31 Health Groups Urge Congress to Reject Appropriations Proposals to Weaken FDA Oversight of E-Cigarettes, Cigars | American Lung Association

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31 Health Groups Urge Congress to Reject Appropriations Proposals to Weaken FDA Oversight of E-Cigarettes, Cigars

(April 18, 2016) - WASHINGTON, D.C.

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Allison MacMunn
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Thirty-one leading public health and medical organizations today urged the U.S. House Appropriations Committee to reject proposals that would greatly weaken Food and Drug Administration (FDA) oversight of electronic cigarettes and cigars and make it harder for the FDA to protect children and public health from these products.

The health groups wrote Appropriations Committee leaders ahead of the committee's consideration at 10:30 a.m. Tuesday of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for Fiscal Year 2017.

The bill includes a provision that would exempt so-called "large and premium" cigars from FDA oversight and block the FDA from implementing a pending rule extending its oversight to all tobacco products, including e-cigarettes and cigars, unless such cigars are exempted.

"No tobacco product should be exempt from regulation," the health groups' letter states. The letter expresses concern the cigar provision could exempt certain cigars, including some cheap, flavored cigars that appeal to kids, and create a loophole tobacco companies would exploit by modifying their products to qualify for the exemption.

The health groups also urged the Appropriations Committee to reject a possible amendment that would weaken FDA oversight of e-cigarettes and cigars already on the market. This amendment would change the so-called "grandfather date" to exempt these products from an important product review requirement to determine whether they appeal to kids or otherwise harm public health.  Such an amendment "would significantly weaken FDA's ability to take prompt action to protect children from the thousands of fruit- and candy-flavored e-cigarettes and cigars that have flooded the market in recent years," the health groups wrote.

These Congressional efforts to weaken FDA oversight come despite a new government survey underscoring the threat that e-cigarettes and cigars pose to children's health. The 2015 National Youth Tobacco Survey released last week showed there was a more than ten-fold increase in current (past-month) e-cigarette use among high school students between 2011 and 2015 – from 1.5 percent to 16 percent. The survey showed that a record-high 3 million middle and high school students used e-cigarettes in 2015.

The survey also showed that high school boys now smoke cigars at a slightly higher rate than cigarettes – 11.5 percent for cigars and 10.7 percent for cigarettes. In 2015, 1.4 million middle and high school students smoked cigars.

The letter was sent to Appropriations Committee Chairman Harold Rogers and Ranking Member Nita Lowey and to Subcommittee Chairman Robert Aderholt and Ranking Member Sam Farr of the subcommittee that oversees FDA funding.

Here is the full letter to House Appropriations leaders and list of groups signing it:

Dear Chairman Rogers, Ranking Member Lowey, Chairman Aderholt, and Ranking Member Farr:

We are writing to express our strong opposition to Section 749 of the House Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for Fiscal Year 2017.  This provision would prevent FDA from implementing a pending rule that gives the agency authority to oversee cigars, e-cigarettes, and certain other tobacco products unless that rule exempts "large and premium" cigars - which could also exempt some inexpensive and flavored cigars - entirely from FDA oversight.  When the Appropriations Committee marks up this bill, we urge you to support efforts to strike this provision and to oppose any amendments that would weaken FDA's current authority to regulate tobacco products.

In 2009, Congress gave FDA authority over the manufacture, sale, and marketing of all tobacco products in order to reduce the disease and premature death caused by these products.  Under that authority, FDA issued a proposed rule in April 2014 that would enable it to begin to oversee cigars, e-cigarettes and other tobacco products that the agency does not currently regulate.  A final rule is expected soon.  Section 749 of this bill would block FDA from using funds to "finalize, implement, administer, or enforce" this rule unless the rule excludes "large and premium cigars" from FDA oversight.

No tobacco product should be exempt from regulation. We are also concerned that under this bill's definition of "large and premium cigars" some machine made cigars, including some that may cost as little as $1.00, would be exempted from FDA oversight and that some flavored cigars could qualify for an exemption. Moreover, we are concerned that the number of cigars exempted from FDA oversight under this definition would increase over time as cigar manufacturers modify their products to qualify for the exemption.  Tobacco manufacturers have a history of modifying their products to avoid public health protections or attain lower tax rates and, because of Section 749, would have a strong incentive to do so again.
Exempting certain cigars from FDA oversight will have serious consequences. There are known health risks linked to cigar smoking, including several types of cancer as well as lung and heart disease.  Exempting large and premium cigars could also inaccurately imply that they are safe to use and pose no harm.  In addition, cigar smoking is not limited to adults. High school boys smoke cigars at the same rate as cigarettes.  Section 749 would create a regulatory loophole that will enable manufacturers of some cheap, fruit- and candy-flavored cigars to escape from FDA oversight and prevent FDA from implementing common sense rules for all cigars.

We also urge you to oppose any amendment that would weaken FDA's existing authority to oversee tobacco products. Specifically, we are concerned about a possible amendment that would change the so-called "grandfather date" to exempt e-cigarettes, cigars, and other currently unregulated tobacco products from an important product review requirement. The Committee included such a provision in last year's agriculture appropriations bill. 

Under current law, manufacturers are required to provide information to the FDA so that the agency can assess the risks to public health of new tobacco products, which are defined as products introduced to the market after February 15, 2007.  Changing this date would exempt e-cigarettes, cigars and other products now on the market from this FDA review and would significantly weaken FDA's ability to take prompt action to protect children from the thousands of fruit- and candy-flavored e-cigarettes and cigars that have flooded the market in recent years. Youth use of e-cigarettes has increased dramatically in recent years and now exceeds youth use of regular cigarettes. An amendment that would exempt these products from an FDA review would take away an important tool the agency could otherwise have to address this problem.

Assessing the risks to public health of different types of tobacco products and determining how they are regulated is best determined by FDA. Tobacco use remains the leading preventable cause of death in the United States and is responsible for an estimated $170 billion in health care costs each year. The Committee should not make it more difficult for FDA to address this public health problem.

Sincerely,
Action on Smoking and Health
American Academy of Otolaryngology - Head and Neck Surgery
American Academy of Pediatrics
American Association for Cancer Research
American Association for Dental Research
American Association for Respiratory Care
American Cancer Society Cancer Action Network
American College of Cardiology
American College of Preventive Medicine
American Congress of Obstetricians and Gynecologists
American Heart Association
American Lung Association
American Medical Association
American Psychological Association
American Public Health Association
American School Health Association
American Society of Clinical Oncology
American Thoracic Society
Association of Schools and Programs of Public Health
Association of State and Territorial Health Officials
Big Cities Health Coalition
Campaign for Tobacco-Free Kids
ClearWay Minnesota
Community Anti-Drug Coalitions of America
Eta Sigma Gamma - National Health Education Honorary
March of Dimes
National African American Tobacco Prevention Network
National Association of County & City Health Officials
National Network of Public Health Institutes
Oncology Nursing Society
Society for Research on Nicotine & Tobacco

CC: House of Representatives Appropriations Committee Members

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