FDA Introduces Draft Guidance on MRTPs and HPHCs for Tobacco

FDA intends to focus reporting enforcement on 20 HPHCs during 2012, and provides details for those seeking to market a tobacco product as modified or lower risk.

Today, the U.S. Food and Drug Administration (FDA) released two separate draft guidance documents to “help fight the tobacco epidemic and stop children from using tobacco.”

The draft guidance documents implement provisions of the Family Smoking Prevention and Tobacco Control Act to provide the public with previously unknown information about the chemicals in tobacco products and help prevent misleading marketing about the risks associated with tobacco products.

The two separate draft guidance documents do the following:

• The first document provides guidance on how companies will comply with the requirement to report on the quantities of potentially harmful chemicals in tobacco products.

• The second document provides guidance to companies that seek to advertise or market a tobacco product as less harmful or associated with reducing the risk of tobacco-related disease.

“Today’s actions represent critical steps forward on providing Americans with the facts about the dangers of tobacco use and to stop children from smoking,” said Health and Human Services Secretary Kathleen Sebelius. “We will continue to do everything we can to help smokers quit and prevent kids from starting this deadly addiction.”

The Family Smoking Prevention and Tobacco Control Act requires tobacco product manufacturers and importers to report quantities of harmful and potentially harmful constituents (HPHCs) found in tobacco products or tobacco smoke by brand and sub-brand. HPHCs are chemicals or chemical compounds in a tobacco product or tobacco smoke that cause, or could cause, harm to smokers or non-smokers. All HPHCs included on the list cause or may cause serious health problems including cancer, lung disease, and addiction to tobacco products.

While there are more than 7,000 chemicals in tobacco and tobacco smoke, FDA has today established a list of 93 HPHCs that tobacco companies will be required to report for every regulated tobacco product sold in the U.S. The FDA recognizes that industry may be unable to meet the deadline due to current testing limitations. In recognition of this, the draft guidance released today identifies 20 HPHCs that are representative of the full list and for which testing methods are well established and widely available.

“Tobacco products in this country at least are the only mass consumed product that consumers do not today know what’s in them and with this action today FDA is ending that era,” noted Dr. Lawrence Deyton, M.S.P.H., M.D., director of FDA’s Center for Tobacco Products (CTP), in a conference call today.

FDA intends to focus reporting enforcement on these 20 HPHCs during 2012. FDA intends to make information about the amount of HPHCs in specific products available to the public in a consumer-friendly format by April 2013.

FDA also issued draft guidance today on submitting applications to sell modified risk tobacco products (MRTPs). Modified risk tobacco products are tobacco products that are sold, distributed, or marketed with a claim to reduce harm or the risk of tobacco-related disease.

The Tobacco Control Act establishes rigorous scientific criteria an applicant’s tobacco product must meet before FDA can allow the applicant to sell that product with a claim to reduce harm. The draft guidance describes scientific studies and analyses an applicant should submit to demonstrate its product will, or is expected to, significantly reduce harm or exposure to individuals, and benefit the health of the population as a whole.

“We are forging new territory to ensure that tobacco companies provide accurate information and do not mislead American consumers,” said FDA Commissioner Margaret Hamburg, M.D. “We are committed to stopping such practices that may cause people to start or continue using tobacco products that could lead to preventable disease and death.”

The draft guidance for MRTPs provides details for those who seek to market a tobacco product as modified or lower risk including how to organize and submit an MRTP application, what scientific studies and analyses should be submitted, and what information should be collected through post-market surveillance and studies.

“FDA currently regulates cigarettes, roll-your-own and smokeless tobacco,” Deyton noted in today’s conference call. “Those are what we consider the regulated products today. So, today, if a tobacco manufacturer of any of those types of products would be interested in a marketing claim of modified risk, then we’re giving them instruction on what scientific evidence we would need. Today there exists no modified risk tobacco product. We’re signaling the scientific standards FDA would need to allow a company to have marketing with those kind of claims.”

The draft guidance document and a December 2011 report from the Institute of Medicine (IOM) titled “Scientific Standards for Studies on Modified Risk Tobacco Products” are open for comments from the public until June 4, 2012.  These announcements on draft guidance are being released today because they were required in the The Family Smoking Prevention and Tobacco Control Act to be completed on or before April 1, 2012.  Before issuing the final guidance, FDA will consider public comments, the IOM report and feedback from an FDA public workshop held in August 2011.

 

 

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