Thursday, May 9, 2013

When will the FDA Publish the List of Harmful Constituent in Tobacco?

On May 7th, I sent the following email to AskCTP@fda.hhs.gov, the address listed for general inquiries on the FDA Tobacco Products page.

To Whom it may Concern:

According to the Timeline of the Family Smoking Prevention and Tobacco Control Act at http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm237395.htm, the following was to be done by April of 2013:

Publish the list of harmful and potentially harmful constituents in a format that is understandable and not misleading to the lay public

– Sec. 904(a)(3)25, 904(d)(1)26, 904(e)27

If this has been done, can you tell me where it was published (the online location if available)? If not, can you tell me when it is planned to be published?

The same day, I got the following reply:

Thank you for your email. The Family Smoking Prevention and Tobacco Control Act gives the FDA an extraordinary opportunity to improve the health of all Americans, whether they use tobacco or not. One of the goals of the law is to improve consumer understanding of tobacco products and their related harms, as tobacco use continues to be the leading cause of preventable death and disease in the United States.

Part of the law requires FDA to publicly display information about harmful and potentially harmful constituents (HPHCs), chemicals in tobacco products and tobacco smoke that cause harm, or could cause harm, to users and non-users. FDA is required by law to provide this information to the public, including the amount of each chemical present in specific brands and sub-brands of tobacco products, in a way that is understandable and not misleading by April 1, 2013.

FDA was unable to make this information available by the April deadline, but will do so once the Agency is confident that the information is accurate, understandable and not misleading to the public. Currently, the Agency is still evaluating the data it has received from manufacturers, including verifying its accuracy. In addition, FDA is planning to conduct scientific studies to assess consumer understanding of how the Agency presents information about HPHCs. Upon completion of these important activities, FDA intends to publish the HPHC information so that consumers can make more informed decisions about tobacco products.

____________________

Center for Tobacco Products

Food and Drug Administration

CTP Call Center: 1-877-CTP-1373 www.fda.gov/tobacco

Nearly identical comments were made in an FDA response to a news reporter posted at this link. Also, googling the phrase "once the Agency is confident that the information is accurate, understandable and not misleading" turns up several other references to this action.

So when does the FDA intend to "publish the HPHC information so that consumers can make more informed decisions about tobacco products"? They do say that they are "still evaluating the data it has received from manufacturers, including verifying its accuracy". This sounds like it could conclude at any time. However, they also say that they are "planning to conduct scientific studies to assess consumer understanding of how the Agency presents information about HPHCs". This implies that the studies have not even started so it doesn't sound like this will be finished any time soon.

As mentioned at this link, you could find recent figures for the tar and nicotine content of cigarettes manufactured by Philip Morris on their website until late 2008. An explanation for their removal can be found on this page. Following is an excerpt:

On November 26, 2008, however, the FTC rescinded its 1966 guidance. In support of its decision, the FTC stated that, "there is now a consensus among the public health and scientific communities that the Cambridge Filter Method is sufficiently flawed that statements of tar and nicotine yields as measured by that method are not likely to help consumers make informed decisions."

As with the FTC before it, the FDA seems to feel that it is better that people have no information about the tar and nicotine content of cigarettes than that they have imperfect information by which they might be misled. This seems like a questionable policy to me, treating people like children who "can't handle the truth". To be fair to the FDA, this may be because the law itself says that the list of constituents is to be published "in a format that is understandable and not misleading to the lay public". In any event, if anyone should hear any information on when or where this information is to be published, please leave a comment here.

No comments:

Post a Comment