Read Full Ag-FDA Appropriations Letter for Conference 9.11.18

Excerpt:

As you proceed to conference on H.R. 6147, which includes the FY 2019 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations bill, we urge you to reject all tobacco riders, including the one in the House Agriculture-FDA Appropriations bill that would weaken FDA oversight of tobacco products, including e-cigarettes and cigars.

The tobacco rider in the House Agriculture-FDA Appropriations bill would completely exclude “large and premium cigars” from FDA oversight. We agree with FDA’s conclusion in 2016 that there is no appropriate public health justification for exempting premium cigars from FDA oversight. FDA’s scientific review found that all cigars are potentially addictive and pose serious negative health risks, including about 9,000 premature deaths a year.

The House rider would exempt from FDA oversight more than just hand rolled, expensive cigars. The rider defines “large and premium cigars” so broadly that it creates a loophole that manufacturers will surely exploit to exempt cheap, machine-made, flavored cigars from any FDA oversight. These cigars appeal in particular to youth. The prospect of exempting flavored cigars that cost as little as $1 or $2 from any restrictions on flavors, youth access rules, and other basic public health protections is troubling given the substantial levels of youth cigar smoking. Each day more than 1,800 kids under 18 try cigar smoking for the first time. More than 1.1 million high school students were current smokers in 2017 according to the National Youth Tobacco Survey.

The House rider would also exempt cigars that entered the market between February 15, 2007 and April 25, 2014 from a scientific review of their health risks and appeal to youth. By eliminating the obligation of manufacturers to submit these products for review by FDA, the provision would make it much harder for FDA to address concerns about the many kid-friendly flavored cigars that entered the market during this period.

In addition to the cigar-specific provisions, the House rider would also make it easier for manufacturers to introduce tobacco products to market in the future. By changing which products can serve as “predicate products”, it would enable more e-cigarettes, cigars, and other tobacco products to be eligible for a less rigorous “substantial equivalence” review by FDA instead of a full review of these products’ effect on public health.

There are clear health risks if a tobacco product is not thoroughly reviewed and evaluated before being allowed on the market. E-cigarettes are the most popular tobacco product among youth, and FDA has not fully assessed their appeal to kids or impact on health. The House rider opens the door for the next generation of these products to escape a complete and thorough review by FDA.

Read Full Ag-FDA Appropriations Letter for Conference 9.11.18