The Trump Administration recognized an opportunity to save thousands of small businesses across Colorado. The president issued an executive order requiring federal agencies to identify burdensome regulations hindering economic recovery and propose modifications or waivers “for the purpose of promoting job creation and economic growth.” One Food and Drug Administration (FDA) regulation that must be on the list to alter per this executive order is the pre-market tobacco application (PMTA) that would destroy approximately 125 small vapor businesses, like mine, across Colorado.
We can all acknowledge that over-regulation can be the death knell for many small businesses. At no time in our history is that more evident than right now.
The gist of the regulation lumps small businesses in with big tobacco. Their incongruous approach falls under tobacco regulation although nearly no vapor products actually contain tobacco. Most, if not all, small vapor businesses view themselves as a safer alternative to big combustible tobacco. We are dedicated to getting adults off combustible tobacco and stopping youth access.
It is one thing for our industry to believe our products are safer, but we are not alone. First on the list is the FDA, the very government regulatory agency that lumps small vapor businesses in with big tobacco. They want to regulate vaping like tobacco but think vaping is a safer alternative for adults.
The FDA said they view “products like e-cigarettes and other novel forms of nicotine-delivery to provide a potentially less harmful alternative for currently addicted individual adult smokers” than combustible tobacco. The list of organizations echoing this notion includes the American Cancer Society, National Academy of Science, American Association of Public Health Physicians, Royal College of Physicians, British Medical Association, British Lung Foundation, and more.
Despite the FDA’s position, it still plans to enforce PMTA this fall. Unfortunately, the inconsistent and arbitrary regulation of PMTA compels vapor and e-liquid manufacturers to submit a new application for every nicotine product they want to continue selling. If any product does not submit a PMTA by the September deadline, it must be pulled from the market.
While vapor manufacturers are required and actually do adhere to the highest safety standards, we also want to provide the safest and best products possible for our customers. Regrettably, PMTA applications cost, on average, $2,000,000 in legal and other fees. For my business, which has over 1,800 products, the cost to comply with this regulation would surely put all of us out of business. The FDA is asking small businesses to foot the bill again, in spite of the fact that they have endorsed the safety of a master list of the products and their ingredients. Talk about over regulation; the FDA is merely saving big tobacco because it can afford multiple tests. Small businesses lose.
My business, with two stores in Colorado, is no different than the 125 vapor owners, who employ 1,100 people throughout the state. But the very regulation meant to control tobacco or vapor use, regardless of how you feel about it, merely puts the small guys out of business while strengthening big tobacco. One-size PMTA is an effective ban on small businesses and their employees as big tobacco will not replace those jobs or businesses. But this is about more than just dollars, it’s about our health.
This obstacle that small businesses in the vapor industry face with this regulation makes David and Goliath look like a comparatively fair fight, wiping out roughly $50 million in annual economic activity.
It seems counterintuitive, however, nearly 350,000 Coloradans have found vaping products critical to reducing and stopping combustible cigarette use. It is working as cigarette use continues to plummet across nearly every American demographic. Effectively banning vapor products by destroying the industry through regulation would only drive adults back to smoking cigarettes.
Ours is an industry worth saving and, now, there is an easy way to do so. It is highly unlikely that my two little vape shops in Colorado will put the big guys out of business, but the regulation the FDA is considering only goes one way; it saves big tobacco and kills small business. I believe this runs counter to the president’s recent executive order. Our industry is asking President Trump and his administration to acknowledge that one size does not fit all when it comes to the PMTA. Our families, our businesses, our employees and our customers are looking for certainty and solutions as we are one answer to continued harm reduction, tax revenue and better health.
Amanda Wheeler is the vice president of the Rocky Mountain Smoke Free Alliance, an owner of five vape shops and a vapor manufacturing facility, and a mom.
