A Public Participation Forum for the FDA Center for Tobacco Products and its Federal Advisory Committee (TPSAC)

From KTVZ.COM News Sources

WASHINGTON — A group of senators, led by Jeff Merkley of Oregon and Sherrod Brown of Ohio, called on the Food and Drug Administration’s Center for Tobacco Products on Monday to reverse a recent decision that could potentially open the door to the possible sale of tobacco candy – addictive and dangerous dissolvable tobacco products. 

Merkley and Brown were joined in this effort by Senators Tom Harkin (IA), Barbara Mikulski (MD), Ron Wyden (OR), Bob Casey (PA), Al Franken (MN), Michael Bennet (CO), Jeff Bingaman (NM), Richard Blumenthal (CT), Frank Lautenberg (NJ), and Bernie Sanders (VT). 

In a letter to the FDA, the group questioned why the agency had chosen not to exercise its ability to regulate a new form of smokeless tobacco products produced by Star Scientific, despite asserting jurisdiction over other dissolvable products. The Senators expressed concern that this determination could encourage other tobacco manufacturers to push ahead in selling flavored, dissolvable tobacco candy, such as R.J. Reynolds’ “Sticks”, “Strips” and “Orbs”. 

“Given the compelling evidence that these products pose an immediate and significant health risk to children, we urge CTP to reconsider its decision that certain dissolvable tobacco products are outside CTP’s current authority,” wrote the senators. 

The group noted that dissolvable tobacco poses very clear health risks, particularly for children. In April 2010, the medical journal Pediatrics found that dissolvable tobacco products can poison and ultimately cause death in children. The Indiana Poison Center estimates that dissolvable tobacco products like Camel Orbs contain between 60 to 300 percent of the nicotine found in one cigarette, an amount of nicotine that can cause noticeable health effects in both adult and youth users. Medical experts estimate that ingesting 10 to 17 Orbs could kill an infant. 

Full text of the letter is below. 

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June 16, 2011 

The Honorable Margaret Hamburg Commissioner Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20903 

Dear Commissioner Hamburg: 

When Congress passed the Family Smoking Prevention and Tobacco Control Act granting the Food and Drug Administration (FDA) authority over tobacco products, it intended to have dissolvable tobacco products fall under the definition of smokeless tobacco and therefore be immediately subject to Chapter IX requirements. Therefore, we are deeply concerned about the Center for Tobacco Products’ (CTP) determination that Star Scientific’s products, Ariva-BDL and Stonewall-BDL, are not currently subject to Chapter IX requirements. This failure to immediately regulate such products as smokeless tobacco creates a dangerous loophole. 

Although we recognize that FDA has not yet asserted jurisdiction over the full range of tobacco products potentially subject to regulation under the statute, FDA does have authority over smokeless tobacco products. For this reason, we do not understand why Ariva-BDL and Stonewall-BDL should not be categorized as “smokeless tobacco products” and subjected to immediate FDA regulation. We fear that this action will encourage other tobacco companies to introduce new forms of dissolvable tobacco products in an effort to avoid regulation as smokeless tobacco products, an outcome that Congress intended to prevent. Already, another tobacco manufacturer, R.J. Reynolds, recently reintroduced dissolvable, candy-like Camel products, including Sticks, Strips and Orbs, in Charlotte and Denver. Yet another manufacturer, Altria has debuted its “smokeless tobacco stick” and is test marketing it in Kansas. The recent proliferation of dissolvable tobacco products—which can easily end up in the hands of children—in the marketplace, makes FDA’s decision particularly disturbing. 

A research study published April 19, 2010, by the medical journal Pediatrics found that dissolvable tobacco products can poison and ultimately cause death in children. The Indiana Poison Center estimates that dissolvable tobacco products like Camel Orbs contain between 60 to 300 percent of the nicotine found in one cigarette, an amount of nicotine that can cause noticeable health effects in both adult and youth users. Medical experts estimate that ingesting 10 to 17 Orbs could kill an infant. Given these dangers, in March 2010, FDA sent a letter to the manufacturers of dissolvable tobacco products expressing concern that children and adolescents may find dissolvable tobacco products particularly appealing, given the brightly colored packaging, candy-like appearance and easily concealable size of many of these products. In the letter, FDA also expressed concern that the use of the products could lead to nicotine addiction and could cause significant health problems from the ingestion of too much nicotine. 

In addition to our concerns that these products entice children to use tobacco, we also believe that the unregulated marketing of these products is not “appropriate for the protection of public health” because they may perpetuate tobacco use among people who would otherwise quit all tobacco use as a result of smokefree laws. Past marketing campaigns of dissolvable tobacco have explicitly encouraged smokers to use these products to ingest nicotine in smokefree environments. 

FDA’s acknowledgement of the danger to children posed by dissolvable tobacco makes the recent determination, that Ariva-BDL and Stonewall-BDL are not currently subject to Chapter IX requirements of the FDCA, to be particularly puzzling. Section 900 of the statute indicates that smokeless tobacco means any tobacco product that consists of cut, ground, powdered, or leaf tobacco that is intended to be placed in the oral or nasal cavity. Based on this definition, these products would appear to be smokeless tobacco products and therefore fall under the immediate regulatory authority of Chapter IX. 

We would like a clear and full explanation of your decision that Ariva-BDL and Stonewall-BDL, which Star Scientific publicly declared to be smokeless tobacco products, are not smokeless tobacco products and therefore not currently subject to Chapter IX of the FDCA. We also request answers to the following questions: 

· Does FDA believe that earlier versions of Stonewall and Ariva currently on the market meet the definition of “smokeless tobacco” in the statute and therefore are currently subject to Chapter IX requirements? 

· Does FDA believe that other dissolvable tobacco products, including Camel’s Sticks, Strips, and Orbs, are smokeless tobacco products and currently subject to Chapter IX requirements? 

· Do Ariva-BDL and Stonewall-BDL consist of or include substances that are not derived from tobacco? Does FDA believe that Ariva-BDL and Stonewall- BDL are tobacco products? If not, will FDA take any other action so these nicotine containing products are regulated by another chapter of the FDCA? 

· If FDA believes that Ariva-BDL and Stonewall-BDL are tobacco products but not subject to Chapter IX requirements does FDA intend to issue regulations to subject Ariva-BDL and Stonewall-BDL to Chapter IX so the manufacture, marketing, and distribution of these products are regulated by CTP? If so, what is the timeline for the issuance of such regulations? 

· Is FDA planning to conduct a systematic review of currently marketed tobacco products to determine which are currently subject to Chapter IX requirement or will CTP make such determinations on an ad hoc basis? 

Given the compelling evidence that these products pose an immediate and significant health risk to children, we urge CTP to reconsider its decision that certain dissolvable tobacco products are outside CTP’s current authority. 

Thank you for your consideration and we look forward to hearing from you.