Regulating e-Cigs: The FDA Wants to Hear From You

Sandra Adamson Fryhofer, MD


June 23, 2014

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Hello. I'm Dr. Sandra Fryhofer. Welcome to Medicine Matters. The topic: electronic cigarettes and the newest US Food and Drug Administration (FDA) proposal. Here’s why it matters.

E-cigs. Electronic cigarettes. They look like real cigarettes, but they are not. Instead of smoking them, you "vape" them, and vaping is catching on. This is a multibillion-dollar business. Big tobacco companies have gotten on this bandwagon with their own e-cig brands.

What’s very worrisome is young people are also starting to vape. There is concern this could trigger a new generation of smokers.

On April 24, 2014, implementing the Family Smoking Prevention and Tobacco Control Act, signed by the President in 2009, the FDA proposed a new rule extending its tobacco authority to electronic cigarettes. The new proposal does not stop at adding e-cigs. It also includes cigars, pipe tobacco, nicotine gels, hookah water pipes, and dissolvables. The new proposal addresses advertising, promotion, packaging, and age restrictions on sales.

Here are some of the proposed requirements for the newly deemed tobacco products:

No free samples.

No vending machine sales, unless it’s in a location that never admits youth.

Ban sale to minors; minimum age restrictions are a must to prevent sales to underage youth.

Companies must register their products with the FDA and list ingredients.

New tobacco products can only be marketed after FDA review.

Any direct or implied claims of reduced risk must be supported by scientific evidence that is confirmed by the FDA. Reduced risk claims can only be made if the FDA confirms that marketing the product will benefit public health as a whole. They also have to include health warnings.

Products that are marketed as having therapeutic benefits will continue to be regulated as medical products under FDA’s existing authority.

This is a proposed rule released on April 24, 2014. Next is a 75-day public comment period. Although e-cigs seem to be the driver here, the FDA is also specifically seeking comments on whether cigars should be subject to this ruling.

One complaint that is already on the table: The rule doesn’t address candy-flavored e-cigs or candy-flavored cigars. It’s no secret who those are targeting.

How do e-cigs executives view these new FDA proposals? Time magazine says manufacturers are actually thrilled with the new regulations and see them as business-friendly. What do you think about that?

It all boils down to whether e-cigs are a public health menace, a lure for new smokers, a gateway to smoking, or a lifesaving alternative to conventional cigarettes and possibly the end of all smoking in America. The jury is still out. We need more scientific evidence, but right now the FDA wants to hear from you. Send in your comments by August 8, 2014. [Editor's note: Previously the closing date for comments was July 9, but it was recently extended.]

For Medicine Matters, I’m Dr Sandra Fryhofer.


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