As new notices come out of Washington, DC about plans by the Food and Drug Administration to make retroactive regulations on e-cigarette and vaping products, the industry’s fighting back and questioning the regulator’s timeline on its notifications, based on the established process for making changes to industry rules.
Some of the issue is that new FDA rules could be retroactive to products that are already on the shelves.
Specifically, there’s the suggestion that the FDA will require certain kinds of child-resistant packaging and warning labels on products.
Responses From the Industry
Spokespersons for the e-cigarette and vaping industry are calling for a review of FDA practices, saying that the FDA has moved too soon. Citing something called deeming regulation that must be in place before new rules are set, Gregory Conley, President of the American Vaping Association points to delays in past FDA activity around the deeming regulation and other issues. Calling current FDA activity “a public relations strategy”Conley suggests that the regulator is not acting consistently to start enforcing the regulation, but in a vitriolic way that may have a negative impact on the e-cigarettes industry.
Arguments on E-cigarettes
Industry leaders point to the child resistant packaging already in use by most vaping and e-cigarette manufacturers, and say they don’t have a problem with this type of secure container. What’s a little more troubling are the warning labels that should be put on the products, according to FDA indicators. In the view of vaping advocates, it’s inconsistent to have the same warning labels on these newer products as on standard tobacco products which were heavily regulated following specific scientific studies. Some also point to relatively lax FDA work on labels for conventional cigarettes.
The Actual Numbers on Unhealthy Exposure
While some who support heavier regulations for e-cigarettes are pointing to poisoning and exposure risks, studies are finding that these types of products are an extremely small part of the household risks that regulators like the FDA must cover.
The 2015 annual report of the American Association of Poison Control Centers shows a table of calls made for exposure to household products. While those for e-cigarette products are around several thousand, calls for pain relief medications are up at 300,000, with 200,000 calls annually for exposure to cosmetics products, and around the same number for exposure to cleaning substances. Next are sedatives with 150,000, and antidepressants with around 100,000. Calls for alcoholic substances range around 75,000.
The Double-Edged Nature of E-cigarettes and Vaping
Some of the most ardent advocates of e-cigarettes and vaping products are not arguing that there are no health risks related to these products, especially those that contain nicotine. What they are saying is that the FDA, other regulators and other parties need to view these products in the context of the greater market for conventional tobacco products. The bottom line is that these products, which carry less risk than conventional cigarettes, have helped many people to cut down or eliminate tobacco smoking over time, saving lives and decreasing the pressure on the national healthcare system. Looking at the numbers, insurers and many other parties can find that there is a net positive from these products, and that’s what’s behind the argument that regulation should be sensible and take in the positives as well as the negatives associated with vaping.
Another component of this discussion regards the rights of individuals to make their choices. Regulators always have to set the regulations against the free will of the marketplace. There are limits for the extent to which regulators can act, even for the common good, and especially when their actions may be punitive to a particular industry.
Look for more information on the issue as the FDA moves forward on evaluating these products, and as smoking cessation experts keep looking at how they work, and at the good and the bad of having these products on the market.