I talked about this in-depth when the draft guidance came out in January 2017, and not much has changed as far as I can tell. But this new guidance is finalized and out of draft form, so I wanted to cover it again for anyone who missed me talking about it before.
This is still only guidance and not all of it is legally binding, but it gives us an idea of what the FDA recommends and also what they might eventually regulate and/or enforce. That said, it’s also important to note that some of this info IS legally binding because they are laws covered by other regulations, for example:
- There are regulations that do not allow free samples to be given out unless it’s smokeless tobacco distributed in a “qualified adult-only facility”
- Cigarettes and smokeless tobacco can’t be sold to anyone under the age of 18
- Age must be verified for all sales using photo ID if the buyer is under 27
Those laws have existed since 2010 when the FDA finalized Code of Federal Regulations Title 21. But with the deeming rule, which went into effect in August 2016, this gave the FDA the authority to further regulate all tobacco products similarly, whether smokeless or not. That means those previous regulations do apply to vaping too.
In the new finalized guidelines, the FDA clarifies that all components, materials, and even software are a covered tobacco product. That includes atomizers, e-juice, devices, coils, and probably other parts. The exception to this is accessories.
The FDA defines accessories as:
- Products that are used to for tobacco products, but that do not contain tobacco and that do not alter performance or characteristics of the tobacco product. The FDA isn’t clear exactly what that might be, but maybe something like the screws on an atomizer.
- They also define accessories as products that DO alter a tobacco product but are used to control moisture or temperature of a stored product. This sounds to me like they are referring to humidors for cigars.
- And finally, accessories can be products that alter tobacco products but solely provide an external heating source but not to maintain combustion. I don’t know how the FDA is classifying combustion. Our coils maintain heat, but not combustion, since nothing is lit on fire. But I think this most likely refers to lighters.
Who These Recommendations Apply To
I know a lot of people are wondering if reviewers will be allowed to keep doing what they’re doing. So first, the FDA defines distributors as any person who further distributes a tobacco product at any point between the sale of the device and the buyer receiving it. I believe this excludes reviewers since reviews happen before the sale. I also don’t believe that reviewers would fall under the manufacturer or retailer labels.
From what I can tell, reviewers are mostly in the clear, unless they sell products, which I think is technically the case if a reviewer does giveaways. Doing a giveaway would probably classify a reviewer as a distributor and maybe even a retailer since the FDA requires that no products are given away for free and must be given away in a transaction.
Free Sample Ban
Now let’s talk about the free sample ban. This says that no manufacturer, distributor, or retailer can distribute, or cause to distribute any free samples of tobacco products. That statement about no company being allowed to “cause to distribute” would probably mean that a company is not allowed to distribute samples through a third party, such as a reviewer or blogger.
There’s one exception here and that’s for smokeless tobacco products. If in a “qualified adult-only facility”, free samples are allowed. I’ve seen some questions on this too and what the FDA considers to be a qualified adult-only facility. This is defined in the FDA’s Code of Federal Regulations Title 21.
To be a qualified facility:
- There must be a law enforcement officer or security guard to check IDs
- The facility cannot serve alcohol
- It can’t be in close proximity to a space primarily used by youth
- It must be a temporary structure designated for the purpose of free samples
- The space must be covered with an opaque material so that people outside cannot see in
- Tobacco advertising cannot be seen from the outside
All of these requirements would probably rule out most vape shops. I can only think of a couple of examples such as strip clubs that don’t serve alcohol or black tents set up in local street fairs. I’ve seen Marlboro with black tents downtown at events like the Oktoberfest.
Based on everything I’ve already said, we can imply that pretty much all vape equipment is prohibited from being given away as a sample, but the guidance document clarifies that this does include atomizers and e-liquids.
All Tobacco Products Must Be Sold
And to shore it all up, they require that all tobacco products are sold to people meeting the legal purchase age and using photo ID’s. You’ve probably seen many giveaways in the last year that require a fee and photo I.D. This is why. A tobacco product can only be given to someone through a transaction as if they are a retailer. This transaction must be monetary.
The guidelines also cover coupons, membership and rewards programs, and giveaways. Free samples are allowed in these instances but only if the free product is given away during a transaction.
Business to Business Exchanges
I’ve seen many people saying that this is the end of giving away free products to reviewers. This section existed in the original draft guidance and hasn’t changed. The FDA’s recommendations for Business to Business exchanges say that businesses are not prohibited from distributing free samples in limited quantities, for example to market or raise awareness of the product when it’s part of an effort to sell or market a product to that business. I think a product reviewer would fall into this definition, which means reviewers can still receive free products.
So that’s it. I don’t think much has changed, if anything at all, from the original draft guidance, but since this is such a popular topic now, I thought I’d cover it again.