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Notes

3m38sWhat you will learn in this classIt’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.
5m15sThe growing e-cig market and where it startedThe industry is projected to be $3.5B this year and could surpass cigarette sales within 10 years.
6m50sE-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.
8m20sIntroduction to the FDA and why they will be regulating the vape industry.They are responsible for tobacco guidelines and include vaping in that category.
9m10sAre vape products a tobacco “product?” This is a critical issue.That determination will dictate how we grow
10m00sWhat is “tobacco?” That definition is unclear and important.
10m45sHistory of the FDA’s attempt to regulate vape products.The FDA tried to regulate e-cigarettes as drug delivery devices.
12m00sA brief history of how the FDA got involved.Drugs must have FDA “premarket approval”
13m30sDefining a nicotine product vs. a tobacco product.Since not all vape products include nicotine, the issue becomes unclear.
14m25sThe 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.”
16m15sThe 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.
17m05sThe FDA’s current deeming regs135,000 comments were submitted over 105 days
17m10sThe “final decision” may take 1-2 years before it is law.The FDA’s current regulations would be damaging to our industry.
18m20sNew Deeming Regs may come out as early as later this summer.The Office of Management & Budget will review the FDA’s data and opinions.
19m45sPossible outcomes and scenarios of the deeming regsMay be subject to the same requirements as cigarettes or remain unregulated
20m10sWould vaping be regulated like a cigarette? What about components, devices, hardware and accessories?These are undecided issues
22m30sGuaranteed outcomes of the deeming regsAnything that affects the vaper will be regulated. Warning labels will be required. No youth or vending machine sales (with exceptions.)
24m10sUsing free samples to promote your e-liquid brandFree samples may be restricted. Be careful not to make health claims. This would affect vape shops, trade shows, etc.
25m10sManufacturers 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)
28m20sThe “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.
33m10sA 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.
34m50sWhat isn’t covered in the deeming gegsFlavors are excluded-for now. Online sales are permissible
36m20sQuick Tips & Actionable ItemsDo 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
44m20sWe offer legal packages and review of your current processes
46m30sQuestions & 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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