Proposed FDA Rule Changes for E-Cigarettes

The FDA has been making rumblings about regulating e-cigarettes for some time now. Today, they published their proposal [pdf].  It’s 241 pages, but this is what I’ve gathered on first pass:

Expect a ban the sale of e-liquid to minors via the internet, but not to adults. There’s no call for ban on those candy-flavored liquids that supposedly reel children into the habit. It doesn’t look like they’re going after liquid nicotine, either.

There are calls for labeling standards, but the industry never really opposed that. As far as the hardware goes, it looks like it will be exempt:

For purposes of this part, FDA considers any loose tobacco, including pipe tobacco, and the nicotine in e-cigarette cartridges to be within the definition of “covered tobacco product.” FDA proposes to treat covered tobacco products in a manner consistent with FDA’s treatment of cigarettes and smokeless tobacco throughout part 1140. In current part 1140, FDA imposes restrictions on cigarettes and smokeless tobacco, but not on the components, parts, and accessories of such products. [p. 131]

Now comes the troubling part. They also want to classify e-cigarettes as Modified Risk Tobacco Products under section 911 of the Food, Drug & Cosmetic Act. That would require liquid manufacturers to petition the FDA for approval–a process that is neither easy or cheap. There doesn’t appear to be a grandfather clause, so manufacturers will have to apply within two years if they wish to continue selling existing products. This could have a chilling effect on smaller manufacturers and retailers.

Most surprising is the fact that they repeatedly admit to ignorance on the harm-reduction potential, the actual risks, and even the content of the products they want to regulate. This whole thing feels like a rush job under the pretext of looking like they’re doing something. 

It’s not as bad as expected, but we’re not out of the woods. There’s going to be a comment period, and there’s going to be lobbying. CASAA is our advocate, but they need our help. It’s far easier to stop a bad regulation than it is to repeal it.