FDA will have a complex public health impact equation to balance as its Center for Tobacco Products faces its first application for "modified-risk" tobacco product claims.

While it is charged with considering claims for such products as alternatives to smoking, the agency will have to factor in their potential to undermine smoking-cessation efforts and products and the possibility they would entice those who have never used tobacco to start.

Smokeless tobacco product manufacturer Star Scientific submitted Feb. 19 the first application to CTP, asking the agency to approve a modified-risk claim for its dissolvable tobacco lozenge with wintergreen flavoring, Ariva-BDL .

In a Feb. 22 release, the Glen Allen, Va.-based firm touts levels of tobacco-specific nitrosamines "below detectable limits" in the product, which it says was developed for adults who "cannot or choose not to smoke."

Ariva-BDL is not currently available in stores and has lower TSNA levels than the Ariva product currently sold in some drug and convenience stores, the firm says.

"Star wants to be able to tell adult smokers what TSNAs are and what the TSNA levels in the product are," a spokeswoman said. "We are seeking to share with tobacco users that the TSNA levels are such that their risk of exposure is lessened."

The spokeswoman said the firm's application contains proprietary information and that the firm will share specific language when it hears back from the agency.

The approval of modified-risk tobacco product claims could undermine nicotine replacement therapy products if smokers choose to use the product instead of making a quit attempt.

Pinney Associates consultant Mitch Zeller noted if a tobacco product is approved with a modified-risk claim and it "leads to less quitting" or "less interest in quitting," that creates a public health concern.

Some modified-risk products also could lead to tobacco use initiation by someone who otherwise was tobacco-free, he said.

Pinney's Saul Shiffman, who consults with NRT manufacturer GlaxoSmithKline, pointed out if the products "ended up reducing quitting, that would have an adverse health impact, as well as presumably some impact on medicines for quitting smoking."

But, he said, it would in a sense be "making tobacco use a competitor to quitting, not making the particular product a competitor to medicines as cessation aids."

"Just keeping people smoking and reducing interest in quitting is the concern."

Close Scrutiny

The Family Smoking Prevention and Tobacco Control Act, which passed in June and gives FDA regulatory authority of tobacco products, asks the agency to consider modified-risk claim applications in an effort to reduce the harm of smoking to society.

The agency has its work cut out for it with its still-new authority over tobacco. It is tasked with considering moving away from an overall abstinence mentality to one where harm reduction is weighed in terms of public health, experts say.

The tobacco control law instructs FDA to consider approving modified-risk claims, directing the agency to ensure such products "significantly reduce harm" and benefit the public health in terms of tobacco users and the tobacco-free population (¹ Also see "Tight 90-Day Countdown To Create Tobacco Center Poses Challenge To FDA" - Pink Sheet, 15 June, 2009.).

The law also directs FDA to vet the claims carefully.

"Permitting manufacturers to make unsubstantiated statements concerning modified-risk tobacco products, whether express or implied, even if accompanied by disclaimers would be detrimental to the public health," the law says.

Already On The Radar

FDA already was giving Star's products and other lozenges close scrutiny before the application was filed.

In Feb. 1 letters to Star and tobacco firm R.J. Reynolds, FDA shows it is taking very careful consideration of whether oral tobacco products are used by children and young adults.

The letter to Star addresses two dissolvable smokeless tobacco products - Ariva and Stonewall - which are marketed in tablet form with 1.5 mg and 4 mg of nicotine, respectively.

The Reynolds letter deals with dissolvable products the firm is test-marketing: Camel Orbs, Camel Sticks and Camel Strips.

FDA asks each firm for a summary of its research on its products' use, misuse and perception among the population under age 26, as well as potential toxicity levels in children and research on consumer understanding of any potential toxicity in children

Further, the agency seeks information on user demographics and patterns, "including initiation of use in tobacco-naïve consumers by age."

FDA in the letters notes it is tasked with collecting information on smokeless tobacco products and having its Tobacco Products Scientific Advisory Committee study their impact on the public health, specifically on children. TPSAC then is expected to provide FDA with a report with recommendations.

Star says its application process for modified-risk claim approval began months before it received the letter from the agency.

But the information FDA is requesting in the letter could influence the agency's decision if it determines the product is potentially more harmful than beneficial

The agency requests the firms respond to its letters within two months.

Reynolds already has invested in NRT. In December it purchased Swedish cessation product firm Niconovum (² Also see "Tobacco Firm Reynolds Enters NRT Market With Niconovum Buy" - Pink Sheet, 14 December, 2009.). Reynolds said the buy was aimed at expanding its harm-reduction strategies.

Handicapping The Claim

Jonathan Foulds, a professor at the University of Medicine and Dentistry of New Jersey's School of Public Health, said Star's product, according to the firm's data, contains "very small amounts of nicotine, relative to a cigarette" and levels of TSNAs comparable to other tobacco products.

He said since the product is taken orally and not inhaled, it "automatically implies no risk for respiratory diseases."

"It will be very interesting to see how FDA handles this, because this product delivers very little of anything and on that basis it is hard to see how it could not have reduced risks relative to smoking," he added.

But Foulds pointed out FDA will be assessing not only whether the product reduces harm in an individual user, but its societal impact as well.

Arnie Friede, an attorney with Arnold I. Friede & Associates, said if science proves the product poses less harm than cigarettes, it could be beneficial to the public.

"I think it is fair to say that if we can meaningfully reduce the risk of tobacco-related illness through the use of products like this, without creating a variety of unintended consequences, then this would certainly be a benefit to the public health and a terrific early consequence of the new law," Friede said in an e-mail.

FDA Response Could Indicate Future MRP Policy

FDA's ultimate response will set the tone for similar modified-risk claims applications.

Foulds said he presumes the outcome "will influence the enthusiasm for other subsequent applications."

He added he would not be surprised if the agency's tobacco center takes its time to mull it over. "This is all new stuff for FDA, they are still hiring their basic staff, and there is a possibility they could get bombarded with multiple applications," he said.

Zeller explained that the agency is required to collect comments on any modified-risk claim application.

According to FDA's draft guidance document for modified-risk tobacco products, the agency must hear from TPSAC on the issue, which must respond to it within 60 days of the referral.

The agency says in the draft guidance it plans to respond to applicants within 360 days of its receipt of requests.

- Katie Stevenson ( ³ k.stevenson@elsevier.com )

FDA's Tobacco Center To Mull First Modified-Risk Claim Application

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