CASAA Call to Action: Speaker of the House John Boehner (a smoker), House Majority Leader Kevin McCarthy, and Fred Upton, Chair of the Energy and Commerce Committee recently sent a letter to Secretary Burwell of the Department of Health and Human Services (the parent organization) with CCs to FDA Commissioner Hamburg and Director Zeller, Center for Tobacco Product at the FDA. A remarkable turn of events and my first reaction concerned the authenticity of the letter. It is authentic and I verfied same directly with Speaker Boehner’s office and so did Julie Woessner, the president of CASAA. The letter link and the letter also appears below:
This letter is huge! When three very powerfull and influential politicians advocate some changes to the FDA’s Deeming Regulations, all of us should be very happy. The letter spells out some very valid and reasoned thoughts in an effort to advacate changing the effective date of the “grandfather clause” from February 15, 2007 to: “…that the grandfather date for them be set at either April 25, 2014 (the date the proposed deeming regulation was published) or the date the final rule is published.”
In a nutshell and simplified, the current grandfather date of February 15, 2007 effectively means that 99% of the vaping products currently on the market today would be required to obtain new product approval, which would be very expensive, time consuming (years), and involve a tremendous amount of documentation. When I say expensive I mean each product could easily cost roughly $100,000.00. The net net effect is that most vendors could not afford this cost and burden and the Vaping industry would be decimated. Innovation would be non existent. With a revised grandfather date of “the date the final rule is published” which is my preference or the other option of April 25, 2014, vaping products would not have to endure these huge costs and mountains of paper work. They are effectively “grandfathered” since they were available for purchase in the USA based on the revised effective date which the letter advocates. Innovation would continue, and Vaping would survive. Most importantly, millions of additional lives would be saved as smokers embrace vaping. These grandfathered products would still need to obtain a far less burdensome “substantial equivalence” approval from the FDA which is covered later in this section. Having said this, other “planed” provisions of the FDA deeming regulations may have a negative effect on vaping. For example, many vapers think the FDA will attempt to ban Internet sales and specific flavors. Finally, new products that did not qualify as “grandfathered” would still need to obtain new product approval and endure the time consuming procedures, very high costs and extensive paper work for approval. Another option for some new products entering a FDA regulated market is to obtain approval using an application for “substantial equivalence” with a “predicate product”. A predicate product is one that existed before the grandfather date and is a required provision of this procedure. This procedure is less burdensome but still involves paper work, application fees, and could take years for a product to gain FDA approval. It’s also worth noting that all vaping products sold on or after the effective date of the proposed FDA deeming will need to obtain FDA approval using one of the procedures documented above.
Their is a school of thought in the Vaping Community which understandibly advacates the elimination of the FDA Deeming regulations. While I think these are lofty goals they are not realistic for the following reasons:
– Multi billon dollar industries always get regulated. No exceptions!
– Their are some valid provisions in the FDA Deeming that are good. To name just a few: best practices for juice production, labeling, reasonable advertising guidelines, reasonable protection for kids under 18, and hardware disclosures.
– The Vaping Community lacks media traction. Nearly every single day vaping gets inaccurately portrayed in the media.
– The Vaping Community is not cohesive and contains numerous “factions”. Some of whom are very apathetic and others appear to live on another planet.
Please don’t assume that I welcome the intervention of the FDA. I originally wanted to eliminate the FDA entirely from the regulatory equation. I recently came to the painful realization that this could never happen. The tipping point for me was the deplorable performance of the Vaping Communities leadership which I documented in my post titled A Vaping Tragedy. Rather, I’m realistic and believe that reaching a reasonable compromise always makes both parties slightly uncomfortable. When the “wind is at your back” via this political support, you make the best of it via an imperfect agreement, guided by realistic expectations. Finally, props to SmokeyJoe aka Oliver Kershaw the founder and head mucky muck of ECF for starting my journey with this post.