AAFP to Congress: Stop HR 2058 Before it Kills FDA Tobacco Review Authority

Thursday, Dec. 2, 2015

Leslie Champlin
Senior Public Relations Strategist
American Academy of Family Physicians
(800) 274-2237, Ext. 5224

LEAWOOD, Kan. — Don’t cripple the FDA’s ability to protect the public from potentially harmful effects of cigars and e-cigarettes. That’s the adamant message from family physicians across the United States.

The message came in a letter, sent to Congress by the American Academy of Family Physicians and 51 constituent chapters, urging U.S. representatives to vote against the FDA Deeming Authority Clarification Act or HR 2058.

“Review of new tobacco products is crucial for the protection of public health,” the letter says in reference to e-cigarettes. “Since these products have entered the market, there has not been an independent assessment of the health risks of the substances these products contain and emit, the amount of nicotine they deliver, the quality of the manufacturing processes used, the effect of flavors on youth, or other factors to determine if they will have a detrimental effect on the nation’s health. The decision to market a potentially addictive and harmful product should not be left to manufacturers alone; an independent science-based assessment by the FDA is essential.”

HR 2058 undermines the impact of the Family Smoking Prevention and Tobacco Control Act, enacted in 2009. The Tobacco Control Act requires all tobacco products introduced since Feb. 15, 2007, to undergo FDA review before being sold. HR 2058 changes the effective date for that review.

Not only would the change allow more tobacco products on the market without FDA approval, but it also would impinge on states’ ability to regulate tobacco, the letter says.

“Many state legislatures have proposed to tie state law to the FDA’s deeming authority,” the AAFP letter says. “Were HR 2058 to pass Congress and be signed into law, the FDA exemptions would extend to state-level oversight. Thus the states would lose any ability to regulate or review tobacco products.”

Since 2009, the AAFP has strongly urged legislative and regulatory efforts to control tobacco products. The organization’s policy on tobacco products includes calls for:

  • Rigorous research on e-cigarettes to assess their safety, quality, and efficacy as a potential cessation device.
  • The cessation of access and marketing of e-cigarettes to children and youth.
  • Enhanced access to tobacco cessation services for all patients regardless of health insurance.
  • More aggressive FDA Center for Tobacco Products regulation of all products containing nicotine     including e-cigarettes.
  • Evidence-based tobacco control policy changes, including increased tobacco excise taxes.
  • Smoke-free indoor air laws covering all public and workplace settings.
  • Availability of smoke-free housing.
  • Tobacco-free pharmacies.
  • Comprehensive tobacco control programs using tax revenue.

“Because e-cigarette manufacturers are not yet required to undergo FDA review prior to introducing new products to the market, the FDA is not able to assess whether the thousands of flavors used in these products would likely contribute to the rise in youth e-cigarette use or present other health concerns,” the letter says. “This situation clearly illustrates why FDA review is needed.”



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Founded in 1947, the American Academy of Family Physicians represents 136,700 physicians and medical students nationwide, and it is the only medical society devoted solely to primary care.

Family physicians conduct approximately one in five of the total medical office visits in the United States per year – more than any other specialty. Family physicians provide comprehensive, evidence-based, and cost-effective care dedicated to improving the health of patients, families and communities. Family medicine’s cornerstone is an ongoing and personal patient-physician relationship where the family physician serves as the hub of each patient’s integrated care team. More Americans depend on family physicians than on any other medical specialty.

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