Tuesday, January 25, 2011

D.C. Appeals Court Will Not Re-Hear Electronic Cigarette Case

According to an article in the Wall Street Journal, the D.C. Circuit Court of Appeals has denied a request by the FDA to re-hear, as a full court, a three-judge panel's decision in favor of the electronic cigarette industry. In that decision, the Appeals Court ruled that the FDA cannot regulate electronic cigarettes as a drug-device combination under the Food, Drug, and Cosmetic Act, but must instead regulate these products as tobacco products under the Tobacco Act.

A three judge panel of the D.C. Circuit Court of Appeals previously upheld a lower court's injunction against the FDA seizing shipments of NJOY electronic cigarettes under its Food, Drug, and Cosmetic Act regulatory power. The FDA appealed that decision, asking the full Appeals court to re-hear the issue. The Appeals Court has denied that request, meaning that if the FDA wants to appeal further, it must ask the U.S. Supreme Court to accept the case.

Thus, the original Appeals Court decision remains in effect, and at the present time, the FDA does not have the authority to regulate electronic cigarettes as drug delivery devices, but must instead regulate them as tobacco products.

The Rest of the Story

The FDA now has three basic options:

1. Accept the Appeals Court ruling and regulate electronic cigarettes as tobacco products.

2. Appeal the decision to the Supreme Court.

3. Issue a formal rule-making on electronic cigarettes and hope that the Courts will give the Agency deference in its definition of statute.

It is very unlikely that the FDA will choose option #1, since it seems determined to deny vapers the potentially life-saving benefits of electronic cigarettes and seems to have no understanding of the benefits of harm reduction as a public health strategy.

The FDA may choose option #2, but I think it is very unlikely that the Supreme Court would take on the case at this early stage, given that the FDA has never issued any formal rulemaking on the regulation of electronic cigarettes. I think the Supreme Court would likely wait until there is a formal rulemaking on the issue before it accepts the case.

This leaves, as a most likely outcome, option #3. However, the FDA may be reluctant to do this because it could mean taking electronic cigarettes off the market and the Agency will face quite a fight if it takes this approach.

I suppose a fourth option is simply a continuation of the status quo, where the FDA regulates the marketing claims of certain electronic cigarette companies but leaves the overall market intact. From the perspective of public health, this might actually be the best outcome, at least in the short-term.

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