title: Substantial Equivalence Standards in Tobacco Governance: Statutory Clarity and Regulatory Precedent for the FSPTCA.
abstract: The Family Smoking Prevention and Tobacco Control Act (FSPTCA) of 2009 creates the first national system of premarket regulation of tobacco products in American history. The FDA must now review and give marketing authorization to all new tobacco products, based on a public health standard, before they can be legally marketed. Yet the law also contains an alternative pathway for market entry-the substantial equivalence (SE) clause-by which novel and altered tobacco products can be marketed by demonstrating their substantial equivalence to existing products. Over 99 percent of tobacco product applications sent to the FDA under the new law have used this mechanism, and loose application of the SE mechanism carries the risk of undoing the FDA's gatekeeping power under the law. We review the statutory and regulatory precedent for SE, examining the FSPTCA itself as well as regulatory precedent from drug and device regulation (from which the termsubstantial equivalenceand much of the associated statutory language was derived). Our review of standards and scientific precedent demonstrates that exacting scrutiny under the public health standard should govern all SE reviews and that clinical data incorporating social scientific evidence should be routinely required for SE claims by tobacco product sponsors.
authors.affiliation: Harvard University.
authors.forename: Daniel
authors.initials: D
authors.lastname: Carpenter
authors.affiliation: Northeastern University.
authors.forename: Gregory N
authors.initials: GN
authors.lastname: Connolly
authors.affiliation: Northeastern University.
authors.forename: Lauren Kass
authors.initials: LK
authors.lastname: Lempert
mesh_terms: D003132:Commerce / Q000331:legislation & jurisprudence; D033161:Government Regulation; D006801:Humans; D007880:Legislation, Drug; D040541:Marketing / Q000331:legislation & jurisprudence*; D012907:Smoking / Q000331:legislation & jurisprudence; D019460:Tobacco Industry / Q000331:legislation & jurisprudence*; D062789:Tobacco Products / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration
keywords: FDA; Family Smoking Prevention and Tobacco Control Act of 2009; cigarettes; substantial equivalence; tobacco