Congressional appeal to update grandfather date for newly deemed vaping products
Informed sources at ECF have learned of a letter sent November 24 to US Health and Human Services head Sylvia Burwell from Speaker of the House of Representatives John Boehner, requesting that the “grandfather date” for newly deemed tobacco products be reset when the new regulations come into effect. This action, if implemented, will ease the regulatory burden on recently introduced vapor products, and will go a long way toward preventing the stifling of innovation in the industry that many had feared.
A grandfather date is a means for exempting existing entities from new regulations. The term came into use when new rules about voting rights were not to be applied to those whose grandfathers had voting rights. In that particular instance, the rule was used to effect racist policies after the Civil War, but the term “grandfather date” has no racist connotation in and of itself. The classic example is the rule that US presidents must have been born in the US, a country which did not exist when George Washington was born, so he and his fellow founders were exempt from the rule.
In the case of the deeming of tobacco products, the existing grandfather date is February 15, 2007, simply because on that date the Tobacco Control Act was introduced to Congress as part of the Federal Food, Drug, and Cosmetic Act. At that time, of course, vaping products barely existed, as electronic cigarettes had come on the market only a few months earlier, and regulators were virtually unaware of them. They were not considered to be tobacco products by the Food and Drug Administration (FDA) until several years later.
According to FDA bureaucratic procedure, new products coming onto a regulated market must establish “substantial equivalence” with a “predicate product” – one that existed before the grandfather date. The application procedure for establishing substantial equivalence is onerous, and the backlog of such applications at the FDA's Center for Tobacco Products is already large. But if a predicate product cannot be found, the bureaucratic burden for new products is even greater, and would effectively wipe out scores of new products. Innovation, and consequently product variety, would be crushed in the vaping supplies industry.
The House leaders are proposing that the date be reset at the date the new deeming regulations were proposed, April 25, 2014, or at the date of publication of the final rule, predicted to be sometime in 2015. The Speaker's letter was also signed by Majority (Republican) Leader Kevin McCarthy and Fred Upton, Chair of the Energy and Commerce Committee of the House of Representatives, and it was copied to FDA Commissioner Margaret Hamburg, and to Mitch Zeller, the Director of the Center for Tobacco Products at the FDA.