FDA Chief Scott Gottlieb issues new statement of vaping products
In a newly published statement by the FDA this month, Chief Scott Gottlieb identifies four priority areas regarding the agency’s policies on tobacco and vaping for 2018. The general tone of the document at first appears rather promising, but after delving deeper into the fine print, there are some specific word choices that are causing concern within some sectors of the vaping community.
The FDA publication is entitled Healthy Innovation, Safer Families: FDA’s 2018 Strategic Policy Roadmap, and it’s four priorities include the following:
Gottlieb states that the FDA plans to take a “fresh look” at vaping products and electronic delivery systems of nicotine to ensure that “adults” can access the nicotine they want without having to burn tobacco leaves. This sounds good, until the document then seemingly continues to recategorize vaping devices as “medicinal” in nature.
“With appropriate product regulation, new technology, and product innovation – including new medicinal nicotine products and electronic nicotine delivery systems (ENDS) – could present an opportunity for more smokers to quit combustible tobacco and stay quit. Our plan takes new steps to foster innovation in nicotine delivery, where such innovation could truly make a positive public health impact. It also makes sure that FDA has the foundational regulations to put products such as electronic cigarettes through an appropriate series of regulatory checkpoints.”
When Donald Trump tapped Scott Gottlieb to run the FDA, many in the vaping community were hopefully optimistic. After all, Gottlieb has a long history with vaping. He was once a major financial investor in the KURE e-cigarette company. But the agency’s recent actions since Gottlieb has taken office may be painting a very different picture than that of being 100% vaping-friendly.
Is the FDA planning to ban vape flavors?
For example, multiple Pre-Market Tobacco Applications (PMTAs) for smokeless tobacco products have been rejected by the FDA in 2018. In at least one instance, the FDA even banned a manufacturer from producing new flavors of one of its products. Meanwhile in a new draft for an addendum to the Advanced Notice of Proposed Rulemaking (ANPRM), the agency seems to suggest that a national flavor ban on e-juices (other than tobacco) is a viable option.
“Evidence shows that flavored tobacco products, especially those that are sweet or are described with terms attractive to kids, appeal to youth and also shows that youth may be more likely to initiate tobacco use with such products. Evidence also shows that the presence of flavors in some non-combustible tobacco products may play a role in helping some tobacco users transition away from combusted tobacco products, which are likely the most harmful currently marketed form of nicotine delivery for an individual user.”
Another major red flag of the FDA roadmap is the phrase “safer families” contained within the document’s title. Is Gottlieb once again signaling a potential flavor ban, based on the popular misconception that vaping manufacturers are intentionally targeting minors as customers by peddling e-liquids that taste like cotton candy or gummy bears? And why does the FDA roadmap refer to vapor products and low-nicotine cigarettes in a section entitled Reducing Misuse and Abuse of Opioid Drugs?
Scott Gottlieb may be a former investor in the vaping industry, but he is also a former consultant for the Big Pharma company GlaxoSmithKline. A substantive section of the FDA roadmap deals specifically with “medical product manufacturers,” of which vaping is again referenced as a medicinal product.
As head of the FDA, Gottlieb has a very fine line to walk. He is responsible for regulating food, drugs, and thanks to the Obama Administration’s deeming regulations, vaping and tobacco. Even though he may personally be a huge fan of vaping, he is walking through a political minefield. Will the FDA implement a flavor ban on e-liquids nationwide? If the FDA roadmap is any indication, they appear to be at least considering the option.