The Mod Squad

FDA requires studies that prove--and disprove--tobacco product modified risk claims

Greg Lindenberg, Editor, CSP

WASHINGTON -- The U.S. Food & Drug Administration's (FDA) move last week instructing tobacco makers how to submit applications to sell modified risk tobacco products (MRTPs) is drawing mixed reviews.

Though concerned by what she considers an onerous process, Deutsche Bank Group Equity Research analyst Christina McGlone praised the MRTP for spearheading a "potential growth category."

"This document keeps open the possibility of eventually getting to commercialized MRTP (most likely in smokeless)," she said in a research note. "The other positive is that it creates a looser secondary channel for 'reduced exposure' products, where full science evidence is not available, but a company can show that a specific harmful substance is reduced."

The guidelines were publicly introduced last Friday by the FDA during a conference call for media. During the call, Dr. Lawrence Deyton, director of the FDA's Center for Tobacco Products (CTP), said that under the Family Smoking Prevention & Tobacco Control Act, "tobacco products cannot be marketed as reduce risk unless that claim is supported by science. The experience with 'low-tar' and 'light' cigarettes demonstrates the importance of having sufficient data to support any claim of modified risk."

This draft guidance, he said, "sets very high scientific standards for demonstrating that products sold to reduce harm or risk actually do so."  Deyton also said the guidelines require his department to issue a determination within 360 days once an MRTP application is received.

Tobacco companies have been watching carefully how the FDA would proceed with a congressionally mandated category for modified-risk products. Observers believe the designation could potentially create a robust retail category depending on how the FDA defines modified risk.

Bill Godshall, executive director of Smokefree Pennsylvania and outspoken critic of cigarettes, lambasted the guidance. "[It] ignores the fact and fails to acknowledge the scientific consensus that smokeless tobacco products are far less hazardous than cigarettes. ... Any manufacturer that wants to make that claim must conduct millions of dollars of research to demonstrate to [the FDA] why they think their new smokeless product is less hazardous than cigarettes."

Godshall said that he fears the cost and complexity of the guidelines will impose barriers for new products that would easily pass the threshold of being modified risk. "If a smokeless product wants to make a claim that it is less hazardous than cigarettes, the FDA shouldn't require any studies, because it is already existing scientific consensus," he said. "Instead, the FDA in its MRTP guidance application, is requiring these companies to literally spend millions in new research to submit to the FDA, and then the FDA will decide if smokeless is less hazardous."

Following Deyton's prepared statements, the Q&A portion of the press conference in large part focused on whether the new draft guidance opened the door any wider than before for smokeless tobacco makers to officially make the claim that smokeless tobacco as less harmful than regular, "combustible" tobacco.

Deyton, however, would not name specific types of products--electronic cigarettes, snus, sticks, orbs, dissolvables or smokeless--that would need to go through this process. He would only say that "the FDA currently regulates cigarettes, roll your own and smokeless tobacco. … Today, there exist no modified-risk tobacco products."

Past applications, such as those made by Star Scientific for its Stonewall and Ariva dissolvables, would be irrelevant. The new process resets the application clock. Deyton said that he would not comment on any specific applications that may have already been submitted.

In a statement, Glen Allen, Va.-based Star Scientific did not address the MRTP move, but did offer comments concerning the FDA's other March 30 announcement, requiring tobacco companies to list chemicals in tobacco products (see Related Content below for details).

"That the FDA is moving forward to require disclosure of significant toxins, including TSNAs, underscores that not all tobacco products are created equal and that some are less hazardous than others."

David Ashley, director of the CTP's office of Science, described two different types of determinations that can be made on modified risk. One shows that there is sufficient evidence to show that that product actually reduces harm. The second is a "special rule" that indicates while evidence is not complete to show reduced harm, there is evidence to suggest reduced exposure.

The document and a December 2011 report from the Institute of Medicine (IOM), "Scientific Standards for Studies on Modified Risk Tobacco Products," are open for comments from the public until June 4, 2012.

Click here to read the draft guidance for Modified Risk Tobacco Product Applications. And click here for the IOM report.