May 06

FDA to Regulate New Tobacco Products, E-Cigarettes

On April 24, 2014, the U.S Food and Drug Administration (FDA) announced its publication of newly proposed regulations pertaining to new tobacco products, as permitted by the Family Smoking Prevention and Tobacco Control Act of 2009. The products covered under the newly-proposed regulations are any tobacco related products that fall under the statutory definition of tobacco products, including presently uncontrolled, advertised products like pipe tobacco, electronic cigarettes (e-cigarettes), nicotine gels, water pipe tobacco, cigars and other related products. While some products, like electronic cigarettes, don’t directly consist of tobacco, these products fall under FDA’s tobacco authority, as promulgated by Congress, in that they are derived from tobacco and/or contain nicotine, i.e., e-cigarettes contain nicotine derived from tobacco and therefore meet the definition of tobacco product under federal law. Currently, the FDA’s final regulations only cover smokeless tobacco, cigarettes, rolling tobacco and cigarette tobacco. More information about the FDA’s announcement may be found here.

Similar to tobacco products previously regulated by the FDA, the new regulations would require product manufacturers and marketers, including marketers of e-cigarettes, to follow certain guidelines, such as the following:

  • FDA registration and reporting of product information
  • Certain new tobacco products can only be marketed after a full FDA review
  • Free samples cannot be distributed
  • Only scientifically proven, direct claims of a decreased health risk, i.e., “smoking e-cigarettes is safer than traditional cigarettes”,  can be made where the FDA is able to verify that the evidence meets a certain level of scientific support

Additionally, the new proposed rules will include certain restrictions on newly-regulated tobacco related products, including e-cigarettes, that apply to marketing and sale of previously-regulated tobacco products, such as the following:

  • Product packaging must list health warnings
  • Identification and minimum age requirements in order to prevent underage purchases
  • Products cannot be sold in vending machines unless the machine is located in a facility does not allow underage youths

The full text of the proposed regulations may be accessed here.

Although new tobacco products like e-cigarettes are not subject to current, final regulations pertaining to other tobacco products, the agency is working hard to gain control over these items, as illustrated through the proposed rule. If and when the regulations pertaining to e-cigarettes and other new tobacco products are finalized, importers and marketers of these products will be required to comply with the various requirements in order to ensure that their products may be marketed in a manner consistent with federal law. Accordingly, product registration and changes in marketing, including revisions to current labeling for e-cigarettes and the like, may be necessary in order to continue doing business in the United States.

If you have any questions about the FDA’s proposed tobacco product regulations or how you can maintain compliance with FDA regulations, please contact us at contact@giannamore-law.com.

FDA Lawyer

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