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Time | Topic | Notes |
| 3m38s | What you will learn in this class | It’s important to understand a bit of history, which can prepare us for the future. Note: E-cigarettes and vape products are used interchangeably and considered the same for regulatory purposes. |
| 5m15s | The growing e-cig market and where it started | The industry is projected to be $3.5B this year and could surpass cigarette sales within 10 years. |
| 6m50s | E-liquid and brick and mortar companies have proliferated; why this has happened? | There have been no federal regulations, so states and cities have stepped in. It has been a wide open market. That will change. |
| 8m20s | Introduction to the FDA and why they will be regulating the vape industry. | They are responsible for tobacco guidelines and include vaping in that category. |
| 9m10s | Are vape products a tobacco “product?” This is a critical issue. | That determination will dictate how we grow |
| 10m00s | What is “tobacco?” That definition is unclear and important. | |
| 10m45s | History of the FDA’s attempt to regulate vape products. | The FDA tried to regulate e-cigarettes as drug delivery devices. |
| 12m00s | A brief history of how the FDA got involved. | Drugs must have FDA “premarket approval” |
| 13m30s | Defining a nicotine product vs. a tobacco product. | Since not all vape products include nicotine, the issue becomes unclear. |
| 14m25s | The defining and precedent-setting NJOY decision allowed the vape space to grow. | It was a watershed victory when vape products were deemed not be “drug delivery devices.” |
| 16m15s | The aftermath of the NJOY decision. | The FDA decided not to appeal that decision. They are currently not regulated, as long as there are no health or medical claims. |
| 17m05s | The FDA’s current deeming regs | 135,000 comments were submitted over 105 days |
| 17m10s | The “final decision” may take 1-2 years before it is law. | The FDA’s current regulations would be damaging to our industry. |
| 18m20s | New Deeming Regs may come out as early as later this summer. | The Office of Management & Budget will review the FDA’s data and opinions. |
| 19m45s | Possible outcomes and scenarios of the deeming regs | May be subject to the same requirements as cigarettes or remain unregulated |
| 20m10s | Would vaping be regulated like a cigarette? What about components, devices, hardware and accessories? | These are undecided issues |
| 22m30s | Guaranteed outcomes of the deeming regs | Anything that affects the vaper will be regulated. Warning labels will be required. No youth or vending machine sales (with exceptions.) |
| 24m10s | Using free samples to promote your e-liquid brand | Free samples may be restricted. Be careful not to make health claims. This would affect vape shops, trade shows, etc. |
| 25m10s | Manufacturers will have to register their facilities. All ingredients must be listed. | Disclosures could also include the sub-components of ingredients. Be aware of Good Manufacturing Processes (GMP) |
| 28m20s | The “Premarket Authorization” issue and when the “grandfather date” will be set. | The FDA may not be able to change the grandfather date of Feb. 15, 2007. Very few products pre-date that date. |
| 33m10s | A possible two-year window has been proposed that would allow manufacturers to get approved or remove their products from the market. | Big Tobacco may appeal or litigate if they do not like the outcome. They have money, connections and lobbyists. |
| 34m50s | What isn’t covered in the deeming gegs | Flavors are excluded-for now. Online sales are permissible |
| 36m20s | Quick Tips & Actionable Items | Do not make any health or medical claims. |
| Be sure all websites and labels carry warnings and age restrictions (18+ only) | ||
| Use child-resistant caps. This is a major issue. | ||
| There are no “FDA-approved labs” even if it is approved for drug manufacture | ||
| Know the ingredients you use and where they came from | ||
| Avoid “child enticing” flavor names, like Gummy Bears | ||
| Avoid diacetyl in your ingredients, which are often used in “buttery” flavors | ||
| Test your products and aerosol through a reputable lab. We can recommend one. | ||
| Be proactive with advocacy groups (SFATA/ CASAA) and with your legislators | ||
| The FDA is still accepting comments | ||
| 44m20s | We offer legal packages and review of your current processes | |
| 46m30s | Questions & Answers | |
| Should we be concerned about flavoring bans? | This will probably be more likely at the state level, but the FDA will overrule any state regulations. States have banned e-cigs based on public perception, not science. | |
| Will zero nicotine products still be regulated as a tobacco product? | Tobacco authority may not include zero nicotine products. This is a big question mark. | |
| Where does the online market fit into this picture and how can they protect themselves? | This is unregulated, but subject to underage sale issues. Include every roadblock possible on your website. Use age verification tools such as Idology.com or veratad.com. Label your products. | |
| Where does Big Tobacco fit into this conversation? | Big Tobacco supports “closed systems” and oppose open tank systems. They are all in the flavoring market so they have a vested interest in their availability. | |
| Will the deeming regs require Congressional or Presidential approval? | These are not statutory laws and do not require Congressional approval. | |
| Can shops sell nicotine separately since some states have instituted large taxes against nicotine? | Generally not, but the drop in cigarette sales impacted tobacco companies as well as many states that got subsidies through the Tobacco Control Act. Note: states can only tax the nicotine content, not the full purchase price. | |
| Does social media create any exposure for vape space companies? | Have all your caveats and disclosures prominently displayed. | |
| Is there a window of opportunity before the FDA puts on substantial restrictions? | It will be a while before the restrictions are in place. | |
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Jesse is the Digital Marketing Director at VapeMentors and Chief Technology Mentor. He is an ecommerce and internet marketing expert with a background in business and technology.