Consumer Health Digest #01-46
Your Weekly Update of News and Reviews
November 12, 2001
Consumer Health Digest is a free weekly e-mail newsletter edited by Stephen Barrett, M.D., and cosponsored by NCAHF and Quackwatch. It summarizes scientific reports; legislative developments; enforcement actions; news reports; Web site evaluations; recommended and nonrecommended books; and other information relevant to consumer protection and consumer decision-making.
"Diet pills" seized at E'OLA International. At the FDA's request,U.S. Marshals seized unapproved drug products from Biogenics Inc., of St. George, Utah, doing business as E'OLA International, and at its contract manufacturer, Nature's Energy, Inc., of Pleasant Grove, Utah. About 140,000 bottles of "AMP II Pro Drops" valued at $2.8 million were seized along with bulk ephedrine hydrochloride (HCl) used in their manufacture. The drops had been marketed as a "dietary supplement" but labeled for use against obesity. The FDA maintains that because ephedrine is approved as a drug, it cannot be marketed as a "dietary supplement" and that dietary supplements cannot be marketed to treat obesity (which the agency classifies as a disease). [US Marshals seize unapproved drug in FDA case. FDA Talk Paper T01-53, Oct 31, 2001] According to San Francisco Attorney Christopher Grell, who represents plaintiffs in personal injury and wrongful death lawsuits against E'OLA, the company had received more than 3,500 complaints about side effects but did not report any problem to the FDA.
Dirty politics after the anti-aging hearing. On September 10, 2001, the U.S. Senate Special Committee on Aging held a hearing on quackery related to marketing of anti-aging products. After the hearing, Representative Dan Burton (quackery's best friend in Congress) falsely accused Timothy N. Gorski, MD, a National Council Against Health Fraud board member, of misrepresenting his credentials at the hearing. Two weeks later, Senator Larry Craig, the committee's ranking Republican member, suggested to committee chairman John Breaux that Gorski's "misstatement" be referred to the United States Justice Department for criminal prosecution. Gorski, however, had done nothing wrong. He was permitted to submit a rebuttal for inclusion in the hearing record; and Breaux notified Craig that Gorski was innocent. Gorski's rebuttal includes detailed criticisms of the Dietary Supplement Health and Educational Act (DSHEA) of 1994, the National Center for Complementary and Alternative Medicine (NCCAM), and the White House Commission on Complementary and Alternative Medicine Policy (WHCCAMP), all of which help undermine consumer protection and should be abolished.
Bill introduced to outlaw amalgam fillings. U.S. Representative Diane Watson (D-CA) has drafted a ''Mercury in Dental Filling Disclosure and Prohibition Act," which is intended to stop dentists from using amalgam to fill cavities. The bill, which falsely states that "the mercury in a dental amalgam continually emits poisonous vapors," would amend the Federal Food, Drug, and Cosmetic Act to "prohibit the introduction of dental amalgam into interstate commerce . . . effective January 1, 2007, if it is a mercury alloy intended for use as a dental amalgam." As of July 1, 2002, it would ban amalgam use in children under 18 years of age, pregnant women, and lactating women, and would require a warning that " the product contains mercury, which is an acute neurotoxin, and therefore poses health risks.'' Quackwatch has posted a point-by-point rebuttal to Watson's irresponsible statements. Watson, a longtime California state senator, was elected to the U.S. House of Representatives in a special election on June 5, 2001, with 75% of the vote. The top 20 contributors to her campaign included the American Medical Association ($5,000), the American Academy of Ophthalmology ($2,500) and the American Dental Association ($1,500).
California dental board issues dental materials fact sheet. Responding to pressure from the California Department of Consumer Affairs and the California legislature, the Dental Board of California has released a 6-page fact sheet comparing the common types of dental restoration. The document was required by a 1992 law that its sponsor (Diane Watson, who was then a state senator) intended to generate a consumer warning that the mercury content of "silver" fillings poses a hazard. However, the board's fact sheet states otherwise:
There are differences between dental materials and the individual elements or components that compose these materials. For example, dental amalgam filling material is composed mainly of mercury (43-54%) and varying percentages of silver, tin, and copper (46-57%). . . . Like all materials in our environment, each of these elements by themselves is toxic at some level of concentration if they are taken into the body. When they are mixed together, they react chemically to form a crystalline metal alloy. Small amounts of free mercury may be released from amalgam fillings over time and can be detected in bodily fluids and expired air. The important question is whether any free mercury is present in sufficient levels to pose a health risk. Toxicity of any substance is related to dose, and doses of mercury or any other element that may be released from dental amalgam fillings falls far below the established safe levels as stated in the 1999 US Health and Human Service Toxicological Profile for Mercury Update. [Dental Board of California. Dental materials fact sheet, adopted Oct 17, 2001]
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This page was posted on November 12, 2001.