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The Senators Letter: Pro-Vaping FDA Commissioner under pressure?

On May 9th, vapers got some good news in the appointment of Scott Gottileb as the head of the Food and Drug administration, better known as the FDA. Gottileb is a man that has shown a more favorable attitude towards vaping in a time where there has been a significant amount of push back against the entire practice and industry. However, soon after his appointment, it became evident just how much pressure that the commissioner is going to be coming under by taking such a stance on e-cigarettes.

A three-month reprieve was sanctioned by the FDA back on May 1st giving manufacturers in the industry a further period where they will still not have to register their products. The extension was introduced in accordance with a change in the leadership of the department, as FDA policy analyst Lindsay Tobias proclaimed as follows:

“This extension will allow new leadership at the FDA and the Department of Health and Human Services additional time to more fully consider issues raised by the final rule that are now the subject of multiple lawsuits in federal court.”

However, with Gottileb acting as Trump’s pick for the head of the FDA showing signs of being more sympathetic to the aggressive kick-back against vaping, not everyone has gotten on board with the new commissioner, as demonstrated by the actions of some senators in recent weeks. Just ten days after his appointment, eleven United States democrat senators signed off on a letter stating their ‘serious concerns’ about the extension. The opening paragraph summarizes the tone of the two-page letter, as seen below:

“Given your recent confirmation as Commissioner of the Food and Drug Administration (FDA), we write to encourage you to prioritize agency efforts to prevent tobacco-related disease and keep tobacco products out of the hands of children.

“We urge the administration to stand up to special interests and reconsider its decision to delay all compliance deadlines set forth in the tobacco deeming rule; such delays will have dangerous consequences and hamper the ability of the FDA to carry out its mandate to protect the public’s health.”

So, what can we say about the Senator’s letter?

Well Forbes medicine and culture writer Sally Satel gives a straightforward answer to the idea posed in it’s content that vaping is a threat to the health of young children: “It’s a compelling story, but it just isn’t true.”

Satel concludes that the senators are claiming that teens are directly targeted by the industry with the emergence of flavors such as ‘cookies and cream’ and ‘cotton candy’, implying that this is used in a predatory way. However, the Forbes journalist argues that whilst this might be true, and youngsters might be targeted somewhat, it also has to be noted that “in adolescents, daily or regular vaping is highly concentrated among those who smoke.” In this sense, vaping is an alternative to smoking, not a gateway.

The letter is a key example of this ongoing debate, even with the numerous amounts of statistical proof out there that vaping is not a lead to cigarettes. Countless studies have been shown that the rate of entry level smoking has drastically fallen (the University of Michigan recorded that cigarette smoking among 12th graders fell from 19.2% in 2010 to 10.5% in 2016), but with many high-level politicians and government officials ignoring these facts for whatever reason, the deeming rule has continued to threatened the vaping industry.

For those of you who don’t know, the deeming rule would bring e-cigarette liquids and devices under the Tobacco Control Act, effectively classifying them as tobacco products and imposing the same strict regulations upon them. This would be of huge detriment to the industry, as thousands of smaller brands, shops and companies that would not be able to afford the license fees and application costs, estimated by Forbes to be in the hundreds of thousands, would be wiped out. It would also remove a significant amount of competition from the smoking market, giving the oligopoly back to the big-name brands and large corporations in the cigarette industry.

However, whilst this all sounds like doom and gloom, the appointment of Scott Gottileb, and the three-month reprieve are signs that the direction that vaping was headed might now be rescued. Whilst the extension has accounted for a smooth transition period in the FDA leadership, it could also be said that this will also pave the way for a new school of thought in the FDA on vaping, something which might kill off the deeming rule, at least under the Trump administration. Gottileb takes a similar attitude to Trump in that there should be fewer regulations on businesses, and whilst there is a lot of political controversy on this in some areas, as is always the case in government, for vaping it can only be a good thing under the circumstances.

Furthermore, it might seem like the opinions of eleven senators will make the world of difference to the FDA, but Satel reaffirms that whilst the letter is importance, it is unlikely to have a huge impact on decision making of the FDA:

“Will a letter from a small group of lawmakers exert much impact on FDA practice? It’s doubtful. For one thing, the agency and the Department of Health and Human Services have considerable latitude in executing tobacco policy reform. What’s more, funding for the Center for Tobacco Policy (CTP), the engine room of tobacco product regulation, is funded by the tobacco industry through generous statutory user fees, not appropriated dollars.”

So, with the FDA having a degree of freedom, and with Gottileb seemingly taking the agency in a different direction to that of recent months, ultimately this letter isn’t much to worry about as things continue to look brighter for the vaping industry.

Electronic Cigarettes • July 4, 2017

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