October 28, 2015
“The FDA claims that it lacks the legal authority to change the February 15, 2007 date even though it has used regulatory authority to make a number of decisions that were not spelled out in the initial Act.”
HR 2058 vs. FDA – truly a story of the good, the bad and the ugly.
The FDA, supposedly a champion of public health and science based regulatory policy, has turned a hypocritical blind eye to both. Without regard for exhaustive research studies done by many of the world’s foremost tobacco control researchers, without regard for the inexcusable death toll attributed directly and undeniably to combustible tobacco, without regard for public health, the FDA is aggressively and irresponsibly attempting to virtually eliminate the vaping industry and the potentially life-saving products it offers.
If it becomes law, the FDA’s proposed “deeming regulation” would result in the following:
Premarket Tobacco Product Applications (PMTA)
- PMTAs would be required for every single vaping product not on the market prior to February 15, 2007 (the so-called “grandfather date”).
- Cost estimates for PMTAs – $2 to $10 million dollars. For each individual product.
- PMTAs would wipe out 99% of vaping product manufacturers and retailers.
- Who wins? Big Tobacco.
- Who loses? Everyone else.
Modified Risk Tobacco Product Applications (MRTP)
- Under FDA’s proposed regulation, manufacturers and retailers will not be allowed to inform consumers of crucially important information that would allow them to make informed decisions.
- Any mention of relative safety when compared to combustible tobacco products – prohibited.
- Any mention of reduced risk – prohibited.
- Any mention of harm reduction – prohibited.
- Any mention of the fact that electronic cigarettes do not contain tobacco – prohibited.
- All factual. All supported by science. All needed by consumers to make informed choices. All vitally important in the interest of public health. All prohibited.
- Unless an MRTP application is filed with the FDA. FDA’s estimate for review and rendering of a decision on each MRTP – one year.
- To date, the FDA has not approved a single MRTP application. Including one submitted by Swedish Match that includes more than 100,000 pages of data, spanning more than 40 years of research, on the smokeless product snus. Undeniable research from the country that has the lowest rate of lung cancer in all of Europe.
The Good – HR 2058
The FDA Deeming Authority Clarification Act of 2015
- On April 28, 2015, Representative Tom Cole introduced this bill to the U.S. House of Representatives – HR 2058 .
- The bill has one, and only one, purpose. Rep. Cole:
“I rise to introduce legislation, the FDA Deeming Authority Clarification Act of 2015, to make a technical change to the Family Smoking Prevention and Tobacco Control Act (FSPTCA).”
- What was the basis of the February 15, 2007 date? Rep. Cole:
“Questions may be raised as to why the so-called predicate/grandfather date of February 15, 2007 was picked in the Act. If you look at the legislative history, February 15, 2007 was the date the Act was introduced in the 110th Congress. There was no other specific reason for the date chosen in the Act. Moreover, the 2007 date reflects the predicate/grandfather date for those immediately regulated products–not for products that FDA could choose to regulate at a later time.”
- Does the FDA have the authority to modify the grandfather date? Rep. Cole:
“The FDA claims that it lacks the legal authority to change the February 15, 2007 date even though it has used regulatory authority to make a number of decisions that were not spelled out in the initial Act. The agency should apply that same authority to altering the predicate/grandfather date for newly deemed tobacco products, while maintaining this important transition period.”
- What impact will FDA’s failure to exercise their authority to change the grandfather date have? Rep. Cole:
“Should the agency choose not to alter the date, the February 15, 2007 predicate/grandfather date will make it [prohibitively] costly and create significant [insurmountable] barriers for the industry and the FDA to bring innovative new products that may significantly reduce the harms associated with tobacco to market, and could force the withdrawal of many products that have come to market since February 2007.”
- What about Big Tobacco’s products? Rep. Cole:
“The end result will be that newly deemed tobacco products would be treated much more harshly than immediately regulated products. Specifically, the “look back” period for cigarettes, smokeless tobacco and roll-your-own tobacco products was two years (June 2009 to February 2007) while the period for newly deemed products would be eight years (June 2015 to February 2007) if FDA meets its June 2015 target to publish a final deeming rule, and perhaps longer if FDA does not publish its final rule in time.
It makes no sense that immediately regulated products–which Congress decided were most in need of FDA regulation–get such an advantage over later regulated products.”
- What effect will HR 2058 have? Rep. Cole:
“Even though the FDA already has this authority, the legislation I introduce today will underscore that FDA should choose a new grandfather/predicate date each time the agency deems new tobacco products. Specifically, the bill would make the grandfather/predicate date for newly deemed tobacco products the effective date of the final rule and mimic the 21-month transition period provided for cigarettes, smokeless tobacco and roll-your-own tobacco.
Accordingly, on the crucial issue of path to market, later regulated products would be treated no better and no worse than immediately regulated products.”
The American people are faced not only with an unbelievably irresponsible act on the part of the federal agency entrusted with protecting public health. We are faced with sitting idly by while hundreds of thousands are condemned to a premature, painful and preventable death. If you find that unacceptable – do something about it!
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Dave Coggin has a Master’s Degree in business and spent 35 years in corporate America. He is a co-founder and partner in DIYELS. He has spent the last five years actively researching and following the evolution of the e-cigarette industry. He is a strong proponent of e-cigarettes as the most promising option currently known for tobacco harm reduction. He may be contacted directly at firstname.lastname@example.org .
The opinions presented here are exclusively those of the author. Vaper’s Vortex is offered as a service to our customers and followers. Anyone considering e-cigarettes as an alternative to tobacco cigarettes should seek qualified advice from a medical professional.