Tuesday, December 02, 2014

U.S. House Members Urge FDA to Change Grandfather Date in Proposed Deeming Regulations

Speaker of the House John Boehner, along with the House Majority Leader Kevin McCarthy and Chair of the Energy and Commerce Committee Fred Upton, have sent a letter to the FDA and Center for Tobacco Products urging that the proposed deeming regulations be changed. Specifically, they have requested that the FDA change the grandfather date of February 15, 2007 to either April 25, 2014 (the date the deeming regulation was published) or to the effective date of the final deeming regulation.

The representatives' concern is that with the proposed grandfather date, it will be virtually impossible for current electronic cigarette products to claim substantial equivalence to a predicate product. Therefore, virtually every electronic cigarette company will need to file a new product application, which is a burdensome and expensive undertaking. The net result could be the removal of thousands of electronic cigarette products from the market.

The letter asks the FDA to change the grandfather date "to ensure that these innovative products are not snuffed out by overly burdensome regulations."

According to the letter: "As a practical matter, many newly deemed products could be removed from the market. ... [T]he cost and barriers surrounding a new product submission would largely prevent new entries, posing an unwarranted regulatory barrier to innovation. ... This is a critical issue, and we request that manufacturers of newly deemed tobacco products have the same market entry opportunities as manufacturers of cigarettes and other currently regulated tobacco products. ... Any final provision on this issue should ensure equity among all regulated tobacco products and encourage innovation while achieving the purpose of the law."

The Rest of the Story

I agree with the request that is being made in this letter. However, I would go further and recommend that the FDA not require new product applications for any products. Doing so stifles innovation and makes it difficult if not impossible for newer products that may be safer and more effective to enter the market.

These comments are similar to those expressed by Altria Client Services, Lorillard, and the American E-Liquid Manufacturing Standards Association.

They also echo my initial comments about the proposed deeming regulations, when I wrote:

"The regulations require pre-approval (or substantial equivalence determinations) for all new electronic cigarette products."

"This provision is going to present a huge obstacle to innovation in this category. The newer products tend to be safer and more effective, so it makes no sense to allow the older products to remain on the market while requiring pre-approval for the newer and better products. The implications of this regulation is going to depend on the evidence that the agency requires to approve these applications. A stringent interpretation of the regulations will put a huge dent in electronic cigarette innovation and could limit the expansion of the market. In addition, this provision is going to place an undue burden on smaller companies and give a huge advantage to larger companies, including the tobacco companies that have entered the e-cigarette market."

"The regulations require pre-approval or substantial equivalence determinations of almost all existing electronic cigarette products."

"This provision is going to wreak havoc with the industry. The agency is determined that it cannot extend the grandfather date beyond 2007. This means that any product not on the market as of 2007 (which includes almost all electronic cigarette products) must either obtain a new product approval or a substantial equivalence determination. Given the snail's pace at which the FDA has processed cigarette substantial equivalence determinations, this could result in a literal quagmire of pending applications for the more than 250 brands of e-cigarettes currently on the market."

(Thanks to Greg Conley for the tip.)

Disclosure: I have not received any funding or compensation from the tobacco, electronic cigarette, or pharmaceutical industries. However, I am seeking funding from several electronic cigarette companies to conduct a behavioral study on the effects of electronic cigarettes on smoking behavior. 

1 comment:

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