FDA & PMTA Updates 10.17.2020

Vape Industry Update

FDA PMTA List Update

The FDA promised to release a PMTA list of products that have been submitted to provide some guidance for retailers, wholesalers and distributors on what they can carry. Although we don’t yet have a date, the FDA is proactively taking steps to accomplish this. Should the FDA not roll out a list, it’s likely that legislators will pass laws requiring the FDA, something we have seen threatened in the past. One manufacturer who submitted their PMTA application for their products told us the FDA specifically requested a spreadsheet for all the products they submitted for before sending out an acceptance letter to help them create a database for these products and make them searchable. With many surprises we have seen this year, the FDA might surprise us with a list before the end of the year. 

4 eJuice Companies Now in the PMTA Substantive Review Stage

This week Charlie's Chalk Dust released public statements and documents reported to the SEC: “On October 12, 2020, Charlie’s Holdings, Inc. (the “Company”) issued an open letter to customers discussing current operations and announcing that the Food and Drug Administration has issued its determination that the Company’s Premarket Tobacco Application (“PMTA”) is sufficiently complete and the Company’s PMTA can enter the substantive review phase.” There are 5 basic stages for the PMTA process. Submission, Acceptance, Filing, Substantive Review, Decision. The most important stage is the Substantive Review and it is also the longest often taking multiple years to complete. However, it’s possible the FDA could move stages along rapidly to accommodate the large amount of submissions they have received. The 3 other companies with similar public announcements for their filings include: Air Factory, Humble and most recently today USA Vape Labs (Naked 100).

Vape Market Growing 25% year to year

While COVID and other regulations have made it challenging for many retailers to thrive this year the projects are still looking positive to a growing marketplace for vapor products. A recent article was released estimating that a continued 25% growth will continue into the next year. 

$1.72 Million Dollars of Chinese Disposables Seized at US Border

US Customs announced that they intercepted a shipment of nearly 86,000 Alphaa Onee Plus disposables on Sept 18th that were listed as “LED lights” on the commercial invoice. The shipment was headed to Lehigh Valley in eastern Pennsylvania with nearly 216 boxes from China. After customs inspected it and reported the incident to the FDA, the FDA determined they violated the Federal Food, Drug, and Cosmetic Act as misbranded consumer goods being imported by an unauthorized agent. The products were destroyed. It was estimated to be worth $1.72 million ($20 per unit). Ouch. Whether or not they would have been accepted if they were truthfully identified to customs is currently unknown.

Filling The Gaps on your Shelves

By now, many of you probably are being impacted by the shrinking availability of e-juice products from some of the most popular brands. A key for success is not to have empty shelves waiting till those items become available again because it’s possible they never will and likely not anytime soon. Instead there are many brands that have similar flavors and replacements that customers may not have had a chance to try in your store. Most of them have also made PMTA submissions including their salts. Here’s a list of the more popular lines and some replacement options to consider.

New Products:

Twist Liquids - Two new flavors have been added to the Twist line up that originally were from the DNA Vapor Line. Pampaya and Dragonthol in 2x60ml bottles 0,3,6mg

Basix TFN will be making it’s way to our warehouse towards the end of the month to replace the Basix original line that we are currently selling through. TFN (Tobacco Free Nicotine) is the only change.