CASAA’s Comment to FDA on Flavors

The Food and Drug Administration (FDA) issued an advance notice of proposed rulemaking (ANPRM), Regulation of Flavors in Tobacco Products, to obtain information related to the role that flavors play in tobacco products. Specifically, FDA is seeking comments on, among other things, how flavors attract youth to initiate tobacco product use, and about whether and how certain flavors may help adult cigarette smokers reduce cigarette use and switch to potentially less harmful products. In addition to encouraging individual consumers to submit comment, CASAA has submitted a thorough and comprehensive comment to the FDA.

Highlights

• • Comments being submitted by CASAA and thousands of individual consumers should be given serious and primary consideration, given that consumers are in a very real sense the most important stakeholders. It is our lives and our health that are most profoundly impacted by the decisions FDA makes in connection with Tobacco Harm Reduction (THR) products. In fact, we consider the right of consumers to obtain honest information about the full range of THR products (and access to those THR products) to be a human rights issue.

• • THR products are indisputably low risk as compared with smoking. It is therefore self-evident that extraordinary care should be taken to regulate THR products lightly and to do nothing that would make them less accessible, less affordable, less effective, or less enjoyable to adult consumers.

• • The “problem” of youth use of THR products is not nearly the crisis that it is being portrayed as in the media and by public health activists. Far from youth tobacco use being a public health crisis, we are seeing a very steady decline in use. And even though there is a modest uptick in use of low-risk THR products, use of the most dangerous products is decreasing.

• • The collateral harm of making THR products less attractive and less available to adult consumers is that the most risky tobacco products, combustible cigarettes, remain the most popular and visible products to young people. Parents and close family friends, in turn, act as unknowing sources of both product and marketing for smoking.

• • The goal of reducing youth use of tobacco products generally (and of THR products specifically) should not outweigh the critical need to provide effective and satisfying low-risk smoking alternatives to adults.

• • There has not been a serious exploration of just how “addictive” nicotine is for various methods of delivery beyond FDA-approved nicotine replacement therapies (NRT), and there is substantial evidence that vapers (those who use vapor products) exhibit less dependence on vapor product use than they did as compared to smoking.

• • Contrary to notions that THR products might serve as a gateway to the most harmful combustible products, the declining smoking rates would suggest low-risk products are acting as a path away from smoking.

• • It is important to empower young people with truthful, accurate information, and it would be public health malpractice to mislead youth to believe that all tobacco products carry similar risks.

• • Federal law requires age verification and prohibits sales of all tobacco products, including low-risk THR products, to anyone under the age of 18. It is within FDA’s power to strictly enforce these laws in order to reduce youth access.

• • The definition of “flavors” is far from simple. Because vapor products contain no tobacco, even “tobacco-flavored” vapor products contain added flavorings. Moreover, “tobacco-flavored” vapor products, while in many cases reminiscent of some tobacco notes, do not replicate the taste of smoking a cigarette since there is no combustion to impart the taste, sensation, and aroma of smoke. Even completely unflavored liquids designed for use with vapor products impart a flavor since vegetable glycerin and propylene glycol (common ingredients) have a slightly sweet taste.

• • Non-tobacco and non-menthol flavors in and of themselves do not constitute marketing to children. If this were a genuine issue, the pharmaceutical industry would be under fire for producing NRT gums and lozenges (which can be used without detection in schools and other places in order to circumvent smoking bans) that come in trendy flavors like Fruit Chill™, Cinnamon Surge™, White Ice Mint® and Spearmint Burst™, to name a few.

• • Of those who quit smoking entirely (87% of the CASAA Survey respondents), 72% credited interesting flavors with helping them quit. This response very clearly demonstrates that among the CASAA Survey respondents who have been successful in completely replaced their smoking habit with vaping, flavors were instrumental in helping them quit. Of those who still smoke, 53% credited interesting flavors as helping them move towards quitting entirely.

• • Reducing flavor choices will reduce overall enjoyment of THR products for many consumers. This loss of enjoyment is not only detrimental to consumers, it will inevitably lead to fewer smokers successfully reducing or eliminating their smoking habit by switching to THR products.

• • There are now thousands of brick and mortar vapor shops across the United States which sell a wide variety of products. As discussed in more detail below, these shops play a vital role in the fabric of the vaping community and are instrumental in helping smokers who are interested in reducing or eliminating their smoking habit. Anything but a relatively trivial intervention by FDA in connection with flavors will have a devastating impact on those vapor shops and on the consumers who rely on them to become or remain smoke-free.

• • Given the low-risk nature of vaping as compared to smoking, there is nothing misleading in informing consumers that vaping poses fewer risks than smoking. Yet vapor companies are prohibited from even suggesting to consumers that vaping is likely less hazardous than smoking. From a consumer rights standpoint, it is simply indefensible that the government would prohibit consumers from receiving this basic, truthful information from vapor companies.

• • Limiting the supply will not eliminate the demand. Any non-trivial restriction on flavors will result in an increase in consumers seeking out black market sources and engaging in Do It Yourself (DIY) activities in order to be able to use the flavors they enjoy.

CASAA’s full comment to the FDA can be read below or here.

07.19.18 – CASAA comments – FDA-2017-N-6565 – Regulation of Flavors in Tobacco Products