U.S. lawmakers and health groups are upset about how the Food and Drug Administration (FDA) is handling e-cigarettes and other smoke-free products. They shared their concerns at a House of Representatives Energy and Commerce Subcommittee hearing on Tuesday."Manufacturers filing premarket tobacco product applications [PMTAs] with the goal of meeting the standard of an 'appropriate protection of public health' still have no clear guidance and are waiting for hundreds of days for outreach on their applications," said Brett Guthrie, Chair of Health Subcommittee."More importantly, these products pending at FDA could present an opportunity to improve public health by providing less harmful alternatives to traditional cigarettes. This lack of transparency has consequences."Cathy McMorris Rodgers pointed out that the FDA's Center for Tobacco Products (CTP) has a massive backlog of product applications to review. "Out of the over 26 million applications for electronic nicotine delivery systems, or ENDS products, the center has authorized fewer than 50 products," said Rodgers."However, according to recent market data, those products only account for about 10% of sales, showing how behind the FDA is in keeping up with demand."Representative Richard Hudson blamed the FDA for the rise in illegal products coming from other countries. "Millions of illegal products are on the market targeting our youth while some legitimate companies have been waiting for years for review or even hear a word from FDA about their application," said Hudson."The illicit market has been enabled by the Center for Tobacco Products' lack of action … the fact is, the inefficiency of CTP has driven an illicit market that has been filled by China.""More than 26 million premarket tobacco product applications have been submitted to the FDA for review, but the agency has authorized only several dozens of those applications, and none within the 180-day deadline set by Congress," said Matthew Sheaff, Philip Morris International Director for Regulatory Communications."FDA's goal to strike 'an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes' is far from the reality of its actions. It is our hope the FDA will fully embrace the tobacco harm reduction principles enshrined in the Tobacco Control Act and, more importantly, provide the millions of adult smokers in the United States access to better alternatives to combustible cigarettes."Americans For Tax Reform (ATR) urged the FDA to inform the public about the "continuum of risk" associated with different nicotine products."The agency's failures to educate the public about the continuum of risk in nicotine products—despite their own internal documents demanding the need to do so—has meant that 75% of Americans inaccurately believe vaping is equal to or worse than smoking," wrote Tim Andrews on ATR's website."The fact that the agency's leadership continues to ignore its own comprehensive plan for tobacco and nicotine, where harm reduction is supposed to play a central role in the FDA's tobacco control plan, is a downright scandal."
U.S. lawmakers and health groups are upset about how the Food and Drug Administration (FDA) is handling e-cigarettes and other smoke-free products. They shared their concerns at a House of Representatives Energy and Commerce Subcommittee hearing on Tuesday."Manufacturers filing premarket tobacco product applications [PMTAs] with the goal of meeting the standard of an 'appropriate protection of public health' still have no clear guidance and are waiting for hundreds of days for outreach on their applications," said Brett Guthrie, Chair of Health Subcommittee."More importantly, these products pending at FDA could present an opportunity to improve public health by providing less harmful alternatives to traditional cigarettes. This lack of transparency has consequences."Cathy McMorris Rodgers pointed out that the FDA's Center for Tobacco Products (CTP) has a massive backlog of product applications to review. "Out of the over 26 million applications for electronic nicotine delivery systems, or ENDS products, the center has authorized fewer than 50 products," said Rodgers."However, according to recent market data, those products only account for about 10% of sales, showing how behind the FDA is in keeping up with demand."Representative Richard Hudson blamed the FDA for the rise in illegal products coming from other countries. "Millions of illegal products are on the market targeting our youth while some legitimate companies have been waiting for years for review or even hear a word from FDA about their application," said Hudson."The illicit market has been enabled by the Center for Tobacco Products' lack of action … the fact is, the inefficiency of CTP has driven an illicit market that has been filled by China.""More than 26 million premarket tobacco product applications have been submitted to the FDA for review, but the agency has authorized only several dozens of those applications, and none within the 180-day deadline set by Congress," said Matthew Sheaff, Philip Morris International Director for Regulatory Communications."FDA's goal to strike 'an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes' is far from the reality of its actions. It is our hope the FDA will fully embrace the tobacco harm reduction principles enshrined in the Tobacco Control Act and, more importantly, provide the millions of adult smokers in the United States access to better alternatives to combustible cigarettes."Americans For Tax Reform (ATR) urged the FDA to inform the public about the "continuum of risk" associated with different nicotine products."The agency's failures to educate the public about the continuum of risk in nicotine products—despite their own internal documents demanding the need to do so—has meant that 75% of Americans inaccurately believe vaping is equal to or worse than smoking," wrote Tim Andrews on ATR's website."The fact that the agency's leadership continues to ignore its own comprehensive plan for tobacco and nicotine, where harm reduction is supposed to play a central role in the FDA's tobacco control plan, is a downright scandal."
