Don't Exempt Tobacco Products From FDA Review, AAFP Urges

Academy, Chapters Push House Leaders to Oppose Industry-friendly Bill

December 09, 2015 01:30 pm News Staff
[Hands holding a cigarette and e-cigarette]

The AAFP has again sounded off about legislation that would exempt many tobacco products from the requirements of FDA review laid out by the 2009 Family Smoking Prevention and Tobacco Control Act (TCA). Together with 51 of its chapters, the Academy recently pressed House leaders to oppose H.R. 2058(www.congress.gov), known as the FDA Deeming Authority Clarification Act.

The bill, introduced in April by Rep. Tom Cole, R-Okla., "would entirely undermine the FDA's ability to review tobacco products, such as cigars and e-cigarettes," said the groups in a Dec. 2 letter(3 page PDF) to House Speaker Paul Ryan, R-Wis.; Majority Leader Kevin McCarthy, R-Calif.; and Minority Leader Nancy Pelosi, D-Calif. "As organizations representing family physicians across the nation, we ask you to consider the impacts that FDA's review of these products have on public health."

Under the TCA, the FDA now regulates cigarettes, cigarette tobacco and smokeless tobacco products; the act also ensures states and local governments have the authority to impose additional review or restrictions on these products. In addition, the TCA grants the agency the ability to regulate other tobacco products via a process known as "deeming" them(www.fda.gov) through rulemaking.

Story Highlights
  • The AAFP has again protested legislation that would exempt many tobacco products from FDA review as laid out in the 2009 Family Smoking Prevention and Tobacco Control Act.
  • As stipulated in the act, any tobacco product introduced or modified after Feb. 15, 2007, would have to be reviewed by the FDA before it could be marketed.
  • H.R. 2058, if enacted, would exempt all commercially available tobacco products that are not currently regulated by the FDA from review by changing the statutory grandfather date for the products.

In April 2014, the FDA issued a proposed rule to implement that latter part of the act. Specifically, it would deem currently unregulated products such as electronic cigarettes (e-cigarettes), some or all cigars, pipe tobacco, nicotine gels, waterpipe (hookah) tobacco and dissolvables not already under the agency's authority, as well as future nicotine/tobacco products, as meeting the statutory definition of "tobacco product" and, therefore, subject to FDA regulatory authority under the TCA.

As stipulated in the act, any new tobacco product introduced or modified after Feb. 15, 2007, would have to be reviewed by the FDA before it could be marketed. H.R. 2058, however, would exempt all commercially available tobacco products that are not currently regulated by the FDA from review by changing the statutory grandfather date for the products.

"This would set a concerning precedent for the quality and safety of these products, as well as future products that may enter the market," said the organizations in their letter.

"Furthermore, the proposed legislation would have far-reaching consequences for states and their ability to regulate tobacco, which furthers our concerns," the groups added. "Many state legislatures have proposed to tie state law to the FDA's deeming authority. Were H.R. 2058 to pass Congress and be signed into law, the FDA exemptions would extend to state-level oversight."

As pointed out in a previous letter(3 page PDF) from the AAFP, the Campaign for Tobacco-Free Kids and numerous other health professional and advocacy groups to House members, many stakeholders appear unaware of the allowances the FDA has already made for currently unregulated tobacco products. According to that earlier letter, "FDA's proposed deeming rule provides that newly regulated tobacco products would not have to be pulled from the market while FDA is conducting its review."

Rather, the agency's proposed rule would permit all such currently unregulated products to remain on the market(www.federalregister.gov) as long as the product manufacturers file an application with the FDA within two years after the final rule is issued. Companies could also introduce new products during this two-year period.

That leniency alone stands to have negative effects on public health, said the AAFP and its chapters in their letter -- let alone a blanket exemption from review for these newer products.

Citing the skyrocketing popularity(www.cdc.gov) of e-cigarettes -- particularly among youth -- the groups noted that "a recent study(jama.jamanetwork.com) in JAMA: the Journal of the American Medical Association found that students who used e-cigarettes before starting ninth grade were more likely than their nonuser peers to start smoking traditional cigarettes and other combustible tobacco products within the next year."

Because e-cigarettes are not now subject to FDA review, the agency has no way of determining whether the myriad flavors used in these products are contributing to this rapid rise or present additional health threats.

"This situation clearly illustrates why FDA review is needed," said the groups.

Related AAFP News Coverage
Include Cigars, E-cigarettes in Final Tobacco-deeming Rule, Say AAFP, Other Groups
(8/13/2014)

AAFP, Others Move to Pre-empt Cigar Exemption in FDA Proposed Rule
Academy Calls on Agency to Closely Scrutinize E-cigarettes

(6/17/2014)

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