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FDA Extends Regulations to E-Cigarettes and Other Tobacco Products

Jason Reese

Last week, the U.S. Food and Drug Administration extended its regulation of tobacco products last week by ruling they are subject to the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act).

The Tobacco Control Act gives the FDA regulating authority over cigarettes, cigarette tobacco, smokeless tobacco, roll-your-own tobacco and other tobacco products as determined by the Agency’s regulation. This now applies to e-cigarettes, cigars, hookahs, and other future possible products that meet the statutory definition of “tobacco products.”

The FD&C Act defines “tobacco product” as “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).”

Tobacco Products to Be Regulated Similarly to Cigarettes

The new regulations in many ways mirror those already in place for traditional cigarettes. E-cigarettes, cigars, and hookah tobacco will no longer be legally for sale to minors under the age of 18. Additional new regulations include:

  • A requirement for e-cigarettes to include a warning stating the products contain nicotine and may be addictive.
  • A ban on distribution of free samples.
  • A prohibition on selling e-cigarettes in vending machines where minors are allowed.
  • A requirement for submission of ingredient listing.
  • Required registration of tobacco manufacturing locations.
  • Prohibition against sale or distribution of tobacco products with risk-minimizing descriptions.

Vaping business owners in Indiana and elsewhere are most concerned with the requirement for government approval of all electronic cigarette products made after 2007. Vaping advocacy groups go as far as calling the new regulations “a prohibition” that will essentially close down a majority of the businesses in the industry.

Disagreement Over Health and Addiction Concerns

The FDA says it is responding to overwhelming concerns about the number of new tobacco addicts being created through vaping, which many people believe to be safe. The marketing and sales of these products to young people is of particular concern, as evidenced by the strong new regulations regarding sales of e-cigarettes to minors.

Not everyone agrees. In April, the Royal College of Physicians in the U.K. essentially endorsed the promotion of e-cigarettes in the name of increasing public health. They believe e-cigarettes are an important tool in the fight against smoking traditional cigarettes, which carry a much more significant set of individual health risks than e-cigarettes. Many Hoosiers agree with this second perspective and are concerned about a relapse into addiction to traditional cigarettes. For some, e-cigarettes have provided a lifeline out of their decades-long struggles to quit smoking.

It’s hard to tell what the future will be for the tobacco products newly subject to FDA approvals. For certain, the health risks of traditional cigarettes are very real, with tobacco companies like Philip Morris and R.J. Reynolds in constant litigation over the illnesses and deaths of their customers. Billions of dollars have been awarded to lung cancer victims, often as a result of claims the big tobacco companies knew the hazards and did not properly inform consumers.

If you or a loved one have become ill due to the use of tobacco or other products, the product liability attorneys at Wagner Reese will fight for the justice and compensation you deserve. Call us today for your no-cost, risk-free consultation: (888) 204-8440.


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