliminary name search and a corporate search for Canadian companies.
Work Accidents: When do you need to report an accident at work?
By: Jessica Parker | 19/06/2009Employers and self-employed people, as well as people in control of premises, must legally report certain types of accident to the Incident Contact Centre of the Health and Safety Executive (HSE).
The Rules of Redundancy
By: Victoria Cochrane | 19/06/2009It pays to be informed, whatever the situation. Stay on top of employment relations by keeping yourself up to speed with redundancy rules and regulations and how they affect you, whether you are an employee or employer.
ASIAN GARMENT INDUSTRY RATTLED BY MARKET SITUATION
By: Mallikarjuna N.L. | 14/06/2009As American countries to head towards a recession, many will begin to question exactly how the garment industry affected by global trade in near future. The US has recently found itself approaching what some economics fear could be the next recession and its impacting many industries negatively in terms of profit and human capital
Landlords Should Choose Their Words Carefully
By: Daniel Butler | 10/06/2009If a tenant asks for your consent think twice before responding with phrases such as “in principle” and “subject to licence”.
How to Improve Corporate Governance in China with Online Training
By: Alex Raymond | 10/06/2009Online training (e-learning) is a powerful tool to improve corporate governance. Here are 5 ways that e-learning can help improve corporate governance and lead to China SOX compliance.
Fda Consulting Assistance With Fda Regulations, Fda Compliance and Fda Validation
By: Russell K. Statman | 25/05/2007 | BusinessFDA Registrar Corp provides FDA consulting assistance for FDA's Quality Systems Regulation(QSR), FDA law, & FDA validation for US & Non-US Companies in the food & beverage, medical equipment & cosmetics Industries.
Fda Approved Products
By: Russell K. Statman | 02/05/2007 | Regulatory ComplianceFDA approval process ensures that products related to food & beverage, cosmetic and medical device are safe in use and the labels show the actual ingredients and does not make false claims. To know more about fda approved products, read further.
International Coordination of Food Safety Regulations
By: Russell K. Statman | 06/04/2007 | Regulatory ComplianceFDA Registrar Corp helps companies comply with the U. S. food & beverage safety laws that are required of companies doing business in the US. These services are particularly helpful to nonU.S. companies that may need to overcome language barriers, time barriers & cultural barriers with regard to FDA requirements.
The United States Food and Drug Administration and Nafta
By: Russell K. Statman | 07/03/2007 | Regulatory ComplianceNAFTA helps safeguard the ability of the United States Food and Drug Administration to ensure food safety and quality within North America. For more information about United States Food and Drug Administration and NAFTA read this article.
Fda Registration of Food Facilities
By: Russell K. Statman | 15/02/2007 | AdviceFDA Registrar Corp registers your domestic or foreign facility with the FDA & gives you the mandatory FDA Establishment Registration Number. It serves as your mandatory US Agent required for foreign facilities to get you the FDA Certification.
Avoid Food Labeling Violations With Fda Registrar
By: Russell K. Statman | 24/11/2006 | Regulatory ComplianceFDA Registrar Corp's provides compliance assistance with FDA food facility registration, U.S. prior notice, U.S. food product labeling regulations etc for U.S. and Non-U.S. Companies.