Rethinking Healthcare

FDA claims jurisdiction over e-cigarettes

FDA claims jurisdiction over e-cigarettes

Posting in Food

The FDA letters show these companies are pushing child-friendly flavors and phony drug claims as well.

The Food and Drug Administration has sent letters to five major suppliers of e-cigarettes, and the industry's trade group, warning them they must be approved as drug delivery devices, and that their marketing programs must be approved as well.

The letters give the companies 15 working days to describe specific steps being taken to end what the agency termed violations of the law. The Los Angeles Times called it "another shot across the bow" of the industry.

A letter to "juice" maker Johnson Creek Enterprises noted an inspection of its plant last September identified several violations of its manufacturing regulations, and said it has not launched the quality control program its regulations demand.

Johnson Creek's "juice" is used to fill e-cigarette cartridges.

The Johnson Creek facility makes a variety of flavored cartridge fillers, including mint chocolate, strawberry and peach flavors. A spokesman for the company said it welcomed regulation and did not think it would hurt sales.

The letter to E-Cig Technology of Las Vegas cited its claims on E-Cialis, a cartridge the company claimed cures erectile dysfunction, and E-Rimonabant, which it claimed helps with weight loss. The company did not comment to local reporters.

Note that E-Cig doesn't make either Cialis or Rimonabant, which are recognized brands in their fields.

While comments to this blog insisted that e-cigarettes are primarily used to stop smoking or avoid it with a less-harmful nicotine delivery system, the FDA letters show these companies are pushing child-friendly flavors and phony drug claims as well. This is why I gave my original piece the headline I did.

The agency also sent out a press release and updated its consumer update page on the products. The page notes the approved alternatives to e-cigarettes for those who want to quit smoking.

In reaction The Campaign for Tobacco Free Kids sent out an approving press release, saying in part:

No one is suggesting that these products should never be allowed on the market if they meet appropriate safety and efficacy standards. Rather, like other drugs and delivery devices, electronic cigarettes should be regulated to protect public health before they are permitted to be sold to consumers.

Only one headline I found even asked if e-cigarettes should be banned, and the text of the article doesn't take a position.

This is the first regulatory action since I wrote about the e-cigarette scam about a month ago.

An e-cigarette is a battery-powered device that looks like a cigarette, but delivers nicotine from a cartridge which is slowly vaporized by electricity.

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Dana Blankenhorn

Contributing Editor

Contributing Editor Dana Blankenhorn has written for the Chicago Tribune, Advertising Age's "NetMarketing" supplement and founded the Interactive Age Daily for CMP Media. He holds degrees from Rice and Northwestern universities. He is based in Atlanta. Follow him on Twitter. Disclosure