New Certification Requirement for Certain Iron-Containing Dietary Supplements Effective Nov. 12, 2008

The “Consumer Product Safety Improvement Act of 2008” (15 U.S.C. § 2063(a)(1)) (CPSIA) requires that products subject to a consumer product safety rule include a Certificate of Compliance when shipped in commerce on and after Nov.12, 2008. For dietary supplement manufacturers, products subject to a consumer product safety rule are those that contain over 250 mg of elemental iron and are required to be in childproof closures by regulations promulgated under the “Poison Prevention Packaging Act,” a statute administered by the U.S. Consumer Product Safety Commission (CPSC).

The CPSIA is directed mainly at children’s products. “Children’s products” is a defined form of consumer product that by definition does not include foods (dietary supplements are a form of food), drugs or cosmetics. However, the provision discussed here does apply to certain dietary supplements containing iron.

The iron provision of the “Poison Prevention Packaging Act” regulations (16 CFR § 1700.14(a)(13)) is a consumer product safety rule that establishes dietary supplements containing an equivalent of 250 mg or more of elemental iron as a substance requiring special packaging (set forth in 16 § 1700.15). Guidance provided on the CPSC Web site at explains that the CPSIA expands the reach of an established Certificate of Compliance requirement to “all products subject to CPSA bans as well as standards, or to any ‘similar rule, ban standard or regulation under any other Act enforced by the Commission.’” The “Poison Prevention Packaging Act” constitutes a “similar rule” for purposes of the CPSIA.

The Certificate requirement is effective Nov. 12, 2008. Each shipment of products covered by this provision must include a Certificate:

· Certifying, based on a reasonable testing program, that the product complies with all rules, bans, standards, or regulations applicable to the product under any Act enforced by the CPSC; and

· Specifying:

o The applicable regulation;

o The manufacturer issuing the certificate and any third-party on whose testing the certification is based;

o Date and place of manufacture of the product packaged into containers for retail sale;

o Date and place where the closure was tested, i.e., by the closure supplier;

o Each listed party’s name, address, and telephone number;

o Contact information for the individual responsible for maintaining records of test results;

· Certificate shall accompany the regulated product, and copies shall be distributed to each distributor and retailer;

· Upon request, copies of certificates shall be furnished to CSPC.

· In the guidance provided on its Web site CPSC has advised that the testing and certification requirements also apply when a product bears a private label, and that the manufacturer and the private labeler must both certify the product. It is also noted that copies of the certificate furnished distributors and retailers need not be paper copies but they must accompany the regulated product

· Knowing violations of the certification requirements may lead to civil penalties;

· Knowing and willful violations of the certification requirements may lead to imprisonment.

The current certification requirements are set forth above. CSPC has issued a “Request for Comments and Information,” seeking, in particular, comments on the use of electronic certificates to facilitate the “accompanying” and “furnishing” requirements as well as comments on the issue of multiple certifications for the same product. Accordingly, CPSC will likely refine requirements as it gathers information on the most effective ways to manage these certification requirements.

“The American Herbal Products Association is reviewing CPSC’s request for comments to determine what comments if any to submit,” said AHPA President Michael McGuffin. “The association is committed to keeping members abreast of any developments and will provide guidance as needed.”

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