FDA to Regulate Electronic Cigarettes Under Rules for Tobacco Products
The U.S. Food and Drug Administration plans to oversee electronic cigarettes marketed for non-therapeutic use as tobacco products after a court ruled the products can’t be regulated as drugs or medical devices.
The FDA will propose subjecting e-cigarette companies to rules that already cover the makers of regular cigarettes, such as providing the government with lists of product ingredients, the agency said today in a letter on its website.
The U.S. Court of Appeals in Washington said in December the FDA can regulate e-cigarettes only as tobacco products if they aren’t marketed for therapeutic purposes. The ruling meant that while the agency can review new e-cigarette products before they go on sale, it can’t require manufacturers to conduct the types of animal and human studies mandated for FDA approval of drugs or medical devices.
“The government has decided not to seek further review of this decision, and FDA will comply with the jurisdictional lines established” by the ruling, Lawrence Deyton, director of the agency’s Center for Tobacco Products, and Janet Woodcock, director of the Center for Drug Evaluation and Research, said in today’s letter.
Defining ‘Therapeutic’
The agency is considering whether to issue rules or industry guidance on what types of marketing would qualify as a “therapeutic” claim, Deyton and Woodcock said.
E-cigarettes the FDA determines are marketed for therapeutic purposes “will continue to be regulated as drugs and/or devices,” the FDA said in a separate summary of today’s letter on its website.
The agency last year warned five e-cigarette companies that they were illegally marketing their products as smoking- cessation aids without obtaining prior approval from the FDA as drug-delivery devices.
Deyton and Woodcock didn’t say in their letter whether any e-cigarette companies are still making therapeutic claims. Jeffrey Ventura, an agency spokesman, didn’t immediately respond to an e-mail seeking comment.
Sottera Inc., a closely held e-cigarette maker doing business as Njoy and based in Scottsdale, Arizona, argued in the federal lawsuit that its products — battery-powered devices that generate a nicotine vapor instead of smoke — are tobacco products and not drugs. E-cigarettes are marketed as a tobacco alternative for “smoking pleasure,” rather than for therapeutic uses, the company said.
Sottera’s Response
“We look forward to working with the FDA toward the creation of a regulatory framework that we can all work under together,” Sottera President Craig Weiss said today in a telephone interview. The company doesn’t make any health or therapeutic claims and will “flourish in a regulatory environment,” Weiss said.
The e-cigarette consists of a battery, a heating element and a cartridge that contains a liquid suspension with nicotine. When a user inhales from the cartridge, the liquid is heated and a vapor is emitted. The nicotine is obtained from tobacco plants.
Smokers spend $1.2 billion on smoking-cessation products and $80 billion on cigarettes a year, according to the U.S. Centers for Disease Control and Prevention.
The FDA had said in court filings that e-cigarettes may work with smokers the way methadone clinics wean heroin addicts by giving them a less harmful form of an addictive substance.
Alternative to Smoking
Proponents of e-cigarettes say they provide an alternative to traditional cigarettes that may be less harmful because they don’t produce smoke.
Anti-smoking groups including the American Lung Association had urged the FDA to suspend sales of e-cigarettes unless manufacturers proved their safety and effectiveness in clinical trials.
Smoking-cessation products approved as drugs by the FDA include prescription nasal sprays and over-the-counter gums, patches and lozenges.
GlaxoSmithKline Plc (GSK)’s Nicorette gum was the top-selling brand-name nicotine replacement drug for the year ended in June, with $144.6 million in sales, or 12 percent of the $1.2 billion smoking-cessation market, according to IMS Health Inc., a research company in Norwalk, Connecticut.
To contact the reporter on this story: Molly Peterson in Washington at mpeterson9@bloomberg.net
April 27th, 2011 at 5:48 am
Chief, the discussion has started one up, in the legislation news sub-forum. In short, it’s hugely good news – for now – in that it is essentially the FDA’s public announcement that it is conceding to Njoy’s victory in the lawsuit, and will NOT be filing a petition for review by the Supreme Court.
But, there are many battles ahead over the scope and substance of the new regulations the FDA intends to promulgate. Please see my much more lengthy post in this thread: FDA to regulate e-cig as tobacco (Reprinted below)
Not so fast Cash. From the email I recieved from the FDA, now also posted on its website:
“The Agency intends to propose a regulation that would extend the Agency’s “tobacco product” authorities in Chapter IX of the FD&C Act, which currently only apply to certain specifically enumerated “tobacco products,” to other categories of tobacco products that meet the statutory definition of “tobacco product” in Section 201(rr) of the Act. The additional tobacco product categories would be subject to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and the adulteration and misbranding provisions, as well as to the premarket review requirements for “new tobacco products” and “modified risk tobacco products.””
See, Regulation of E-Cigarettes and Other Tobacco Products
The key words are the “Agency intends to propose a regulation … .”
As Bill G. has been posting repeatedly, first the FDA has to propose its new regulations over e-cigs, then there is a public comment period, and only after the whole administrative process is undertaken do the regulations become officially in effect. This can take up to two years, during which time we must all be vigilant and active in the battle to ensure that any actually officialized regulations are reasonable and science-based. And we must start to prepare, now, whatever evidence will be needed in that battle, starting with a very careful reading of the full announcement I linked to above, and then paying equally close attention to other “guidance” documents the FDA issues as it proceeds.
Yes, we have a lot of other battles to wage, but this concession to the court ruling in favor of Njoy is still a HUGE win for now!
And a PS: this does NOT mean automatic PACT Act inclusion. That would ONLY happen with an amendment of the PACT ACT itself. Nor does it mean an automatic flavor ban, as that specifically only applies to cigarettes. ALL future regulation of e-cigs remains to be proposed, warred over (and that can include further litigation, even, if the proposals are unnecessarily harsh or rigid), and then ultimately enacted. Last edited by yvilla; 04-25-2011 at 04:23 PM