The FDA Deeming Regulations, officially published in the US Federal Register on May 10, 2016, inspired us here at White Cloud Electronic Cigarettes to do a quick spring-cleaning of the 499-page document to squash the questions we are all asking. From redesigning our packaging to pre-market tobacco applications and discontinuation of sampling, questions about the new regulations move like rapid fire through our inbox and social feeds. Armed with resources and answers, we decided to bring the information we have learned about the regulations to the forefront.

48 Questions and Answers About FDA Deeming

This guide has been built from our internal artifacts to create an external resource that can help empower the vaping industry with information about the FDA’s Deeming Regulations. We have sourced information from experts from our webinars and interviews, as well as from hours of our personal research to bring you these answers.

The FDA’s “deeming regulations” are often discussed as if they describe a static environment in which small e-cigarette and vape businesses are already dead. But the truth is, the vaping industry is bound to change and evolve as any growing industry would — for better or for worse.

Our hope is that this guide proves helpful in understanding the FDA’s Deeming Regulations, including how to comply and what changes we here at White Cloud have already made.

Now, let’s take a quick look at the topics we’ll cover.

1. Pre-Market Tobacco Applications

2. Grandfather Date

3. Substantial Equivalence

4. DIY Vaping

5. E-Liquids and Nicotine

6. Vape Shops

7. Vape Product Sampling

8. Vapor Product Importing & Exporting

9. Vaping Advocacy

Please note, the FDA’s Deeming Regulations are listed out in an extensive document consisting of 499 pages. The interviews contained within this series were conducted very shortly after their release, so if you see conflicting answers from the speakers, this is most likely a symptom of a shortened time frame to interpret the document.

---

Meet the Vaping Industry Experts

In selecting the answers for our list, our team at White Cloud pored over state and federal data, analyzed news coverage, examined academic studies, and listened to the perspectives of our vaping peers. We also spoke with educators, innovators, and directors in the e-cigarette space. The experts listed below shared insights and knowledge to help us answer your questions.

Dr. Michael Siegel has joined us for a couple of our DeMISTified webinars, both before and after FDA regulations took effect. He is a Professor in the Department of Community Health Sciences at the Boston University School of Public Health, and has been a researcher in the tobacco control field for the past 25 years. Dr. Siegel has published extensively on a wide range of areas in tobacco control, including health effects, secondhand smoke, evaluation of tobacco policy, and national strategies to reduce tobacco use. He has been a leader in the anti-tobacco movement, testifying in support of smoke-free workplace laws and serving as an expert witness in lawsuits against tobacco companies. He writes a popular tobacco policy blog – The Rest of the Story – where he provides commentary and insight on current tobacco policy issues.

Cynthia Cabrera joined us as a key speaker in our webinar on May 24, 2016. She is the former President and Executive Director of the Smoke-Free Alternatives Trade Association (SFATA) representing over 1,000 members within the vapor supply chain. SFATA is the largest and leading trade association in the vapor space and has worked at the federal level since 2012 to promote dialogue and education about vapor products. SFATA has 25 state chapters across the country and is the go-to for questions about the industry, state legislative actions, and trends.

After our webinar, on June 30, 2016, SFATA announced that Cynthia Cabrera was stepping down as the Executive Director.

Tony Abboud came in as a guest speaker for our webinar on May 26, 2016. He is the National Legislative Director for the Vapor Technology Association (VTA). a vaping advocacy group promoting entrepreneurship, responsible public policies, and a high standard of safety for the vapor industry through the representation of manufacturers, wholesalers, and small business owners of innovative vapor products. The VTA has been working tirelessly on changing the FDA’s predicate date by implementing a bipartisan strategy to pass the Cole-Bishop Amendment.

Dimitris Agrafiotis has also joined us for webinars both before and after the regulations took effect. He is Chairman of SEVIA USA, the COO of Mountain Oaks Vapor and the Secretary of VISTA. Dimitris is also the Founder of the Tennessee Smoke Free Association and hosts The Smoke Free Radio Network, a popular podcast series discussing all things vaping.

---

Disclaimer: This guide is not meant to be legal advice. If you’re a manufacturer or vape shop owner with specific questions, we advise you to speak with a lawyer. The information we provide in this guide is based on public knowledge.

---

Resources for Vapers

The vaping industry isn’t just an industry: It has become a tight-knit community of people who are always happy and willing to talk about vaping and answer questions from people just getting started with e-cigs. From vaping advocacy groups to discussion forums, vapers have plenty of options for becoming part of this community and staying up-to-date on all things vaping.

Vaping Advocacy Groups to Join/Follow:

Vaping Forums

Blogs to follow:

Podcasts to follow:

Facebook Groups to Follow/Join:

Industry News: State Vaping Laws