United States Patent Application Links Grain Toxins to Tobacco: Physician-Researcher Generates New Support for FDA Regulation of Tobacco

United States Patent Application Links Grain Toxins to Tobacco: Physician-Researcher Generates New Support for FDA Regulation of Tobacco

For Additional Information, Contact:
Elizabeth P. Gibbens or
Bradford E. Kile
Kile, McIntyre & Harbin
815 Connecticut Ave., N.W., 12th Floor
Washington, D.C. 20006
(202) 835-1642 or (202) 452-7016

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United States Patent Application Links Grain Toxins to Tobacco: Physician-Researcher Generates New Support for FDA Regulation of Tobacco

Citing a 1968 article published in a mainstream medical journal, a physician-researcher revealed today that a potent carcinogen, aflatoxin, worsens the carcinogenic effects of tobacco consumption. "Tobacco stored in curing barns may become contaminated with aflatoxin, an extremely potent carcinogen that renders agricultural commodities such as peanuts and grains extremely harmful and unmarketable," stated Kerry S. Lane, M.D., who practices in the Boca Raton-Delray Beach area of Florida. He also noted that the toxin's presence in foodstuffs and the experience of the Food & Drug Administration in dealing with aflatoxin contamination make the FDA the ideal authority for monitoring the presence of aflatoxins in cigarettes, which, after all, are processed from another American agricultural commodity, tobacco.

Aflatoxin is a toxic metabolite produced by the common fungus Aspergillus, and aflatoxin contamination is a problem when commodities are stored in damp and warm environments. Last year's corn crop in North Carolina was particularly damaged by aflatoxin contamination.

Aflatoxin endangers human health to such a degree that the Food & Drug Administration currently bans the sale and transport of corn and peanuts when the level of aflatoxin contamination exceeds 20 parts per billion (ppb). When levels reach 0.5 parts per billion in milk, it is removed from commerce.

Aflatoxin was one of the agents stockpiled by Saddam Hussein in his arsenal of chemical weapons. [See a study by Anthony H. Cordesman, co-director of the Middle East Program at the Center for Strategic and International Studies, entitled "Weapons of Mass Destruction in Iraq" (November 14, 1996).] What's more, Dr. Lane related, "Researchers have shown that aflatoxin raises levels of the AIDS virus in the blood 400%, and benzpyrene raises them 500%, when these toxins are exposed to cells in the laboratory." He noted, "This is especially disconcerting, because benzpyrene is already an acknowledged carcinogenic component of tobacco smoke, and benzpyrene stimulates cells to form the active metabolite of aflatoxin, the epoxide. Furthermore," he said, "aflatoxin causes mutations in the p 53 tumor-suppressor gene at codon 249 in liver cells, the same site often mutated in lung cancer. It is highly unlikely that this is a coincidence."

As Dr. Lane explained, the danger is that "The level and extent of aflatoxin contamination is not being monitored in tobacco products, because the FDA does not presently have jurisdiction over tobacco." He added, "There is a complete disregard for monitoring the presence of this fungal toxin in tobacco products, and it is one of the most potent carcinogens known." He suggested that because it is generally described as a liver carcinogen in Africa and Southeast Asia, researchers have failed to appreciate its role in tobacco-related carcinogenesis.

Lung cancer is a recognized hazard of cigarette smoking, however, and its connection to aflatoxin seems to have fallen through the cracks. "We have not adequately studied its potential to cause smoking-related cancers," said Lane.

In the early 1990's, Swedish researchers found a class of chemicals known as dibenzofurans, a class that includes aflatoxin, in secondhand smoke, at levels two times higher than in primary smoke. Additionally, R.J. Reynolds obtained a patent in December 1997, for a process to inhibit mycotoxin production in refined agricultural products, including tobacco. (Aflatoxins are a subclass of mycotoxins.) Dr. Lane recently filed an application for a patent that is designed to remediate the threat of aflatoxin contamination in tobacco products. "I do not know of any patents for processes that specifically remediate aflatoxin contamination in tobacco, even though there are patents on inventions that deal with aflatoxin in other agricultural commodities," Lane reported.

One of the most promising approaches to ridding tobacco of aflatoxin may involve spraying ammonia on the tobacco; this has worked on corn and grains. In his research, Dr. Lane found a patent issued in 1970 on an invention that ammoniated cigarette paper, thus reducing tar-induced skin tumors in experimental mice by 50%. Dr. Lane believes that ammoniation may concurrently lower levels of aflatoxin in cigarette smoke.

"The technology I developed is a significant advance over what is already on the market," Dr. Lane explained. "The invention also provides a means for monitoring levels of aflatoxin, and other toxins, at each step as tobacco products are processed," he said.

"This invention deals with a problem that deserves immediate attention, and I hope the FDA is provided jurisdiction by Congress to devote some resources to assessing the role of mycotoxins in tobacco-related disease," concluded Dr. Lane.

For Additional Information, Contact: Bradford E. Kile, (202) 452-7016, or Elizabeth Gibbens, (202) 835-1642, Kile, McIntyre & Harbin, 815 Connecticut Ave., 12th Floor, Washington, D.C. 20006

mailto:Bkile@kileiplaw.com Bkile@kileiplaw.com .

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