The FDA Regulatory Environment--What Does It Mean for Us?

The vaping industry has been on the brink of government regulation for years. In 1996, the FDA tried to regulate all tobacco products as drugs, and the Supreme Court ruled against it. Later, in 2009, this led to the Tobacco Control Act, which gives the FDA the authority to regulate the manufacturing, distribution, and marketing of tobacco products.

In 2010, the FDA attempted to ban e-cigarettes under the Tobacco Control Act, stating that they were illegal drug-delivery devices. There were a series of lawsuits filed by larger vaping corporations, such as NJOY, based out of Scottsdale, Arizona. The Supreme Court again ruled against the FDA, deeming that electronic cigarettes were not tobacco products and after the backlash of consumers who had successfully quit smoking advocated for their rights.

In the wake of that suit, the industry has been the 'Wild, Wild West' in terms of regulation. Most states have passed bans on selling to minors, and some have passed bans on vaping in public places, similar to bans on smoking. However, there are no guidelines for the manufacturing of e-Liquid that come from any regulatory authority.

The FDA is again gearing up to regulate the industry that has grown so massively and quickly. After years of revising and polling for comments, the FDA sent proposed regulations for e-cigarettes to the White House Office of Management and Budget (OMB) for review on October 19^th, 2015. While proposed regulations had been made public months earlier, the final proposal was not made public. The OMB has 90 days to review the proposal and may extend for 30 days after that by law. The industry continues to anxiously await the outcome.

Most of the proposed regulations were deemed acceptable by the vaping community, such as labeling requirements, a federal ban on sales to minors, and the prevention of vending machine sales. These are items that the industry has already implemented in efforts to foresee the future of regulations. 

However, one MAJOR item of contention in these deeming regulations is a provision that mandates that any nicotine delivery devices that hit retail shelves after February 15^th, 2007 be subjected to review. Each company would have to file mountains of paperwork in a pre-market tobacco application (PMTA) two-year process that could potentially cost millions and shut down the industry with the exception of closed-system convenience store brands (now predominately owned by Big Tobacco). Each PMTA is estimated to cost about $300K to file, at a very LOW estimate.  That would be for EACH flavor, in EACH nicotine level, in EACH base. 

So, in other words, for Velvet Vapors, that means about 42,000 possible flavor/nic/base combinations times $300K each equals OVER $1 BILLION DOLLARS. Effectively, we would only be allowed to sell "approved" e-cigs after that...which would most likely drive us and 99% of the industry out of business.

What ticks me off me the MOST...Big Tobacco can FUND their PMTAs for VUSE, MarkTEN, and Blu eCigs (now owned by Big Tobacco companies). So essentially, the power and the money that former smokers spend who turned to vaping would be taken BACK to Big Tobacco...the guys that got us smoking in the first place. 

So, regulation against our industry...leads to Big Tobacco back in control of our vaping habits. RJ Reynolds is projected to make about 50/50 profits from e-cig sales/tobacco sales in 2021. That is a SIGNIFICANT market shift from regular tobacco, and they are trying to OWN it and shut; US the regular vape market, such as the the smaller vape brands and your local shops, out of the market. 

There would be a 24-month grace period after the FDA regulations are passed to comply. Essentially, this would kill the couture brick-and-mortar industry and send more consumers to Big Tobacco, who can afford the costly PMTA process, ensuring that Big Tobacco remains in control of the entire market forever, creating the oligopoly (a situation where 3 or 4 firms dominate the market)  in the vaping industry that they have enjoyed with analog cigarettes for the last century. 

Congressman Tom Cole of Oklahoma has already introduced HR 2058, the FDA Deeming Authority Clarification Act of 2015. While it does not remove the threat of registering all products with the FDA, it does change the grandfather date of Feb 2007 to a point in time that will allow all current products to remain on the market. The grandfather date would effectively be changed to the date that the FDA regulations become legal authority. 

Any new "products" (ejuices, liquids, batteries, etc.) introduced after that date would need to file for PMTA before sales...essentially freezing the market in place. No new flavors, no new batteries...no new anything for years and likely only crappy things would get approved, AKA the VUSE e-cig, created by the RJ Reynolds Vapor Company...an extension of Big Tobacco. 

So, write your congressman. If your local Representative is not supporting HR 2058, you need to tell them your story. If you like vaping as you KNOW IT at all...you need to advocate for yourself. 

Here is a link to which congressmen are supporting HR 2058. So far, it does not include our own, Martha McSally. We are working on that presently.

https://www.congress.gov/bill/114th-congress/house...