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FDA rocks vapor industry with sweeping regulations

May 5, 2016

Featured

FDA 2016 E-Cigarette RegulationBy COREY NOLES

The Food and Drug Administration this morning gave the vapor industry a rude awakening when it issued sweeping regulations that deemed vapor products to be tobacco products.

>> read the full FDA regulatory document.

The 499-page document places all vapor products under the jurisdiction of the Tobacco Control Act of 2007. Under the changes, vapor products including e-liquid containing no nicotine, will be held to the same requirements.

Numerous vaping advocacy groups have already denounced the regulations. The American VapingAssociation, in a statement, referred to the regulations as “downright prohibition.”

On Twitter this morning, AVA President Greg Conley noted that the regulations effectively freeze the market to new products 90 days after they are published. Any product moving forward that is not already on shelves, would have to go through theprocess immediately, as opposed to being allowed two years for compliance.

SFATA also weighed in on the discussion earlier this morning

“Our industry has a long history of supporting sensible science-based regulations, including license requirements, as well as banning sales to minors and adopting child-resistant packaging,” according to SFATA President and Executive Director, Cynthia Cabrera. “Today’s final rule pulls the rug out from the nine million smokers who have switched to vaping, putting them in jeopardy of returning back to smoking, which kills 480,000 Americans each year and costs the U.S. more than $300 billion in annual health care expenses.”

The regulations include federally requiring age identification, banning of vending machines, free samples and a laundry list of other items. As we at VAPE Magazine are still investigating the documents, more will come in the near future.

Specific warning label instructions are included in the regulations as well, with active manufacturers having 24 months to come into compliance.

In addition, all products — hardware and e-liquid — will have to go through one of two processes to reach the public. The pre-market tobacco application would have to be completed; otherwise manufacturers will be required to show substantial equivalence to a product on the market prior to February 15, 2007.

SFATA is challenging this date with the idea that virtually no products were on the market at that time.

“Although the FDA states it has found a vapor product on the market in 2006, it has yet to be determined whether the far more technologically advanced vapor products on the market today can be considered substantially equivalent to that product,” Cabrera said in a statement. “These new regulations create an enormously cost-prohibitive regulatory process for manufacturers to market their products to adult smokers and vapers. It also limits access to the 40 million adult smokers in the U.S. yet to make the switch to vaping and cripples a multi-billion dollar job-creating industry, the majority of which are made of small businesses.”

More information, reaction and specific requirements will be posted later today.

Corey Noles is the managing editor of VAPE Magazine. He has worked as a journalist for more than a decade and is the founder, owner of Inked Up E-Liquid Co.

Watch the Webcasts: The Second Biomarkers Public Workshop

KxKIYTYqThe Center for Tobacco Products recently sent Agent VAPE its newsletter, and the top story invited readers to view archived webcasts held in April.

On April 4-5, the FDA hosted a two-day “Biomarkers of Potential Harm–A Public Workshop” designed to open the discussion on how to identify and use biomarkers in support of tobacco product regulation. The objectives of the workshop were to identify approaches for assessing and selecting biomarkers of potential harm, processes for finding those that may be useful in tobacco product regulation, and areas of research that may further strengthen knowledge about them.

To view the webcasts, click here.

Small Businesses Ponder FDA Reg Impact

FDA-creates-guidelines-for-small-and-homemade-cosmetics-businesses_strict_xxlSmall business owners will be very impacted by the new regulations the Food and Drug Administration has put forth. Entrepreneurs are reeling by the news, and some of them shared their counterarguments with arklatexhomepage.com.

  1. the obvious, that shop owners do not agree with regulating vaping products as tobacco products
  2. vaping is an outlet for innovation and new business in America
  3. the extremely costly Premarket Tobacco Application is something that eludes pretty much everybody that applies for it and one that will put many small businesses out of business
  4. the grandfather date pretty much prohibits everything made after 2007 in this newer industry, only giving way to Big Tobacco to be able to afford the process
  5. shops do not target children or minors

If you would like to get involved, visit http://casaa.org/ and http://www.theoneletter.com/.

SFATA’s Episode 6 Podcast: Senator Ron Johnson Speaks About FDA Deeming Reg

Screen Shot 2016-05-26 at 3.14.35 PMSFATA president and executive director, Cynthia Cabrera, spoke with U.S. Sen. Ron Johnson (R-Wis.), chairman of the Senate Homeland Security and Governmental Affairs Committee, who recently sent a letter to the FDA’s Commissioner Robert Califf raising concerns about the impact the final deeming regulations will have on the small businesses that make up the majority of the vapor industry.

To listen in, visit http://sfata.org/episode-6-u-s-senator-ron-johnson-speaks-sfata-fda-deeming-reg/.

Public Health Professor Says FDA’s Regulations ‘Ignore’ Smokers’ Harm Reduction Benefits

Kenneth_Warner-thumbStandardIn a recent editorial for the New York Times, Kenneth E. Warner, university professor of public health and former dean of the School of Public Health at the University of Michigan, address the Food and Drug Administration’s regulations regarding smokers and harm reduction.

Warner says while the FDA has a right to assert authority over products containing nicotine and/or tobacco, the agency must be careful.

“Novel products such as e-cigarettes hold the potential to help thousands of Americans to quit smoking. Vaping is unquestionably less dangerous than smoking. The trick, then, is how to regulate e-cigarettes and other novel products to maximize their potential to reduce harm while simultaneously discouraging their use by young people who otherwise would never be exposed to nicotine,” he writes.

He says while regulations could keep young smokers away, they don’t address vaping as a harm-reducing, lower-risk product. He suggests the FDA evaluate classes of products and establish better basic standards. He says the current approach is “unbalanced” in ignoring potential harm-reduction benefits and placing too much of an emphasis on a “hypothetical risk to children.”

For the full story, visit http://www.nytimes.com/roomfordebate/2016/05/10/will-regulating-e-cigarettes-mean-fewer-will-quit-smoking/the-fda-rules-ignore-harm-reduction-benefits-for-adult-smokers.

Join the Right to Be Smoke-Free Coalition

r2b-logoThe Right to be Smoke-Free Coalition is a non-profit, industry-led trade association of e-vapor businesses dedicated to promoting the interests of the industry by advocating for reasonable and responsible laws and regulations, and fighting for the right of vapers to be smoke-free.

The Right to be Smoke-Free Coalition works with expert legal counsel and the broader industry to develop comprehensive litigation strategies to challenge unlawful Federal and State Laws and Regulations. To join the fight please contribute to become a member of the Coalition.

The Coalition is positioned to enforce and defend the industry, and it needs your help. Lawsuits of these nature are costly and the Coalition expects vigorous defense against its efforts. If you are an industry advocate, e-liquid producer, device manufacturer, vape shop owner or internet retailer that believes in responsible and appropriate regulations, you can join the Coalition or contribute to the cause.

Click here to become a member or to contribute.

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