Tobacco Product Standards

James Swauger, Ph.D., DABTVice President, Regulatory Oversight

Tobacco Control ActProduct Standards

• FDA has the authority to require reduction or elimination of: – additives – constituents (including smoke constituents)– other components of a tobacco product

• The FDA may not:– ban a product category– reduce nicotine levels to zero

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Center for Tobacco Products Strategic Priorities

“We’re working on a strategy to give us the opportunity to take advantage of what is really one of the most powerful tools in the Family Smoking Prevention and Tobacco Control Act…”– Mitch Zeller

Zeller, M. (Presenter). (2014, June 11). Center for Tobacco Products Strategic Priorities. [Webcast]. Washington, D.C. Legacy Kenneth E. Warner Lecture Series. Retrieved from One-on-one with Mitch Zeller, Director of the FDA Center for Tobacco Products. https://www.webcaster4.com/Webcast/ListenPage?companyId=219&webcastId=4381

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Product StandardsReasonable Regulation

• Must be: – Fairly balanced to reflect interests of all

stakeholders– Technologically achievable– Science-based– A reasonably certain driver of health

outcomes– Free of unintended consequences

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Product StandardsConsiderations

• Preservation of culturally significant product categories

• Uniform enforcement

• Challenges associated with pre-market clearance

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Preservation of Culturally Significant Product Categories

• Relevant US Examples include:– Dry Snuff– Moist Snuff– American-blend Cigarette

• Substantial alteration would change product identity

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Uniform Enforcement

• Compliance regardless of size of manufacturer or country of origin

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Pre-market Clearance Challenges • Manufacturers would likely employ diverse

approaches to comply with a standard, requiring significant:– research by the applicant– lines of inquiry by FDA

• Each approach would require careful scrutiny to mitigate the potential for unintended consequences

• A single product standard, unless exemptions are created, would generate thousands of new Substantial Equivalence submissions based on current rules

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Unintended Consequences

• From a toxicological perspective, even in their simplest forms, tobacco products represent complex mixtures

• Tobacco blend changes and /or processing changes have the potential to impact the chemistry, toxicology and risk associated with tobacco products

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Unintended Consequences

“It is also important to evaluate unintended consequences of potential product standards and how they could be minimized in order to maximize the desired improvement in public health.”

Ashley, D.L., Backinger, C.L., van Bemmel, D.M., Neveleff, D.J. "Tobacco regulatory science: research to inform regulatory action at the Food and Drug Administration's Center for Tobacco Products." Nicotine & Tobacco Research (2014): doi: 10.1093/ntr.ntu038

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Potential Examples

A standard targeting the reduction of tobacco specific nitrosamines in cigarette smoke

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Potential Examples

A standard targeting the reduction of volatile organic compounds in cigarette smoke

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QUESTIONS

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