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BREAKING: FDA Deeming Authority Clarification Act of 2017 to reboot Cole-Bishop Amendment

Posted by Matt Rowland on

In Breaking News, Congressmen Tom Cole of Oklahoma and Sanford Bishop of Georgia have just issued a press release announcing their joint proposal of a new piece of pro-vaping legislation.  Named The FDA Deeming Authority Clarification Act of 2017, this nine-page proposal is likely meant to replace the previously proposed and highly-regarded Cole-Bishop Amendment to the FDA deeming regulations.

Otherwise referred to as HR 2058, last year’s Cole-Bishop Amendment has been stalled in Congress for nearly a year.  It’s primarily objective is to redefine the controversial predicate date of February 15, 2007 which currently applies to approximately 99 percent of all vaping technology and e-cigs currently on the market.

The FDA Deeming Authority Clarification Act of 2017 proposes a new predicate date

According to the existing FDA deeming regulations, all products released to market after the predicate date must comply with the very expensive Pre-Market Tobacco Applications (PMTA) process which can cost an estimated $1 million or more per product.  Estimated time for application approval is still largely undetermined, but the FDA claims that the process might take as many as 5000 man-hours.

(Related Article:  NEW FDA E-CIG REGULATIONS AND THE MILLION-DOLLAR PMTA PROCESS)

Should The FDA Deeming Authority Clarification Act of 2017 pass both houses of Congress completely intact, it will theoretically redefine this predicate date by moving it forward “21 months after the date of enactment of the FDA Deeming Authority 3 Clarification Act of 2017.” The two Congressmen have issued statements that include the following portions.

“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.  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.”
-  Representative Tom Cole
 
“Vapor products offer a promising path for harm reduction for those seeking to quit or limit their smoking.  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.”
-  Representative Sanford Bishop

The FDA Deeming Authority 3 Clarification Act of 2017 is defined as a newly proposed amendment to the Federal Food, Drug, and Cosmetic Act of which the FDA deeming regulations were originally derived.  The newly announced Cole-Bishop proposal is published on the Cole.house.gov website in its entirety.

(Related Article: TWO NEW CONGRESSMEN ENDORSE COLE-BISHOP AMENDMENT TO FDA E-CIG REGULATIONS)


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