- Apr 2, 2009
- 5,171
- 13,288
- 67
Here's an article in FDA Weekly that I was interviewed for.
FDA Pushed To Define Scope, Line Between Drug And tobacco Products
By Alaina Busch
FDA Weekly
March 31, 2011
A key Democratic lawmaker and a stakeholder group are urging FDA to close loopholes in the tobacco Control Act that enable exemptions for certain tobacco goods, with the agency saying it is still considering its options for some tobacco-derived products as it defines the line between tobacco and drug products. FDA, citing current limitations in the law, recently said it could not to regulate dissolvable tobacco lozenges from a tobacco company, a decision that drew the ire of an anti-tobacco group, while a tobacco policy expert contends that drug companies could seize on the agency's conclusion to market their smoking-cessation goods without certain warnings or claims.
As part of this debate on how to draw FDA's jurisdictional lines for tobacco, some lawmakers are pressing the agency to expand the ban on clove cigarettes to cigars, which are not explicitly covered under the law. The issue also plays into how FDA will balance the interests of the drug and tobacco industries (see FDA Week March 4).
FDA recently indicated that it would not yet expand its jurisdiction over tobacco to also subsume dissolvable tobacco products. Star Scientific applied for modified risk tobacco status for its ARIVA-BDL and STONEWALL-BDL dissolvable tobacco products last year, but FDA said last week that the products did not fall under requirements for cigarettes, cigarette tobacco, smokeless tobacco and roll-your-own tobacco, which are currently subject to the law, according to the company.
The agency's decision could open the market to other tobacco or drug companies to market their dissolvable or smoking cessation products without warnings, which are required for tobacco, said Bill Godshall executive director of Smokefree Pennsylvania. Drug companies have run clinical trials to make therapeutic claims to market similar tobacco products aimed at helping smokers quit, but these products must also include risk information, as they are regulated as pharmaceuticals. Drug companies could also have a piece of the market without stringent premarket and treatment controls, provided they drop the claims that their products help smokers quit, Godshall said.
The recommended course of treatments for these nicotine replacement therapies are 10 to 12 weeks, but recovering smokers often use the products longer, which is considered an off-label use, Godshall said. By marketing without therapeutic claims, drug companies would also not have to warn consumers to only use the products for a limited time, he added.
"I don't see the drug companies doing that because this is a public relations issue for them," he said. "They don't want to be viewed as another competitor in the tobacco industry."
While the agency has explicit powers to regulate the products stated in the law, the statute gives it the authority to draft regulations for all tobacco-derived products, provided the agency proves the requirements would be beneficial to public health, said Godshall. "The burden of proof is on the FDA now," he said.
FDA's Star Scientific decision was met with criticism from the Campaign for Tobacco-Free Kids, which said the products meet FDA's definition of smokeless tobacco and are explicitly regulated by the law.
"The FDA has created a loophole where no loophole existed in the law and issued an invitation to tobacco companies to introduce new unregulated tobacco products," according to the group's president Matthew Myers. "This is exactly what Congress sought to prevent when it passed the 2009 law granting the FDA authority over tobacco products. The FDA should reverse course and close this dangerous loophole immediately."
The law outlines a schedule of studies to be conducted on various topics regarding the public health implications of regulating or banning certain products. Like the agency's recent analysis of menthol cigarettes, FDA's Tobacco Products Scientific Advisory Committee will next study dissolvable tobacco. "They can still promulgate regulations and I anticipate they're going to," Godshall said.
FDA is grappling with establishing the boundaries between tobacco and other regulated products, including drugs and devices. The agency has pending litigation over its decision to regulate electronic cigarettes as medical devices, with federal courts saying the products are derived from tobacco and should be subject to those regulations.
"FDA recognizes there are uncertainties regarding the regulatory status of a variety of nicotine-containing products derived from tobacco; more specifically, whether these products are regulated as drugs or tobacco products," the agency said in response to its Star Scientific decision.
Aside from electronic cigarettes, FDA could expand its control over products like pipe tobacco and cigars, Godshall said. Clove flavored cigars drew the attention of Rep. Henry Waxman (D-CA), ranking member of the House Energy and Commerce Committee, who encouraged the agency to take advantage of the discretion allowed by the law to ban these products. In letter Monday (March 28) to FDA Commissioner Margaret Hamburg, he said the lead manufacturer of clove cigarettes, Kretek International, switched its clove cigarettes to cigars to circumvent FDA oversight.
Citing company documents from 2007, Waxman said company executives -- in anticipation of a ban -- started the process of switching the products to cigars. They did not plan to change the product formulation, but would not use a paper wrapper, thereby evading the definition of cigarette, according to Waxman.
"I recognize that there are historical differences between cigarettes and cigars," according to the letter. "Congress recognized these differences by requiring FDA to ban flavored cigarettes, while giving FDA discretion to decide whether to ban flavored cigars. In this case, however, Kretek is exploiting the distinction to keep its dangerous product on the market." The company did not respond to a request for comment.
With passage of the law, Congress instituted a ban on all cigarette flavoring, aside from menthol. While the legislation gives FDA the power to ban flavored products, it cannot enact a complete ban on nicotine or all cigarettes.
FDA Pushed To Define Scope, Line Between Drug And tobacco Products
By Alaina Busch
FDA Weekly
March 31, 2011
A key Democratic lawmaker and a stakeholder group are urging FDA to close loopholes in the tobacco Control Act that enable exemptions for certain tobacco goods, with the agency saying it is still considering its options for some tobacco-derived products as it defines the line between tobacco and drug products. FDA, citing current limitations in the law, recently said it could not to regulate dissolvable tobacco lozenges from a tobacco company, a decision that drew the ire of an anti-tobacco group, while a tobacco policy expert contends that drug companies could seize on the agency's conclusion to market their smoking-cessation goods without certain warnings or claims.
As part of this debate on how to draw FDA's jurisdictional lines for tobacco, some lawmakers are pressing the agency to expand the ban on clove cigarettes to cigars, which are not explicitly covered under the law. The issue also plays into how FDA will balance the interests of the drug and tobacco industries (see FDA Week March 4).
FDA recently indicated that it would not yet expand its jurisdiction over tobacco to also subsume dissolvable tobacco products. Star Scientific applied for modified risk tobacco status for its ARIVA-BDL and STONEWALL-BDL dissolvable tobacco products last year, but FDA said last week that the products did not fall under requirements for cigarettes, cigarette tobacco, smokeless tobacco and roll-your-own tobacco, which are currently subject to the law, according to the company.
The agency's decision could open the market to other tobacco or drug companies to market their dissolvable or smoking cessation products without warnings, which are required for tobacco, said Bill Godshall executive director of Smokefree Pennsylvania. Drug companies have run clinical trials to make therapeutic claims to market similar tobacco products aimed at helping smokers quit, but these products must also include risk information, as they are regulated as pharmaceuticals. Drug companies could also have a piece of the market without stringent premarket and treatment controls, provided they drop the claims that their products help smokers quit, Godshall said.
The recommended course of treatments for these nicotine replacement therapies are 10 to 12 weeks, but recovering smokers often use the products longer, which is considered an off-label use, Godshall said. By marketing without therapeutic claims, drug companies would also not have to warn consumers to only use the products for a limited time, he added.
"I don't see the drug companies doing that because this is a public relations issue for them," he said. "They don't want to be viewed as another competitor in the tobacco industry."
While the agency has explicit powers to regulate the products stated in the law, the statute gives it the authority to draft regulations for all tobacco-derived products, provided the agency proves the requirements would be beneficial to public health, said Godshall. "The burden of proof is on the FDA now," he said.
FDA's Star Scientific decision was met with criticism from the Campaign for Tobacco-Free Kids, which said the products meet FDA's definition of smokeless tobacco and are explicitly regulated by the law.
"The FDA has created a loophole where no loophole existed in the law and issued an invitation to tobacco companies to introduce new unregulated tobacco products," according to the group's president Matthew Myers. "This is exactly what Congress sought to prevent when it passed the 2009 law granting the FDA authority over tobacco products. The FDA should reverse course and close this dangerous loophole immediately."
The law outlines a schedule of studies to be conducted on various topics regarding the public health implications of regulating or banning certain products. Like the agency's recent analysis of menthol cigarettes, FDA's Tobacco Products Scientific Advisory Committee will next study dissolvable tobacco. "They can still promulgate regulations and I anticipate they're going to," Godshall said.
FDA is grappling with establishing the boundaries between tobacco and other regulated products, including drugs and devices. The agency has pending litigation over its decision to regulate electronic cigarettes as medical devices, with federal courts saying the products are derived from tobacco and should be subject to those regulations.
"FDA recognizes there are uncertainties regarding the regulatory status of a variety of nicotine-containing products derived from tobacco; more specifically, whether these products are regulated as drugs or tobacco products," the agency said in response to its Star Scientific decision.
Aside from electronic cigarettes, FDA could expand its control over products like pipe tobacco and cigars, Godshall said. Clove flavored cigars drew the attention of Rep. Henry Waxman (D-CA), ranking member of the House Energy and Commerce Committee, who encouraged the agency to take advantage of the discretion allowed by the law to ban these products. In letter Monday (March 28) to FDA Commissioner Margaret Hamburg, he said the lead manufacturer of clove cigarettes, Kretek International, switched its clove cigarettes to cigars to circumvent FDA oversight.
Citing company documents from 2007, Waxman said company executives -- in anticipation of a ban -- started the process of switching the products to cigars. They did not plan to change the product formulation, but would not use a paper wrapper, thereby evading the definition of cigarette, according to Waxman.
"I recognize that there are historical differences between cigarettes and cigars," according to the letter. "Congress recognized these differences by requiring FDA to ban flavored cigarettes, while giving FDA discretion to decide whether to ban flavored cigars. In this case, however, Kretek is exploiting the distinction to keep its dangerous product on the market." The company did not respond to a request for comment.
With passage of the law, Congress instituted a ban on all cigarette flavoring, aside from menthol. While the legislation gives FDA the power to ban flavored products, it cannot enact a complete ban on nicotine or all cigarettes.
