Food and Drug Administration Commissioner David A. Kessler, explicitly rejecting a tobacco industry claim that it does not manipulate nicotine levels in cigarettes, Tuesday described a secret project by one company to genetically engineer a tobacco plant with twice the usual nicotine content.
In congressional testimony, Kessler released the results of an agency investigation into a decade-long project by the Brown & Williamson Tobacco Corp. The company developed and grew in Central and South America a high-nicotine plant known as Y-1, brought several million pounds of it from Brazil and used it in at least five of its American brands, he said.
Appearing before the House Energy and Commerce subcommittee on health and the environment, Kessler also said several tobacco companies chemically regulate nicotine by adding ammonia, a substance that "liberates" nicotine from the tobacco blend, in effect delivering more nicotine to the smoker. Last April, cigarette manufacturers released a list of 599 ingredients added to tobacco, including ammonia, but did not describe the reasons for using the additives.
"These findings lay to rest any notion that there is no manipulation and control of nicotine undertaken in the tobacco industry," Kessler said.
Industry officials have repeatedly denied they deliberately spike their products with nicotine. However, they have acknowledged that nicotine levels can be changed through the blending of different tobaccos and that all of their companies engage in this practice.
Asked about the Brown & Williamson project, a company spokesman said Kessler had misrepresented its motives. The objective of the Y-1 operation, he said, was to enhance flavor.
Kessler's examples and other evidence the agency is gathering likely will serve as the legal and scientific underpinnings of the case the agency is building to support its regulatory authority over cigarettes. The FDA has been exploring the possibility of regulating cigarettes as drugs--or, more precisely, as drug delivery systems--because of the addictive nature of nicotine.
FDA officials believe they would have statutory authority over nicotine if it can be proved conclusively that nicotine is addictive and that its levels in cigarettes can be controlled.
Ann Witt, FDA's special assistant to the deputy commissioner for operations, told the subcommittee that during a May 3 meeting with Brown & Williamson executives she asked whether the company had bred a high-nicotine plant. Company officials denied it, saying "it wasn't feasible," she said.
Last week, however, when confronted with the results of the FDA inquiry, the company admitted that it had done so, Witt said.
Furthermore, the company, which had been seeking a patent for the plant, withdrew its application in March, Kessler said. He refused to speculate about the company's reasons for doing so. But Rep. Henry A. Waxman (D-Los Angeles), the subcommittee chairman and a leading congressional foe of tobacco, noted that the action occurred less than two weeks before Kessler disclosed that the FDA would study the possibility of cigarette regulation.
Kessler said Brown & Williamson cigarettes--Viceroy King Size, Viceroy Lights King Size, Richland King Size, Richland Lights King Size and Raleigh Lights King Size--all contain approximately 10% of the genetically bred high-nicotine tobacco.
Thomas E. Sandefur Jr., chairman of Brown & Williamson, is scheduled to appear before the subcommittee Thursday.
Tom Fitzgerald, a spokesman for the company, declined to respond to the specifics of the FDA testimony, saying: "We'll be setting the record straight Thursday."
But he added: "Contrary to what Dr. Kessler said, there was nothing secretive about the development of Y-1 tobacco. He has totally blown the issue out of proportion. What Dr. Kessler called manipulation was an effort on our part to lower tar levels in our brands and provide the taste that consumers were expecting. We've used a variety of domestic and foreign grown tobaccos to provide the unique recipes that go into each cigarette blend. Y-1 was a blending tool for flavor."
Moreover, he said: "What we have here is an agency with an agenda--and their agenda is to acquire jurisdiction over tobacco so it can regulate it out of existence."
Kessler said interest in developing a high-nicotine plant dated back to the mid-1970s when Dr. James F. Chaplin, then of the Department of Agriculture and North Carolina State University, conducted genetic research in search of a high-nicotine tobacco.
Several years later, an employee of Brown & Williamson asked Chaplin for some of his seeds, which were used as a basis for the company's work, Kessler said.
The company grew a number of different plant lines on its experimental farm in Wilson, N.C., Kessler said.
The company contracted with another firm, DNA Plant Technology, of Berkeley, to work on tobacco breeding and much of the later work took place in DNA's laboratories and greenhouses in New Jersey, Kessler said.
During the ensuing years, the high-nicotine tobacco variety Y-1 was developed by a combination of conventional and advanced genetic breeding techniques that Kessler said ultimately resulted in a male sterile plant, which he said was an indication of its value to the company.
"This procedure ensures that when a plant is grown, it will not produce seeds that can be appropriated by others," he said.
He added: "What was accomplished was the development of a tobacco plant with a high nicotine content--about 6%--that grew well and could be used commercially," he said.
The plants were grown in Brazil in farms under contract to Souza Cruz Overseas, a sister company of Brown & Williamson, Kessler said.
"We do not yet have all the details of how Y-1 came to be growing in Brazil," Kessler said, pointing out that until 1991, it was illegal to export tobacco seeds or live tobacco plants out of the United States, except for special experimental purposes and in very small amounts--less than half a gram.
How the Y-1 seeds were shipped outside the United States is not known. Kessler said officials from each company--Brown & Williamson and DNA Technology--have told the FDA that the other company may have been responsible.
On June 10, officials from DNA Technology told the FDA that "it had been authorized by Brown & Williamson to tell the FDA that Y-1 had never been commercialized," meaning that it had never been used in its cigarettes, Kessler said.
But Kessler described a paper trail of invoices, obtained by the FDA, which showed that more than half a million pounds of Y-1 were shipped to the company in September, 1992, from Souza Cruz Overseas.
"Four days ago, after our questioning . . . Brown & Williamson told FDA that, in fact, 3 1/2 to 4 million pounds of Y-1 tobacco are currently being stored in company warehouses in the United States," Kessler said, and "more significantly, that Y-1 had, in fact, been commercialized" and used in five of the company's brands.