The FDA Deeming Regulations and Mister E Liquid

As most of you know, the FDA released its deeming regulations for tobacco products on May 5, 2016, with an effective date of May 10, 2016. There was much in the way of common sense regulation in the 499 page document. We support a ban on sales to minors. We support truth in labeling. We support clean manufacturing conditions and good manufacturing practices. In fact, Mister E Liquid is already in compliance with most of these regulations and has been for some time.

We oppose the predicate date of February 15, 2007. All products brought to market since that date will need to go through an extremely costly Pre-Market Tobacco Product Application (PMTA) process. Cost estimates for this process range from one to three million dollars PER SKU!

Let’s assume a company produces 50 flavors in three different bottle sizes and six nicotine strengths. That’s 900 SKU’s. The cost estimate for said company to complete the PMTA on all of those products ranges from $900 million to $2.7 billion. Given that most companies in this industry are small businesses that were founded since 2007, it’s not likely that any of them will be able to complete the PMTA on all of their products, and most won’t be able to complete it on any products. If the predicate date stands, the death knell will chime for this industry.

What is this industry? For the most part, it consists of small businesses managed and run by passionate people who deeply believe they are helping people. An estimated 17,000 (or more) vaping related companies contribute to our economy. They contribute in excess of 100,000 jobs. They contribute income to 100,000 families to buy homes, pay rent, buy cars, buy food, pay utilities and contribute to our great society in so many other ways.

But, all is not lost. There is a chance to change the predicate date, and if the predicate date is changed, the industry can survive. It will never be the same, but it can survive. There are two pieces of legislation in congress that would change the predicate date. Rep Tom Cole’s bill, HR2058, was introduced April 28, 2015 and is currently referred to the House Committee on Energy and Commerce. This bill will permanently change the predicate date to August 8, 2016. The other is the Cole-Bishop Amendment to the 2017 Agriculture and Rural Development Appropriations Bill. This would also change the predicate date, and while it is not the permanent solution that HR2058 is, it is a bi-partisan effort that has moved through committee.

What are we doing? As members of AEMSA, SFATA, and CASAA, we are participating in litigation that we hope will help. We are also working with our employees to craft individual letters to their members of Congress. Mister E Liquid supports CASAA and all that it does, and they make it easy to send a “form email” to each member expressing your support for HR2058 and the Cole-Bishop Amendment. We believe that the impact of an individually crafted letter on paper is much higher than a form email, and each employee has committed to sending letters.

What can you do? You can send a letter too! Our congressional representatives work for US, their constituents. Their mandate is to listen to us. If you have found your way to this blog, you are most likely a vaper, or you at least know and love a vaper. Maybe you even work in the industry or know and love someone who does. Make your voice heard. You can help make a difference. Here is a link to a template for your letter. We encourage you to “make it your own”. It’s a guide with some facts and talking points. If you need any help crafting a letter, contact us! We’re easy to find via Facebook, our Contact Us page, or by phone at 855-MISTERE (855-647-8373). Let’s do this!

1 thought on “The FDA Deeming Regulations and Mister E Liquid”

  1. Well done Russ Swanson!! I appreciate the knowledge and care Mister-E’s has in “hopefully” keeping this industry up and running for customers who what to quit smoking cigarettes!! The template is perfect!!

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