In combating the tobacco epidemic, the U.S. Food and Drug Administration has released two separate draft guidance documents designed to help implement provisions of the Family Smoking Prevention and Tobacco Control Act.

In one case, the FDA wants to provide consumers with previously unknown information about harmful and potentially harmful constituents in tobacco products. HPHCs are chemicals in tobacco products that either cause or could cause harm to smokers or nonsmokers.

In the other case, the FDA wants to prevent misleading marketing of modified-risk tobacco products. MRTPs are tobacco products that are distributed, marketed, or sold with claims that they cut either the harm or the risk of tobacco-related disease.

The Tobacco Control Act was signed into law by President Barack Obama on June 22, 2009.

Harmful And Potentially Harmful Constituents

The FDA's draft document on HPHCs provides guidance on how companies will comply with the requirement to report on the quantities of these substances in tobacco products.

Although there are more than 7,000 chemicals in tobacco and tobacco smoke, the FDA on Friday established a list of 93 HPHCs that each tobacco company will be required to report for every regulated tobacco product sold in the United States.

All HPHCs on this list cause or may cause serious health problems, including lung disease, cancer, and addiction to tobacco products, according to the FDA.

The agency will phase in the reporting under this requirement, focusing on 20 HPHCs this year and the others thereafter.

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, the agency said.

This reporting requirement appears likely to have a more or less equal effect on all publicly traded companies in the U.S. cigarettes industry. They, their ticker symbols, and their market capitalizations are as follow:

--  Philip Morris International Inc. (PM), $152.6 billion

--  British American Tobacco PLC (BTI), $99.0 billion

--  Altria Group, Inc. (MO), $62.9 billion

--  Reynolds American Inc. (RAI), $23.9 billion

--  Lorillard Inc. (LO), $16.9 billion

--  Vector Group Ltd. (VGR), $1.4 billion

--  Star Scientific Inc. (CIGX), $477.8 million

Modified-Risk Tobacco Products

The FDA's draft document on MRTPs provides guidance to companies that seek to market a tobacco product as either being associated with cutting the risk of tobacco-related disease or being less harmful.

The Tobacco Control Act establishes rigorous scientific criteria an applicant's tobacco product must meet before the FDA can allow the applicant to sell that product with a claim to reduce harm, according to the agency.

The draft document describes scientific analyses an applicant should submit to demonstrate its product either will or can be expected to significantly reduce harm to individuals and benefit the health of the population as a whole, the FDA said.

We are forging new territory to ensure that tobacco companies provide accurate information and do not mislead American consumers, said Dr. Margaret Hamburg, the FDA's commissioner. 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 provisions pertaining to MRTPs seem likely to have their most significant impacts on Star Scientific, even though the company's peers do have varying degrees of interest in this area.

In Star Scientific's U.S. Securities and Exchange Commission Form 10-K filed March 15, the company noted:

We are a technology-oriented company with a mission to promote maintenance of a healthy metabolism and to reduce the harm associated with the use of tobacco at every level. Over the last several years, through our Rock Creek subsidiary, we have been engaged in:

[T]he development, manufacture, sale and marketing of two nutraceutical, dietary supplements designed to promote the maintenance of a healthy metabolism: Anatabloc®, for anti-inflammatory support, and CigRx®, our tobacco alternative; and

[T]he development of other nutraceutical, dietary supplements and pharmaceutical products, particularly products that have a botanical-based component and that are designed to treat a range of neurological conditions, including Alzheimer's disease, Parkinson's disease, schizophrenia, depression and tobacco dependence.

We also have continued our prior efforts relating to:

[T]he development, implementation and licensing of the technology behind our proprietary StarCured® tobacco curing process, which substantially prevents the formation of carcinogenic toxins present in tobacco and tobacco smoke, primarily the tobacco-specific nitrosamines, or TSNAs;

[T]he manufacture, sale, marketing and/or development of very low-TSNA dissolvable smokeless tobacco products that carry enhanced warnings beyond those required by the Family Smoking Prevention and Tobacco Control Act, or FDA Tobacco Act, including Ariva® compressed powdered tobacco cigalett® pieces and Stonewall Hard Snuff®,and modified risk tobacco products.

Comments From The Public

The draft guidance document and a December 2011 report from the Institute of Medicine titled Scientific Standards for Studies on Modified Risk Tobacco Products are open for comments from the public until June 4, the FDA said.

Before issuing the final guidance, the agency will consider these public comments, the IOM report, and feedback at an FDA public workshop conducted last August.