Articles of Interest   GAO Disputes Claims on Ephedrine Over the past few years, the Food and Drug Administration (FDA) has vigorously tried to restrict the production and distribution of dietary supplements containing ephedrine alkaloids, citing several cases of injury due to the consumption of the substance. However, a new study released by the General Accounting Office (GAO) is disputing the validity of the FDA’s claims.   The GAO report accuses the FDA of neglecting to confirm the reliability of the Adverse Event Reports used in their findings. It also states that the documentation used was inadequate. It was discovered that out of the 1000 or so incidents reported, only 13 cases were used by the FDA to make their recommendations. Many of these cases were found to be unrelated to the consumption of products containing ephedrine. Two examples of the Adverse Event Reports used include a man who shot himself and a woman with a blood alcohol level twice the legal limit who ran a car into a tree.   Since the FDA is responsible for maintaining the safety of drugs, food, cosmetics and now dietary supplements, many politicians and industry leaders are speaking out against the apparent irresponsibility displayed by the FDA in this matter. “I am concerned with the apparent lack of scientific data behind the FDA’s actions,” House Science Committee Chairman F. James Sensenbrenner said. "This case appears to be part of a disturbing trend of sloppy science, often at the heart of extremely important governmental regulatory decisions.”   Congressman Ralph Hall stated , “I would suggest that the FDA withdraw the proposed rule, do their job right and see whether we can't come up with a rule that everyone can support grounded in real science and reliable data.”   If approved, the new regulations will restrict and reduce the serving and daily intake amounts, place a seven-day limit on the use of the products and will prohibit ephedrine from being marketed for weight loss and weight management. If the FDA’s restrictions are implemented, most ephedrine products will be banned.   Currently, Nebraska is the only state that prohibits the sale of ephedrine based products. Michael Matthews, WIN Director of Regulatory Affairs, states, “Wellness is heading the forefront to have that (law) amended, and we’ll be able to market in that state, hopefully, by the end of the first quarter of 2000.”   Matthews, like other citizens and industry leaders, is concerned that a ban on ephedrine products will lead to restrictions on other health supplements. “If this (proposed rule) is passed, it’s just the start. They could go after vitamin C next,” he says.   Earlier this year, the American Herbal Products Association (AHPA), along with trade associations representing manufacturers and distributors of ephedrine products, presented a set of guidelines calling for responsible serving limits, adequate warning labels, prohibition on sales to minors and for illicit purposes. In an attempt to support this industry self regulation, WIN currently meets and exceeds all AHPA labeling recommendations. The AHPA hopes the FDA will adopt their guidelines and move on to other important matters.   The Committee on Science, headed by Chairman Sensenbrenner, is currently conducting hearings to determine how to improve the science behind federal regulations. Main Article Index click here Our copyright and Privacy statements / Medical Disclaimer © 2002, Makena Werks, Int'l, All Rights Reserved.