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FDA orders R.J. Reynolds to pull major brand off the market

| September 16, 2015

The U.S. Food and Drug Administration (FDA) has ordered tobacco giant R.J. Reynolds to pull their Camel Crush Bold cigarette brand off the market. The FDA acted under a key provision of the 2009 law that requires prior FDA review and authorization before tobacco companies are permitted to market new or changed products.

The decision, which was announced on Sept. 15, marks the first time the agency has ordered a tobacco company to remove a major cigarette brand from the market since it was granted regulatory authority over tobacco products by the 2009 law. This move sets an important precedent that could apply to other brands as the FDA works to prevent the introduction of tobacco products to the market that may be more appealing to youth, more addictive or more harmful.

The 2009 law prohibits the introduction of a new or changed tobacco product unless the manufacturer proves to the FDA that the product is either “appropriate for the protection of public health” or “substantially equivalent” to a product already on the market. Manufacturers must also prove that the product “does not pose different questions of public health.”

In addition to Camel Crush Bold, the FDA also issued orders that will stop the further sale and distribution of three other cigarette products currently marketed by R.J. Reynolds: Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13 cigarettes. The FDA determined that these products were not substantially equivalent to existing products.

The FDA found that R.J. Reynolds failed to demonstrate that these products do not “raise different questions of public health,” particularly because of the higher levels of menthol, the addition of sugars and other sweeteners, a new method of delivering menthol, and increased levels of harmful and potentially harmful constituents.

Camel is one of the three most popular cigarette brands among youth smokers, with 15.1 percent preferring Camel, according to the 2013 National Survey on Drug Use and Health. Camel Crush is an extension of the brand with a capsule in the filter that releases menthol when crushed.

Gellman to facilitate 22nd Century’s FDA applications

| September 9, 2015

22nd Century Group, a leader in tobacco harm reduction, has appointed Gregg M. Gellman as the company’s director of business development and regulatory affairs. Gellman, who was hired for his experience in achieving U.S. Food and Drug Administration compliance approval for various types of products, will be tasked with driving 22nd Century’s regulatory affairs strategies for the company’s two modified risk cigarettes in development: “Brand A,” the world’s lowest nicotine tobacco cigarette, and “Brand B,” the world’s lowest tar-to-nicotine ratio cigarette.


Califf appointed deputy commissioner of FDA

| March 6, 2015

Robert Califf, a cardiologist and researcher at Duke University in Durham, North Carolina, USA, was appointed as the U.S. Food and Drug Administration’s (FDA) deputy commissioner for medical products and tobacco on March 2. Califf—who was previously overseeing the FDA’s drug, medical device and tobacco policy—is a recognized global leader in cardiology, clinical research and medical economics, according to the FDA. He was appointed by FDA Commissioner Margaret A. Hamburg, who will leave the organization at the end of March, leading to speculation that Califf may be nominated to lead the FDA following her departure.

In his new role as deputy commissioner, Califf will provide executive leadership to the Center for Drug Evaluation and Research, the Center for Tobacco Products, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health. His duties will include providing policy direction and advice on the FDA’s medical product and tobacco priorities, and he will manage clinical, scientific and regulatory initiatives in areas ranging from pediatric science and personalized medicine to orphan drugs and the advisory committee system.

Califf previously served as vice chancellor of clinical and transnational research at Duke University, professor of medicine at Duke University Medical Center’s Division of Cardiology, director of the Duke Transnational Medicine Institute and founding director of the Duke Clinical Research Institute, the world’s largest academic research organization. The Institute for Scientific Information has recognized Califf as one of the top 10 most-cited medical authors due to his more than 1,200 peer-reviewed publications.

SE approval for S&M’s Riverside

| July 16, 2014

S&M Brands has received substantial equivalent orders from the U.S. Food and Drug Administration on its redesigned Riverside cigarette brand. S&M Brands is one of the few companies, behind Lorillard, that has navigated the Tobacco Control Act to obtain approval of a new cigarette tobacco product, and the first to obtain approval of a full line of king and 100s in regular and menthol.

“We are treating this as a milestone in the industry, for our company and the industry as a whole,” says Steven Bailey, president, S&M Brands.

“Introducing a new tobacco product under FDA regulation is an arduous, technical and scientific process that takes substantial time and resources. We felt, however, that improving our Riverside product was paramount for our adult customers, so our excellent in-house team, together with our outside consultants, worked tirelessly with the FDA to navigate the substantial equivalent process.

“We believe this achievement demonstrates that our company is staffed up for regulatory compliance to be around for our distributor and retail partners and customers for the long haul.”

The redesigned Riverside brand will be distributed to retailers and available to consumers by Oct. 15, 2014.

Cigar makers hope to snuff out FDA efforts

| April 19, 2013

Cigar makers are trying to snuff out an effort by the Food and Drug  Administration to regulate their products for the first time.

The FDA said in its regulatory agenda for the year that it would propose rules in April to expand federal oversight of tobacco products under the Family Smoking Prevention and Tobacco Control Act. The news was welcomed by tobacco giants, such as Altria, that want all tobacco products to be brought under the same regulations, according to a Washington, D.C. regulation blog The Hill.

Sellers and makers of premium cigars — often hand-rolled, slow-burning and made with aged tobacco leaves — say the FDA is overreaching, and are hiring lobbyists to fight back.

Glynn Loope, the executive director of Cigar Rights of America, said the  FDA’s move is “a classic case of going beyond congressional intent.”

“When Congress passed the original Tobacco Control Act, it was really to address two primary points: youth access to tobacco and chemical addition. Premium cigars don’t meet that criteria,” Loope  said.

Another trade group for cigar retailers and manufacturers agreed that the FDA  is distorting the law.
“It’s our belief that the act was to prevent youth from smoking and curtail the health effects for youth,” said Bill Spann, CEO of the International Premium Cigar & Pipe Retailers Association.

Spann said FDA meddling could have a devastating impact on cigar shops. The group has warned that regulators could ban walk-in humidors and seasonal cigar blends, restrict store advertising or even place graphic warning labels on the ornate cigar boxes that are coveted by collectors.

The pushback against FDA rules is also coming from overseas.

In February, the Cigar Rights of  America organized a letter from the ambassadors of the tobacco-growing nations Honduras, the Dominican Republic and Nicaragua to officials at the White House,  State Department and the FDA, warning that new regulation would threaten thousands of jobs and “raise the specter of political and economic consequences within our region.”

Critical condition

| March 1, 2011

The future of U.S. tobacco manufacturer Lorillard hangs in the balance while the government decides whether to ban menthol.


By Brandy Brinson


This month is critical to the future of Lorillard Inc., the third-largest manufacturer of cigarettes in the United States. On March 23, the Tobacco Products Scientific Advisory Committee (TPSAC) is scheduled to announce its recommendation on the use of menthol in cigarettes to the U.S. Food and Drug Administration (FDA). If the committee advises an all-out ban on menthol and the FDA follows the recommendation, Lorillard will face a huge challenge. Its top brand Newport, a premium menthol brand, accounts for more than 90 percent of total company sales.

Proponents of a ban say menthol is attractive to African-American smokers as well as minors. Opponents say a ban would result in the loss of thousands of jobs as well as create a massive black market for menthol products. The TPSAC has been reviewing the issue for more than a year.


The debate

The legislation granting the FDA the authority to regulate tobacco banned all flavorings except for menthol in September 2009, in the name of protecting minors from smoking. Menthol was tabled for further study, which is being conducted by the TPSAC. The legislation said the FDA should review the issue and decide by 2012 whether it should be banned.

Menthol accounts for 29 percent of all cigarette sales in the U.S. It was first added to cigarettes in the 1920s and became a marketing priority for the industry in the 1960s.

Anti-tobacco activists want menthol banned because they say young smokers begin smoking with menthol because of the minty taste. Part of the debate surrounding menthol is race-related, as approximately 80 percent of African-American smokers choose menthol cigarettes.


Sound science

Throughout the process, the TPSAC has stated that it will apply fact-based science to its decision-making process. The committee is examining several factors—such as whether menthol affects nicotine absorption, addictiveness, smoking initiation, perception of risk, desire to quit and conversion from experimentation to regular smoking.

Manufacturers, having submitted hundreds to thousands of pages of research, have shown that menthol does not make a cigarette more harmful or addictive.

The industry has also demonstrated grave concern for the development of a substantial black market if menthol is banned. Approximately 70 percent of menthol could turn into contraband if banned, which would equate to 20 percent of total U.S. market volume.

Lorillard presented findings of a study examining the effects of a ban to the TPSAC. The study found that an ensuing black market would substantially mitigate any decline in cigarette smoking and inspire a “significant increase in organized crime activity,” potentially increasing youth access to cigarettes. The study was conducted by Compass Lexecon, a Chicago-based economic consulting firm.

Lorillard urged the panel to not lose sight of the congressional and FDA mandate to “follow the science” in developing its report, and to keep in mind that “Congress’ purpose of granting FDA with authority to regulate tobacco was to create order and supervision of the industry—not create chaos the likes of which have not been seen since prohibition.”

Unfortunately for Lorillard, the committee appears to be downplaying concerns about a black market and lost revenue.

At this point, TPSAC appears to be focusing mainly on the issue of youth smoking.


Latest developments

Analysts for Deutsche Bank Andrew Kieley and Marc Greenberg predict that the probability of the TPSAC recommending a ban (or severe restrictions) in late March is slightly over 50/50.

While the evidence actually points in favor of not banning menthol for epidemiological reasons, they fear that youth smoking concerns and the negative tone of the committee will lead to a recommended ban.

“TPSAC emphasizes an evidence-based report, and significant portions of data do not support restricting menthol. However the reasons we remain concerned are youth over-indexing to menthol, and its masking effect. TPSAC is highly-attuned to the youth issue, and it would be the most likely grounds for ‘weight of the evidence’ to support a ban or other penalties,” say Kieley and Greenberg.

Just after the February TPSAC meetings, Kieley and Greenberg said, “It is frustrating that TPSAC is still not discussing recommendations, to give us some visibility. However we view discussions of draft report chapters and Committee’s tone as negative overall.”

Actions and remarks by the committee especially during the February meetings indicate that they will recommend a ban. Kieley and Greenberg say, “The negative stance of some TPSAC members is obvious; they continue to hypothesize about potential ramifications of a ban (including a large section of the Summary chapter), and their statistical model will explicitly consider a world without menthol (‘For the purposes of the present report, TPSAC is concerned with counterfactual scenarios in which menthol cigarettes never existed.’). These are not encouraging signs.”

The tone of the committee is not much of a surprise, given that members of the TPSAC have been criticized for having a conflict of interest. Two of the members have clear ties to pharmaceutical companies that manufacture smoking cessation products, with one member (Jack Henningfield) being one of eight patent holders of a nicotine chewing gum.

During the last meeting in February, Henningfield made his position even more clear when he told Philip Morris at the end of a Q&A on a long presentation, “I don’t know why you bothered.”


The report

While the final recommendation is still unclear, the TPSAC did announce in February its expected format for the report. It will consist of eight chapters, though the titles have not been finalized.

The chapters are:

* Chapter 1: Introduction

* Chapter 2: Approach to Evidence Gathering and Review

* Chapter 3: Physiological Effects of Menthol

* Chapter 4: Patterns of Menthol Cigarette Smoking in the U.S.

* Chapter 5: Marketing, Initiation, Addiction, and Cessation

* Chapter 6: Effects of Menthol on Disease Risks of Smoking, Toxicology, Biomarkers, and Epidemiology

* Chapter 7: Public Health Impact of Menthol Cigarettes

* Chapter 8: Conclusions and Recommendation


In addition, the FDA has asked industry representatives who serve on the committee to develop an industry perspective document on the public health impact of menthol cigarettes that will accompany the report.


While much of the report had not yet been written in February, the presentations offered some insight. Kieley and Greenberg see the most risk from Chapters 3 and 4, especially as they are fed into the TPSAC’s statistical model of menthol’s “public health” impact. “If TPSAC recommends a ban or restrictions, these chapters could likely comprise the ‘weight of evidence,’” they say.

In Chapter 3, the Physiological Effects of Menthol, the writers claim that menthol’s cooling sensory perception makes it easier to smoke, and that menthol potentially interacts with nicotine to create higher cigarette “impact” and addictiveness. They do say it is unclear if menthol impacts nicotine metabolism. However, they say menthol “clearly” reduces harshness of cigarette smoke, there is “strong plausibility” that menthol increase addictiveness of cigarettes, and that it “likely” boosts the impact of low-tar cigarettes.

Kieley and Greenberg say, “This matters for the report because in terms of a ‘public health’ risk, it would portray menthol as a starter product, a ‘conversion’ product to turn experimenters into regular smokers, or keeping people smoking rather than quitting. The risk is magnified because these factors could be inputs into TPSAC’s statistical model of mortality rates and societal disease burden.”

Chapter 4, Patterns of Menthol Smoking, is also seen as a significant negative by Kieley and Greenberg, given the FDA’s mandate to consider public health impact on underage and minority groups. The chapter shows heavy reliance on unfavorable survey data, showing higher rates of menthol preference among minority groups and women, as well as increasing share of menthol among underage smokers.

Chapter 6, Risk Factors, is certainly the most favorable to the industry. “In this section covering biomarkers and disease rates, TPSAC seems to agree with industry arguments that there is a lack of evidence that menthol is any different from regular cigarettes in these aspects,” say Kieley and Greenberg.

As of the February meeting, the draft summary was not fleshed out and did not contain firm conclusions. It is expected to summarize the statistical model and explicitly address potential repercussions of a ban.


The FDA. The recommendations in the TPSAC’s report are nonbinding—meaning the FDA does not have to accept them. How the FDA will respond is another area of debate.

Unfortunately, say Kieley and Greenberg, it is difficult to tell. “We think it will largely come down to 1) how much they weight TSPAC’s recommendations, 2) what strength of evidence they require, and 3) how the contraband argument resonates.” They think contraband could be critical. However, with the World Health Organization (WHO) now recommending restrictions on menthol, there will be pressure on the FDA to follow suit.

An outright ban on menthol is not the only potential outcome. Other possibilities include additional regulation—such as rules on content or marketing—as well as changing product formulation, by adjusting menthol and nicotine content.

There will also be the possibility for Lorillard to challenge a ban in court. While March 23 is a critical date, the fallout will likely carry on for months if not years.