FDA Deeming Rule Coming into Effect August 8, 2016

On May 10, 2016 the FDA issued its final Deeming Rule, extending its authority to all tobacco products excluding accessories. This Deeming Rule does 2 things (1) it deems all products that meet the definition of "tobacco product" under the law, except accessories of newly-deemed products, to be subject to FDA's tobacco product authorities; and (2) establishes specific restrictions that are appropriate for the protection of public health for newly-deemed tobacco products. The Deeming Rule also states if a retailer mixes and/or prepares e-liquids, or creates or modifies vaporizers, the business will be regulated as both a retailer and a manufacturer.

What does this mean for Vixen Vapors? It means that we are now under the control and regulations of the FDA and are subject to all rules, fines, and punishments deemed by the FDA. Because we create our own e-Liquid on premises at each of our three locations it also means that we are now regulated as both a retailer and a manufacturer.

On August 8th, 2016 the FDA Deeming Rule will become effective, below you will find a small portion of the Deeming Rules that we feel are what will affect both retailers and consumers the most:

  • Only sell to customers age 18 or older and check photo ID of everyone under age 27. This will not affect us any since it is already a regulation that we have enforced to the best of our abilities since the company began in 2011.
  • Do not give away free samples. This means that our Flavor Bar will now require the purchase of a Flavor Bar Membership. It will cost $17 for an entire year and you will also have the option to purchase a 30mL for just a dollar more when you purchase the Flavor Bar Membership.
  • Do not sell products in a vending machine (vending machine is permitted when in a facility where those under 18 years are not allowed. This will not affect Vixen Vapors directly as we have never carried a vending machine but it could potentially affect other retailers
  • Compliance period begins for manufacturers to submit a substantial equivalence exemption request, substantial equivalence application or premarket tobacco product application (PMTA) for new, newly deemed finished tobacco products on the market as of August 8, 2016. This means that the 2-year time period all retailers and manufacturers have to submit all products for approval by the FDA begins. It is a long and expensive process and this will be what drives most retailers out of the market.
  • Although not emphasized in the final deeming rule or in FDA guidance, it is important to note that as of August 8, 2016, newly deemed tobacco products will become subject to the “self- executing” statutory provisions of Family Smoking Prevention and Tobacco Control Act.– For example, FDA will be able to take action against manufactures or distributors of newly deemed tobacco products that are “adulterated” (e.g., contaminated with harmful substances or produced or held under unsanitary conditions) or “misbranded” (e.g., bearing labeling that is false or misleading or that fails to meet certain basic labeling requirements).

We here at Vixen Vapors strive to ensure that our customers have the best experience possible while operating within the regulations set forth by the FDA. However, we would like to ask that if you, as a customer and consumer, would like to help us voice our concerns with these regulations driving so many out of the market that you follow the below suggestions.

Find and contact your representatives. These are the people who represent us in the law making process for the federal and local levels. If you’re not sure who your representatives are you can click the following link to find out http://www.house.gov/representatives/find/

Find and contact your Senator. Send them a letter or email or give them a call and let them know your stance on the FDA regulations. You can find your Senator and their contact information here http://www.senate.gov/senators/contact/

Find and contact your Congressman. Send them a letter or email or give them a call and let them know your stance on the FDA regulations. You can find your Congressman and their contact information here http://www.contactingthecongress.org/

Join CASAA, the Consumer Advocates for Smokefree Alternatives Association. They have great resources to use when contacting your representatives. They’re mission statement reads “Our mission is to ensure the availability of effective, affordable and reduced harm alternatives to smoking by increasing public awareness and education; to encourage the testing and development of products to achieve acceptable safety standards and reasonable regulation; and to promote the benefits of reduced harm alternatives.”. The link for their website can be found here http://casaa.org/Home_Page.html


Last but not least VOTE! A lot of representatives are up for reelection in the coming year, you have the ability to vote for people who support vaping and e-cigs. This can help make a difference in the policies that are put into place. If you’re not registered to vote you can go here https://www.usa.gov/register-to-vote to do so.


Vixen Vapors is here to answer all your questions and we have some great resources and tools that we will happily share with you. Safe Vaping out there Ladies and Gents.