Last month, the US Food and Drug Administration (FDA), issued an Advance Notice of Proposed Rulemaking (ANPRM) to seek comments pertaining to eliquid flavours’ regulations. In response to this, five public health experts sent a letter to FDA Commissioner Dr. Scott Gottlieb urging him to look at the bigger picture.
Last month, the FDA together with the Department of Health and Human Services (HHS) launched this consultation in order to gather feedback on how to best regulate flavours. Echoing what Gottlieb said days earlier, the agency said it aimed to limit flavours’ appeal to adolescents, whilst considering the role that they are having in helping adult smokers take the leap from smoking to vaping.
In response to this, Attorney General of Iowa Thomas Miller, and four Public Health experts amongst whom renowned anti-smoking activists Clive Bates and David Sweanor, sent a briefing and letter to Dr. Gottlieb “that form a chain of reasoning that connect flavors to harms or, more likely in reality, to public health benefits.” The briefing goes as follows:
Briefing: Assessing potential harms and benefits arising from flavors in nicotine products
And here is the briefing… structured in the form of the ten questions below.
Is the flavor used in a combustible or non-combustible product?
Is the cause for concern an actual flavor or the way it is described (or both)?
Are all flavors, whole flavor categories or specific flavors the cause for concern?
How will the subset of flavors that have a particular role in attracting youth be identified?
Does a flavor preference create a change in behavior to increase e-cigarette use?
What is the behavior of concern and what is a distraction?
Would youth uptake of e-cigarettes caused by flavors be harmful or beneficial to health?
How are trade-offs between potential harms and potential benefits to youth addressed?
How will beneficial impacts for adults be reconciled with any potential impacts on youth?
What impact would a rulemaking intervention by FDA have?
Assessing potential harms and benefits arising from flavors in nicotine products
Following the 28 July announcement of FDA’s new nicotine strategy, publication of several Advanced Notices of Proposed Rulemaking (ANPRMs) is expected within months. These will provide a more detailed articulation of the strategy This memo discusses significant issues for consideration in the drafting of the forthcoming ANPRM on the role of flavored tobacco/nicotine products in attracting youth.
In articulating its strategy, FDA should be mindful of the real-world complexity governing potential harms and benefits of flavors. To that end, this memo sets out a possible framework for assessing harm and benefits as a series of questions below.
1. Is the flavor used in a combustible or non-combustible product?
Very different considerations are required depending on whether or not there is combustion. Flavored non-combustible products offer a ‘harm reduction’ pathway to smokers (or users who would otherwise smoke), and the appeal of such products may thereby create a benefit. No such benefit applies in the case of combustibles – and a completely different approach is required to analyze public health impacts and to define appropriate policy. Combustible and non-combustible flavored products should never be lumped together in policy considerations, given the pronounced variation in risk and the opportunity to substantially reduce health risks to people who would otherwise smoke.
The rest of this memo concerns flavors in non-combustible tobacco/nicotine products.
2. Is the cause for concern an actual flavor or the way it is described (or both)?
The first step is to identify the actual cause for concern and hence the possible the subject of rule-making. There are three potential options for regulation of flavors: (1) any properties of the flavor chemical that are harmful to health; (2) characteristics of the flavor itself (i.e. its sensory properties) that make the product inherently more palatable or appealing to younger people; (3) characteristics of the flavor descriptor (i.e. descriptive words or imagery – including trademarks or brand values from other products). We believe the first of these should beyond the scope of this ANPRM, but could managed through technical standards as required. For concerns about youth appeal, any rule-making initiative in this area requires a clear system for defining which flavor characteristics or descriptors are subject to regulation, and how a rule will define what is in scope and what is out of scope.
3. Are all flavors, whole flavor categories or specific flavors the cause for concern?
At one level, it is obvious that flavors play a role in all use of vaping products. If the products taste bad or are flavorless then few people will use them. But flavors are integral to vaping products – all products are flavored in some way, even if with a tobacco flavor. Supposedly ‘unflavored’ cigarettes are not flavorless, but taste of the thousands of chemicals in tobacco smoke. Every orally consumed tobacco/nicotine product is flavored in some way. Eliminating an essential component of vaping products (the flavor) would amount to a de facto prohibition of vaping products. Such action would run counter to FDA’s new nicotine strategy, which stresses the importance of the availability of low-risk nicotine products as alternatives to combustible cigarettes2. It follows that the question is how to identify a subset of flavors, with well-described selection criteria, that present concerns above and beyond simply making vaping products viable.
Read more at vapingpost.com