FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death
For Immediate Release
July 28, 2017
The U.S. Food and Drug Administration today announced a new 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 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.
Read the rest of the news release here——–> FDA Press Announcement
Representatives Tom Cole (ROK) and Sanford Bishop (D-GA) introduce HR1136.
Released February 16, 2017
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VAPOR TECHNOLOGY ASSOCIATION COMMENDS COLE/BISHOP FOR COMMONSENSE, BIPARTISAN LEGISLATION TO PROVIDE ADULT CONSUMERS WITH A SAFER ALTERNATIVE TO TOBACCO
WASHINGTON, DC – Today, the Vapor Technology Association (VTA) issued the following statement in support of bipartisan legislation introduced by Representatives Tom Cole (ROK) and Sanford Bishop (D-GA) that would modify the predicate date for e-cigarettes and provide much needed regulation of vapor products as the technology that they are rather than the tobacco products that they are not.
“The deeming regulations issued by the FDA represent a one-size-fits-all approach that unfairly categorizes vapor products as tobacco, creating a regulatory regime so onerous that only Big Tobacco will have the resources to survive. In addition to leveling the playing field for small vapor businesses and ensuring that vapor products remain on the shelves as a healthier alternative to tobacco, the FDA Deeming Authority Clarification Act of 2017 will implement responsible regulations that are necessary to protect consumers and keep nicotine out of the hands of children.”
Read the complete article by following the link below.
New VTA Guidance – Sampling and Promotions – FDA Regulations
The Vapor Technology Association releases new guidance on regulations.
“There is something rotten in the State of Denmark (a/k/a the FDA) but things are not quite as bad as they
may have appeared to Hamlet when he gave his famous “to be or not to be” speech. Yes, there are many
questions about what the FDA will and will not permit. And, unfortunately, the FDA does not always provide
clear answers or, for that matter, any answers. Though what follows does not constitute legal advice, we
wanted to try to bring some clarity to some important and practical issues based on our cumulative decades
of FDA experience. Use this information as guideposts but, as always, please consult your own counsel to
determine what your corporate policies should be and how to legally comply with the Deeming Regulation.”
6.1 million Europeans have quit smoking with the use of electronic cigarettes
New Study: 6.1 million Europeans have quit smoking with the use of electronic cigarettes
More than six million smokers in the European Union have quit smoking and more than 9 million have reduced smoking consumption with the use of electronic cigarettes, according to a study published today in Addiction. Scientists from the University of Patras-Greece, Onassis Cardiac Surgery Centre-Greece and the French National Research Institute for Health and Medical Research analyzed the data from the 2014 Eurobarometer on smoking and the use of the electronic cigarettes. According to the study findings, 48.5 million Europeans have ever tried electronic cigarettes, but 7.5 million are current users. Among current users, 35.1% have quit smoking while an additional 32.2% have reduced smoking consumption.
“These are probably the highest rates of smoking cessation and reduction ever observed in such a large population study,” said principal investigator of the study Dr. Konstantinos Farsalinos. “The European Union data show that the use of electronic cigarettes seems to have a positive impact on public health for two main reasons: 1. High smoking cessation and reduction rates are observed, and 2. Electronic cigarette use is largely confined to smokers (current and former), with minimal use by non-smokers.”
More information here…..
Vapor Industry law suit filed in D.C.
On behalf of the E-Vapor Industry, R2B filed the attached Complaint in the U.S. District Court for the District of Columbia on Monday challenging portions of FDA’s Deeming Regulation and the Tobacco Control Act on various constitutional and administrative grounds. The named Plaintiffs in the lawsuit are:
1. Right To Be Smoke Free Coalition (www.r2bsmokefree.org)
2. American E-Liquid Manufacturing Standards Association (www.aemsa.org)
3. American Vaping Association, Hoboken, New Jersey (http://vaping.info/)
4. Electronic Vaping Coalition of America, New Berlin, Wisconsin (http://evapingcoalition.org/)
5. Georgia Smoke Free Association, Fort Oglethorpe, Georgia (http://www.gasmokefree.org/)
6. Kentucky Vaping Retailers Association, Inc., d/b/a Kentucky Smoke Free Association, Louisville, Kentucky (http://www.kysmokefree.com/)
7. Louisiana Vaping Association, Chalmette, Louisiana (http://laecr.org/)
8. Maryland Vape Professionals, LLC, Baltimore, Maryland (https://vape-professionals.myshopify.com/)
9. Ohio Vapor Trade Association, Miamisburg, Ohio (http://www.ohvta.org/)
10. New Jersey Vapor Retailers Coalition, Roseland, New Jersey (http://www.njvaporcoalition.org/)
11. Tennessee Smoke Free Association (http://tnsmokefree.org/)
Also supporting the lawsuit are the Smoke-Free Alternatives Trade Association (http://sfata.org/), the Consumer Advocates for Smoke-free Alternatives Association (http://casaa.org/) and NOT Blowing Smoke (http://notblowingsmoke.org/).
In the Complaint, we argue the following:
(1) Count I – Violation of Administrative Procedure Act – Grandfather Date: FDA had the authority and the statutory duty to establish a new Grandfather Date for e-vapor products (ENDS) or apply its enforcement authority so that some ENDS manufacturers, including e-liquid companies, would have the opportunity to forego the Premarket Tobacco Application (PMTA) pathway and avail themselves of the option to submit Substantial Equivalence (SE) Reports. By not doing so, FDA violated the Administrative Procedures Act.
(2) Count II – Violation of Administrative Procedure Act – Pre-market Authorization Process: FDA was obligated to consider the continuum of risk of tobacco products and exercise flexible enforcement authority mandated by Congress, instead of a “one-size-fits-all” regulatory regime treating ENDS the same as cigarettes and other harmful products and forcing ENDS manufacturers into the PMTA process, which will all but ban the entire e-liquid and device categories. Accordingly, FDA’s application of the PMTA process to ENDS products violates the Administrative Procedures Act.
(3) Count III – Violation of Due Process and Equal Protection Clauses – Tobacco Control Act: In the Tobacco Control Act, Congress made clear that different tobacco products present different risks and that FDA should exercise its enforcement authority in a flexible manner. But if, as FDA argues, the Agency is mandated to enforce a “one-size-fits-all” regime to all products, including less harmful ENDS, than Congress did not provide FDA with the necessary tools and regulatory flexibility to achieve the Tobacco Control Act’s stated goals, which include allowing newer and safer products to enter the market. As a result, the Tobacco Control Act is unconstitutional under the Due Process and Equal Protection Clauses.
(4) Count IV – Violation of First Amendment and Administrative Procedure Act – Ban on Free Samples: FDA does not have a substantial interest in prohibiting access to free samples of ENDS products by – including taste testing e-liquids in vape shops. The complete ban on free samples does not directly advance the government’s interests. There were more narrow options available to FDA to advance their stated interest in preventing youth access while still allowing vape shops and others to market using free samples. Accordingly, the total ban on free samples violates the First Amendment and the Administrative Procedures Act.
(5) Count V – Violation of First Amendment and Administrative Procedure Act – Modified Risk Tobacco Products: The Modified Risk Tobacco Product (MRTP) provision of the Tobacco Control Act, as applied to ENDS products – which do not produce smoke, combust e-liquid when used as intended, or produce aerosol that contains the harmful substances found in tobacco smoke – does not advance any purported government interests (which focus on traditional tobacco products), and captures commercial and non-commercial speech that is clearly not misleading (e.g., smoke free claims). By applying the MRTP provision and its extensive review process to ENDS products, FDA violated the Administrative Procedures Act and the prior restraint doctrine.
(6) Count VI – Violation of Administrative Procedure Act – Definition of “Tobacco Product” and Application to ENDS: FDA considers a broad range of ENDS products to be regulated as tobacco products or “components or parts,” including software that operates devices, batteries, displays, tanks, etc. FDA intends to regulate these products as tobacco products despite the fact that they do not contain tobacco, are not derived from tobacco and are not components and parts of an actual tobacco product. There is nothing in the legislative history of the Act, and FDA has provided no supporting rationale, for why these items should be regulated as tobacco products merely because they are used to consume the product. Accordingly, FDA’s application of the Tobacco Control Act’s definition of “tobacco product” to certain ENDS is unreasonable and unlawful under the Administrative Procedures Act.
(7) Count VII – Violation of Regulatory Flexibility Act – Unlawful Cost/Benefit Analysis: The Regulatory Flexibility Act requires administrative agencies to consider the effects of their regulatory actions on small business entities. FDA failed to consider significant alternatives, including, but not limited to, the impact of any compliance period on the ability of small entities to successfully navigate the PMTA process given that FDA concedes that there are no long-term clinical studies or other data necessary to support such applications. FDA only considered several, modest alternatives focused on discrete issues like labeling burdens. The Agency did not make a reasonable, good faith effort to consider alternatives that would have an overall impact on all small entities. In short, FDA substantially overestimates the benefits of the Deeming Rule and underestimates the costs. Accordingly, the Court should take corrective action, set aside and remand the Deeming Rule to FDA, and defer enforcement until the Agency complies with the Regulatory Flexibility Act.
(8) Count VIII – Violation of Administrative Procedure Act – Unlawful Cost/Benefit Analysis: The Tobacco Control Act makes clear that FDA was required to adequately consider the costs and benefits of the Deeming Rule. As with the Regulatory Flexibility Act, FDA failed to consider regulatory alternatives, such as an extended compliance period, that would have significantly increased the chance that ENDS manufacturers would be able to comply with the PMTA process, thus avoiding what will be close to an effective ban on ENDS products. The Agency also failed to properly estimate key factors necessary to an adequate cost/benefit analysis, including the number of entities and products affected, as well as the number of PMTA applications that will be filed. For many of these numbers, FDA did not adequately explain or support its conclusions. As a result, FDA violated the Administrative Procedures Act and, therefore, the Deeming Rule must be remanded to the Agency so that a proper cost/benefit analysis may be conducted.
Compliance: Are you ready for August 8’th?
New deeming rules begin to take affect August 8’th. Is your business ready? Are your customers? Business owners can find a lot of information directly on the FDA.gov website. Trade associations at the federal level are also a great source of information and help. This is why we value our partnership with the Vaport Technology Association (VTA). Business owners should also be joining their state advocacy groups and trade associaiton if they have not done so already. The time is NOW.
VTA releases its Next Level Analysis on the Deeming Regulation
What the US should learn from the UK’s wisdom on e-cigarettes – Sally Satel
This is one of the better articles to come out recently discussing the data needed to submit for approval through the PMTA pathway the FDA has laid out in the current deeming regs. Very much worth the read.
From the article….
“…Added to this onus is the so-called “public health or population impact.” According to the FDA, “Manufacturers must, for each product, quantify the likelihood that nonsmokers will start using the product, the likelihood that former smokers will relapse back to nicotine use by using the product, the likelihood that nonsmokers who do start using the product will progress to cigarette smoking, the likelihood that former smokers who relapse back to nicotine use will then progress to smoking, the likelihood that consumers will use the product in conjunction with other tobacco products, and the likelihood that smokers who start using the product would otherwise have quit smoking.”