May 25, 2016
The FDA hosted a special Q&A webinar today specifically targeted towards retailers. (A separate webinar tailored toward manufacturers will be announced at a later date.) This webinar was supposed to answer questions but many participants walked away more confused and concerned than ever. Hopefully, this will clear up some of the confusion and once again, light a fire under everyone to get on the phones and spread the word.
- Stores may no longer offer free samples and/or testers. There must be a charge; however, there is no mandatory charge specified. Some stores have discussed perhaps charging a $2 tester fee and then crediting that $2 to the customer’s purchase. This ban on free samples also pertains to all parts and components.
- Zero nicotine liquid, cotton, wire, batteries, and the like are all now considered tobacco products. It does not matter to the FDA that they do not in fact contain tobacco or even nicotine. The qualifier here is that they could potentially deliver nicotine, and so they are all classified as tobacco products.
- DIY is safe for now. As long as you are making it for personal consumption and that alone, you are not subject to the regulations and also will not require any kind of licensing to buy or use nicotine.
- Stores can no longer advertise and/or perform coil builds for customers. Doing so would immediately classify the store as a manufacturer. Some stores have suggested coil “repairs” as a way around this, but it remains to be seen.
- If a person sells any vape-related device or product, then he/she is immediately considered a retailer. You do not have to own a B&M or even a business to be considered a retailer; it is the exchange of goods for money that now classifies you as a retailer.
- If you choose to give away a device or product for free, you are no longer a retailer but you now are subject to the ban on free samples.
- By this December, all manufacturers must register their businesses with the FDA. There is no cost to do this, but the document with the instructions is 104 pages long so it is not recommended that you delay this task. Shops do NOT have to register unless they make their own e-liquid. (Note: I have the instructions and am happy to share them if you email me at email@example.com.)
- Age verification of 18 and older is required for all B&M and online retails. The FDA will begin sending secret shoppers in to check both age verification and no free samples as soon as August 8, 2016. When asked about the specific parameters concerning age verification guidelines, the FDA representatives did not answer the question.
- May 8, 2018 is when new warnings will take effect.
- Multi-pack promotions such as “Buy 1, Get 2 Free” are allowed.
- On August 8, 2016, you may continue to manufacture products that were already on the marketing prior to the effective date while you prepare, submit, and await response on your application/s. The approval period can take up to 36 months.
- Pre-market authorization will be required before releasing any new products after August 8, 2016.
The webinar will be edited and then posted to the FDA website. I will let you know when it is available for viewing on the site.
Personally, I think there was a lot of tap dancing going on. Beyond the infuriating saccharine smiles on their faces, their refusal to acknowledge some of the more detailed, upfront questions made the entire experience that much more frustrating. I can hardly wait (note the heavy sarcasm) to see what they do with the manufacturer’s webinar. It was glaringly obvious to me that instead of taking our questions and comments as legitimate, educated responses, they instead used our thoughts and ideas as further ammo to obliterate what few loopholes the regulations had afforded us. We fed them the very details that could be used against us, and it was very difficult to keep up hope while we awaited their return from their many “breaks” throughout the webinar.
This only further demonstrates the need to hold our elected leaders accountable. Passing legislation is not enough; they need to explain themselves and the reasoning that led them to these laws, and when they do not make sense and do not fit the needs of the people they represent, well then by God they need to be changed.