In a move aimed to address tobacco epidemic and deter children from using tobacco, the Food and Drug Administration has released two draft guidance documents, paving way for consumers to know the harmful ingredients in the tobacco products and ensuring that they are not misled by deceptive marketing practices.
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. Accordingly, the FDA has established a list of 93 harmful and potentially harmful constituents, or HPHCs, that tobacco companies will be required to disclose for every regulated tobacco product sold in the United States, an information, which was previously unavailable to the public.
However, given the fact that the tobacco companies may be unable to meet the deadline of reporting the HPHCs in their tobacco products due to current testing limitations, the draft guidance has identified 20 HPHCs that are representative of the full list. This year, the FDA will be focusing on reporting enforcement on the 20 HPHCs and, by April 2013, make available to the public, information about the amount of HPHCs in specific products in a consumer-friendly format.
The second document provides guidance to companies that seek to advertise or market modified risk tobacco products, or MRTPs, that are sold with a claim to reduce harm or the risk of tobacco-related disease. This document describes scientific studies and analyses a tobacco company should submit if it has to market modified risk tobacco products.
Tobacco use is the leading preventable cause of death in the nation, according to the U.S. Department of Health and Human Services. It is estimated that 46 million people, or 20.6% of adults (aged 18 years and older), in the United States smoke cigarettes. Every day, over 1,000 youth under 18 become daily smokers. Cigarette smoking accounts for about 443,000 deaths, or 1 of every 5 deaths, in the U.S. annually.
Smoking is said to cost the American economy almost $200 billion a year, in medical costs and lost productivity.
Health and Human Services Secretary Kathleen Sebelius said, "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. We will continue to do everything we can to help smokers quit and prevent kids from starting this deadly addiction."
by RTT Staff Writer
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