The New Frontier at FDA: What Does It Mean and How to Survive

When FDA Commissioner Dr. Scott Gottlieb announced the FDA’s new approach to nicotine policies on July 28th, and said that vapor products can be part of the solution to saving lives from smoking related deaths, it was clear that the long political stalemate had broken. But when he announced that they would delay the PMTA deadline by an additional four years – the vapor industry breathed a big cloud of relief.

I myself felt like the noose was removed from our necks. But not for very long. I’m paid to worry about what comes next, and navigate to a better future. So I knew that this was not a resolution to our problems, but just a bridge to a new set of policies that would bring their own problems to solve. Remember, all the other regulations remain in place. All the other reporting and filing deadlines remain in place. So let’s be clear-eyed about what we still need to do, and some of the issues that leaders in the industry should be focused upon.

Manufacturers, I hope you are well into registering your establishment and filing your product listings (including advertisements and labeling) by now. It is due the end of this month. Also, in November you will be required to submit any health documents on your products to the FDA if you have not already done so. None of the regulations – other than the deadline for PMTA filing have changed.

And if the requirements for PMTAs remain as unpredictable as currently, are we just handing over the keys four years later? Proving the Population Level impacts of each e-liquid, flavor and strength, with all coil and resistance combinations, and whether they will entice new people to use those products is an absurd hurdle to clear. Not only will it be ridiculously costly to prove, but there is a great deal of subjectivity involved. If the FDA decides that because the flavor is blueberry it will entice youth to use it, they can deny your application regardless of any clinical trials, gas spectrometry, and human factors studies you may have performed.

We have to make sure that the method of regulation itself changes. This system was NOT set up for vapor products. I was chief of staff to a U.S. Senator when we passed the Tobacco Control Act in 2009. I can tell you from first-hand experience, we did not have any clue that there could be less harmful vapor products. No, this law was intended to regulate cigarettes in a way that did not allow new products on the market.

What would be an appropriate way to regulate vapor products? Just as the FDA does with consumer products, dietary supplements, cosmetics and many foods, there should be standards for ingredients, good manufacturing processes (GMPs), and performance standards for devices. These standards should be established with input from experts in the industry, and be flexible enough to evolve as technology does. This is what we at SFATA are asking Congress and FDA to do. This would establish a clear, objective bar for safety, and manufacturers would know exactly what they need to do to be approved.

It will take working together to educate and advocate to make this change happen. The good news is we have a few years to get it done, but we will need to start NOW!

However, the PMTA standards are not the only thing to consider. The FDA has announced that they are working on a regulation on flavors. If you think this might be good, you’re probably vaping a tobacco flavor right now.

Flavors have long been the “proof” that the e-cigarette industry is “going after our children.” I know this narrative is false, but for those who believe it, it is powerful. And they don’t need to look far to find some genius marketing a Gerber-labeled “crushed peas” flavored e-liquid to prove they are addicting babies. If we don’t police ourselves, there is no doubt the government will do it for us.

So yes, there will be a coming debate – and rulemaking – about what flavors will be allowed, and our opponents are out shopping for cartoon-labelled bottles right now. Flavors WILL BE restricted, but drawing the line in regulation is difficult. They may be tempted to define flavors with broad brush, which could be very bad for consumers, for smoking cessation, and for the future of vapor.

And what about innovation? The regulations absolutely stifled innovation – froze it really – at August 8, 2016. Any new products that can’t prove they were on the market on that date will require a PMTA be APPROVED 60 days before they can be sold. Yes, there seem to have been many new products introduced since then, and yes, FDA can deem them misbranded and confiscate them with fines, penalties, and facility closures.

The regulations create NO predicate products. And this means that every product hereafter will need a full PMTA before it can be sold. This is a real problem. And if FDA determines they don’t have the authority to change it – something many think likely – then we will have to change the underlying law in Congress.

That is possible, but it will likely take years not months to get it done. What we will need is everyone’s involvement, responsible business leaders will need to get active and have intelligent dialogue with their customers, the media, and legislators, to paint a new picture of a mature and responsible industry that is working to help people. I hope to see you out there! SVBS

Michael Hogan is the principle federal lobbyist for SFATA – the Smoke Free Alternatives Trade Association. He has been an avid vaper and represented the industry since 2013. He has over 30 years in national policymaking experience including senior staff positions in the House of Representatives and the U.S. Senate. His firm, The Alpine Group represents nearly 90 clients including, Wal-Mart, Bose, Ford, Nike, Intel, the thoroughbred racing industry and the distilled spirits council. When not fighting for more intelligent policies, Mike plays guitar, rides his motorcycle and let’s his dogs drag him through the woods.

 

2017-09-19T07:40:31+00:00 September 19th, 2017|Editorial|Comments Off on The New Frontier at FDA: What Does It Mean and How to Survive