Tobacco companies will have to inform purchasers about all the harmful substances they place in their products, the Food and Drug Administration (FDA) has ruled. They will also have to back up any “reduced harm” claims with compelling proof, the Agency added.

The FDA says the two draft guidance documents form part of the provisions stipulated in the Family Smoking Prevention and Tobacco Control Act. To date, consumers have not been told what chemicals there are in tobacco products.

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.”

According to the The Family Smoking Prevention and Tobacco Control Act, makers of tobacco products, as well as importers, must report what HPHCs (harmful and potentially harmful constituents) exist in their products or the smoke that comes from their products, by brand and sub-brand.

HPHCs are substances that exist in cigars, cigarettes and other tobacco products, and/or their smoke; they might harm the smoker and those nearby (passive smokers, people breathing in environmental smoke).

HPHCs in the tobacco list may potentially cause serious illnesses and/or health problems, including cancer, lung diseases and addiction to tobacco products.

Over 7,000 chemicals and chemical compounds are present in tobacco and the smoke that emanates from tobacco. A list of 93 HPHCs has been established by the FDA that tobacco companies will need to inform consumers about in their products sold throughout the country.

In its website, the FDA wrote:

“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 In recognition of this, the draft guidance released today identifies 20 HPHCs that are representative of the full list and for which testing methods are well established and widely available.

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FDA also issued draft guidance today on submitting applications to sell modified risk tobacco products (MRTPs).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.”

FDA Commissioner Margaret Hamburg, M.D., said:

“We are forging new territory to ensure that tobacco companies provide accurate information and do not mislead American consumers. 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.”

Written by Christian Nordqvist