FDA Commissioner Scott Gottlieb is considering pulling all flavored e-cigarettes from the US market, stating that the number of teenagers using e-vapor products have “reached an epidemic proportion”.  The FDA has said more than 2 million middle school and high school students had used e-cigarettes in 2017. As a result, the agency is giving the five top-selling e-cigarette brands sixty days to provide plans for how they will mitigate sales to minors. Does the FDA actually have the legal right to do this, and if so, how can manufacturers respond?

Regulatory considerations

Indeed, if it is found that the use of flavored constituents of vapor products or e-cigarettes are harmful to the overall public health with respect to tobacco and tobacco disease-related health burdens, the FDA does have the right to ban those products. Section 907 of the Tobacco Control Act explicitly gives the agency this authority, but only once it has gathered the scientific evidence to back their claim. Once a determination is made about the need to control tobacco-related diseases, particularly to do with addiction amongst youth, the FDA then has the right to ban the variety of flavors that are currently being used in the market today. It also remains to be seen if the agency will deem some flavors more attractive to adolescents and ban only, for example, the products more associated with a “sweet” flavor.

If the FDA is unsatisfied with responses from manufacturers regarding steps towards prevention of youth addiction, and has scientific data to back their views, the FDA can then issue a draft regulation for comment and give notice in the Federal Register. The draft would be open for a minimum of 60 days for comment from stakeholders. Manufacturers who do not comply can either be prohibited from selling products, fined or face criminal penalties if caught knowingly selling to a minor.

Imposing a blanket ban on any type of e-cigarettes or ENDS products, however, would be beyond the authority of the agency. This is because products on the market before February 15th, 2007 were grandfathered in under regulation, meaning it is impossible to get rid of them as long as they maintain the same characteristics they had in place prior to 2007.

There is a net benefit argument in favor of flavored vapes, however. If flavored e-cigarettes were to be taken off the marketplace, there is a chance that the younger generation might then switch over to traditional cigarettes and be affected by the higher nicotine levels and constituent chemicals found in leaf-based products.

A proactive response

Experts close to the situation are advising manufacturers of flavored vape products to take preemptive action to avoid the FDA taking a regulatory route of action. In the first instance, manufacturers are being encouraged to provide the FDA with their own marketing data on the breakdown of preferred flavors per age group. If certain flavors are found to be more attractive to teens, they can then be withdrawn voluntarily. Manufacturers are also being encouraged to show some effort to mitigate the sale of their products to those under-age. This can be done by either putting contracts and audits into place with wholesalers and retailers regarding to sales to minors.

Voluntary compliance

The potential for any future regulation will be centered around whether the FDA considers flavor an important factor in regards to mitigating sales of regulated products to minors because of the addictive behavior and dangers of nicotine that can be entrenched in minors. Manufacturers will need to start paying closer attention to who their customers are and if any sales are occurring to minors. Companies have this chance to be proactive and deal with the issue by the introduction of retail compliance programs in order to mitigate any potential regulation. 

You can request a replay & transcript of the Hosted Event discussed above, or any of our Hosted Events, by emailing [email protected].

Coleman Research Group, Inc. (“Coleman” or the “Firm”) sponsors events featuring a wide range of speakers (“Guest Speakers”). The opinions, estimates, projections, and views contained in this summary are those of, and exclusively sourced from, the Guest Speakers and are not reviewed or endorsed by the Guest Speakers.  In respect of this summary, Coleman makes no representation or warranty, express or implied, is not providing investment, legal, tax, financial, or accounting advice, and accepts no liability whatsoever. Coleman retains sole discretion as it relates to accessing this information by clients and prospective clients.