Vape Industry Update

PMTA enforcement since Sep 9th

The deadline for PMTAs is now more than 2 weeks past due. The FDA is still working on reviewing the paperwork and submissions they received which still leaves lots of questions in regards to what people can and cannot sell along with what their risk of enforcement is. At the moment we have NOT seen any additional warning letters from the FDA in regards to PMTA violations exclusively. In fact one of the more recent warning letters issued on 9/11 (after the deadline) and posted 9/22 to Lucid Liquids calls into question how thoroughly they are sweeping for violations specifically for unauthorized products or post August 8 2016 products. The warning letter was issued in regards to the missing warning label: “WARNING: This product contains nicotine. Nicotine is an addictive chemical.” which is a requirement for all nicotine products and advertising since 8/10/2018. Their website https://lucid-liquids.com at the time of review also had salts and disposables for sale which many have challenged are unlikely to receive extended marketing orders since they generally are newer products produced after August 8 2016. As I’ve discussed in my prior emails, with the way the FDA has structured current compliance, it's likely that nearly 95-99% of online retailers, distributors or brick and mortar sellers of vapor products are in violation of the sale of products that are unauthorized. Yet there haven't been any retailers that have been cited for selling unauthorized products in general. This piece isn’t to pick on Lucid Liquids but to showcase a scenario where a retailer who likely is in violation of unauthorized products is only cited for one thing without additional items or products called into question. 

What if the FDA doesn’t release a PMTA list at all?

It was rumored this week that the FDA may not release a PMTA list at all. There are several reasons they may not release a list despite the FDA saying they would. It’s worth noting that the FDA has said many things that have never actually been followed through on. The first reason is that the FDA would then become liable for all products that receive marketing orders and would be responsible for the compliance of all stores and retailers on an individual product basis. This means that a company could technically sue the FDA if they were misinformed on a product. That company likely would claim the FDA didn’t do their due diligence to protect the business if they are then put in a position to get rid of those products overnight that were previously given the greenlight. Although it’s rare and extremely challenging to win a lawsuit against the FDA, it would bring some legal battles to the forefront when it comes to the question of a product you can or cannot sell. In other words, it’s better for the FDA to give everyone a yellow or redlight on products instead of actually giving anyone a greenlight on anything. The FDA would also find themselves in potential trouble if they greenlight a product that turns out to be abused or harmful. Second is the FDA must respect the confidentiality requirements under the Federal Food, Drug and Cosmetic Act. The FDA can’t simply publish their finds and ongoing communications between companies that could potentially violate non-disclosure agreements for sensitive information such as intellectual property. Third, the FDA would need more of a “database” and not just a “list”. PMTA approval relates to products specifically in terms of SKUs and not just their overall brand or products as a whole. Each and every product needs to be reviewed and some products might get rejected while others are accepted. With the complex review process of PMTA submissions, such information will need to be heavily scrutinized to ensure no wrong information is published and include clear distinctions on the products, packaging and marketing orders for example. In the meantime, some public lists have been made available to follow PMTA submissions per vendor based on variable, written, verbal or partial confirmation. The best site I've come across is VapePMTA.com - Vendors

FDA “will” or “can” enforce a non-PMTA product?

This is a controversial section, but I’d like to help forecast what the future might look like for products that don’t have a marketing order for business owners who still might be experiencing panic. Although this section is primarily my own analysis, I’m using information from the FDAs past actions and currently available information to predict PMTA enforcement for illegal products. At a glance you can review the FDAs enforcement page for yourself to get an idea. When it comes to the FDAs deeming rule for ENDS products they are prioritizing enforcement in specific areas such as illegal underage sales (the most important), flavored pre-filled pods, solicitation of products that appear to be enticing to minors, and lastly products that don’t have PMTA approval or market authorization as of Sept 9th. “FDA has repeatedly publicly discussed the fact that enforcement discretion timelines for deemed tobacco products were under reconsideration and solicited views from stakeholders.” - FDA Enforcement Priorities. The FDA frequently mentions they have the “discretion” for enforcement with regard to their list of priorities and are “subject to change” based on new information. It appears that not all products are equally weighted. This can also be reasoned by the FDAs own statements issued on Sept 10th with regard to PMTA enforcement stating: “based on several factors – including the likelihood of youth use or initiation – the FDA will make the best use of agency resources to enforce against any other deemed new tobacco product that does not have the required premarket authorization” FDA also states: “FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities.” Past enforcement has shown the FDA is prioritizing their violation notices on mainly 2 key items. 1) selling to minors, 2) advertising products that appear to be enticing to minors. Unauthorized products never even made the priority list, until Sept 9th. The FDA was pressured to start enforcement earlier which they have been doing long before Sept 9th (in case you didn’t know). The FDA has shown based on warning letters issued so far, selling illegal products that were unauthorized has not been the primary reason the FDA went after them, but rather using that as a reason for why the product needed to be removed in conjunction with the other 2 key items. Take for instance, the warning letter issued to Provape.com who is a large online retailer with 1000s of vapor products including disposables. In the warning letter, only one item was cited, the Acacia Q-Watch Pod Kit stating: “FDA finds Acacia Q-Watch Pod Kit particularly concerning because the design of the ENDS product is likely to appeal to children because it is designed to conceal a tobacco product from parents, teachers, or other adults.” The FDA then goes on to state that the product does not have market authorization, therefore it must be removed. The most recent instance of this enforcement on Sept 10th was also in the following statement from the FDA: “In line with its enforcement priorities, today the FDA issued warning letters notifying three companies who sell or distribute unauthorized ENDS products to remove those products from the market. The FDA issued a warning letter to XL Vape LLC (doing business as Stig Inc.), a popular disposable e-cigarette brand among youth, warning the company to remove their disposable e-cigarettes from the market because they do not have the required premarket authorization. Additional warning letters were issued today to Flavour Warehouse LTD (doing business as Vampire Vape) and Pretty Women UK LTD (T/A Coil2oil and Mad Kingdom Liquids) for illegally marketing unauthorized menthol-flavored e-liquids. The labeling and/or advertising of these products also features cartoon images, such as vampires and kings, that are commonly marketed and/or appeal to youth.” In both of these cases advertising products that appear to be enticing to minors or are being used by minors is specifically mentioned. All the other products sold by these companies were not mentioned at all. You can find this sort of language and reasoning amongst nearly ALL of the warning letters issued to sellers of unauthorized products. The FDA understands the risk of a black market and that an exodus of all products would be unwise by their own admissions. Nicotine products are addictive, and without proper alternatives, people go back to combustible tobacco products or to the black market (which the FDA agrees may be more harmful). The best the FDA can do is ensure these products aren’t doing more harm than good overall and nothing gets out of control. The PMTA pathway gives the FDA the full power of authority to go after specific companies and products that are seen to be the most harmful without debate because they are illegal already. If they want to fight the FDA on it, great, the PMTA pathway is how you are supposed to do it lawfully. If the FDA gets complaints about a product or a company (that is unauthorized), they have the authority to shut it down easily with “You don’t have our permission” and call it a day without additional paperwork as long as they comply. It’s likely the FDA will do just that. Target specific companies based on youth appeal continuing forward. The FDA knows vape stores and warehouses are still full of inventory today. The FDA has already acknowledged there are millions of products they have identified with only a few thousand who have filled. By their own numbers accumulated they must realize that nearly 99% of the products out are unauthorized. You would think they would start the clean up sooner than later and just start with the products that weren’t submitted at all. Perhaps a full blown market clearing is not part of their plan. The FDA admits it’s not practically even possible stating: “FDA will make enforcement decisions on a case-by-case basis, recognizing that it is unable, as a practical matter, to take enforcement action against every illegally marketed tobacco productproduct, and that it needs to make the best use of Agency resources. This guidance does not in any way alter the fact that it is illegal to market any new tobacco product without premarket authorization.” Imagine just how many warning letters would need to be issued today, in addition to follow ups, citations, and legal penalties for each and every violator. From what we have seen from the warning letters issued so far, the FDA is still trying to enforce the other priorities that predate PMTA enforcement. The #1 used product by minors today discussed by the CDC for the new 2020 data is still the banned prefilled flavored pods. The FDA surely knows it’s best use of resources is to still go after the sources by which those flavored pre-filled pods are still getting into minors hands rather than focus on the other products NOT being used by minors. In my opinion, the enforcement of PMTA products could likely drag out for decades since they can’t feasibly clear the market and avoid the black market if there aren’t enough currently legal ENDS products for people to transition to. With regard to the FDA’s tone towards enforcement they had this much to say in a statement on Sept 10th: Companies that continue to manufacture, distribute, and sell unauthorized tobacco products risk FDA compliance and enforcement actions ranging from warning letters to injunction, seizure, and/or civil money penalty actions where warranted. The key words in this statement are “risk” and “where warranted”. Why include those discretionary words? If the FDA was planning to move in on ALL unauthorized products, the FDA should state plainly: “you must remove all unauthorized products, within x days, or you will receive x penalty.” At this point we are more than 2 weeks into stores and online sellers continuing to sell unauthorized products everywhere with no additional notices in regards to unauthorized product selling specifically. PMTA approval for a product provides it protection against enforcement. But without PMTA approval, those products risk enforcement at the FDAs discretion. While I’m not saying you are risk free if you have unauthorized products, everyone should have a clear understanding of what those risks are. Especially business owners. Simply put, as retailer, if you want to limit your risk for any unauthorized product citations, don’t advertise questionable products that might be seen as appealing to minors and don’t fucking sell to minors. However, just because the FDA hasn’t gone after products before, solely because they are unauthorized in general, doesn’t mean it won’t ever happen. The FDA says in their enforcement priorities: “This approach strikes an appropriate balance between restricting youth access to such products, while maintaining availability of potentially less harmful options for current and former adult smokers who have transitioned or wish to transition completely away from combusted tobacco products.”

To clarify, I'm not advocating that the mostly illegal vape market is a good thing, because it's not. There are some realistic strategies our industry can use to work with the FDA's PMTA process to transition to a legal market overtime without disrupting the market or resulting in massive business closures at once. I'll be discussing this in next week's email. The point of the section above is to provide perspective that the vape industry will likely remain mostly stable for the foreseeable future and that a total market clearing all at once is unlikely based on relevant data.

Who will be the next FDA target?

If there is one product class that is likely to be the next target for larger scale enforcement measures it would be disposables and smaller pod systems that are easy to hide. The FDA generally hasn’t targeted ejuices unless there was questionable child appeal. The FDA recently stated: “New data, such as that from the 2020 National Youth Tobacco Survey (NYTS), will also inform the FDA’s enforcement and other actions, and flavored disposable ENDS will now be an enforcement priority for the agency.” That’s about as clear cut as it gets. We can likely suspect the next major round of warning letters will be in this direction before anywhere else. 

Product Updates and Brand Changes

Nasty Juice will not be importing the other flavors at this time because they were not submitted through PMTA. Only the following will continue to be imported:

• Slow Blow

• Cushman

• ASAP Grape

Aqua - Marina Vapes reportedly is discontinuing all of their flavors besides the following available in freebase ONLY. All other flavors and salts are temporarily discontinued.

• Oasis

• Pure

• Flow

BLVK on the other hand, has rolled out a new Salt Line called Pink. They have also added Banana Ice and Grape Ice to their Salt Plus Line. Their branding has changed slightly for their freebase bottles.

Coastal Clouds has also changed their packaging for their PMTA submissions. It's pretty bland, but I can't imagine the FDA will complain.