FDA says tobacco firms control nicotine levels - C&EN Global

Jun 27, 1994 - In his lawyerly fashion, Food & Drug Administration head David A. Kessler continues to build a case for regulating tobacco products. Ap...
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evacuated area who is now executive di- states that "many U.S. tobacco comparector of the Citizens Clearinghouse for nies use ammonia technologies," Kessler Hazardous Wastes, Falls Church, Va., noted. Development and use of high-nicotine believes the area should remain vacant. However, she is "really happy" the par- tobacco and the use of ammonia technolties finally settled. 'The attorney general ogy 'lay to rest any notion that there is no made the right decision. The downside manipulation and control of nicotine unis [OxyChem was] not really hurt by dertaken in the tobacco industry," Kessler concluded. He also said that B&W's rethis. It sends a bad message." Elisabeth Kirschner cently released internal documents on the pharmacologic effects of nicotine "lay to rest, once and for all, the industry's assertion that nicotine is not addictive." However, testifying before the same In his lawyerly fashion, Food & Drug In his testimony before the House panel a few days later, B&W chairman Administration head David A. Kessler Health & Environment subcommittee, Thomas F. Sandefur Jr. refuted many of continues to build a case for regulating Kessler recounted how Brown & Wil- Kessler's allegations and accused the FDA tobacco products. liamson (B&W) Tobacco Corp. of Louis- chief of "grandstanding." Sandefur said, Appearing for the second time before ville used what he called genetic engi- "I do not believe nicotine is addictive," a House panel considering such action, neering to secretly develop a tobacco not in the way cocaine and heroin are adKessler described how tobacco compa- plant, called Y-l, with nearly twice the dictive. "We don't spike our products nor nies—using genetic breeding and chem- nicotine content of ordinary tobacco. do we manipulate nicotine in our cigaical additives—are intentionally manip- Seeds from this plant were shipped to rettes to keep people hooked, as FDA alulating the nicotine content of cigarettes. Brazil for cultivation. The leaves have leges." He acknowledged the health risks Nicotine is the naturally occurring sub- been imported and blended into several associated with smoking but noted that many of the same illnesses "have also stance in tobacco that addicts smokers. of the company's cigarettes since 1993. If cigarette makers are controlling However, B&W spokesman Tom Fitz- been tied to other human conditions, innicotine levels—and they say they are gerald says, "What Dr. Kessler called ma- cluding lifestyle, diet, and heredity." Sandefur said regulating the tobacco not—then cigarettes could be consid- nipulation was an effort on our part to ered drug delivery systems, subject to lower the tar levels in our brands and industry is tantamount "to back-door FDA regulation. Cigarettes are not now provide the taste that consumers were prohibition of tobacco sales— The pathso classified, and Kessler says he is not expecting." Techniques that lower the way to FDA regulation is the pathway yet ready to recommend a change in tar content also lower the nicotine con- to prohibition." his agency's regulatory policy. Instead, tent of cigarettes. Fitzgerald explains: On another front, Attorney General Jain August he will ask an FDA drug ad- "Y-l was a blending tool for flavor. ... net Reno announced last week that her visory panel to decide the level at The products that used Y-l delivered es- department's criminal, civil, and antitrust which nicotine is addictive, suggesting sentially the same nicotine as the prod- divisions are considering whether to that the agency may regulate the ucts they replaced." But, he notes, "Be mount a full-scale investigation into alleamount of nicotine in cigarettes rather cause concerns and doubts were raised gations against tobacco industry executhan ban cigarettes outright. by FDA, we decided to discontinue [Y-l] tives. The executives are suspected of misuse a number of weeks ago." leading Congress when they testified in In April, six major tobacco compa- May before the same House panel about nies released a list of 599 substances several tobacco-related issues, including added to tobacco. The list includes am- their denial of any efforts to manipulate monia compounds that, Kessler ex- nicotine levels. Lois Ember plained, are added to boost the amount of nicotine delivered to smokers. Most of the nicotine in the average cigarette is in the bound form. But as Kessler found from reading a U.S. tobacco company's handbook, ammonia, when added to a tobacco blend, reacts with indigenous nicotine salts to liberate free nicotine. Some of the chemistry has just been According to the company handbook, made public for a new detergent formudiammonium phosphate, ammonium lation that has been causing a row in hydroxide, and urea are most common- Europe. Unilever scientists describe in last ly added to reconstituted tobacco to act as "impact boosters" to deliver more week's Nature [369, 637 (1994)] a family nicotine to the smoker. Kessler told the of organomanganese complexes that catpanel that ammonia-treated tobacco has alyze hydrogen peroxide bleaching at "almost double the nicotine transfer ef- about 20 °C. One of these catalysts, Kessler: building a case for regulation ficiency of tobacco." The handbook known as Accelerator, is an ingredient in 1992, says Love Canal Area Revitalization Agency salesman Ken Denman. The agency has sold 193 of the 280 available houses. Appraisers once deducted 20% from house prices because of the location. But perceptions are changing: For the past year and a half, appraisers have deducted only 15%. Some 30% of the purchasers lived in the area before the evacuation. Lois Gibbs, a former resident of the

FDA says tobaccofirmscontrol nicotine levels

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JUNE 27,1994 C&EN

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