The e-cigarette industry has blossomed into a $2 billion business, providing thousands of manufacturing and retail jobs while offering smokers a safer alternative. Unfortunately, this thriving market is under threat due to new rules finalized in May by the U.S. Food and Drug Administration (FDA).
The new rules expand the regulatory authority of the FDA to cover all tobacco or tobacco-related products — including e-cigarettes, many of which contain no tobacco whatsoever.
Like cigarettes, other forms of tobacco consumption can be addictive because of nicotine — which is why the FDA has asserted regulatory authority. While most e-cigarette products do not contain tobacco, they still use flavored juices that contain nicotine. Smokers can use e-cigarettes to supplement or, in some cases, replace their regular tobacco usage. The FDA worries that these products will increase nicotine addiction rates, especially among youth, and thereby lead to increased tobacco usage overall.
While it could be argued that e-cigarettes and other tobacco-related products should be regulated in a way that puts them on an even playing field with cigarettes, the rules do not limit the FDA to making regulations fair. The rules give the FDA broad authority to regulate tobacco products in whatever way the agency wants. For many of these rules, the FDA will issue “guidance” rather than spelling out the restrictions in the finalized regulations. Unlike formal rules, guidance does not need to go through a formal approval process. Thus, there is simply no oversight to ensure equitable regulation.
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The Food and Drug Administration released its long awaited e-cigarette regulations on Thursday. E-cigarette users’ worst fears are confirmed—these regulations will destroy the burgeoning industry, leading to increased mortality and higher healthcare costs.
Though the FDA marketed its regulations as restrictions on minors who purchase tobacco products, the 499-page release contains far more. Perhaps the most ridiculous FDA claim is that these regulations will lead to increased innovation—even though the agency admits that 99 percent of the market will not be able to comply.
As stated on page 267 of the regulations, “FDA believes that [premarket review] (and the deeming rule as a whole) will not stifle innovation but could, instead, encourage it.” This is a nonsensical claim that could only be made by a government agency.
Through these regulations, the FDA “deems” that all tobacco products are under its regulatory scope. Hookahs, cigars, pipe tobacco, and electronic nicotine delivery systems (ENDS) were not previously covered under the FDA’s authority to regulate tobacco, which began with the 2009 Family Smoking Prevention and Tobacco Control Act. Now, all tobacco products that were not commercially marketed on February 15, 2007 (the predicate date) are required to gain FDA approval. Tobacco products that were available on the predicate date are exempt from the FDA approval process.
Newer tobacco products will be able to stay on the market if they show that they are “substantially equivalent” to a product that was commercially available on predicated date. Virtually no ENDS were available to American consumers at that time, meaning each currently available vaping product will have to go through the FDA’s other path to market, the premarket tobacco product application process.
Read the full article at Economics21.