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• Clarification regarding FDA authorities relating to modified risk claims
  Erc N. LIndblom
  Published on: 2 September 2018

• Published on: 2 September 2018

  Clarification regarding FDA authorities relating to modified risk claims

  • Erc N. LIndblom, Public Health Lawyer and Policy Analyst O'Neill Institute for National & Global Health Law, Georgetown Law

  NOT PEER REVIEWED
  This study has some important findings that could, if replicated, guide FDA decision making on applications from manufacturers to make modified risk tobacco product claims. However, while it does not detract from the study’s findings, the article does not accurately describe the standards FDA must apply when evaluating those applications. The abstract inaccurately suggests that tobacco products in the U.S. may make reduced-risk or reduced-exposure claims so long as they are not misleading, and does not mention that any explicit or implicit reduced-exposure or reduced-risk claims may not be legally made without first submitting an application to FDA and receiving a permissive order, which considers various other factors, as well.

  The introduction of the paper does a bit better, accurately stating that the Tobacco Control Act requires prior review by FDA before making lower-exposure or lower-risk claims. But it then suggests that manufacturers can receive that permission if they either demonstrate that the product lowers harm or risk compared with other tobacco products or if they demonstrate that the product is free of or contains reduced levels of harmful chemicals and the related claims don’t mislead consumers to believe that the reduced-exposure means lower risk. While that description is accurate as far as it goes, it leaves off the enormously important requirement, in both cases, that a manufacturer’s application for permission to...

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  NOT PEER REVIEWED
  This study has some important findings that could, if replicated, guide FDA decision making on applications from manufacturers to make modified risk tobacco product claims. However, while it does not detract from the study’s findings, the article does not accurately describe the standards FDA must apply when evaluating those applications. The abstract inaccurately suggests that tobacco products in the U.S. may make reduced-risk or reduced-exposure claims so long as they are not misleading, and does not mention that any explicit or implicit reduced-exposure or reduced-risk claims may not be legally made without first submitting an application to FDA and receiving a permissive order, which considers various other factors, as well.

  The introduction of the paper does a bit better, accurately stating that the Tobacco Control Act requires prior review by FDA before making lower-exposure or lower-risk claims. But it then suggests that manufacturers can receive that permission if they either demonstrate that the product lowers harm or risk compared with other tobacco products or if they demonstrate that the product is free of or contains reduced levels of harmful chemicals and the related claims don’t mislead consumers to believe that the reduced-exposure means lower risk. While that description is accurate as far as it goes, it leaves off the enormously important requirement, in both cases, that a manufacturer’s application for permission to make a modified-risk claim must also show that the proposed claim will benefit the health of the population as a whole (taking into consideration impacts of the product and its marketing with the modified-risk claim on implementation, cessation, relapse, etc.).

  This study’s findings could have been presented even more powerfully if the article had also discussed their relevance to FDA’s consideration of how reduced-risk or reduced-exposure claims would impact the public health based on the claims likely influence on youth and adult consumer behaviors.

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  Conflict of Interest:
  None declared.

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