The Public Health, Science & Research

Harmful and Potentially Harmful Constituents (HPHCs)

Harmful and potentially harmful constituents (HPHCs) are chemicals or chemical compounds in a tobacco product or tobacco smoke that cause, or could cause, harm to smokers or non-smokers.
The Family Smoking Prevention and Tobacco Control Act requires tobacco product manufacturers and importers to report quantities of HPHCs found in tobacco products or tobacco smoke by brand and sub-brand.

While there are more than 7,000 chemicals in tobacco and tobacco smoke, FDA established a list of 93 HPHCs that tobacco companies will be required to report for every regulated tobacco product sold in the U.S.  All HPHCs included on the list cause or may cause serious health problems including cancer, lung disease, and addiction to tobacco products.  

Menthol Cigarettes

Menthol is a flavor additive widely used in consumer and medicinal products; however, its use in tobacco products is not currently regulated. It has a minty taste and aroma, and may have cooling or painkilling properties – which can reduce the irritation and harshness of smoking when used in cigarettes. 
 

Inviting Public Input on Menthol in Cigarettes

Menthol cigarettes raise critical public health questions. The FDA issued an Advance Notice of Proposed Rulemaking (ANPRM) to take public input on menthol in cigarettes. Specifically, the FDA is requesting information to inform its thinking about potential regulatory options such as:

• tobacco product standards;
• sale and distribution restrictions; and
• other regulatory actions and considerations.

The FDA also conducted a preliminary independent scientific evaluation of existing data and research on menthol cigarettes. The Preliminary Scientific Evaluation of the Possible Public Health Effects of Menthol Versus Nonmenthol Cigarettes addresses the association between menthol cigarettes and various outcomes, including: 

• initiation;
• addiction; and
• cessation.

The preliminary scientific evaluation, along with other relevant scientific information on the topic of menthol, is included in the docket for the ANPRM to give all interested parties an opportunity to comment on these materials. The ANPRM will be available for public comment for 60 days.

 

 

Modified Risk Tobacco Products (MRTPs)

Modified risk tobacco products are tobacco products that are sold, distributed, or marketed with a claim to reduce harm or the risk of tobacco-related disease.
The Tobacco Control Act establishes rigorous scientific criteria an applicant’s tobacco product must meet before FDA can allow the applicant to sell that product with a claim to reduce harm.
 
 The draft guidance for MRTPs provides details for those who seek to market a tobacco product as modified or lower risk including how to organize and submit an MRTP application, what scientific studies and analyses should be submitted, and what information should be collected through post-market surveillance and studies.