FDA Vaping Regulations – 2016-2017 Documents
Good news! Welcome changes (Draft Guidance) to the Final Rule by the FDA for Vape Shops.
Final Rule
Draft Guidance on PMTA
REVISED FDA Timeline/Compliance Calendar for the Final Rule
FDA Tobacco Compliance Webinars Index Page – See the 2016 Webinars Section
Final Regulatory Impact Analysis (FRIA)
Old FDA Documents – 2014-2015
- Economic Impact Analysis
- All 241 Pages of the Regulations
- Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007
- Demonstrating Substantial Equivalence for Tobacco Products
Other resources to inusre the survival of vaping.
- CASAA – The Consumer Advocates for Smoke-free Alternatives Association
Their mission is to ensure the availability of effective, affordable and reduced harm alternatives to smoking by increasing public awareness and education; to encourage the testing and development of products to achieve acceptable safety standards and reasonable regulation; and to promote the benefits of reduced harm alternatives. Please join and support this organization. - SFATA – The Smoke Free Alternatives Trade Association
The Smoke Free Alternatives Trade Association represents a wide cross section of the “Smoke Free” industry including distributors, manufacturers, retailers and consumers of Personal Electronic Vaporizing Units such as electronic cigarettes and the liquid solutions they contain. - AVA – American Vaping Association
A nonprofit organization that advocates for small- and medium-sized businesses in the rapidly growing vaping and electronic cigarette industry. - AEMSA – The American E-liquid Manufacturing Stanadards Association.
A manufacturers trade association completely dedicated to creating responsible and sustainable standards for the safe manufacturing of “e-liquids” used in electronic cigarettes. Read their Standards. - The FDA Forum on ECF. I encourage you to join this quality Community and get involved in this fight.
- A positive video with evidence titled Are electronic cigarettes safe? BBC News
- The Ultimate List of E-Cig Studies: Are E-Cigs Actually Safe? A fantastic resource.
- Dr. Michael Siegel is a Professor in the Department of Community Health Sciences, Boston University School of Public Health. A great Blog dealing with critical issues relevant to Vapers.
- Propylene glycol (PG) facts.
- Vegetable Glycerin (VG) facts.
- Contacting The Congress. An outstanding resource to locate your State Representatives.
- Details on how the anti vaping bloviaters frame their specious arguments: Pseudoscience when scientific arguments are lacking.
- THE CASE FOR OR AGAINST E-CIGARETTES: WHAT THE SCIENTIFIC RESEARCH SAYS. A well balanced and fair assessment of the current ecig issues. Written by two Professors at Columbia University. Jam packed with footnotes/references you can use in your activism.
- Peering through the mist: systematic review of what the chemistry of contaminants in electronic cigarettes tells us about health risks. Scientific study by Igor Burstyn from Drexel University which dispels the lies and spins of the FDA and others. A great talking point link in your activism. The complete scientific study.
- Electronic cigarettes: review of use, content, safety, effects on smokers and potential for harm and benefit. A fantastic scientific study. Dispells many of the medias deplorable spin and well suited as another talking point with your activism. A more detailed story on this study.
- A study by ASH which highlighted that e-cigarettes are not a gateway product. In fact, it seems the vast majority of electronic cigarette users are people who previously smoked tobacco and turned to vaping in an attempt to quit.
- Tobacco Truth is a great Blog. “Tobacco Control has morphed into a crusade intent on demonizing both tobacco users and the industry supplying them. This blog examines and comments on scientific issues surrounding tobacco policies – and fallacies.”
- Search the FDA Deeming Regulations docket to find submissions. This is the procedure I used to find submissions by Health Departments, Bureaucrats, and the Mayor of Las Vegas, Nevada. Experiment with different keywords and look for attachments (paper clip) in the listing of results. Try your state first like “Nevada”.
- Evaluation of Electronic Cigarette Liquids and Aerosol for the Presence of Selected Inhalation Toxins. Conducted by Dr. Konstantinos E. Farsalinos this outstanding Scientific study deals with the presence of Diacetyl (DA) and Acetyl Propionyl (AP) in ejuice. A summary poster for your reading pleasure.
- E-Cigarette Research is a site which primarily contains scientific e-cigarette studys in a simplified and easy to understand form. Created by Dr. Farsalinos, it’s a must read and a marvelous resource for activists.
- The Rest of the Story: Tobacco News Analysis and Commentary. An outstanding Blog written by Dr. Siegel, a Professor in the Department of Community Health Sciences, Boston University School of Public Health.
- Anti-THR Lies and related topics is a Blog written by Dr. Carl V. Phillips. With outstanding credentials and a long history of fighting ANTZ he currently serves as Chief Scientific Officer, handling most of CASAA’s scientific communications.
- The counterfactual. What’s the right thing to do? Analytical advocacy – getting beyond the rhetoric of campaigners. A Blog written by Clive Bates who is not a smoker or vaper. This fact provides him with a valuable and unique perspective of THR, Vaping, and the entire regulatory landscape. A valuable read which you should bookmark.
- Robert West’s study surveyed 5,863 smokers between 2009 and 2014 who had tried to quit without using prescription medicines or professional help. Smokers trying to quit are 60 percent more likely to report success if they switch to e-cigarettes than if they use nicotine products like patches or gum, or just willpower, scientists said Tuesday. The Abstract and the complete study.
- Vaping.com is the sister site to E-Cigarette Forum. An insightful Blog with a distinctly and enjoyable British sence of humor. Posts cover current Vaping issues and enhance our collective fight with regulators on either side of the pond.
- Evaluation of Electronic Cigarette Liquids and Aerosol for the Presence of Selected Inhalation Toxins. This Scientific study was led by Dr. Konstantinos E. Farsalinos and focused on the presence of diacetyl (DA) and acetyl propionyl (AP) in eJuice/liquids. Either of which, at a certain level, pose a health risk for Vapers. A must read and worthy of telling your eJuice vendors about. The full text of a related Scientific study titled Harmful and potentially harmful constituents in e-Cigarettes also contains this study data.
- Levels of selected carcinogens and toxicants in vapour from electronic cigarettes. This “Goniewicz” scientific study is a must read. A valuable analysis of this study was written by Dr. Siegel.
- ECigIntelligence is a news-led, analytical, and independent resource, focused on tracking regulatory change and market intelligence for the e-cigarette and tobacco-alternatives sector.
- A large list with links of some of the already existing Peer-reviewed and Published research citations related to Electronic cigarettes. Use this page the next time someone tells you that not enough research has been done.
- Angry Vaper is a Blog written by Andria Duncan full of useful content. I love the “tone” and “style”. Ladies and gentlemen, this is the real deal honest and candid thoughts of many vapers delivered in a delightful “snarky” fashion.
- NOT Blowing Smoke is a site with lots of facts and arguments which counter the liars at the California Department of Public Health. The content is very useful for any state or Federal legislation. The presentation is unusual on a single page with jump links which make it very easy to read and understand.
- William T. Godshall, Executive Director of Smokefree Pennsylvania’s 7/2/15 comment to the FDA. 158 pages evaluating the scientific and empirical evidence on e-cigarettes, and exposing more than a hundred false and misleading fear mongering claims about e-cigs by Obama’s DHHS and/or its funding recipients. Another version which spans multiple posts in the same thread.
- Vapers.org.uk A website run by Vapers for Vapers. Collecting News and comments from around the world with regard to Vaping. We are all volunteers and not funded in anyway by any aspect of “Big Industry” Be it Electronic Cigarette, Tobacco or Pharmaceutical.
- Royal College of Physicians strongly endorses e-cigarettes as smoking substitutes. Great news and analasys by Dr Farsalinos.
- New study: 6.1 million Europeans have quit smoking with the use of electronic cigarettes. Dr. Farsalinos and other scientists performed this study on over 27K respondents. Another abstract for your reading pleasure.