Exporting to the United States – A Team Canada Inc Publication

7.6 Labelling and marking requirements of U.S. agencies

As well as requiring licenses for certain types of imports, several United States agencies have special marking and labelling rules. If your shipments don't comply with them, your exports may not be allowed to cross the border. Check with the appropriate agency for specific information about your product and the marking and labelling it requires.

The major American agencies with special labelling rules are:

Federal Trade Commission (FTC)

The FTC provides business-oriented information about labelling, including the requirements of the U.S. Fair Packaging and Labeling Act. The Act applies to goods that are consumed – a candle is consumed, for example, and is subject to the Act, while the candle holder, which isn't consumed, is not.

There are other regulations that apply to textiles, clothing, wool, fur and leather. The FTC publication, "Threading Your Way Through the Labeling Requirements Under the Textile and Wool Acts"  is a user-friendly source of information on these rules. Visit the FTC Business page for more information on labelling.

Food and Drug Administration (FDA)

The FDA regulates food labelling in the United States and also has authority over the labelling of dietary supplements, cosmetics, drugs (both prescription and over-the-counter), medical devices, devices that emit radiation, animal foods, drugs and cosmetics. Their Web site provides information for industry about such labelling.

If you're a small business, be sure to check out the Small Business Food Labeling Exemption, which may make your labelling requirements less rigorous. Note that the exemption applies only to the requirement for a nutrition facts statement, one of the five mandatory statements which FDA requires on a label.

U.S. Department of Agriculture (USDA)

The USDA, though its Food Safety and Inspection Service (FSIS), is responsible for ensuring that the U.S. commercial food supply is safe, wholesome and correctly packaged and labelled. The FSIS Labeling and Consumer Protection page provides much of the information you'll need.

Most labels on retail packages of meat or poultry must be pre-approved by the FSIS. You obtain such approval by submitting your proposed label on Form FSIS 7234-1, "Application for Approval of Labels, Marking or Device," available through the Labeling and Consumer Protection page referred to above. The same page leads to information about products that may enter the U.S. with generic labelling, which doesn't require pre-approval.

The USDA is also responsible for the National Organics Program (NOP). The USDA Web site provides information on the NOP, including the accreditation requirements of the program.

Note that the recent U.S. Bioterrorism Act will probably affect you if you export food and agricultural products to the United States; see Section 9.4, "New U.S. regulations affecting exporters".

Bureau of Alcohol, Tobacco and Firearms (ATF)

The ATF ensures that alcoholic beverages sold in the U.S. are labelled according to regulations. You must apply to have your label approved, which you do through the Alcohol Labeling and Formulation Branch; you can contact them in Washington, D.C. at 1 202 927-8140. You'll need to fill out Form F5100.31, "Application for and Certification/Exemption of Label/Bottle Approval", which you can order online (but not download) through the ATF Distribution Centre.

U.S. Customs

Unless otherwise specified, all articles entering the United States must be marked with a country-of-origin statement. The rules for country-of-origin marking are in Title 19, Part 134 of the U.S. Code of Federal Regulations (CFR).

If you're sending printed material across the border, a label must state the country in which it was printed; "Printed in Canada," for example. However, if the material is NAFTA-qualified and is not intended for resale (such as brochures you'll be giving away), this label isn't necessary. For more information, refer to NAFTA Article 306.

Environmental Protection Agency (EPA)

The EPA deals with protection of the environment in the U.S. If your product contains chemicals that may come under the U.S. Toxic Substances Control Act, it may need special labelling.

Any product that purports to be a pesticide, fungicide, rodenticide or anti-microbial agent is subject to the U.S. Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), which is under the authority of the EPA. (This excludes products associated with cosmetics or over-the-counter drugs, which are under the FDA.) Information on labelling pesticides is in Chapter Two of the EPA Label Review Manual. The rules governing the FIFRA are in Title 40, Part 152 of the CFR.

The EPA is also responsible for the national volatile organic compound emission standards for consumer products. These are in Title 40, Subpart C of Part 59 of the CFR.

For more information, contact one of the EPA regional offices.

Consumer Products Safety Commission

The CPSC is responsible for the proper labelling of various hazardous substances and articles. These rules can be found in Title 16, Part 1500 of the CFR. The CPSC is also responsible for the labelling requirements of flammable products. The rules for this are in Title 16, Parts 1608 and 1609 of the CFR.

U.S. Department of Labor

The Department of Labor is responsible for the Occupational Health and Safety Administration (OSHA).  The rules on hazard communication, including labelling and information sheets regarding hazardous products, are in Title 29, Section 1910.1200 of the CFR.