WASHINGTON, D.C. — Efforts to change the grandfather date for affected products under the Food and Drug Administration's (FDA) proposed deeming rule, particularly electronic cigarettes, are winding their way through Congress.
On Tuesday, the House Appropriations Committee voted in favor of an amendment to the FY 2017 Agriculture Appropriations Bill that would change the predicate date — also known as the grandfather date — for e-cigarettes, cigars and other tobacco products covered under the deeming rule from Feb. 15, 2007, as it is now proposed, to whatever date the FDA's final deeming rule goes into effect.
The bipartisan amendment, introduced by Rep. Tom Cole (R-Okla.) and Rep. Sanford Bishop (D-Ga.), passed the committee by a 31-19 vote.
In its draft deeming rule, the FDA proposed that e-cigarettes be held to the same grandfather date as traditional cigarettes, which is Feb. 15, 2007. That date was spelled out in the Family Smoking Prevention and Tobacco Control Act of 2009. However, since e-cigarette and vaping products are relatively new compared to other tobacco products, many in the industry have argued that the February 2007 date would effectively remove most products from the market.
"This is fantastic news for public health and small businesses," George Conley, president of the American Vaping Association (AVA), said of the House committee's passage of the amendment. "The vapor industry and its consumers do not oppose sensible regulation, but the FDA's proposal is anything but sensible."
Conley added that modernizing the predicate date will not interfere with the FDA's ability to regulate vapor products.
"All this change does is force the agency to regulate the vapor products rather than just ban 99 percent-plus of products on the market today," he said.
House Panel OKs New FDA Deeming Rule Grandfather Date
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The Cole-Bishop amendment, aside from changing the predicate date, also directs the FDA to set product standards, dictate labeling requirements, require retailer registration to effectuate youth access compliance checks, and ban self-service displays and vending machines in stores that permit minors. The amendment restricts the advertising of vapor products, too.
Still, the House committee's vote is just one step in the process of moving back the grandfather date in the deeming rule. The 2017 spending and budget bills may not be voted on by the full House and Senate until the end of the year, so uncertainty in the market will continue to linger, said the AVA.
"This is only the start of a long fight to keep this provision in the overall budget bill. The industry and its consumers need to put forth a massive effort to ensure that both Democrats and Republicans do not lose sight of the importance of this policy change," Conley urged.
Here is the bill:
https://www.congress.gov/bill/114th-congress/house-bill/2058
114th CONGRESS
1st Session
H. R. 2058
To amend the Federal Food, Drug, and Cosmetic Act to provide for a certain effective date with respect to deemed tobacco products, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
April 28, 2015
Mr. Cole introduced the following bill; which was referred to the Committee on Energy and Commerce
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to provide for a certain effective date with respect to deemed tobacco products, and for other purposes.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the “FDA Deeming Authority Clarification Act of 2015”.
SEC. 2. DATE FOR APPLICATION OF FEDERAL FOOD, DRUG, AND COSMETIC ACT TO DEEMED TOBACCO PRODUCTS.
Section 901(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387a(b)) is amended—
(1) by striking “This chapter shall apply” and inserting the following:
“(1) IN GENERAL.—This chapter shall apply”; and
(2) by adding at the end the following new paragraph:
“(2) DEEMED TOBACCO PRODUCTS.—For each tobacco product deemed subject to the requirements of the Act pursuant to paragraph (1), each reference in sections 905(j) and 910(a)—
“(A) to ‘February 15, 2007’, shall be considered to be a reference to ‘the effective date of the regulation under which a tobacco product is deemed subject to the requirements of this Act pursuant to section 901(b)(1)’; and
“(B) to ‘21 months after the date of enactment of the Family Smoking Prevention and Tobacco Control Act’, shall be considered to be a reference to ‘21 months after such effective date’.”.
Congress.gov
