How The FDA Regulations Will Impact Your Vape Business

Attention Vape Shops And Juice Brands

 

Vape shops and e-liquid manufacturers across the United States saw the industry change forever on August 8th, 2016, but almost no one knew what to do. While we’ve covered a lot of facts and figures about the FDA regulations on our webinars and our online courses, this article and presentation will provide a mini “crash course” on how your vape shop or e-liquid brand should adjust to the new regulations.

This article is part 1 of our FDA regulation mini-course. To signup for all training sessions, click here >>>

We know that “e-cigs” help reduce smoking rates among 21 to 35 year-olds from well-researched reports and mounds of anecdotal evidence, but the government won’t allow that line of reasoning to sustain. Because of this oversight we are now relegated to the same harsh regulations as cancer-causing cigarettes. Arguments aside your shop or e-liquid brand needs to accept this as the new reality: Once the new regulations go into full-effect, the Vaping Industry will be treated like cigarettes and all other nicotine based products.

The good news is that e-juice manufacturers and vape shops with products already on the market can continue on, business as usual, until August 8, 2018. This is of temporary relief, since “99 percent of these companies can’t afford these new regulations.” (Alex Clark, legislative coordinator for CASAA).

The FDA regulations affecting vape shops include age verification, FDA approval for all new products, and a crackdown on free e-liquid samples.

Products that existed in the market before February 15, 2007 won’t be subject to these new regulations. However, very few vape products existed before this date so only a small fraction of retailers and manufacturers stand to benefit. If you produced vape product between February 15, 2007 and August 8, 2016, the FDA will require you to submit a Pre-Market Tobacco Application (PMTA), with all the fees and annoyances that go along with that. While your PMTA is under review, your products can remain on the market until August 8, 2019. For products introduced after August 8, 2016, all must submit a PMTA.

To learn from Azim Chowdhury, our first expert on the FDA regulations, scroll to the bottom of this article. For a quick overview of the highlights, see the bullet points below:

What The August 8th Regulations Mean For Vape Shops:

  • No more free samples. You MUST charge for samples
  • No sales to minors under 18. You MUST verify their date of birth by photo ID. Checkout this app for easier ID verifications.
  • You are NOT considered a manufacturer if you modify “Electronic Nicotine Delivery Systems” (ENDS) i.e. if you build coils for your customers. (updated on 1.28.17)
  • You are considered a manufacturer if you mix your own e-liquids, no matter how insignificant or small scale. This means you need to follow the same PMTA requirements as any other e-liquid brand.
  • It’s OK to sell finished, branded products without needing to undergo FDA review
  • Starting in 2018: Required nicotine warnings on product package labels and advertisements: “Warning: This product contains nicotine. Nicotine is an addictive chemical.” NOTE: manufacturers are required to put this on their products, so vape shops just need to work with reputable suppliers.
  • Vape shops are allowed to show and explain the use of an ENDS product without assembling the product.
  • Vape shops are allowed to maintain a product for the customer, such as cleaning, inspecting and replacing coil heads, glass tubes, and seals, as well as general maintenance.
  • Vape shops are allowed to replace coils in an ENDS product for customers, but the coils must be identical coils — same ohm and wattage range.
  • Vape shops are allowed to assemble products that were packaged together in an ENDS kit.

What The August 8th Regulations Mean For E-Liquid Brands:

  • All new products require a PMTA. Existing products have until August 8, 2019 to pass a PMTA
  • Small-scale operations have until February 2020 to meet the requirements – The FDA guidelines define “small scale” as less than 150 full time employees and revenues less than $5 million per year.
  • As of January 2017, there have been no moves to regulate “clean room” requirements, prohibiting certain ingredients, maximum nicotine content limits or prohibiting Internet sales.
  • Manufacturers need documented proof that their products were on the market before August 8, 2016. Proof can include invoices and dated receipts
  • Manufacturers must have submitted a PMTA by August 8, 2018 in order to continue selling their products after August 8, 2019. All vape products not approved by the FDA by or before August 8, 2019 can no longer be sold anywhere.
  • Required nicotine warnings on product package labels and advertisements: “Warning: This product contains nicotine. Nicotine is an addictive chemical.” (effective in 2018)
  • You MUST have ingredient lists on your E-Liquids (effective in 2017)
  • You MUST provide a “Harmful and Potentially Harmful Constituent” report (effective in 2019)

Manufacturers and retailers must keep up to date on new FDA regulations, since the FDA is likely to continue making policy adjustments in the coming years. Also keep in mind that there are many pending lawsuits and litigations happening as we speak to fight all of these new regulations.

But what about regulations on the state level? The next lesson discusses how state regulations compare with the FDA’s Deeming Regulations.

Watch the entire presentation from Vape U III – The Vape Shop Master Summit below.

Author: Jesse Plautz