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April 3, 2014 | Posted By Bruce D. White, DO, JD

A March 24, 2014, article in the New York Times about the dangers of liquid nicotine used in e-cigarettes and the lack of Food and Drug Administration (FDA) involvement in its regulation emphasized a decades old problem.

Before 2009, Congress prohibited the FDA from regulating tobacco products as customarily marketed. When the Food, Drug, and Cosmetic Act (FDCA) was enacted in 1938, Congress specifically defined drug so as to exclude tobacco products. In effect, Congress reserved the regulation of tobacco products to itself. More than likely, Congress – understanding the economic impact of tobacco at the time – preferred to retain a direct hand. This singular control by Congress was reiterated by the US Supreme Court in FDA v. Brown & Williamson Tobacco Corp. (1990) when the FDA asserted itself and attempted to prohibit the sale of tobacco products to minors by regulation. In Brown & Williamson, the Court struck the regulation down.

Much changed in 2009 when Congress passed the Family Smoking Prevention and Tobacco Control Act. But the legislation had a very limited scope; it permitted FDA regulatory control over cigarettes and smokeless tobacco only. As reported in the New York Times, the FDA does not exert regulatory over e-cigarettes currently.

Nicotine is a powerful drug. One should recall that nicotine is a paralytic agent used in tranquilizer dart guns to fell wild animals. [Feurt SD, et al. Pharmacology and toxicology of nicotine with special reference to species variation. Science. 1958;27:1054–1055.] The March 24 New York Times article warned about the dangers of accidental poisonings in children, highlighting the 300% increase in such cases in 2012.

Moreover, on the very next day – March 25, 2014 – the Washington Post reported that a new study questions the value of e-cigarettes as a smoking cessation tool. Also, the Los Angeles Times that same day – in commenting on the very journal article reported in the Post – noted that FDA Center for Tobacco Control researchers questioned the smoking cessation claims that companies were using to market their e-cigarette products.

Regardless, with the poisoning dangers of liquid nicotine becoming more apparent and the benefit of using e-cigarettes as smoking cessation aids being questioned, perhaps it is time for the FDA to step in and assert stronger regulatory control over liquid nicotine and e-cigarettes as a matter of public safety.

Signs and symptoms of nicotine poisoning can be found here.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

1 comments | Topics: Bioethics and Public Policy, Drug Safety, Regulatory Affairs

Comments

Sofia Rhodes

Sofia Rhodes wrote on 04/09/14 2:32 AM

I am glad that I got a chance to share my views on this. I really don't understand why companies are producing different ways to die. Nicotine is a stimulant drug which makes a real life hell. Today, almost 70% of people are addicted and thanks to the manufacturing companies that they are modifying their technologies to feed nicotine. Really, some action needs to be taken.

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BIOETHICS TODAY is the blog of the Alden March Bioethics Institute, presenting topical and timely commentary on issues, trends, and breaking news in the broad arena of bioethics. BIOETHICS TODAY presents interviews, opinion pieces, and ongoing articles on health care policy, end-of-life decision making, emerging issues in genetics and genomics, procreative liberty and reproductive health, ethics in clinical trials, medicine and the media, distributive justice and health care delivery in developing nations, and the intersection of environmental conservation and bioethics.
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