The Food and Drug Administration’s long-awaited proposal to regulate e-cigarettes, cigars, and other tobacco products as if they were cigarettes does not go far enough to protect the public, and especially children, from the harmful effects of tobacco products, including nicotine addiction, according to its critics.
And, they say, it gives manufacturers too much time to continue selling their products without oversight while the FDA takes an undetermined period of time to consider comments on the proposal and make the rule final.
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The new proposal would extend the FDA's power to regulate e-cigarettes, cigars, pipe tobacco, nicotine gels, hookah tobacco, and dissolvable tobacco products.
The 2009 Family Smoking Prevention and Tobacco Control Act gave the FDA authority to extend its regulation of tobacco over all tobacco-derived products. A few years ago, the agency indicated that it would "deem" all tobacco-derived products as similar to cigarettes but had not issued any regulation until now. The new proposal would extend the FDA’s power to regulate e-cigarettes, cigars, pipe tobacco, nicotine gels, water pipe (or hookah) tobacco, and dissolvable tobacco products.
"This proposed rule is the latest step in our efforts to make the next generation tobacco free," said HHS Secretary Kathleen Sebelius, in a statement. The regulation would also allow the FDA to determine whether products like e-cigarettes serve as a gateway to cigarette use, she told reporters.
Mitch Zeller, director of the FDA’s Center for Tobacco Products, said that the agency is "funding massive studies" to get a better handle on the potential benefits and risks of e-cigarettes and the patterns of use. "We have far more questions than answers about who is using e cigarettes and how they are being used," he told reporters, in a briefing.
Under the proposed rule, makers of tobacco products would have to:
• 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.
• Not distribute free samples.
FDA Commissioner Margaret A. Hamburg said the agency will take comments on the rule for 75 days and then, after analysis, make it final. But she would not give a timetable for when the rule would be made final.
Manufacturers who’ve had products on the market as of February 2007 will be required to submit applications for approval within 24 months of the final rule’s effective date. During that period, they will be allowed to continue to sell their products, subject only to a few regulations that will go into effect immediately. That would include a ban on retail and Internet sales to children under age 18 years; a prohibition on free samples; the requirement that companies register with the FDA; a prohibition on direct or implied claims that the products reduce the risks from tobacco use; and, a prohibition on vending machine sales unless located in facility that never admits youth.
The FDA would not ban Internet sales altogether or prohibit TV ads. The agency would have to issue separate rules on marketing and promotion, said Mr. Zeller.
There’s no proposed ban on flavored tobacco products. That will also require separate rules, once the agency has established jurisdiction over all the products deemed similar, said Mr. Zeller. The agency is also proposing to give so-called "premium" cigars that meet certain criteria a pass on most of the regulation.
Dr. Margaret Foti, CEO of the American Association of Cancer Research said in a statement that FDA regulation of "all tobacco products, including e-cigarettes and cigars," is imperative and that the agency should "prohibit the sale and marketing of these products to children. She added that "the proposed rule is an important step forward in expanding the FDA’s regulation of tobacco and protecting the health of the American people."
The Campaign for Tobacco-Free Kids lauded the FDA for moving forward, but also was disappointed in the decision to not regulate flavorings. The Campaign said in a statement that the flavorings, often found in cigars or e-cigarettes may appeal to youth. It also called the potential premium cigar loophole "deeply disturbing," adding that, "There is no justifiable public health rationale for exempting any category of cigars."
Noting that e-cigarette use is skyrocketing among young Americans, the Campaign said that, "Effective regulation by the FDA and the states is needed to minimize the potential harms of e-cigarettes and ensure any potential health benefits are supported by sound science."