Consumer Health Digest #06-08

Your Weekly Update of News and Reviews
February 21, 2006

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.

FDA drafts "whole grain" label definition. The Food and Drug Administration has issued draft guidance on what the term "whole grain" may include. The FDA document clarifies that the agency considers "whole grain" to include cereal grains that consist of the intact, ground, cracked or flaked fruit of the grains whose principal components—the starchy endosperm, germ and bran—are present in the same relative proportions as they exist in the intact grain. Such grains may include barley, buckwheat, bulgur, corn, millet, rice, rye, oats, sorghum, wheat and wild rice. In contrast, in the grain refining process some of the bran and germ is removed resulting in a loss of dietary fiber, vitamins and minerals. Manufacturers can also make factual statements about whole grains on food labels such as "10 grams of whole grains" or "1/2 ounce of whole grains." [Whole Grain Label Statements. Draft Guidance, Feb 17, 2006] The 2005 Dietary Guidelines for Americans recommend that half of the grain that consumers eat should be whole grains.

Barbara Brewitt ordered to curb homeopathic marketing. The Washington Department of Health has ordered Barbara Brewitt and her company Biomed Comm, Inc. to stop manufacturing drug products without a license. The Temporary Order to Cease and Desist also directs her to stop representing herself as a medical doctor. Documents in the case state that (a) Biomed manufactures and markets homeopathic products for conditions including Alzheimer’s disease, autism, cancer, menopausal symptoms, attention deficit hyperactivity disorder (ADHD), and HIV/AIDS; (b) Brewitt allegedly represented herself as a medical doctor to a Seattle-based pharmacy in order to obtain a drug used in the manufacturing process; and (c) Brewitt holds a Ph.D. in biological structure but possesses no medical degree. The health department plans to notify firms that bought products for retail sale that the products are unapproved. [Seattle woman ordered to stop making and selling drugs without a license: Head of Biomed Comm also directed to stop posing as a medical doctor. Washington State Department of Health news release, Feb 7, 2006]

Biomed Comm's is described on its Web site as "a small Seattle biotechnology company that sells small proteins that tell an aging body to begin making and repairing cells, a process that sparks internal rejuvenation." Its products include “Cell Signal Enhancer – Human Growth Hormone;” “Athletic Edge;” and “Naturally hGH." According to the site:

Sold in pill form and requiring no prescription, . . . cell signalers are sparking a new classification of medicine. In clinical studies, patients have reported increased memory, focus and energy, stronger heart and immune systems, relief from stress and headaches, weight loss, increased muscle mass and improved sleep, among other factors. Biomed’s cell signalers are being taken by autism and HIV (AIDS virus) patients as well as baby boomers who want to stave off aging.

Some of Biomed's claims violate the FDA Compliance Policy Guideline that restricts the labeling of nonprescription homeopathic drugs to self-limiting conditions readily diagnosable by consumers. The Department of Health's investigation was triggered by a complaint from a former employee who stated that many of the products were mixed by Brewitt herself in her own kitchen as she chanted over a crystal bowl. [Reece K. 'We can make this stuff in a bathtub if we want to.' KOMO TV News, Feb 16, 2006]

Health Canada issues chaparral warning. Health Canada is warning consumers not to ingest the herb chaparral in the form of loose leaves, teas, capsules or bulk herbal products because of the risk of liver and kidney problems. Chaparral refers to three plant species: Larrea tridentata, Larrea divaricata and Larrea mexicana, which may also be called creosote bush, greasewood, or hediondilla. The shrub grows in the Western United States and parts of Mexico and is used traditionally by the indigenous people of these regions to treat such conditions as arthritis, cancer, tuberculosis, bowel cramps, diarrhea, venereal disease, colds and bronchitis. No chaparral-containing products are currently approved by Health Canada for any use. [Health Canada warns consumers not to take products containing chaparral. News release, Dec 21, 2005]

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This page was revised on April 9, 2006.