New rule to extend FDA’s authority over e-cigarettes has been proposed on Friday, 24th of April 2014. The U.S. Food and Drug Administration seeks control over e-cigs and other, currently unregulated tobacco products on the market.
The subject of the proposed rule would be electronic cigarettes (e-cigarettes), cigars, pipe tobacco, nicotine gels, waterpipe (or hookah) tobacco, and dissolvables that are not under the FDA’s authority by now.
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.
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. Such rules would apply for example to Vype e-cigarettes if BAT‘s subsidiary, Nicoventures Ltd., continues its strategy of registering e-cigarettes as cessation helping medical devices.
The FDA acknowledges, 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. It also recognizes, that products, such as e-cigarettes, that do not involve the burning of tobacco and inhalation of its smoke, may need different level of regulation.
The proposed rule, Tobacco Products Deemed to be Subject to the Food, Drug and Cosmetic Act (Deeming), is subject to public comment for 75 days.
While traditional tobacco products are strictly regulated, they remain the leading cause of death and disease in the USA.
“Tobacco-related disease and death is one of the most critical public health challenges before the FDA. 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.”
said Mitch Zeller, director of the FDA’s Center for Tobacco Products.
On the other hand unregulated new products and specifically e-cigarettes are not controlled and consumers are not informed properly on what they are inhaling. E-cigarettes manufacturers are not obliged to disclose ingredients, test for safety or adhere to standards, Mr. Zeller points out.
The industry reacts to the proposed rule calmly. Asked by USA Today for a comment, Jason Healy, president of blu eCigs, the leading e-cigarette company in the U.S. market is glad that the FDA is taking a “scientific-based” approach. Miguel Martin president of LOGIC, the second-largest e-cigarette company is also “encouraged” by the fact that the FDA isn’t simply applying all its current restrictions on regular cigarettes to e-cigarettes.
Indeed, FDA could single-handedly end the prosperity of both companies by applying tobacco regulations to e-cigarettes. So far it has chosen moderate approach, but anti-tobacco campaigners are at the gates. Matt Myers, president of the Campaign for Tobacco-Free Kids, notes, that it’s disturbing FDA would even consider exempting any form of tobacco product, all of which cause disease. While it may not be scientifically true (as there is no research showing direct connection of e-cigarettes with any disease), Mr. Myers is in-line with WHO’s FCTC, and his point may prevail.
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 electrónicos