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    FDA’s Regulations on E-cigarette Industry

    On July 28, 2017 the FDA announced a five-year extension of the deadline for product applications from manufacturers of vaping products. The announcement also lays out the FDA’s vision of lowering nicotine levels and establishing a regulatory framework for tobacco products.

    “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 described in the May 2016 final rule that extended the FDA’s authority to additional tobacco products. The agency will also seek input on critical public health issues such as the role of flavors in tobacco products.”

    In other words, the e-cigarette industry has a five years grace period in which it can continue to sell unregulated products to the American people. One blogger refers to the FDA’s plan as a ‘lifeline’ for producers and vapers, acknowledging that many of these businesses would suffer losses, if not be forced to close, if the FDA had issued its regulations.

    Instead the FDA is planning to issue regulations that seem slight more pro manufacturers, “To complement these larger policy considerations, the FDA plans to issue foundational rules to make the product review process more efficient, predictable, and transparent for manufacturers, while upholding the agency’s public health mission.”

    And that’s not really a fair assessment, while the FDA is extending the deadline for businesses for another five years they also unveiled a fairly comprehensive plan for tobacco and nicotine regulation that will serve as a multi-year roadmap to better protect kids and significantly reduce tobacco-related disease and death.

    The approach places nicotine, and the issue of addiction, at the center of the agency’s tobacco regulation efforts. The goal is to ensure that the FDA has the proper scientific and regulatory foundation to efficiently and effectively implement the Family Smoking Prevention and Tobacco Control Act. 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 will also seek input on critical public health issues such as the role of flavors in tobacco products.

    According to a recent article in the New York Times, “Public health advocates were cautiously optimistic. Matthew L. Myers, the president of the Campaign for Tobacco-Free Kids, called Dr. Gottlieb’s agenda a “bold and comprehensive vision, with the potential to accelerate progress in reducing tobacco use and the death and disease it causes.”

    At the same time, Mr. Myers criticized the five year delay in requiring compliance documentation from e-cigarette and cigar companies, saying, “This long delay will allow egregious, kid-friendly e-cigarettes and cigars, in flavors like gummy bear, cherry crush and banana smash, to stay on the market with little public health oversight. There is no reason to allow these products to stay on the market while developing and implementing the strategy Dr. Gottlieb outlined today.”

    One opinion, from the other side, is that consumers can and will find safer products on their own. I’m not sure we can make that assumption” particularly not when we’re talking about middle school kids.

    The FDA indicates current deaths due to tobacco use to be at 480,000 a year, with over $300 billion a year in associated costs. Clearly, we need a strong public health component and regulation of the tobacco and e-cigarette industry.

    As the FDA notes, it will be scientific research that guides much of the establishment of regulations. Yes, business should always have a voice, but we have to be guided by principles of science and health concerns in setting policies.

    Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products, spoke on the FDA press release, noting, Public input on these complex issues will help ensure the agency has the proper science-based policies in place to meaningfully reduce the harms caused by tobacco use.

    For now, the e-cigarette market remains unregulated. Vaping devices and the nicotine solutions used in these devices remain untested (though research is being conducted). It would seem to me that five years is too long. I agree with Myers in calling for regulation to occur simultaneously with research and public input. Public health and the safety of our children should receive higher precedence than making sure vaping businesses have ample time to justify their businesses and marketing tactics.