FDA Changes Bring New Hope to Vaping Industry

Just as the vaping industry was poised to meet what could have very well been certain demise, it was instead granted a reprieve. New hope for the industry has sprung to life, thanks to Food and Drug Administration changes announced by newly appointed FDA Commissioner Scott Gottleib.

One of the changes was an extension of a deadline that may have had to power to decimate most, if not all, vaping liquid companies still in existence. Another change is a shift in the FDA’s focus, one that seeks to work toward decreasing nicotine addiction rather than seemingly aim to kill off the entire e-cigarette and vaping industry.

Vaping Industry off the Chopping Block

Had existing regulations been left in place, many vaping companies may have had to pull the plug as of Aug. 8, 2017. This was the original deadline for submitting an extensive – and expensive – product application for any vaping liquid on the market as of Aug. 8, 2016.

Known as the Premarket Tobacco Application (PMTA), the process demanded companies submit a full slate of reports, descriptions, applicable product standards, samples, and any and all other related information associated with each product on the market. If the hassle alone wasn’t enough to kill off vaping companies, the estimated cost of $400,000 per application certainly could.

While the PMTA has not been totally annihilated, its deadline has been extended to Aug. 8, 2022. This at least gives the vaping industry a breather – and the FDA time to perhaps make even more changes that may fall in the vaping industry’s favor.

Shift of Focus

The FDA’s notable shift in focus brings another ray of hope to vaping industry. The FDA is launching a new, comprehensive plan for tobacco and nicotine regulation that puts nicotine and addiction at the center of regulation efforts. The overall goal is to better protect kids and decrease tobacco-related death and disease. And there is a glimmer of hope here that the FDA may be seeing the light that vaping may be one way to achieve that reduction.

In fact, the FDA noted the change in the PMTA deadline is directly related to its shift in focus. An FDA press release explained the deadline was extended in order to ensure the agency is “striking an appropriate balance between regulation and encouraging development of innovative tobacco products.”

Those innovative tobacco products, which can definitely include vaping liquids and electronic nicotine delivery systems (ENDS), are a prime focus for Gottlieb. The FDA release not only points out that nicotine is most harmful when “when delivered through smoke particles in combustible cigarettes,” but also quotes Gottlieb saying that alternative and less harmful sources of nicotine needs to be “the cornerstone of our efforts.”

While the e-cigarette and vaping industry can still expect to have its share of oversight from the FDA, another shift in focus involves developing standards to help protect against known risks throughout the industry. These include battery issues that have cropped up with certain electronic nicotine delivery systems (ENDS), children’s exposure to liquid nicotine, and vaping liquid flavors that are particularly appealing to kids.

The PMTA process will also be reviewed, with the FDA aiming to make the entire product review process more predictable, transparent and efficient. Reducing the nicotine levels of combustible cigarettes is another topic on the FDA’s agenda, a move that could double as a way to prompt existing smokers to make the switch to vaping.

Reports in Favor of Vaping

If reducing risk truly is the goal of the newly appointed FDA commissioner, numerous studies and reports could also push sentiment into the vaping industry’s favor. A few of these include:

A Public Health England study that estimated e-cigarettes were approximately 95 percent less harmful than cigarettes

A Cancer Research UK study that found smokers who switch to vaping or e-cigarettes decrease their exposure to known carcinogens as greatly as those who stich to nicotine gum, patches or other FDA-approved nicotine replacement therapies

A recommendation from the Royal College of Physicians that encourages patients who smoke to make the switch to e-cigarettes

Bottom Line

Nothing moves quickly at the government level, which can be another benefit for the vaping industry. This means the vaping industry isn’t likely to be dealt a swift and irrevocable blow that puts the remaining small vaping liquid companies out of business. This also gives the FDA ample time to review and analyze reports and studies, interview experts, gather public input, and make rational decisions about regulations and oversight that may actually have a positive impact on both the vaping industry as well as overall public health.

Sources:

• http://www.wired.co.uk/article/e-cigarette-offered-doctor-quit-smoking
• http://www.upi.com/Health_News/2017/02/06/E-cigarettes-may-be-less-toxic-than-tobacco-study-suggests/2661486436910/
• https://cei.org/blog/how-fda-commissioner-gottlieb-can-save-e-cigarettes-and-lives
• https://www.blacknote.com/fda-e-cigarette-regulations/
• https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm568923.htm