The issue of e-cigarette regulation has been a hot topic throughout all of 2014, and as some are pushing for rules and regulations for the e-cigarette industry, others are now urging the FDA to reconsider the proposed regulations that will soon be enacted. House speaker John Boehner, R-Ohio, House Majority Leader Kevin McCarthy, R-California, and House Energy and Commerce Committee Chairman Fred Upton, R-Michigan sent a letter recently to Syliva M. Burwell, Health and Human Services Secretary regarding the pending regulations that some fear will drive many e-cigarette companies right out of business.
The letter urges the FDA to make allowances for existing e-cigarette companies in order to keep them from going out of business at the hand of the cumbersome processes that will be involved when the FDA enacts regulation on the booming vaping industry.
The proposed rules were released by the FDA in April of 2014. The FDA, a division of the Health and Human Services division, would require manufacturers to obtain “premarket” approval for their products within two years or pull the items from the market. If the new rule is approved it would apply to all e-cigarette products released after February 2007, meaning that in effect almost every e-cigarettes device and e-liquid product currently being sold would have to undergo their strenuous and lengthy new approval process.
The premarket approval process came about following the Tobacco Control Act of 2009, and requires a large expense, both in money and time, for companies to apply for market approval and even then a favorable ruling from the FDA is still needed, but not by any means guaranteed. In 2009, when this Act first took place many traditional cigarettes, which are well known to be much more dangerous, were grandfathered in and did not have to go through the premarket approval process.
That doesn’t seem like that’ll be the case for e-cigarettes if things don’t change. The FDA currently estimates that e-cigarette companies will have to spend 5,016 hours per application, in addition, they estimate a compliance cost of near $300,000 for each item applying for approval. These time consuming and money draining processes stand to put many small e-cigarette companies out of business. In an industry where smaller companies rule, and Big Tobacco is nearly non-existent, this change could disrupt the entire e-cigarette industry, creating a completely different market, with ultimately less options both in flavors and devices, for the consumer.
The letter urges regulators to consider grandfathering in pre-existing devices, enabling businesses to continue operating, rather than going out of business at the hand of the lengthy regulation process. The letter points out that to be grandfathered in at this point a device would have to be introduced into the market before February of 2007, however, this is generally impossible for most products when the first e-cigarette devices only just began hitting the market for the first time that same year. “Most e-vapor products did not exist at that time,” the House Republicans wrote to Secretary Burwell. “FDA did not even consider e-vapor products to be tobacco products until 2011.” They pointed out that, “many newly deemed products could be removed from the market” if the 2007 date is not extended.
The House Republican leaders go on to ask in the letter that existing e-cigarette products could be allowed to stay on the market, setting a grandfathering date of either when the regulations are officially enacted or the April 2014 date when the rules were initially proposed.
A representative from the division of Health and Human Services told U.S. News that, “The secretary appreciates hearing from members of Congress. HHS looks forward to responding to the letter.”
This later grandfathering date would mean a variety of things for the user and the manufacturers. User wouldn’t experience much difference in the availability of the products they already enjoy and love. With crippling regulation restrictions possibly looming, users may find their favorite product disappearing off the shelves, crushed by the lengthy and expensive premarket approval process.
Manufacturers that may have otherwise been forced out of business, could survive the regulation crisis, if the grandfathering period could be extended. In a new multi-billion dollar industry this simple change could not be more important. Unlike so much business these days, the e-cigarette industry is still comprised of the “little guys” with Big Tobacco still fighting to even be recognized in this expansively growing industry. Changing the grandfathering date is absolutely essential to the continuation of this progress.
Gregory Conley is an outspoken figure in the E-cigarette community. As president of the American Vaping Association, he is a frequent commenter on E-cigarette issues. Conley says that many people don’t realize how much a simple thing like changing the grandfathering date can mean. “If you don’t move up the grandfather date, then the FDA is never going to [give premarket approval] for a flavored e-cigarette product – that will be their backdoor prohibition on almost all flavors,” he continues, “Maybe they’ll approve a scotch or whiskey, but they won’t approve the flavors I like.” With many claiming that sweet and candy like flavors are designed to entice youth and teen users, these varieties could be swept off the market at the hand of premarket approval. If the grandfathering date is extended, however, flavors now available will still be available. Under the new regulations, however, many feel these sweet flavors, which are still popular among adult users, would be unable to pass the market approval process.
In addition, Conley says manufacturers would need individual applications for each e-cigarette device and each e-liquid option both for flavor and for different nicotine levels. This would be an incredible burden immediately affecting the consumer and their ability to enjoy the variety of products they have come to love.
Conley is also quick to point out the Tobacco Control Act has sometimes been called “the Marlboro Protection Act” because it grandfathered in existing products while making a logistical nightmare for small companies to have new items on the market.
Regulations are an inevitability, everyone knows that. The effects of that regulation have the possibility to change the e-cigarette industry as we know it. Changing the grandfathering date could be exactly what the e-cigarette industry needs in order to weather the regulation storm. Having the major house leaders speaking out on the behalf of the industry is immensely important in helping this change take place and a clear step in the right direction.