Where There’s Smoke, There’s Guidance: FDA Issues Two Draft Guidance Documents for Tobacco Products

By David B. Clissold & Ricardo Carvajal –

Last Friday, the FDA Center for Tobacco Products announced two new draft guidance documents for tobacco products.  The first guidance, entitled “Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under Section 904(a)(3) of  the Federal Food, Drug, and Cosmetic Act,” identifies 22 harmful or potentially harmful constituents ("HPHCs") in tobacco products and tobacco smoke.  Domestic manufacturers, or their agents, are to submit the required HPHC information for products they manufacture. For imported tobacco products, the required HPHC information is to be submitted by either the foreign manufacturer or the importer, or an agent, of the product.  The reporting obligations under section 904(a)(3) are effective June 22, 2012, but small tobacco manufacturers are afforded three additional months to comply.  For cigarettes, smoke must be tested for 18 HPHCs and the tobacco filler must be tested for six compounds.  Smokeless tobacco (e.g., snus, snuff, plug, chew, loose leaf) must be tested for nine HPHCs and roll-your-own tobacco must be tested for six.  FDA intends to use this list in part to comply with section 904(d)(1) of the Federal Food, Drug, and Cosmetic Act ("FDC Act"), which requires FDA to publish a list of HPHCs, by brand and by quantity in each brand and sub-brand, in a format that is understandable and not misleading to lay persons.

The second guidance is entitled “Modified Risk Tobacco Product Applications.”  Modified risk tobacco products ("MRTPs") are tobacco products that are sold, distributed, or marketed with a claim to reduce harm or the risk of tobacco-related disease.  Before an MRTP can be introduced or delivered for introduction into interstate commerce, an order from FDA under section 911(a) of the FD&C Act must be in effect with respect to the tobacco product.  This may be either an “exposure modification order” or “risk modification order” under section 911(g) of the FDC Act.  Under the draft guidance, an exposure modification order can be issued for an MRTP that reduces or eliminates exposure to a substance and for which the available scientific evidence suggests that a measurable and substantial reduction in morbidity and mortality is reasonably likely to be demonstrated in future studies.  For a risk modification order, the applicant must demonstrate that the product, as it is actually used by consumers, will significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products. The draft guidance describes the numerous scientific studies and analyses an applicant should submit to demonstrate that a MRTP will significantly reduce harm or exposure to individuals and benefit the public health.  These studies include product analyses, nonclinical studies, studies in adult human subjects, and secondary data analyses and modeling.  Human studies will likely include clinical investigations, epidemiological studies, consumer perception studies, actual use studies and other studies that involve humans actually consuming or interacting with the product, its proposed labeling and/or marketing materials.

In a contemporaneous blog posting, Commissioner Hamburg explained the object of the guidance on HPHCs:

The detailed information that we receive will help FDA determine how best to make science-based decisions to reduce the terrible toll of tobacco-related disease and death. We also hope that by having to disclose this information, industry will voluntarily start to make their products substantially less addictive and harmful.

As for the guidance on MRTPs, the Commissioner stated:

We want to make sure consumers and the public have an accurate understanding of the health risks of tobacco products—so mistaken beliefs don’t cause them to start or continue using products that lead to preventable disease and death.

FDA will accept comments on these two draft guidance documents for the next 60 days.