May 8, 2015
“We do not believe that we have the authority to alter or amend this grandfathering date, which is set by statute.”
How ironic is it that the greatest single challenge facing thousands of small vaping stores is the result of nothing more than a clerical formality?
The reason the February 15, 2007 grandfather date exists? That was the date the Tobacco Control Act was introduced to Congress. That’s it. That’s the whole story behind that date. And it may take a courtroom battle to change it. What would be the basis of that battle and could the case be won in court? An attorney and a Congressman offer some insight.
Jeff Stier, Senior Fellow at the National Center for Public Policy Research, Washington D.C.
On August 8, 2014, the last day the FDA accepted comments to their proposed deeming regulations, Stier submitted a comment to the FDA . In his comment, he questions several aspects of the FDA’s interpretation of the TCA.
- FDA’s current proposed rule is based on an erroneous interpretation of the statute. The agency does have the authority to change the substantial equivalence grandfather date for newly deemed tobacco products to a more current date.
- The statute gives FDA direct authority over specific, tobacco products on the market as of February 15, 2007. That date does not apply to products that were not on the market at that time.
- The proposed rule would harm public health by failing to provide oversight of industry efforts to develop safer alternatives.
- The deeming regulation based on the 2007 date would stifle innovation of lower risk products. Products not considered when TCA was enacted – they did not exist.
- The FDA has directly acknowledged that no future products resulting from technological innovation would qualify for substantial equivalence: “Moreover, new products that come on the market in the future would never be grandfathered tobacco products because they would be coming on the market after February 15, 2007.”
- The 2007 date applies to products the FDA must regulate under the statute, specifically cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco products. Not to products that must first be deemed tobacco products by FDA.
- Congress stated the purpose of the statute was in part: “to promote cessation to reduce disease risk and the social costs associated with tobacco-related diseases.” Failure of the FDA to exercise their statutorily granted discretion regarding the grandfather date would be a failure of the FDA to meet the requirements of the statute.
- The statute allows for the substantial equivalence option for cigarettes. FDA misinterpretation of the statute excludes that option for less harmful, non-combustible products and forces the prohibitively expensive Pre Market Tobacco Application as the only option.
The Hon. Tom Cole of Oklahoma in the House of Representatives, Tuesday, April 28, 2015. This was Rep. Cole’s speech to the House when introducing bill HR 2058, the “FDA Deeming Authority Clarification Act of 2015”, that would eliminate any reference to the February 15, 2007 grandfather date in the Family Smoking Prevention and Tobacco Control Act (FSPTCA).
- The specific date of February 15, 2007 appears in the FSPTCA because it was the date the Act was introduced to 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. [emphasis mine]”
- “…the agency [FDA] stated it would maintain the February 15, 2007 as the predicate/grandfather date for newly deemed products even though the FDA has the regulatory discretion to choose a different date [emphasis mine].
- “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 [emphasis mine].
- “…will make it costly and create significant 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 [emphasis mine]”.
- “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)… [emphasis mine]”
- “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 [emphasis mine]”.
- “Accordingly, on the crucial issue of path to market, later regulated products would be treated no better and no worse than immediately regulated products [emphasis mine].”
Could the case be won in court? We may never know. What we know is that “harmless” is irrational. We know that harm reduction is compelling, and achievable. We know that public health should be based on science, not ideology. We know that reducing smoking related death and disease cannot, must not, be treated as a “contest”.
We know a lot. Only time will tell if what we know, is enough.
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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.