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FDA Brings New Regulations To E-Cigarettes

After years of scrutiny, e-cigarettes are finally facing government restrictions. Earlier this month the Food and Drug Administration (F.D.A.) published extensive new regulations for e-cigarettes and other Electronic Nicotine Delivery Systems (ENDS) like hookah pipes and vapes. The almost 500 pages of regulations will regulate e-cigarettes and other ENDS products much like regular cigarettes, banning sales to individuals under 18 and requiring ID for purchase. Regulations go into effect in 90 days.

E-cigs use a heated liquid base laced with nicotine to create a vapor that can be inhaled. Though they do not contain the same dangerous cancer-causing chemicals as cigarettes, they are still addictive. The liquid used in e-cigs is often flavored and attracts young users. Read more about e-cigs in our blog post here.

Many states have already implemented their own age laws for e-cigs and ENDS products. The most sweeping change to come out of the new regulations is the agency’s decision to call e-cigs “tobacco products”, though they do not contain tobacco (nicotine used in these products is a derivative of tobacco). This means that other nicotine products like gum, lozenges, and sprays will also be considered “tobacco products”.

Under the new regulations all “tobacco product” manufacturers and producers will be required to go through a rigorous registration process with the F.D.A. to gain permission to sell their products.

The new regulations also include strict language about preventing new tobacco products from entering the market if they are “not appropriate for the protection of public health.” E-cigs are often marketed as a healthier option to cigarettes, or as the first step in helping cigarette users break their addiction. British health organizations have actively promoted the use of e-cigs as a step towards quitting tobacco products.

Most health experts in the United States, like the Center for Disease Control and Prevention, have taken an opposite stance. U.S. experts worry that use of e-cigs and ENDS products could lead to nicotine dependency and create new additions in children who are attracted to the wide variety of flavors offered by these products.

To meet the new regulations e-cigs and ENDS companies will be required to demonstrate to the F.D.A. that their products will both “significantly reduce harm and the risk of tobacco-related disease to the individual tobacco users” as well as “benefit the health of the population as a whole, taking into account both users of tobacco products and persons who do not currently use tobacco products.”

This means the F.D.A. will be closely monitoring not only how e-cigs are produced, but also how they are marketed.

One company has already filed a lawsuit against the new regulations. Nicopure Labs LLC, a major manufacture of vaping liquids and related products, argued that the F.D.A. overstepped its power under the Tobacco Control Act of 2009 in arbitrarily ruling that e-cigs and ENDS products are “tobacco products” though they contain no tobacco.

The head of the Tobacco Vapor Electronic Cigarette Association has estimated that compliance with the new regulations will cost e-cigarette makers $1 million per product. More e-cig and vape companies are expected to follow with complaints and lawsuits against the new regulations. Some in the industry worry the regulations signal the beginning of the end.

About the Author

Briggs Bedigian
Briggs Bedigian

H. Briggs Bedigian (“Briggs”) is a founding partner of Gilman & Bedigian, LLC.  Prior to forming Gilman & Bedigian, LLC, Briggs was a partner at Wais, Vogelstein and Bedigian, LLC, where he was the head of the firm’s litigation practice.  Briggs’ legal practice is focused on representing clients involved in medical malpractice and catastrophic personal injury cases. 


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