Science and Law
18th May 2016

New FDA Mandate: Increased Scrutiny of E-Cigarette Efficacy and Safety Claims

As per the FDA’s press release, the new regulations have numerous provisions, including those geared at restricting youth access (i.e. Not allowing products to be sold to persons under the age of 18 years, requiring age verification by photo ID), and the ability for the FDA to evaluate factors such as ingredients, marketing claims (e.g. helping smokers to quit smoking), product design and health risks (to users and non-users), as well as their appeal to youth and non-users.

New FDA Mandate: Increased Scrutiny of E-Cigarette Efficacy and Safety Claims

Last week, the FDA finalized a rule which affects e-cigarettes and other products including hookahs, cigars, and pipe tobacco marketed after February 15, 2007. Essentially, most e-cigarette products currently on the market will not be grandfathered in, and will have to go through the FDA approval process retrospectively. Some have expressed concern that the new regulations are too onerous and costly, and will force many small shops and manufacturers out of business.

As per the FDA’s press release, the new regulations have numerous provisions, including those geared at restricting youth access (i.e. Not allowing products to be sold to persons under the age of 18 years, requiring age verification by photo ID), and the ability for the FDA to evaluate factors such as ingredients, marketing claims (e.g. helping smokers to quit smoking), product design and health risks (to users and non-users), as well as their appeal to youth and non-users.

However, some of these issues are complex, and currently, there are no straight-forward answers. For example, while more than 40 states have banned the sale of e-cigarettes to minors, one recent study suggests that these restrictions have had an unintended consequence. That is, they have increased adolescents’ use of conventional cigarettes when compared to states that have not banned the sale of e-cigarettes to minors. Additionally, the well-respected British Medical Group recently encouraged smokers to switch from conventional cigarettes to e-cigarettes, noting that “…in the interests of public health it is important to promote the use of e-cigarettes, NRT [nicotine replacement therapy] and other non-tobacco nicotine products as widely as possible as a substitute for smoking in the UK.”

Clearly, arguments related to the efficacy and safety of e-cigarettes are still evolving and have certainly matured over the past few years. As we’ve discussed in previous posts (see here, here, and here), the science related to e-cigarettes is emerging quickly, and the vast volume of information can be daunting for manufacturers and attorneys who may not be equipped, skilled, or have the time to track the relevant science. In addition, once new studies of relevance have been identified, they must be evaluated so that the risks and opportunities of the new findings can be evaluated.

Given the new FDA rule, it is reasonable to expect that marketing claims related to the efficacy and safety of e-cigarettes (including safety of individual ingredients such as diacetyl) will come under increased scrutiny. This heightened level of regulatory scrutiny may certainly create additional risks, especially for those e-cigarette manufacturers and attorneys that are not vigilantly staying up-to-date on the science.

To provide our readers with a sense of the volume of new e-cigarette science that is emerging, we did a few simple PubMed searches. Between January 1st and May 16th 2016, more than 75 articles have been published with the term “e-cigarette” in the title of the article, and the number of articles jumps to almost 200 for articles where the term when the term “e-cigarette” appears in the title and/or abstract of the article.

As e-cigarette science continues to emerge and make headlines, it will be increasingly important for manufacturers, attorneys, and other interested parties to stay up-to-date on the science, as well as fully review the science to test its ability to withstand rigorous scrutiny, and better understand the potential risks and opportunities of new scientific findings.

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