WASHINGTON -- "The FDA's proposed regulation would decimate the small businesses that make up America's independent e-cigarette industry and remove a powerful tool smokers are using to kick the habit," Gregory Conley, president of the American Vaping Association (AVA), said in comments the group submitted to the U.S. Food & Drug Administration (FDA) on whether certain tobacco products should fall under the agency's authority.
Aug. 8 was the deadline for interested parties to submit public comments to the FDA on the proposed tobacco "deeming" regulations--"Deeming Tobacco Products to Be Subject to the Food, Drug & Cosmetic Act, as Amended by the Family Smoking Prevention & Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products" (FDA-2014-N-0189).
The AVA's comments were among the 75,735 public comments that retailers, wholesalers, manufacturers, associations, tobacco consumers, health organizations, anti-tobacco advocates and others submitted, as well as those of attorneys general, health organizations, anti-tobacco groups and others, on all sides of the issue.
Here is a selection of some of the comments from groups that issued press statements:
"Congress never intended for the regulations it crafted for cigarettes and smokeless tobacco to apply to innovative tobacco-free products," added Conley. "The FDA has the authority to propose alternate regulation for e-cigarettes that wouldn't ban 99% of the products. They should do so for the betterment of public health."
Craig Williamson, president of the Cigar Association of America (CAA), said, "Our message to the FDA is that when it comes to regulating the cigar industry, fairness means flexibility. We believe a one-size-fits-all approach to regulation will endanger jobs, consumer rights and America's proud cigar tradition."
Click here to view a summary of CAA responses to a variety of issues raised in proposed FDA regulations.
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Williamson is also president of the Pipe Tobacco Council (PTC); in that capacity, he said, "Genuine pipe tobacco represents about 0.1% of all tobacco sales in America, and we believe it is not practical to regulate pipe tobacco like other tobacco products. We're calling on the FDA to approach regulation with fairness and feasibility that safeguards America's proud pipe tobacco tradition."
Click here to view the full PTC comments.
Ahead of the deeming comments deadline, the National Association of Tobacco Outlets (NATO) executive director Thomas A. Briant offered retailers and wholesalers some suggested comments on e-cigarettes, cigars, pipe tobacco and other areas of possible regulation.
For example, on e-cigarettes, he suggested: "Since there were no similar products on the market prior to Feb. 15, 2007, each electronic cigarette manufacturer would need to file a pre-market application for every brand of electronic cigarette currently being sold and new electronic cigarettes introduced into the marketplace. Electronic cigarette manufacturers may not have the financial resources to file pre-market applications resulting in the removal of these brands of electronic cigarettes from the marketplace."
Click here to view NATO's suggested comments.
Jeff Stier, senior fellow at the National Center for Public Policy Research and director of the Risk Analysis Division, said, "If the FDA imposes the rule it drafted, just about all of the e-cigarettes on the market today would eventually have to come off the market because of the huge regulatory burden, and almost all innovation would be stifled. If this happens, smokers who quit smoking using these products have said that they would either buy unregulated products on the market, or simply go back to smoking cigarettes as a result of the FDA's decision.
Click here to view the full NCPPR comments.
In a 110-page comment, Bill Godshall, executive director of Smokefree Pennsylvania, said, "The growing mountain of scientific and empirical evidence … consistently indicates that electronic cigarettes:
- Are 99% (+/-1%) less hazardous than cigarettes.
- Are consumed almost exclusively (i.e. >99%) by smokers and exsmokers who quit by switching to e-cigs.
- Have helped several million smokers quit and/or sharply reduce cigarette consumption,
- Have replaced about 1 Billion packs of cigarettes in the US in the past five years,
- Are more effective than FDA approved nicotine gums, lozenges, patches and inhalers for smoking cessation and reducing cigarette consumption.
- Pose fewer risks than FDA-approved Verenicline (Chantix).
- Have not been found to cause any disease or death in users.
- Pose no risks to nonusers.
- Have further denormalized cigarette smoking.
- Have never been found to create nicotine dependence in any nonsmoker.
- Have never been found to precede cigarette smoking in any daily smoker.
"Accordingly, the FDA should never issue a Final Rule for its recently proposed Deeming Regulation because it would protect cigarette markets, threaten the lives of millions of vapers and tens of millions of smokers, and give the entrepreneurial e-cig industry to Big Tobacco companies by banning >99% of vapor products now on the market, including all of the products that have proven most effective for smoking cessation and reducing cigarette consumption.
"Instead, the Obama administration's FDA (and all other DHHS agencies) should correct, clarify and apologize to vapers, smokers and the public for knowingly and intentionally misrepresenting the scientific and empirical evidence on e-cigs since 2009, for continuously confusing and scaring the public about e-cigs, for unlawfully banning e-cigs in 2009, for funding and encouraging others to demonize and ban vaping, for misrepresenting the public health impact of the Deeming Regulation, and for aggressively campaigning to impose the deadly Deeming Regulation."
The attorneys general of 29 states and U.S. territories submitted joint comments to urge the U.S. Food & Drug Administration (FDA) to strengthen its proposed regulations of electronic cigarettes "to better protect children and young adults from nicotine addiction."
The AGs specifically urged the agency to prohibit marketing tactics that they claim are designed in to attract children and young adults. The attorneys general pressed the FDA to prohibit manufacturers from selling e-cigarettes with flavors and to apply the same advertising and marketing restrictions that traditional tobacco manufacturers must comply with to ensure that ads are not targeting children and young people.
They urged the FDA to:
- Restrict advertising, marketing, and promotion of e-cigarettes in the same way it currently restricts the advertising, marketing and promotion of cigarettes and smokeless tobacco, as well as strengthening and updating those restrictions.
- Strengthen health warnings for e-cigarettes.
- Restrict the advertising, promotion and sale of e-cigarettes and all tobacco products over the Internet.
- Define e-cigarette components and parts and apply the proposed restrictions on age verification, vending machine sales, and health warnings, regardless of whether such components and parts contain nicotine.
- Extend the regulations to include "little cigars," which are nearly identical to traditional cigarettes but lower in cost.
- Regulate pipe tobacco to prevent the use of pipe tobacco as a way to avoid the regulations that apply to roll-your-own tobacco.
The states were Arizona, California, Colorado, Connecticut, Delaware, the District of Columbia, the territory of Guam, Hawaii, Idaho, Illinois, Indiana, Iowa, Maine, Maryland, Massachusetts, Mississippi, Nevada, New Hampshire, New Mexico, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Utah, Vermont and Washington.
Click here to view the full AGs comments.
A group of 24 leading public health and medical organizations including the American Heart Association and the American Lung Association called on the FDA to issue a final rule to regulate all tobacco products by April 25, 2015--one year after the FDA issued a proposed rule, and to reject a proposal to exempt "premium cigars."
The health groups also called on FDA to close gaps in its proposed rule by extending current restrictions on cigarette marketing to newly regulated products, including cigars and electronic cigarettes, and prohibiting the use of flavorings that appeal to kids.
"The deeming of all tobacco products as subject to FDA's regulatory authority is critical to protecting the public health against the risks posed by an increasingly dynamic and diverse marketplace in tobacco products and ensuring continued, and accelerated, progress toward eliminating tobacco-related disease and death," the health groups wrote. "However, the proposed rule must be strengthened, and made comprehensive in scope, to prevent the manufacturers of tobacco products from designing and marketing their products in ways that undercut the full potential of the Tobacco Control Act to achieve its lifesaving objectives."
Click here to read the full comments and recommended actions.
[Editor's Note: CSP Daily News does not necessarily endorse the opinions, assertions, conclusions or recommendations of any organization that it covers as news.]
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