FDA Imposes Strict New Rules on E-Cigarettes

The U.S. Food & Drug Administration (FDA) has issued new rules extending federal authority to regulate the sale and use of e-cigarettes.

After years of debating the potential health risks associated with electronic cigarettes, the U.S. Food & Drug Administration (FDA) has issued sweeping new rules that extend federal authority to regulate the devices.

Free Confidential Lawsuit Evaluation: If you or a loved one has been injured by an e cigarette, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.

What’s the problem?

May 9, 2016 – FDA commissioner Dr. Robert Califf and Secretary of Health and Human Services Sylvia Burwell announced the new regulations (PDF) Thursday. The rule broadens the definition of tobacco products to include e-cigs, hookahs, pipe tobacco, cigars and other products.

“This action is a milestone in consumer protection — going forward, the FDA will be able to review new tobacco products not yet on the market, help prevent misleading claims by tobacco product manufacturers, evaluate the ingredients of tobacco products and how they are made, and communicate the potential risks of tobacco products,” the agency said.

FDA held 3 public workshops to gather data about the effect of e-cigarettes on public health. Some studies have shown that using the devices is a good way to help a person quit smoking traditional cigarettes. In 2014, the Royal College of Physicians (RCP) stated that “electronic cigarettes and other novel nicotine devices can provide an effective, affordable and readily available retail alternative to conventional cigarettes.”

The American Lung Association (ALA) called the new regulations a “long-awaited step to protect public health.” According to the Centers for Disease Control and Prevention (CDC), approximately 3 million middle and high school students used electronic cigarettes in 2015, up from about 2.46 million the year before. Among adults who tried to quit smoking in 2014, over half had tried e-cigs as an alternative, and more than 20% started using them. Slightly over 3% of people who had never smoked tried the devices, but what has troubled health officials is that young adults between ages 18 and 24 were the highest number of new users.

Under the new regulations, minors under the age of 18 will not be able to purchase electronic cigarettes. Not all states currently forbid sales to minors. The products will also have to come with child-resistant packaging.

In 2014, the number of calls to poison control centers about e-cigarettes skyrocketed, according to the CDC. Most of the calls involved small children ingesting the liquid or accidentally getting it into their eyes or on their skin.

The new regulations will also give the federal government a say in what goes into e-cigarettes. Until now, the market has been a “complete unregulated Wild Wild West,” with no laws mandating what chemicals are included in the products.

Companies will be required to show what is in their products, excluding those on the market prior to 2007. FDA first attempted to regulate electronic cigarettes in 2009, when tests revealed “detectable levels of known carcinogens and toxic chemicals to which users could potentially be exposed.” Diethylene glycol, a toxic chemical found in car antifreeze, was found in one cartridge at a 1% level.

As a result, FDA outlawed the sale of e-cigarettes, warning that the devices contained “toxic” and “harmful” chemicals. A year later, however, a court ruled that “the FDA had cited no evidence to show that electronic cigarettes harmed anyone” and that they could continue being sold.

Finally, the new regulations will require e-cig manufacturers to register with the FDA and include health warnings on their packaging and in their advertisements. It gives the agency authority to evaluate the health effects of electronic cigarette ingredients on users. The new rules will not take effect immediately, as companies will need to time to comply.

Do I Have an E-Cigarette Lawsuit?

The Product Liability Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in e-cig lawsuits. We are handling individual litigation nationwide and currently investigating potential settlements in all 50 states.

Free Confidential Case Evaluation: Again, if you were injured by e-cigarette or vape side effects, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and we can help.

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