Tuesday, April 26, 2011

FDA Accepts Appeals Court Ruling; Will Regulate Electronic Cigarettes as Tobacco Products

The Food and Drug Administration (FDA) announced yesterday that it will accept the ruling of the D.C. Court of Appeals and regulate electronic cigarettes as tobacco products under the Family Smoking Prevention and Tobacco Control Act, rather than as drug-device combinations under the Food, Drug, and Cosmetic Act, as long as the manufacturers do not make therapeutic claims.

The FDA plans to issue specific regulations and guidances regarding electronic cigarettes that will clarify exactly how the Agency plans to deal with these products under the Tobacco Act. One major potential guidance is how the Agency will interpret the term "therapeutic claims" with regards to electronic cigarettes.

The FDA wrote: "The court held that e-cigarettes and other products made or derived from tobacco can be regulated as “tobacco products” under the Act and are not drugs/devices unless they are marketed for therapeutic purposes. The government has decided not to seek further review of this decision, and FDA will comply with the jurisdictional lines established by Sottera."

An important detail that the FDA spelled out yesterday was that the Tobacco Act grandfathers in only products that were on the market as of February 15, 2007 or which are substantially equivalent to such products: "'Tobacco products' marketed as of February 15, 2007, which have not been modified since then are considered “grandfathered” and are not subject to premarket review as “new tobacco products.” A “tobacco product” that is not “grandfathered” is considered a “new” tobacco product, and it is adulterated and misbranded under the FD&C Act, and therefore, subject to enforcement action, unless it has received premarket authorization or been found substantially equivalent."

The Rest of the Story

The implications of the FDA's action depend largely on how the Agency chooses to implement the regulation of electronic cigarettes. Therefore, many of the implications of the action are unclear. Below, I have tried to articulate what we definitely know and what we don't know at this point.

What We Know

1. Most importantly, electronic cigarettes will be regulated as tobacco products under the Tobacco Act. The most critical implication of this fact is that these products will not be completely removed from the market. Electronic cigarettes will remain available, which is of tremendous public health significance as many vapers are using these products to stay off of tobacco cigarettes.

2. Electronic cigarette companies will remain free from regulation under the Food, Drug, and Cosmetic Act as long as they refrain from making therapeutic claims. Electronic cigarette companies can safely market electronic cigarettes as smoking alternatives without running afoul of the FDA's guidance.

3. Electronic cigarette companies will need to refrain from making therapeutic claims, unless they put their products through the drug approval process. While the FDA has yet to issue guidance as to what a "therapeutic claim" means with regard to electronic cigarettes, it is clear that electronic cigarette companies cannot claim that these products are intended to treat any disease, such as smoking addiction. No claim can be made that the product will treat nicotine withdrawal symptoms. What is not clear is whether a claim that the product can help a person quit smoking would be considered a therapeutic claim (see below).

4. Electronic cigarette companies will not be able to claim that these products are safer than smoking. While this is ridiculous because there is no question that these products are safer than tobacco cigarettes, it is - unfortunately - the law. This is in fact one of the major reasons why I opposed the Family Smoking Prevention and Tobacco Control Act in the first place. I have written extensively about why the modified risk provisions of the Tobacco Act are antithetical to public health goals. Nevertheless, the law is the law and electronic cigarette companies will not be able to tell the public of the chief benefit of these products: that they are safer than regular cigarettes. Of course, that doesn't stop others - outside of the industry (such as myself) - from informing the public about the relative safety of electronic cigarettes compared to regular ones. It also doesn't stop electronic cigarette companies from submitting an application to the FDA to have their products approved as reduced risk products. But it is unclear what evidence would be required to achieve such a designation.

5. Some brands of electronic cigarettes could potentially be pulled off the market. It all depends on how the FDA interprets the phrase "substantially similar." Electronic cigarettes that were on the market as of February 15, 2007 are fine. But brands introduced subsequent to that date could be determined to be "new" products and would therefore need approval by the FDA. It is unclear whether companies could successfully obtain such approval. On the other hand, all electronic cigarettes are quite similar, and it is also possible that companies could successfully argue that their brands are "substantially similar" to brands that were on the market as of February 15, 2007.

6. All electronic cigarette companies will have to comply with certain blanket requirements, such as registration of their products, disclosure of ingredients, and good manufacturing practices. Companies may also be subject to user fees to help defray the cost of regulation.

What We Don't Know

1. How will the FDA interpret "substantially equivalent" regarding electronic cigarettes? Since all electronic cigarettes are basically very similar, it could be that they are all substantially equivalent to products on the market as of February 15, 2007, and that all brands can therefore remain on the market. But it is unclear whether that is the approach that the FDA will take.

2. How will the FDA interpret "therapeutic claims" regarding electronic cigarettes? The key question is whether stating that these products can help people quit smoking represents a therapeutic claim. Elsewhere, I have argued that such a claim is not a therapeutic claim because smoking is not a disease, but a behavior." Unless companies state that the product is intended to prevent nicotine withdrawal symptoms, then they are not making a therapeutic claim. But it is not at all clear whether the FDA will accept this interpretation.

3. Would the FDA approve an electronic cigarette brand not on the market as of February 15, 2007 as a new tobacco product? If the FDA does not allow brands that were not on the market as of February 15, 2007 to be grandfathered in as "substantially equivalent" products, will the Agency approve them as new products? For this to happen, the company would have to demonstrate that these products would benefit the public's health. I think there is sufficient evidence to make such a claim, but will the FDA?

4. Will the FDA approve reduced risk claims for electronic cigarettes? It is clear that electronic cigarette companies cannot continue to make reduced risk claims because their products would then violate the Modified Risk provisions of the Tobacco Act. However, the question is whether they could successfully apply for modified risk designation. I believe there is sufficient evidence to support such a designation, but will the FDA?


All in all, this is a good thing for the public's health. Regulating electronic cigarettes under the Food, Drug, and Cosmetic Act would essentially remove these products from the market, causing tremendous harm to current and potential future users of these products. Regulating electronic cigarettes under the Tobacco Act is appropriate and ensures that they will remain available to smokers who want to quit and to ex-smokers who have already quit using these products

Just how beneficial this is for the public's health will depend on how the FDA answers the four questions above. How stringent or lenient will the Agency be in interpreting the meaning of "substantially equivalent" and "therapeutic claim" with regard to electronic cigarettes under the Tobacco Act and how much evidence will the Agency require for companies to successfully obtain a designation of their products as being "reduced risk" products?

I will continue to follow this issue and report on any regulations or guidances that the FDA issues.

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