September 11th, 2014 — Current Issues, Electronic Cigarettes, General, Preventing Youth Consumption, Regulations: FDA etc., Science, Snus, Snuff & Alternative Products in US Markets, Tobacco Harm Reduction
Reynolds American Inc. has fired an expected shot across the bow of small vapor cigarette manufacturers.
A Reynolds division recommended to the Food and Drug Administration in a 119-page submission that the agency ban the use of vapor electronic cigarettes.
Traditional e-cigs are battery-powered devices that heat a liquid nicotine solution in a self-contained disposable cartridge and create a vapor that is inhaled. The manufacturers have provided few flavor choices, in part in expectations that the FDA would limit flavorings as they do with combustible cigarettes.
By comparison, vapor products can feature a liquid capsule that is inserted into a cartridge, known as an open-system format. Vapors offer consumers a wider variety of flavors, included fruits and candy.
“We believe FDA should not allow such products to be sold or marketed,” Reynolds spokesman David Howard said in discussing the company’s submission. “We believe open-system vapor products create unique public health risks.
“These systems are highly subject to adulteration and tampering, they are manufactured largely overseas in facilities that would, as proposed, fall outside regulatory inspection and oversight, and many nicotine liquids are sold in non-child-resistant packaging in flavors that may be appealing to youth.”
Industry observers say much of the nicotine liquid for the open-system vapor products are made in China or in unregulated vape shops, a sizable number of which are operating in the Triad.
Altria Group Inc. and Lorillard Inc also submitted recommendations – both less stringent that Reynolds – during a public comment period that expired in August.
The FDA began regulating tobacco products and marketing in June 2009, but it does not have the authority to ban nicotine or tobacco.
The industry, advocacy groups, analysts and adult smokers have been waiting for years for the FDA to decide on approving e-cigs and vapors as a smoking-cessation device. A Wild Wild West environment has emerged in the absence of FDA e-cig regulations.
Reynolds’ recommendations did not come as a surprise to vapor e-cig supporters, who have expressed concern since the category’s emergence about federal regulators allowing the Big Three to dominate e-cigs as they have combustible cigarettes and moist snuff.
“R.J. Reynolds’ call for the FDA to ban the majority of e-cigarette products should be seen for what it really is — an admission that it simply cannot compete in the current e-cigarette market,” said Gregory Conley, president of the American Vaping Association.
“Recent market reports show that while sales of open-system e-cigarette products and e-liquid are booming, sales of closed-system cigarette lookalikes – the kind that Reynolds sells – have stagnated.”
The stakes over the e-cig vs. vapor debate could be significant financially, as well as industry changing.
Wells Fargo Securities analyst Bonnie Herzog estimated overall U.S. e-cig revenue reached $2 billion in 2013. She projects it will increase up to $10 billion by 2017.
Herzog predicts Reynolds will have $4 billion in revenue from e-cigs in 2021, compared with $3.9 billion from conventional cigarettes. That’s compared with barely any e-cig revenue and $6.4 billion in conventional cigarette revenue for 2013.
Herzog also has noted a significant pickup in vapor sales in recent months.
The World Health Organization said in an Aug. 26 report there are 466 global e-cig brands and that $3 billion was spent globally on the products in 2013. “Sales are forecasted to increase by a factor of 17 by 2030,” the report said.,
The WHO report’s authors expressed concern about the ability to manipulate the vapor products to insert liquid compounds other than nicotine solutions. They also said there has not been near enough time to determine whether e-cigs will contribute to “many diseases of interest, such as cancer. … The association of e-cigs with such diseases will not be available for years or even decades.”
Reynolds recently began a national launch of its e-cig brand, Vuse, that top executive Susan Cameron has touted as a “game changer” for the sector.
Reynolds is confident enough in Vuse that it plans to sell the top-selling U.S. brand, blu eCigs, as part of a $27.4 billion offer for Lorillard. Reynolds would sell blu eCigs and its 41 percent U.S. market share to Imperial Tobacco Group Plc in a related $7.1 billion deal.
Cameron said during an investor presentation last week that adult smokers are experimenting with self-contained e-cigs and open system vapor products.
“I think that what you’ve seen is as consumers have tried a lot of these e-cigarettes that aren’t satisfying, this has driven a lot of the growth of what we call tanks,” Cameron said.
“The growth of those is driven by the consumer’s desire to get satisfaction. If you’re not getting satisfaction out of the e-cigarette format because you’re not getting the nicotine that you want, then if you go to those tanks, you can figure out how much nicotine you want, right. You fill it yourself.
“Our position is really that these open tanks are really not appropriate. And the reason for that is because people can put whatever they want to in those tanks, and this is a lot of the public outcry. People are putting a lot of things other than nicotine into these pipes.”
For example, there are companies making e-mail pitches for selling e-liquids containing cannabis.
“Second of all, if you really load a lot of nicotine into a pipe, and there is nothing to stop a kid from picking it up, this is not good,” Cameron said. “So we believe that closed systems are the way that regulators should evolve.”
Reynolds said that if the FDA does allow open-system vapor products to be sold, it “should create a level playing field on which all manufacturers of non-combustible deemed product categories are subject to equal treatment.”
“Such equal treatment will ensure that all such products meet the health and safety requirements that FDA determines are necessary to safeguard and promote the public health.”
Lorillard said in its 132-page submission that e-cigs “hold the potential to advance the public health dramatically by moving existing users of conventional tobacco products to lower risk options.”
“In fact, an international expert panel recently estimated that electronic cigarettes have only 4 percent of the maximum relative harm of conventional cigarettes, suggesting that substitution of electronic cigarettes for conventional cigarettes is likely to provide a significant public health benefit.”
“Lorillard recognizes that reasonable regulation can help foster product quality and consistency, as well as responsible marketing to ensure that the public health benefits of this product category are fulfilled.”
Conley cited surveys of e-cig users that said smokers who try vapor products “are far more likely to be smoke-free than are those who use closed system products that are designed to resemble and taste like cigarettes.”
“We also encourage the Federal Trade Commission to consider Reynolds’ eagerness to see its competitors banned in deciding whether to approve a proposed merger between Reynolds and Lorillard.”
Scott Ballin, past chairman of the Coalition on Smoking or Health, said he expects the FDA to place severe restriction on the open-system vapor products for the reasons Cameron and Reynolds cited.
“The lack of regulatory oversight over the vapor liquid tanks may back the FDA into that stance since otherwise, you open a whole can of worms on what can go into those tanks,” Ballin said.
“The FDA also needs to step in to say that not all e-cigs are OK, and not all of them should be on the market.”
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August 19th, 2014 — Current Issues, Electronic Cigarettes, Key International Business & Market Developments
BRADFORD, Pa. — A German court granted Zippo Manufacturing Co. (ZMC) a temporary injunction against Cygnet UK Trading Ltd., a Lorillard Inc. subsidiary, preventing Cygnet from using the “blu” brand name for its electronic cigarettes sold in that country.
The Regional Court of Frankfurt am Main agreed with ZMC that the “blu” e-cigarette brand creates a likelihood of confusion with ZMC’s European Union Community trademark BLU, used in connection with its line of high-performance, precision butane lighters and fuel.
The court found the confusion was due to the high degree of similarity between the marks, an existing similarity between the parties’ respective goods and the ZMC BLU mark’s “at least” average degree of distinctiveness, according to the announcement made Monday by ZMC.
ZMC’s action in Germany and the resulting preliminary injunction against Cygnet is part of ZMC’s ongoing, global effort to protect its worldwide portfolio of BLU trademarks. The company has begun proceedings to oppose applications to register or to cancel trademark registrations for the “blu” e-cigarette brand in the United States, Canada, Mexico and the European Union. Sweden has already rejected outright Lorillard’s application to register a trademark for “blu,” ZMC noted.
In May, ZMC and its subsidiary ZippMark Inc. sued LOEC Inc., a wholly owned subsidiary of Greensboro, N.C.-based Lorillard, for trademark infringement in the U.S. District Court for the Central District of California, as CSNews Online previously reported. The lawsuit seeks to prevent LOEC from selling its blu eCigs in light of Zippo’s earlier ownership and use of the BLU trademark. A trial is slated to begin in April.
“I am very pleased that the German court affirmed our legal rights to our intellectual property,” said Zippo President and CEO Gregory Booth. “Zippo Manufacturing Co. has invested in innovative technology and trademarked its BLU brands from the beginning, and we are working to vigorously protect all of our marks — worldwide — from any misuse by others.”
ZMC is represented by attorneys from Squire Patton Boggs LLP (US) in Frankfurt.
Lorillard acquired blu eCigs in April 2012. However, under the terms of the Reynolds American Inc. and Lorillard merger agreement, Imperial Tobacco Group will buy blu eCigs, as well as the Winston, Kool, Salem and Maverick cigarette brands for $7.1 billion.
Bradford-based Zippo Manufacturing Co. is also the maker of the Zippo lighter and owns the RONSON brand of lighters and fuel.
Zippo Wins Preliminary Injunction in Trademark Suit
August 13th, 2014 — Current Issues, Electronic Cigarettes, Snus, Snuff & Alternative Products in US Markets, tobacco, Tobacco Harm Reduction
LOGIC Technology, makers of premium electronic cigarettes, announced today the latest results from Nielsen’s C-Track Database, indicating that the brand has captured the No. 1 position in the U.S. for unit share in convenience stores nationwide. Additionally, LOGIC continues to maintain a strong hold on the No. 2 rank for dollar share across the U.S. Currently, LOGIC leads the category in total U.S. unit share at 24.3%. In total U.S. dollar share, LOGIC holds the No. 2 rank at 22.9%. The Nielsen data confirms LOGIC’s strong market presence as it approaches the No. 1 position overall within the electronic cigarette industry in the U.S. Stay tuned to CSD’s daily newsletter tomorrow for more information.
Breaking: LOGIC Captures No. 1 Position For Electronic Cigarettes
August 12th, 2014 — Current Issues, Electronic Cigarettes, Snus, Snuff & Alternative Products in US Markets, Tobacco Harm Reduction
Big Three tobacco companies all launching wider distribution in 7-Eleven, elsewhere.
August 12, 2014
WINSTON-SALEM, N.C. – According to a recent article in the Winston-Salem Journal, the first significant fight for electronic cigarette market share between the Big Three tobacco manufacturers will feature 7-Eleven as a key battleground.
MarkTen, the e-cigarette brand by Philip Morris USA, recently began being sold in 7-Eleven stores in North Carolina, joining blu eCigs (Lorillard Inc.) and Vuse (R.J. Reynolds Vapor Co.), along with offerings from several smaller manufacturers. Reynolds began national distribution of Vuse in June, while blu eCigs has been sold in most national convenience stores for several years.
According to the article, what makes the head-to-head-to-head competition pivotal is that convenience stores are the largest retail channel for e-cigs at 75 percent of brick-and-mortar sales, or about $540 million in 2013, according to the NACS State of the Industry Report .
Philip Morris USA spokesman Brian May told the Winston-Salem Journal that national expansion of MarkTen began in June in the western half of the country. “It will be expanding eastward through the summer and fall,” May said.
The Battle for E-Cigarette Market Share Heats Up
July 15th, 2014 — Acquisitions, Current Issues, Electronic Cigarettes, Regulations: FDA etc., tobacco
Hoping to combat a decades-long slump in smoking, two of the biggest American tobacco companies said on Friday that they were in talks to merge and create a $56 billion cigarette colossus.
A deal between the second-biggest tobacco company in the United States, Reynolds American, and the No. 3, Lorillard, would unite the makers of the Camel and Newport brands and reshape the industry by creating a more formidable rival to the Altria Group, home of Marlboro.
Perhaps more significant, it would give the combined company a leading position in two of the fastest-growing products in a challenged industry: e-cigarettes and menthols.
But a merger, which could be announced as soon as next week, faces a number of significant obstacles.
Antitrust regulators in Washington are certain to scrutinize a deal that would effectively leave cigarette sales — and pricing — in the hands of a duopoly.
A combined Lorillard-Reynolds would control 42 percent of the tobacco market in the United States, according to Credit Suisse research, while Altria has nearly half of the market. And public health advocates have already raised concerns, worried that a merger would increase the influence of cigarette brands that have marketed to children.
Still, a takeover of Lorillard by Reynolds would represent the industry’s boldest response yet to a declining, if still profitable, market. A general drop in smoking rates and aggressive public health campaigns aimed at curbing smoking have cut into sales in the United States.
About 42 million people in the United States, or nearly 18 percent of the adult population, smoke cigarettes, according to the Centers for Disease Control and Prevention. That compares with about 21 percent of the adult population nearly a decade ago and 43 percent of the adult population in 1965, according to the C.D.C.
What remains of the traditional cigarette industry is dominated by Altria, whose Philip Morris arm sells one out of every two cigarettes in the United States.
Opportunity has beckoned in the new business of e-cigarettes. A deal by Reynolds to buy the leading purveyor of e-cigarettes could spur other mergers within the industry as manufacturers jockey for position.
“This transaction in our view will be very positive for the global tobacco industry and could be just the beginning of future transactions with e-cigs/vapor being the underlying catalyst,” Wells Fargo analysts wrote in a note.
At the same time, Reynolds has coveted Lorillard’s strong share of the fast-growing market for menthol cigarettes, which have proved more popular among younger smokers than traditional cigarettes. Lorillard’s Newport brand dominates that business and represents roughly 12 percent of the overall cigarette market.
Under the proposed terms of the deal, Reynolds American would buy Lorillard. It would then sell several billion dollars’ worth of brands and other assets to the Imperial Tobacco Group, the British company that makes Gauloises cigarettes and Montecristo mini-cigars, lifting Imperial to the No. 3 position in the United States.
British American Tobacco, which owns 42 percent of Reynolds American, would invest several billion dollars to maintain the same level of ownership in the combined company and help finance the transaction.
Shares of Reynolds fell 0.8 percent, to $61.75, on Friday, while those of Lorillard surged 4.6 percent to $66.01. Altria shares rose 1.1 percent to $43.43.
A Reynolds and Lorillard deal would combine two of the oldest names in the American cigarette industry. Lorillard traces its corporate ancestry back to 1760 and remains the oldest continuously operating tobacco company in the United States.
And Reynolds was formed from the merger of R. J. Reynolds Tobacco and Brown & Williamson a decade ago.
Talks have been going on for more than a year, with different deal structures contemplated, people briefed on the matter said. The presence of four companies and their particular demands complicated matters. Talks paused about two months ago as the difficulties of negotiating a four-way transaction took their toll.
Still, the companies persisted. The return of Susan M. Cameron as Reynolds’s chief executive helped smooth the process. She had led the company following the merger of Brown & Williamson and R. J. Reynolds in 2004, before retiring in 2011.
While none of the four companies disclosed financial terms for a transaction, Lorillard has a total enterprise value of $24.6 billion, according to Standard & Poor’s Capital IQ.
Given the influence on the market that a combined Lorillard-Reynolds could exert, the companies have long planned to sell some assets to win approval from regulators.
Bringing in Imperial is meant to assuage those concerns. Currently the fourth-biggest player in the American tobacco market with a single-digit percentage of market share, the British company would become a more robust competitor through such a deal.
Antitrust regulators will not be the only source of potential opposition. Public health advocates pointed to what they said was a history of traditional brands like Camel and Newport and e-cigarette brands like Blu marketing to children.
“Regulators beware,” Matthew Myers, the president of the Campaign for Tobacco-Free Kids, said in an interview. “The problem isn’t just antitrust. It’s the increased power of these companies to market to kids.”
While Reynolds describes the United States in regulatory filings as a “mature market” that has declined since 1981, Imperial still sees it as one of the world’s biggest and most profitable markets.
Instead, Reynolds sees opportunity in e-cigarettes, which already have about $2.5 billion in annual sales. Though that is a tiny fraction of the overall tobacco market, e-cigarettes sales are expected to grow quickly in the coming years.
Lorillard is the early leader in the market, having bought Blu eCigs for $135 million two years ago. It spent about $40 million marketing Blu e-cigarettes last year, driving sales up to more than $50 million per quarter and gaining the biggest share of sales at gas stations and convenience stores.
In October, Lorillard purchased Skycig, a British e-cigarette maker, and introduced the Blu brand to the British market.
A Reynolds subsidiary, R. J. Reynolds Vapor, began selling its e-cigarettes last month. Reynolds showed off its device, called Vuse, at the Consumer Electronics Show in Las Vegas and made it the official e-cigarette sponsor of the South by Southwest festival in Austin, Tex.
Altria is also getting into the e-cigarette market with its own subsidiary, NuMark.
In the first quarter, Lorillard, based in Greensboro, N.C., had net sales of $57 million from its e-cigarette business; that accounted for about 45 percent of all such sales in the United States. Lorillard had net sales of $1.59 billion in the first quarter and net sales of $6.95 billion in 2013.
David Gelles contributed reporting.
June 12th, 2014 — Current Issues, General, tobacco
The C-Store Pipe-Tobacco Opportunity
Are retailers missing out on one of tobacco’s greatest growth segments?
OAKBROOK TERRACE, Ill. — The electronic-cigarette boom over the past couple of years has gotten plenty of attention. And while it may be impossible for any segment in the tobacco category to compete with that growth (given the fact that e-cigarettes are a completely new product and thus started with zero sales), pipe tobacco has been experiencing a renaissance of its own in the post-SCHIP era: Sales-data research firm IRI reports that convenience store pipe-tobacco sales have nearly tripled in the last three years, going from 116,061 pounds sold in September of 2010 to 348,011 pounds in April of 2014.
Yes, an easy explanation of the sudden interest in pipe tobacco would be its tax advantage over roll-your-own or make-your-own tobacco after the passing of tax hikes to fund SCHIP (State’s Children’s Health Insurance Program) in 2009. But as vice president of marketing and product development for Scandinavian Tobacco Leonard Wortzel noted, pipe tobacco continues to grow.
“We’re not seeing the 50-60% growth year-over-year, like in 2009, but we are still seeing double-digit growth at tremendous levels,” he said. “There was a whole subset of consumers who were desperate for getting value, and they discovered that pipe tobacco is probably the best value in the tobacco world today.”
“In markets with above-average taxation on cigarettes, retailers have an opportunity to leverage pipe tobacco as a way to deliver value to the price-sensitive consumer,” agreed David Bishop, managing partner of Barrington, Ill.-based sales and marketing firm Balvor LLC.
But are convenience stores taking advantage of that opportunity?
Despite nearly tripling its sales of pipe tobacco over the past four years, “From what we can see, (the c-store channel) has kind of missed this growth story,” Wortzel said. “They have, for the most part, not participated to the extent that other channels have.”
Easily the biggest challenge facing c-store retailers interested in the pipe segment is space. It’s an old story: Between cigarette contracts and burgeoning OTP options, there’s simply not enough room behind the counter. This is all the more challenging when it comes to pipe tobacco.
“Large packages are a key operational issue for convenience retailers as space on the back counter is extremely valuable,” said Bishop.
To help ease some of these space concerns, manufacturers like Scandinavian and Republic Tobacco now offer smaller-format pipe pouches. They still take up more space than the average OTP SKU, but are much easier to fit than the traditional 16-oz. bags.
“Convenience retailers have generally figured out that pouches are the best-selling pipe-tobacco format and the easiest to merchandise,” said Steve Sandman, president of Republic Tobacco.
June 12th, 2014 — Current Issues, General, Key International Business & Market Developments, Regulations: FDA etc., Science, Snus, Snuff & Alternative Products in US Markets, tobacco, Tobacco Harm Reduction
Swedish Match Seeks FDA OK to Label Snus ‘Modified Risk’
Has filed application with Food & Drug Administration for General brand
Published in CSP Daily News - http://www.cspnet.com/category-news/tobacco/articles/swedish-match-seeks-fda-ok-label-snus-modified-risk
RICHMOND, Va. – Smokeless tobacco maker Swedish Match is asking the U.S. Food & Drug Administration (FDA) to certify its General-branded pouches of tobacco as less harmful than cigarettes, according to a report by the Associated Press.
The company, with North American headquarters in Richmond, Va., is filing an application with the FDA to approve the snus products as “modified risk.”
Snus–teabag-like pouches that users stick between their cheek and gum to get their nicotine fix–are popular in Scandinavian countries and are part of a growing smokeless tobacco market in the United States.
Both the public health community and the major tobacco companies are watching closely how the FDA handles the products. The tobacco companies are looking for new products to sell as they face declining cigarette demand due to tax increases, health concerns, smoking bans and social stigma.
Swedish Match is proposing to say that the product is addictive but is “substantially less risky than smoking,” Jim Solyst, director of federal government affairs for Swedish Match North America, said in an interview with AP. Swedish Match also wants permission to remove one of the required health warning labels because Solyst said there’s “excellent scientific evidence” that the product does not cause oral cancer.
The application also highlights a philosophical debate over how best to control tobacco. One camp says there’s no safe way to use tobacco and pushes for people to quit above all else. Others embrace the idea that lower-risk alternatives like smokeless tobacco or electronic cigarettes can improve public health, if they mean fewer people smoke.
A 2009 law gives the FDA authority to evaluate tobacco products for their health risks and lets the agency approve ones that could be marketed as safer than others. None has been given the OK yet, but the agency has noted that some tobacco products could pose less of a health risk to users than smoking.
Once the FDA accepts Swedish Match’s more than 100,000-page application, the agency has one year to evaluate it.
“You would hope that products like General and, for that matter, other alternative, would encourage people to move from smoking to the alternative products,” Solyst said.
Total sales of snus are about 50 million cans per year in the U.S., growing from virtually nothing in the mid-2000s, said the subsidiary of Stockholm-based Swedish Match AB.
Market researcher Euromonitor International estimates U.S. sales at $342 million in 2013 and predicts that snus retail volume will grow by about 20% in the United States by 2017.
General snus was first sold in Sweden in mid-1860s and has been sold in the United States since 2007. It is currently available nationwide in more than 20,000 stores, which keep it in small chillers to preserve the product.
AP said the brand has at least a 6% share of the retail market, dominated by Winston-Salem, N.C.-based Reynolds American Inc., which sells the market-leading Camel-branded snus, and Richmond, Va.-based Altria Group Inc., which sells Marlboro-branded snus.
Swedish Match’s snus brands make up 75% of the market in Scandinavia. But in the United States, the company said it only has a 10% share of the overall smokeless category.
The category grew about 5.5% in the United States last year, said the report.
April 24th, 2014 — Current Issues, Electronic Cigarettes, Flavored Products, Preventing Youth Consumption, Regulations: FDA etc., Science, Snus, Snuff & Alternative Products in US Markets, tobacco, Tobacco Harm Reduction
FDA NEWS RELEASE
For Immediate Release: April 24, 2014 Media Inquiries: Jenny Haliski, 301-796-0776, firstname.lastname@example.org 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:
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.