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VapeMentors to host free webinar on FDA regulations

| October 29, 2015

VapeMentors, the only educational resource exclusively devoted to the vape space, will host a free webinar on Nov. 18 at 5 p.m. PST/8 p.m. EST to help vape space businesses prepare for upcoming U.S. Food and Drug Administration (FDA) regulations.

The FDA sent its final deeming regulations to the Office of Management and Budget last week—the final step in the agency’s process to regulate the marketing and manufacturing of vapor products. The FDA’s final regulations are expected by the end of this year or in early 2016.

The one-hour webinar, which is entitled “‘Knock, Knock. It’s the FDA Calling,” aims to help business owners “future-proof” their vape shop or e-liquid company and avoid getting shut down by the FDA.

The webinar will be run by Azim Chowdhury, an attorney with Washington, D.C.-based Keller and Heckman, LLP and head of the firm’s e-cigarette practice who has represented many e-cigarette and e-liquid manufacturers, suppliers and trade associations in matters of FDA regulatory and corporate compliance.

“We have a pretty good idea what will be in the FDA’s final [regulations] and how will it affect vape shops and e-liquid manufacturers,” said Chowdhury. “Basically, anyone who’s mixing e-liquids would be considered a manufacturer, and your e-liquids will be subject to FDA regulation and inspections. Unless the FDA makes major changes from their deeming [regulations], e-liquid companies must submit their entire list of ingredients and obtain pre-market approval from the FDA. If they don’t comply, the FDA could shut them down forever. And it could happen as early as next spring.”

To register for the FDA webinar, visit The webinar is free and open to anyone working or interested in the vape industry. It will also be recorded and available for replay.

The webinar is sponsored by Molecule Labs, NicSelect, VaporSearchUSA, Calco Commercial Insurance and Parrot Vapors.

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.”