Cole and Bishop Introduce The FDA Deeming Authority Clarification Act of 2017
February 16, 2017
Washington, D.C. – Congressman Tom Cole (OK-04), along with Congressman Sanford Bishop (GA-02) introduced legislation today to ensure sensible regulations for newly “deemed” tobacco products by the Food and Drug Administration (FDA). Named the “FDA Deeming Authority Clarification Act of 2017,” this legislation would amend the Federal Food, Drug and Cosmetic Act to change the predicate date for newly “deemed” tobacco products, impose common-sense licensing and advertising guidelines for vapor products and direct the FDA to establish product standards for vapor product batteries.
In 2009, the Tobacco Control Act gave the FDA authority to regulate tobacco products under a “deeming process.” Instead of using its flexibility to grandfather existing products, in 2016, the FDA finalized a deeming rule to assert jurisdiction over cigars, pipe tobacco and vapor products, using the February 15, 2007 predicate date set in statute.
Without this legislation, the FDA effectively is making it more difficult for vapor products to come to market than cigarettes, even though Public Health England, the British version of our Department of Health and Human Services published a report stating that vapor is 95% less harmful than a cigarette. This legislation builds on the Cole-Bishop Amendment which was included in the House version of the Fiscal Year 2017 Agriculture Appropriations Bill.
“While there is disagreement about whether certain tobacco products should be regulated or not, there should be agreement that new regulations should apply to products moving forward, and not retroactively,” said Cole. “Inconsistent authority like this will be detrimental and unfair to many manufacturers and businesses. This legislation preserves the FDA’s ability to regulate these products on part with cigarettes, grandfathers currently available products and then requires the FDA’s approval before any new product is introduced."
“Vapor products offer a promising path for harm reduction for those seeking to quit or limit their smoking,” said Bishop. “This legislation would ensure the FDA’s regulatory process does not limit the availability of safer tobacco options for those seeking to make use of them.”
To read more about the FDA Deeming Authority Clarification Act, please click here.