The Food and Drug Administration on Thursday issued long-awaited regulations that for the first time place e-cigarettes, vaporizers and other new tobacco products under federal oversight.
Manufacturers can continue to sell the products for up to three years while they submit applications to the FDA. While all of the products will be subject to some kind of registration and pre-market approval, the rules appear to offer e-cigarette makers an opportunity to go through a less costly and time consuming review in line with the path almost all combustible tobacco products take. The final regulations will also require manufacturers to report ingredients and place health warnings on any packages or advertisements.
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Since the industry is composed of many smaller companies, it will be an uphill battle for some players to comply. The publication of the rules will likely set off a legal fight with the e-cigarette industry, which fears that many companies will go bankrupt. Congress may also try to get involved by withholding funds to carry out the rules unless the FDA makes changes.
“This final rule is a foundational step that enables the FDA to regulate products young people were using at alarming rates, like e-cigarettes, cigars and hookah tobacco, that had gone largely unregulated,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “The agency considered a number of factors in developing the rule and believes our approach is reasonable and balanced.”
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The Food and Drug Administration was given oversight of tobacco products in 2009, and while it already has a regulatory regime in place for traditional combustible cigarettes, it has been working on e-cigarette regulations for years. Proposed rules were published two years ago, and the agency considered thousands of public comments before finalizing its oversight.
There are two pathways for new cigarette products to come on the market: pre-market approval or substantial equivalence.
The first pathway is stringent, lengthy and expensive, requiring clinical trials and hundreds of thousands of pages of information. Only one company has successfully navigated this process for several of its products. The majority of new tobacco products that come to market go through substantial equivalence, where a new product must only prove that it is not any more dangerous than a product that was already on sale before February 2007.
Based on draft regulations released two years ago, e-cigarettes and their components would need to go through a similar process. The problem for the industry, however, is that products currently on sale would not have a substantially equivalent product from before February 2007. Makers would have to put all of their products and their parts — the liquid nicotine, batteries and components that heat and vaporize the liquid — through the full pre-market approval process.
While big tobacco companies like RJ Reynolds and Altria would probably not have a difficult time navigating this process, smaller companies could, and the liquids they use are often mixed in small, independent stores. If those establishments want to keep selling their liquids, they would have to go through the approval process too. Industry groups argue that this will force many of them out of business.
An amendment to the House appropriations bill that funds the FDA would change the February 2007 date to the date the agency issued its final regulations, essentially allowing any products now on the market to remain so. It would also make it easier for e-cigarette manufacturers to introduce new products, since they will have substantially equivalent older products to reference.
But the regulations leave that date unchanged, a fact that outrages advocates for the industry.
“The FDA’s refusal to modernize the February 2007 predicate date will cause a modern day prohibition of products that are recognized worldwide as far less hazardous than cigarettes,” said Gregory Conley, president of the American Vaping Association. “If the FDA’s rule is not changed by Congress or the courts, thousands of small businesses will close in two to three years. Tens of thousands of jobs will be lost and consumer choice will be annihilated.”
The regulations don’t do anything to limit the many flavors available for the liquid nicotine that fuels e-cigarettes. Many public health groups view this as a missed opportunity to limit the appeal of the products to youths.
“FDA passed up critical opportunities in this rule by failing to prohibit the sale of tobacco products coming in flavors like cotton candy, gummy bear and grape or to prevent marketing tactics that target children,” the American Academy of Pediatrics said in a statement.
It will take time for the industry and public health groups to scour the 499-page rule and fully understand its implications. But the regulations prompted some early praise, including from lawmakers relieved that the FDA has finally issued the rules.
“Our children cannot wait any longer for us to act and today, the FDA is sending a strong message that we will do everything we can to protect our children’s health,” Rep. Rosa DeLauro , D-Conn., said in a statement. “Now that the FDA has finalized the deeming rule, we must go further and stop the tobacco industry from marketing tobacco products to our children.”