FDA NEWS RELEASE
For Immediate Release April 24, 2014
Media Inquiries Jenny Haliski, 301 796 0776,
Consumer Inquiries 888 INFO FDA
FDA proposes to extend its tobacco authority to additional tobacco products, including e cigarettes
As part of its implementation of the Family Smoking Prevention and Tobacco Control Act signed by the President in 2009, the U.S. Food and Drug Administration today proposed a new rule that would extend the agency s tobacco authority to cover additional tobacco products.
Products that would be “deemed” to be subject to FDA regulation are those that meet the statutory definition of a tobacco product, including currently unregulated marketed products, such as electronic cigarettes (e cigarettes), cigars, pipe tobacco, nicotine gels, waterpipe (or hookah) tobacco, and dissolvables not already under the FDA s authority. The FDA currently regulates cigarettes, cigarette tobacco, roll your own tobacco, and smokeless tobacco.
“This proposed rule is the latest step in our efforts to make the next generation tobacco free,” said HHS Secretary Kathleen Sebelius.
Consistent with currently regulated tobacco products, under the proposed rule, makers of newly deemed tobacco products would, among other requirements
- Register with the FDA and report product and ingredient listings
- Only market new tobacco products after FDA review
- Only make direct and implied claims of reduced risk if the FDA confirms that scientific evidence supports the claim and that marketing the product will benefit public health as a whole and
- Not distribute free samples.
In addition, under the proposed rule, the following provisions would apply to newly “deemed” tobacco products
- Minimum age and identification restrictions to prevent sales to underage youth
- Requirements to include health warnings and
- Prohibition of vending machine sales, unless in a facility that never admits youth.
“Tobacco remains the leading cause of death and disease in this country. This is an important moment for consumer protection and a significant proposal that if finalized as written would bring FDA oversight to many new tobacco products,” said FDA Commissioner Margaret A. Hamburg, M.D. “Science based product regulation is a powerful form of consumer protection that can help reduce the public health burden of tobacco use on the American public, including youth.”
“Tobacco related disease and death is one of the most critical public health challenges before the FDA,” said Mitch Zeller, director of the FDA s Center for Tobacco Products. “The proposed rule would give the FDA additional tools to protect the public health in today s rapidly evolving tobacco marketplace, including the review of new tobacco products and their health related claims.”
The FDA proposes different compliance dates for various provisions so that all regulated entities, including small businesses, will have adequate time to comply with the requirements of the proposed rule.
Products that are marketed for therapeutic purposes will continue to be regulated as medical products under the FDA s existing drug and device authorities in the Food, Drug &Cosmetic Act.
The proposed rule will be available for public comment for 75 days. While all comments, data, research, and other information submitted to the docket will be considered, the FDA is requesting comments in certain areas, including
- The FDA recognizes that different tobacco products may have the potential for varying effects on public health and is proposing two options for the categories of cigars that would be covered by this rule. The FDA specifically seeks comment on whether all cigars should be subject to deeming, and which other provisions of the proposed rule may be appropriate or not appropriate for different kinds of cigars.
- The FDA seeks answers to the many public health questions posed by products, such as e cigarettes, that do not involve the burning of tobacco and inhalation of its smoke, as the agency develops an appropriate level of regulatory oversight for these products. The FDA seeks comment in this proposed rule as to how such products should be regulated.
For more information
- Proposed rule Tobacco Products Deemed to be Subject to the Food, Drug and Cosmetic Act (Deeming)
- FDA Extending Authorities to Additional Tobacco Products
- Consumer Update Recognize Tobacco in Its Many Forms
- FDA Voice Blog Proposed Rule Would Expand FDA s Tobacco Control Authority
- En Espanol La FDA propone ampliar su autoridad para regular otros productos de tabaco, incluyendo los cigarros electró nicos
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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E-cigarette liquid nicotine: toxic, unregulated and overhyped
Several bigger e cigarette stores in New York and other parts of the country label their bottles and include childproof caps. Smaller mom and pop shops tend to bypass labeling, though. Others concoct their own, stronger versions of e liquids part of the reason, some owners say, it’s been getting such a bad reputation.
“It’s a war on both sides,” says Talia Eisenberg, 27, co owner of the Henley Vaporium, an e cigarette company in New York City. “It’s a disparity between those selling pure nicotine online or in these smaller shops and those brands that are doing it responsibly. And because it’s new, and sort of unknown in that regard, people have been quick to jump in and villainize them as a whole.”
Last week, Henley launched an Indiegogo campaign to raise funds for iHenley, a Bluetooth enabled device that tracks e cigarette nicotine consumption through a smartphone app.
“It’s important to know what you’re putting into your body,” she says. “Nobody’s saying nicotine’s healthy.”
But children are curious, and accidents can happen, regardless where parents hide potentially dangerous substances. Few are storing liquid nicotine bottles next to the LEGO sets in their kids’ playroom. But as evidenced by the hundreds of 911 and poison control center calls Orozco and others receive every year, kids have a way of getting into things they shouldn’t.
David Rosen, head of the Life Sciences Industry Team at Foley and Lardner, worked as a regulatory council for the FDA from 1978 to 1992. He agrees that FDA regulation would solve a lot of debates around e liquids, but like most people, he’s not sure when we can expect those regulations to go into effect.
Thursday s FDA proposals are only the beginning of a tiresome process. The agency will publish its suggested regulations, then allow the public and industry to weigh in. From there, they’ll review the feedback and make tweaks before coming to a final ruling. All in all, says Rosen, it could take a year or more to complete.
“What it really comes down to is that we don’t know if these products are manufactured under good conditions,” he says. “Some shops offer bottles with labels and proper caps, but there are plenty of places online where you can buy unmarked e liquids.”
One of the biggest concerns is imported products. If and when the FDA regulates the liquids, Rosen guesses it would put a stop to all imports coming from outside the United States.
Whatever side people are on, Eisenberg says, it’s a “wild, wild west.” The overall consensus seems relatively universal FDA regulations on e cigarettes and e liquids could help drastically. Progress has begun, but until proper and detailed regulations are fully in place, the best course of action is simple caution from everyone.
“Nicotine has been around forever,” Orozco says. “We know what it is and we know what it does. This is just a new form of that. It should be treated the same.”