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FDA Violations

Food Safety Experts have done What with Big Tobacco?

— April 22, 2015

In a landmark investigation released this week, the Center for Public Integrity (CPI) uncovered the alarmingly small and insular circle of experts who are used by food manufacturers to determine if a new ingredient is “Generally Regarded As Safe,” or GRAS. The investigation discovered that at least one of 10 particular consultants participated in over 75 percent of the GRAS determination panels, which usually involve 3 experts who review safety data of an ingredient to try to reach a scientific consensus. One scientist, Toxicologist Joseph Borzelleca, has served on 41 percent of the 379 panel sample that was used for the investigation. Several advocacy groups as well as the U.S. General Accountability Office (GAO) have called the current GRAS process rife with conflicts of interest, however, perhaps the most concerning part of the report is the connection this circle of panelists has with the tobacco industry. Borzelleca, and 3 other of the 10 most frequent GRAS panelists have all provided consultation for Philip Morris, RJ Reynolds, and other tobacco giants. In fact, 10 GRAS consultants altogether have some ties to the industry, including Borzelleca, who served on Philip Morris’s official advisory board, and two others who were once full-time tobacco company employees. This is the time to go ahead and take another bite of your snack before you continue reading. It’s perfectly safe; nothing to worry about here.

Borzelleca defended the insular nature of GRAS experts in questioning conducted by CPI, arguing that, “If you’re good at something, of course you’re going to be in demand.” This must be true for his knowledge of tobacco additives as well as food ingredients, because CPI discovered a confidential memo from 1986, archived by UC-San Francisco, which states that RJ Reynolds strongly considered using him as their “main spokesman” if a list of additives sent to the Department of Health and Human Services was leaked to the press. In an emailed response to the CPI investigation, Borzella responded:

”For one set of additives, my advice to the tobacco industry was that the GRAS substances they were using are safe when ingested, but I could not comment on their effects when they were subjected to the high temperatures of a lighted cigarette, a position that I still have.”

Take a second and read that line again. Maybe Borzelleca knows people who eat cigarettes instead of lighting them on fire. Apparently, the lack of understanding of what happens to the properties of additives when combusted did not dissuade another tobacco company from procuring his expert services. By 1995, Borzelleca was earning $2,000 per day serving as a consultant for Philip Morris, and holding a spot on the company’s Scientific Advisory Board.” Again, Borzelleca’s expert opinion was needed, “to advise PM on a less hazardous cigarette,” which he added was “erroneously referred to as a ‘safer cigarette.’ ” This is the man who has served on more documented GRAS food safety panels than anyone in history. Take another bite of that snack.

While Borzelleca is the most conspicuously alarming example, he is hardly alone. In fact, he served on the Philip Morris board with Michael Pariza, Steve Taylor, and William Waddell, 3 more of the 15 most frequently used food-safety GRAS panelists. Another toxicologist, George A. Burdock, who has served on 10 GRAS food safety panels since 1998, was paid nearly $16,000 in 1995 by the company for consulting services. Edward Carmines, who has served on 3 panels, was employed for 13 years as a scientist for Philip Morris and A. Wallace Hayes served as an executive for RJR Nabisco. An uncovered performance review from 1990, listed one of Hayes’s objectives to be to, “increase our knowledge base regarding the role of nicotine/cotinine in smoking enjoyment/satisfaction.” Don’t forget to chew before swallowing.

Given the small circle of panelists, these examples cannot be seen as outliers or major exceptions. Instead, the CPI investigation appears to have uncovered a largely overlooked culture of cronyism, or at least exposed in great detail the potential for major conflicts of interest. Although an isolated occurrence of the overlapping roles may be understandable, the pervasiveness of food safety experts with ties to big tobacco leads me to believe, where there is smoke, there is uh…well you know how it works, Mr. Borzelleca, don’t you?


Center for Public Integrity – Chris Young and Erin Quinn

Center for Science in the Public Interest

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