FDA & PMTA Updates 10.09.2020

FDA & PMTA Updates 10.09.2020 - BLV Delivery

Vape Industry Update

The Major Brands that made changes - Will they even qualify for extensions?

The intent behind all the PMTA submissions for these major brands was to gain the extended year long exemption from enforcement by the FDA. But something really interesting is at play here. Under the FDA’s own rules any products that were marketed prior to August 8th 2016, have the chance to be granted extensions to stay on the market. All others marketed after August 8th 2016 need to be removed. But it goes one step further. This ruling included products as is, meaning, any alterations whether that be for the packaging, flavors, names etc. would disqualify those products from the extension because any modifications after August 8th 2016 would deem it as a “new product or modified product”. So then why in the world would all these brands decide to change up their brands so drastically including mgs, flavors, names, bottle sizes, packaging, and some even adding new flavors completely to their PMTA submissions? Aren’t they voluntarily disqualifying themselves? The FDA specifically requires: “Evidence that your product is a deemed product that was on the market on August 8, 2016, and has not been modified since that date”. That begs the question, are these PMTA applications misleading their customers of their compliance and chances of getting a market extension? Under section 910 of the FD&C Act (21 U.S.C. 387j) that would appear to be the case. Or is it possible that they made these changes to increase the likelihood of receiving PMTA approval all together and weren’t interested in just a 1 year extension. That is far more forward thinking than a simple year long extension which might take as long as a year just to hear back from the FDA in the first place. However, it’s also possible that companies are banking on the Enforcement Priorities Guidance where the FDA states: if premarket applications are submitted by September 9, 2020, FDA intends to continue to exercise enforcement discretion for up to one year pending FDA review, So while manufacturers who are in direct communication with the FDA probably have some level of confidence, that still leaves shop owners, wholesales, retailers and distributors wondering what they can and can’t sell. Especially with so much conflicting information. That's why the FDA’s promise to release a PMTA applied list is so important. We need some sort of guidance, product by product, that says what people can sell. Without it, not only will it be nearly impossible for vape shops to figure out, but also it will make enforcement incredibly difficult if they can’t identify for themselves what they are even looking for. At this point it would be extremely difficult for the FDA to find just 1 vapor store that sells ONLY compliant products vs those that don’t. 

What ENDS products have marketing orders at this time?

The short answer is 0. Meaning NONE. You can check the FDA’s website for which products have marketing orders for premarket tobacco products (PMTA) here. You can also check to see what products have Modified Risk Marketing Orders (MFTP) (a product that can be advertised as healiter compared to smoking) here. Interestingly enough, all of these products come from Big Tobacco. And none of them are actually homegrown vapor products from our industry. If people want to feel confident about the products they are selling in vapor stores for the long term they need to make these lists. The FDA has already acknowledged that why won’t be able to get through all of them in one year. And if discretionary enforcement ends in 1 year, what happens to the people who still never got answers during that time period? 

The PMTA process with Solace

Solace for the first time in a very long time now offers their flavors in Freebase 60ml bottles in 3mg and 6mg. Solace was one of the many brands with large changes but also one of the few to still keep their salts available in 18mg, 36mg, and 48mg. Here’s some of the key points they wanted to share: 

This line of Solace products were submitted for review. Solace is funding one of the largest applied portfolios with many studies detailing the effects of their products. These studies include PK blood analysis, behavioral studies, shelf life studies and many more. 

The current process of manufacturing liquid is changing to become more strict. After manufacturing a batch of e-liquid, manufacturers are required to run similar tests and studies on each production. They are required to prove that the batch of product manufactured is the exact same as what was applied for (meaning they should always taste the same with no variances). Most liquids in the industry use food grade flavorings and sometimes change ingredients depending if something was out of stock with their main flavor house. Solace has sourced its flavoring from research facilities that specialize in flavoring extracts that were built from the ground up for the purpose of inhalation.

This product from Solace is different because of the amount of testing and studies that have gone into its conception. Solace is setting new bars for stewardship in this industry in hopes that others may someday do the same. Solace's main goal throughout this process is to do everything in their power to make sure you still have a product on your shelf for years to come.

Humble announced that they have moved into the Filing Stage with the FDA. It’s exciting to see some brands making progress through the PMTA process. It’s important to note that HopScotch is not Creamy Crunch like previously mentioned. We were misinformed about that from Humble directly. They confirmed Hopscotch is actually now Toffee Vanilla Custard. Creamy Crunch is a brand new flavor.

NY raised the age of tobacco purchase to 25?

This is not a joke. A legislator in New York is attempting to pass legislation to raise the age of tobacco purchase to 25 years old

No New Warning Letters

There are no new warning letters published by the FDA this week for vapor products. This marks a full month since Sept 9th when the FDA added ALL ENDS products to their list of priorities and we still have not seen the raids the doomsayers predicted…


If there is one thing you should do this year to make an impact on advocacy is VOTE. Election day is just around the corner and there is no more important time in our history than now to cast your choice for who better services you, your family, your business and the community at large. There are many issues affecting our industry from the local, state and federal levels including taxes, potential flavor bans, current flavor bans, and additional regulations that may not be warranted. As an American, it is your duty, as it is your right, to vote. Here’s some of the key bills on the VTA’s website. You can now sign up to be a VTA member for just $25. Encourage your customers to become members to help fund one of the most pivotal groups that’s keeping us around. As the VTA stated: “you vote is essential in making sure legislators at all levels of government who support the vapor industry are elected. Doing so will help increase our chances in city halls, statehouses and in DC to make sure that industry-killing regulations are not enacted

Be sure to encourage your customers as well. Let's make sure #WeVapeWeVote actually means something.

No new products to report.