The authors offer arguments in two realms: the FDA's regulatory powers, and health.
Regulatory Argument
The authors assert:
1
The electronic cigarettes that have been investigated by FDA are not subject to the Family Smoking Prevention and Tobacco Control Act. Thus, they do not fit within the regulatory scheme that Congress has established for tobacco products.
However,
2
Since FDA is not aware of any data establishing that such products are generally recognized among scientific experts as safe and effective, these products are new drugs, as defined by the Federal Food, Drug,and Cosmetic Act of 1938, requiring approval of a new drug application (NDA) to be legally marketed in the United States.
As noted by markarich159 and concerning the "intended use" issue (see Sun Vaporer's coverage of Smoking Everywhere V. FDA [the Daily Docket Sheet Update]), the authors state:
3
Although no electronic cigarette has received FDA-approved labeling, manufacturers continue to make unfounded claims.
Furthermore,
4
Based on consumer inquiries to FDA, electronic cigarettes appear to be viewed by the general public as an aid to smoking cessation.
In terms of the FDA's regulatory power:
5
Independent of the new tobacco legislation, FDA has regulatory jurisdiction over nicotine replacement therapies and other non-nicotine containing oral medications that are marketed as smoking-cessation aids.
It is clear from these arguments that the FDA asserts regulatory power over e-cigarettes.
Health Argument
The authors state:
6
Chronic systemic exposure to nicotine has been found to contribute to accelerated coronary artery disease, acute cardiac ischemic events, and hypertension. Other potential adverse effects of nicotine include stroke, delayed wound healing, reproductive toxicity, peptic ulcer disease, and esophageal reflux.
Discussed in older posts on this forum, as well as by Michael Siegel on his blog, is the scope of testing on e-cigarette liquid. The authors note that the FDA only tested two brands
7 (one being, presumably, Smoking Everywhere) . The conclusions drawn from this test have been discussed elsewhere, and, to avoid redundancy, will not be posted and discussed here.
One striking claim by the authors is that
8
These products may be attractive to minors who may be drawn to the technology, flavoring, and accessibility.
The authors provide no in-paper references to clinical or academic studies to support this claim; however, they may be relying on the facts behind the passage of the
Family Smoking Prevention and Tobacco Control Act of 2009 to carry that weight.
Conclusion
Based on FDA studies of two e-cigarette brands, and the health effects of nicotine cited above, the authors conclude that e-cigarettes are not a proven, safe alternative. Furthermore, the FDA has the power to regulate e-cigarettes as a new drug.
As I stated before, much of what has been written has already been discussed. Much of it is now at the forefront in the legal proceedings in Smoking Everywhere V. FDA (I recommend you follow Sun Vaporer's updates on the ordeal).
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1. Kremzner, Mary E. and Kristine A. Wollscheid. "Electronic cigarettes: Safety concerns and regulatory issues,"
American Journal of Health-System Pharmacy 66, no. 19 (October 2009): 1741.
2. Ibid
3. Ibid; The authors reference Smoking Everywhere's website to assert the claim.
4. Ibid
5. Ibid, 1740.
6. Ibid. 1741.
7. Ibid, 1740.
8. Ibid, 1741.
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Hope this helps Tom
