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
- What are PMTAs?
- How will PMTAs impact the industry?
- What are the scientific burdens of PMTAs?
- What is the history of PMTAs being approved?
- Will manufacturers be able to continue selling products during the PMTA process?
- What are the costs of the PMTA applications? Where are the estimates coming from?
- How much will it cost to get a new SKU/Product through the PMTA process?
- What form of support is offered for smaller manufacturers?
- What are “User Fees” with respect to PMTA?
- What are the modified risk claims? How do they affect the vapor industry?
- How long will manufacturers be able to keep products on shelves if they can’t comply with FDA regulations?
2. Grandfather Date
- How did the FDA choose the February 15, 2007 grandfather date?
- Is there any chance the vapor industry could be regulated separately from the tobacco industry?
- What are the differences between the Cole/Bishop Amendment and HR 2058?
- What initial requirements took effect on August 8, 2016?
3. Substantial Equivalence
- What are the specifications for claiming substantial equivalence to another product that was already on the market before 2007?
- How is it possible for the FDA to say any e-liquid on the market today is not “substantially equivalent” to the e-liquids of 2006 considering the ingredients have not changed?
- Will equivalency files will be held for general ingredients like vegetable glycerin?
- If a company is using vegetable glycerin that has been tested and approved by another company, would other companies that use the same product be subject to their own testing and PMTAs?
4. DIY Vaping
- How will the regulations affect the DIY vaping market?
- Can a shop sell each ingredient separately and have the consumer blend it at home?
- How difficult will it be to purchase DIY e-liquid, PG, VG, flavorings, and parts for mods?
- Will there be restrictions on consumers purchasing liquid nicotine after this?
- What is included in the “tobacco accessories”?
- Do flavoring components have to meet the regulations?
5. E-Liquids and Nicotine
- Will flavor extracts, PG, and VG be considered “tobacco products”?
- Are there going to be flavor bans on e-liquids?
- When do retailers need to do to make sure all products have proper labels?
- What are the requirements for manufacturers for product labeling?
- Will e-liquids without nicotine have to follow the deeming regs?
- Does this include synthetic nicotine?
6. Vape Shops
- If we change a coil, have we “modified” the product enough to be considered a “manufacturer”?
- What are the critical dates that vape shop owners need to be aware of?
- How does photo identification for anyone 18 and over affect online sales of e-liquids and vaping devices?
- Can shops custom mix on site per order after August 8, 2016?
7. Vape Product Sampling
- What is the FDA ruling on sampling in store with or without nicotine?
- Do customer loyalty programs count as “free” product?
- What is the minimum amount that a vendor can charge for samples?
8. Vapor Product Importing & Exporting
- Will e-liquids containing nicotine be allowed to be shipped via “delivery sales” with USPS, UPS, FEDEX, etc.?
- If we’re a US-based manufacturer selling a product line for export, can they still be imported from overseas?
9. Vaping Advocacy
- What more can we do beyond writing and calling Congress?
- How does the FDA plan on enforcing these new regulations?
- Will any of the pending lawsuits put the regulations on hold?
- What would it take to get an injunction?
- Has the release of federal regulations slowed the state level legislation?
- What would you attribute to the different views of England and the U.S.?
- What will happen next?
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:
Blogs to follow:
- The Rest of the Story
- Ashtray Blog
- The Counterfactual
- The blog you’re reading now, of course!