FDA Backs Off: Three Steps Back

Posted by Mitch Clarke on 30th Jan 2017

In recent days, the FDA released several draft guidances that relax the stranglehold it had on the industry. While the FDA receives public comments on these drafts, they remain officially unimplemented, but they give a valuable glimpse into how the FDA will finally provide vape shops and manufacturers with some much needed wiggle room when assisting customers or submitting PMTAs. Before reading any further, please note that we are NOT lawyers and what is written here should not be taken as legal advise or a course of action for your shop in any way. If you have questions about any FDA documents, then please seek legal counsel or contact the FDA directly with your questions to receive further guidance.

The first such document is the Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops. This draft guidance clarifies what a vape shop can and can’t do without invoking a response from the FDA. As it stands now, the clearance given to vape shops is minimal: assembling devices, replacing atomizer heads, building coils, adjusting builds, refilling tanks, and even cleaning devices was disallowed, much to the dismay of vape shops and consumers across the country. This draft guidance, however, would allow retailers to provide some of these services for customers.

Retailers could:

  • Explain use of any product without assembling
  • Replace atomizer head with ones originally included by manufacturer as one package
  • Refill open system ENDS
    • This conveniently allows dripping for customers after they pay for sampling (which we’ll cover below)
  • Clean/maintain device/”tighten fixtures (screws)”
  • Assemble a setup with components sold as part of a kit
    • This could technically swap replacement glass (but not extension kits/tanks); change RBA screws, posts, and positive pins; and possibly even build and install RBA coils with the wire/cotton/prebuilt coils included
    • This includes any kind of kit, even if a retailer doesn’t have that exact kit, but has the individual components for sale; if it’s sold anywhere as a pack, it can be assembled.
  • Modify a device in a manner consistent with the original manufacturer specifications
    • Whether this clarifies if employees can install builds (with wire they’ve already sold to a customer) is up for debate.

However, retailers could not:

  • Refill closed system ENDS
    • Which is fair. Admittedly, it’s pretty dirty that they’re ready to go after anyone who will threaten the profitability of closed-system and HNB devices that, I personally predict, are just over the horizon, ready to invade and plunder the market on Big Tobacco’s orders, but I really don’t know why anyone would even try to mess with it, as closed systems are just the worst. Like, the absolute pits.
  • Assemble a custom setup
    • This includes:
      • Installing batteries not included in the kit
      • Installing aftermarket parts (e.g. atomizer heads, drip tips not included in original package, tank extensions, etc.)
  • Modify a product outside its Marketing Authorization Order
    • Very few e-cigs even have this

On one hand, these updated regulations can eliminate some degree of danger/risk for novice customers looking to move to RBAs if it’s maintained by knowledgeable employees. Employees could easily provide customers with the education that eases them into the rebuilding experience and teaches them the progression of knowledge from basic to advanced rather than taking it upon themselves to jump in headfirst and expose themselves to the full spectrum of risks straight after buying the RBA. It’d be modified in a manner very much intended by the manufacturer—if you can even call it “modifying”, which would imply that it worked at all straight out the package and performance is being modified from what the manufacturer originally intended, rather than requiring by design the installation of wire and cotton just as it requires juice. 

The only way I can imagine rebuilding would “modify in an inconsistent manner” is if employees started rebuilding clearomizer and sub-ohm atomizer heads for customers—a challenging and unrewarding feat but not impossible (my own first rebuilding experience was with Nautilus heads)—but that’s highly unlikely, as customers are hardly likely to request this service over just buying a new head or RBA. I personally think that, if anything, manufacturers could state a safe resistance range or temperature limit for RBAs—this will give an explicit guideline for performance and add additional incentive for employees installing builds to double-check their work.

On the other, the very increase in prevalence of RBAs and mechs in the populace raises the risk for public health dangers, the liability for which would fall on the retailer, even if liability waivers are implemented. In addition, this would go against the FDA’s misplaced desire to have neatly defined specifications for all tobacco products (this tank is sold with this head and battery, so that’s a product, and if another head or battery is installed, that’s a different product; this outdated mindset is a remnant of the now-dying old-world approach to “tobacco”) rather than the slew of custom assembled setups that is the current norm. Perhaps as the PMTAs start rolling in, the FDA will get an idea of the current technological state of the market and how each product is more or less compatible with every other.

The second document is titled Prohibition of Distributing Free Samples of Tobacco Products, a misnomer for guidelines that clarify the definition of a “sample” and describe the circumstances under which a retailer can provide “free” samples.

This document describes a sample as ANY tobacco product, not simply tobacco-derived products. The FDA provides their reasoning for this distinction, explaining that “...components and parts of some tobacco products, such as the aerosolizing apparatus of e-cigarettes, can be the most expensive part of a tobacco product. If minors can obtain the most expensive components or parts of tobacco products as free 'samples,' they face less significant barriers to using tobacco products.” Which, as most vapers know, is minimally true, since an atomizer head is no good without a matching atomizer, an atomizer is no good without a mod, a mod is no good without batteries, etc. But regardless, this is a worthwhile guideline, as it emphasizes youth safety, something the FDA has lauded publicly for months, yet has done little to actually enforce. 

In addition, samples can only be given out when accompanied by a separate tobacco purchase that requires ID, proof of age, and some kind of monetary exchange. Simply put, if someone shows ID and pays for it, they can be given samples.

Under the draft guidance as it stands, the following is A-OK (with extra guidelines for each):

  • Receiving samples by paying & showing ID
  • Coupons, Discounts or Sales that are applied at the time of purchase 
  • Paid “Memberships” that offer a discount on tobacco product purchases
  • Rewards Programs or Stamp cards that give a free or discounted product upon completion when purchasing a separate tobacco product 
  • Contests or Games of Chance that provide a free or discounted tobacco product with the purchase of another
  • B2B sample exchanges/promotions

However, the following are disallowed:

  • “E-juice memberships” that allow for anyone holding the card to consume samples
  • Samples in exchange for customer contact info
  • Coupons or stamp cards that are redeemable for a free tobacco product w/o an accompanying tobacco purchase
  • Contests or games of chance that simply reward the winner with a free tobacco product

Supposedly, these guidelines will restrict youth intake, which makes sense. With openly free and unrestricted sampling, checking for qualifying age should be a priority regardless, but with no restrictions to require it, it would no doubt fall to the wayside, providing “a ‘risk free and cost free’ source of tobacco products for youth.”

Keep in mind as well that these guidelines aren’t set-in-stone as the FDA will review each potential and occurring violation to “consider whether the manufacturer, distributor, or retailer has devised a way to adequately verify that the person receiving the reward is the member or original purchaser [and is of legal age of purchase]”

The third and last recently released document is called Listing of Ingredients in Tobacco Products (Revised). This draft describes the requirements for manufacturers as they submit the ingredient listings of their products. It’s called “Revised” because this document was first released in November of 2009, but was recently updated to reflect the new deadlines. As it was before, the application due date for large manufacturers (≥$5 million in sales and/or 150+ employees) was Feb. 8th, 2017, and Aug. 8th for smaller manufacturers. Now, however, the document has pushed these dates back by six months; the due date for large manufacturers is now Aug. 8th, and for smaller manufacturers, it’s now Feb. 8th, 2018.

The reasoning behind this is vague and unlikely to be because of the FDA’s spontaneous empathy for manufacturers. If anything, it’s most likely to be related to the reason for the deadline delay they announced in December. That delay was attributed to an overload of the FURL, the FDA’s submission portal for tobacco product applications, and such reasons could easily explain further delays.

Now, keep in mind, these documents are merely draft guidances, meaning they aren’t the law of the land just yet. They still have to undergo a public comment period, where anyone can access the regulations.gov page and leave their personal thoughts and opinions on the matter for the FDA to peruse and consider when compiling their final version of these documents.

Also, even if these guidances are officially implemented, they don’t really change the law at all, they simply clarify the FDA’s thoughts and stance on the matter as it currently stands, meaning this stance could easily and legally change without warning. As stated by the FDA:

 “[A draft guidance] does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.” 

So, if you’d feel safer following the official law to the letter, by all means, please continue to do so. These documents are fairly out-of-character for the FDA, so I personally don’t doubt for a second that the FDA would implement these drafts, then immediately start cracking down on vape shops who do the actions allowed in the drafts, but not allowed in the FD&C Act, similarly to how the DEA promised not to raid medical and recreational shops in applicable states, yet almost immediately did so. But if you have hope for the future, be sure to submit your comments on the official page! Every opinion counts, especially from educated vapers such as yourselves!

**DISCLAIMER Once Again: I'm not a lawyer, just a guy who likes reading law. But I like to think I'm relatively smart, so I think I'm mostly right, but feel free (encouraged, even) to confirm these thoughts with your personal lawyer to ensure perfect legal compliance.**