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FDA Answers FAQs About Substantial Equivalence

SILVER SPRING, Md. — The Food and Drug Administration (FDA) issued a final guidance aimed at answering frequently asked questions about the substantial equivalence (SE) process for new tobacco products.

The questions are divided into four sections — label changes, product quantity changes, additives/specifications, and general questions about SE reports. 

The final guidance, entitled "Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions," explains the circumstances under which a manufacturer may submit streamlined SE reports for tobacco products that have certain modifications to labels and changes to product quantity. 

Under the Family Smoking Prevention and Tobacco Control Act of 2009, new tobacco products may not be legally marketed in the United States unless the FDA has issued an order permitting their marketing. However, if a new tobacco product meets certain criteria, then it may continue to be marketed unless the FDA issues an order that the new product is not substantially equivalent to an appropriate predicate product.

The criteria, according to the FDA, is:

  • It was commercially marketed after Feb. 15, 2007 but before March 22, 2011; and 
  • A Substantial Equivalence Report was submitted by March 22, 2011.

The agency will also host an upcoming webinar to discuss its final guidance.

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