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URGENT: FDA NEWS – Extension for ENDS Registration until 2022

Jul 28, 2017
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FDA announces comprehensive regulatory plan to

shift trajectory of tobacco-related disease, death

Agency to pursue lowering nicotine in cigarettes to non-addictive levels and create more predictability in tobacco regulation. The Food and Drug Administration announced plans Friday for a sweeping regulatory “road map” on tobacco and nicotine products.

What FDA Commissioner Dr. Scott Gottlieb called “an all or nothing” approach includes proposals that emphasize:

  • Lowering the nicotine level in traditional cigarettes to non-addictive levels;
  • Limiting or eliminating flavorings, such as menthol in traditional cigarettes and candy and fruits in e-cigs and vaporizers, that the agency says appeal to youths;
  • Establishing rules to make the product review process more efficient, predictable and transparent for manufacturers, while upholding the agency’s public health mission;
  • Easing back on some regulations for product innovations; and
  • Extending the application deadline for FDA regulatory review for new products, such as electronic cigarettes and vaporizers, from late 2018 to as far out as August 2022.

Those products must have been introduced before Aug. 8, 2016, to qualify for the extended application period. Tobacco products introduced after Aug. 8, 2016, can’t be sold in the marketplace without FDA approval.

* FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death

* Plans to begin public dialogue about lowering nicotine levels in combustible cigarettes to non-addictive levels through achievable product standards

* Applications for newly-regulated combustible products, such as cigars, pipe tobacco and hookah tobacco, would be submitted by Aug. 8, 2021

* Intends to issue Advance Notice of Proposed Rulemaking to seek input on potential public health benefits of lowering nicotine in cigarettes

* Under expected revised timelines, applications for non-combustible products such as ENDS or e-cigarettes would be submitted by Aug. 8, 2022

* The FDA expects that manufacturers would continue to market products while the agency reviews product applications

* Says anticipated new enforcement policy will not affect any current requirements for cigarettes and smokeless tobacco

* Anticipated new enforcement policy will affect only the newly-regulated tobacco products such as cigars and e-cigarettes

* Also plans to finalize guidance on how it intends to review Premarket Tobacco Applications for electronic nicotine delivery systems Source text: (bit.ly/2w6oeNF)

FDA Supports Low Nicotine Tobacco

The agency said the original grandfather date of Feb. 15, 2007, for product introductions remains in place for regulatory review. Critics of the grandfather date accuse the FDA of creating a marketplace where only the major tobacco manufacturers would be able to compete.

“The goal is to ensure that the FDA has the proper scientific and regulatory foundation to efficiently and effectively implement the (Tobacco Control Act),” the agency said.

“To make certain that the FDA is striking an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes, the agency is also providing targeted relief on some timelines” for those innovative products.

Gottlieb said the initiative aims to drive and potentially eliminate addiction to nicotine — which he called as critical a public health concern as opioid addiction — but also recognize that “adults who still need or want nicotine could get it from alternative and less harmful sources.”

“Our approach to nicotine must be accompanied by a firm foundation of rules and standards for newly regulated products. To be successful, all of these steps must be done in concert, and not in isolation.”

The FDA proposal must still gain the approval of several other federal agencies.

Reynolds said in a statement that it is “encouraged” by Gottlieb’s comments “recognizing tobacco harm reduction policies and the continuum of risk for tobacco products.”

“We believe future success will require transformative, innovative products and changing the conversation about tobacco harm reduction.”

On May 3, the Trump administration gave federal health officials more time to evaluate Obama administration-era guidelines on electronic cigarettes, vaporizers, and other innovative nicotine and tobacco products. Rules that were supposed to have gone into effect May 10 were put on hold for at least three months.

Those guidelines include manufacturer submission of cigar warning label plans; registration and listing; ingredient listing; health documents; substantial equivalence exemption requests; substantial equivalence applications; premarket tobacco product applications; and harmful and potentially harmful constituent reports.

U.S. Sen. Richard Burr, R-N.C., said in a statement that the FDA plan “ provides the certainty, predictability and transparency greatly needed in the Center for Tobacco Products. It takes a step toward a science- and evidence-based approach to the review of tobacco products.

“It is my hope that these proposed changes will result in timely, fair and predictable action from the FDA.”

David Sweanor, an adjunct law professor at the University of Ottawa and the author of several e-cig studies, said it was key that Gottlieb focused on “continuum of risk, encouraging innovation, backing off from onerous requirements on alternatives to cigarettes.”

“This is a huge switch from the tobacco-free world/abstinence-only/quit or die approach to tobacco and nicotine by U.S. government agencies. It will now be very hard for instance, for the Centers for Disease Control and Prevention, to continue engaging in misinformation campaigns on relative risks.”

‘Good policy is contagious’

Some studies, including one by the Royal College of Physicians, have claimed e-cigs and vaporizers are up to 95 percent less harmful than traditional cigarettes. The Royal College’s study on traditional cigarettes played a key role in the landmark 1964 surgeon general’s determination.

Meanwhile, then-U.S. surgeon general Dr. Vivek Murthy sounded an alarm Dec. 8 about e-cigs, saying there’s no safe use of the products for people younger than 25.

“An informed public is a powerful tool in opposing ill-informed regulations, and after a third of a century of work in this area I am convinced that good policy is contagious,” Sweanor said.

“The anti-smoking side, those pushing a rational, pragmatic public health agenda rather than a moralistic approach to all nicotine products, has apparently made a historic breakthrough.”

Products can go on market while under review

The concession on the grandfather date on new tobacco and nicotine products from Feb. 15, 2007, to Aug. 8, 2016, means most products in the marketplace will face a potentially easier regulatory pathway to FDA approval that could significantly reduce their application and review costs by millions of dollars per application.

Applications for newly regulated combustible products, such as cigars, pipe tobacco and hookah tobacco, would be submitted by Aug. 8, 2021, and applications for non-combustible products, such as e-cigarettes, would be submitted by Aug. 8, 2022.

Manufacturers would be allowed to market and sell existing next-generation products while the agency reviews product applications. Previously, the manufacturers were permitted only until May 2019 with products in the marketplace if they were in the regulatory review pipeline.

“The FDA intends to develop product standards to protect against known public-health risks, such as (e-cigarette) battery issues and concerns about children’s exposure to liquid nicotine,” the agency said.

“It also will provide manufacturers additional time to develop higher-quality, more-complete applications informed by additional guidance from the agency.”

The FDA stressed the initiative will not affect future deadlines for regulatory enforcement of traditional cigarettes, such as required warning statements, ingredient listing, health document submissions, harmful and potentially harmful constituent reports, and the removal of modified risk claims, i.e., “light,” “low,” or “mild,” or similar descriptors.

Gregory Conley, president of the American Vaping Association, said his group “is relieved” by Gottlieb’s willingness to consider the continuum of risk aspect to tobacco products.

“Without Dr. Gottlieb’s leadership, over 99 percent of vapor products on the market today would have been banned in 15 months’ time,” Conley said.

“This is by no means a perfect fix. The deeming rule still bans any innovation in the market, and the FDA has a lot of work to do on fixing the pre-market review process.”

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