New rules reflect slight revisions but no substantive changes to premarket review process required before new products can be authorized for sale.
The U.S. Food and Drug Administration issued two final rules for the premarket review of new tobacco products.
The foundational rules provide additional information on the requirements for the content, format and review of Premarket Tobacco Product Applications (PMTAs) and Substantial Equivalence (SE) Reports – two of the most commonly used pathways through which a manufacturer can seek marketing authorization for a new tobacco product from the FDA.
The finalization of these rules helps ensure that all future submissions contain the basic information needed to determine whether the new tobacco products meet the relevant premarket requirements to efficiently and effectively implement the Family Smoking Prevention and Tobacco Control Act.
“These final rules are important components of the FDA’s comprehensive approach to tobacco product regulation, which includes premarket application review, science-based use of the product standard authority and prioritized compliance and enforcement actions,” said Acting FDA Commissioner Dr. Janet Woodcock. “The FDA is committed to protecting Americans from tobacco-related disease and death by ensuring that new tobacco products undergo appropriate regulatory review to determine if they meet the public health standards set by law. If new tobacco products do not meet the standards for these pathways, they cannot be marketed or sold in the United States.”
Thomas Mulloy – CStore Decisions – 2021-10-04.
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