NIH-ODS AWARDS GRANTS TO STUDY SUPPLEMENTS
The National Institutes of Health’s Office of Dietary Supplements (NIH-ODS) has announced that it will fund four new research projects that will examine dietary supplements and their potential role in health promotion and disease prevention. The four studies are: (1) A project at Brown University to evaluate the possible relationship between low dietary intake of the amino acid tryptophan, a precursor of serotonin, and the susceptibility to problems associated with alcohol abuse in a tribe of rural Native Americans, (2) a study conducted at the Harvard University School of Dental Medicine on the relationship between poor dental health and heart disease, the hypothesis being that poor dentition may lead to a decreased intake of fiber and phytochemicals which may be important in head health, (3) a study at Florida State University to examine the actions of zinc and copper and their relationship to neuropathologic diseases of aging such as Alzheimer’s disease and stroke, and (4) a project at the Baylor College of Medicine in Houston, TX, to study the role of metallothionein, an enzyme that regulates zinc levels in body tissues.
ST. JOHN’S WORT QUESTIONED
A study commissioned by the Los Angeles Times found that out of ten brands of St. John’s Wort examined, three products had about half the potency shown on the label, and four products had less than 90 percent of the potency shown on the label. The study examined 10 pills from each of three containers of one lot of each of 10 products. Identified by only a code, the brand names were unknown to the laboratory. Five independent experts reviewed the research procedures and found the study to be sound.
CONFERENCE ON ZINC
The Office of Dietary Supplements (ODS) at the National Institutes of Health (NIH) recently held a conference entitled “Zinc: What Role Might Supplements Play.” Leading experts in zinc research spoke at the conference on the current state of knowledge regarding zinc nutrition and on potential roles for zinc supplements. Based on data from the National Health and Nutrition Examination Study (NHANES III), only about half of Americans receive an “adequate” amount of zinc, reported Ronette Briefel of the National Center for Health Statistics. While many nutrition experts believe that Americans may not be getting enough zinc in their diets, estimates of daily zinc requirements cannot be made until further studies are conducted.
LACK OF NUTRACEUTICAL REGULATION
Speakers at the 10th Nutraceutical Conference in New York concluded that more regulation of the nutraceutical industry is needed due to an increased demand by consumers for nutritional and botanical products. Stephen L. DeFelice, chairman of the Foundation for Innovation in Medicine (FIM), sponsor of the event, told the conference attendees, “The consumer demand for nutraceuticals is way ahead of regulations and way ahead of doctors’ awareness of these products.” Dr. Felice noted that about one-third of Americans currently take vitamin E, about 100 million take dietary supplements, and 60 million take herbal remedies and botanicals. He expressed concern that these supplements may increase the toxicity of prescription drugs or interfere with the efficacy of prescription drugs taken by consumers. Dr. Felice encouraged Congress to enact the Nutraceutical Research & Education Act (NREA) to expedite the establishment of a research-oriented nutraceutical industry.
FTC CREATES GUIDE FOR SUPPLEMENT ADVERTISERS
The Federal Trade Commission (FTC) has created a guide to help dietary supplement manufacturers ensure that their ads are truthful. The guide describes the basic principles of the law and addresses such products as vitamins, minerals, herbs, hormones, and amino acids. “A Guide for the Dietary Supplement Industry” is available online at http:www.ftc.gov/opa/1998/9811/dietary.htm.
SOY PROTEIN RULE PROPOSED
The FDA is proposing to permit soy products to be marketed with claims that soy protein included in a diet low in fat may reduce the risk of coronary heart disease (Federal Register 63:62977-63015, 1998). Based on a review of approximately 40 studies, the agency tentatively concluded that a minimum level of approximately 25g of soy protein per day can have a clinically significant effect on total and LDL-cholesterol levels without lowering HDL-cholesterol levels. The New England Journal of Medicine published a meta-analysis with similar conclusions in 1995 (333:276-282). The full text of the proposed FDA rule is available online at http:// www.fda.gov/ohrms/dockets/98fr/ 111098a.txt.
FRAUDULENT LABELING UNCOVERED
Welder Nutrition Group, which markets many products for athletes, has settled a class-action lawsuit alleging that the company misrepresented the fat, sodium, vitamin, and mineral content of several “Steel Bar” nutrition products that it distributed. The suit charged, for example, that in 1995, coconut bar labels stated that the product contained 4 grams of fat, even though the company knew that independent laboratory tests had found four times that amount. The settlement called for buyers to receive $1 for every bar purchased between December 20, 1994 and April 24, 1998, with an individual maximum of $5 and a collective maximum of $750,000.
ANTIOXIDANT DRI PROPOSAL ANNOUNCED
The Institution of Medicine has proposed a definition and will consider establishing antioxidant-related Dietary Reference Intakes for beta-carotene, other carotenoids, vitamin C, vitamin E, and selenium. The proposal can be accessed at http://www.nap.edu by searching the National Academy Press’s “Reading Room” for “antioxidants.”
GARCINIA CAMBOGIA INEFFECTIVE
A study has found that taking 1,500 mg/day of hydroxycitric acid (the active ingredient in the herbal compound Garcinia cambogia) did not produce significant weight or fat loss beyond that observed with placebo. The study followed 135 obese participants, 84 of whom completed 12 weeks of treatment. All followed a low-calorie, high-fiber diet and lost a significant amount of weight. However, the hydroxycitric acid group did no better than the placebo group (JAMA 1998;280:1596-1600).
SAW PALMETTO DESERVES FURTHER STUDY
A meta-analysis has examined whether saw palmetto extract may be helpful for men with symptomatic benign prostatic hyperplasia (BPH). The authors evaluated 18 randomized controlled trials involving 2,939 patients. The studies were mostly short-term and varied considerably in design, products used, and reports of outcomes. The authors concluded that further research should be done with standardized preparations to determine long-term effectiveness and ability to prevent BPH complications (JAMA 1998;280:1604-1609).
CHILD NUTRITION GUIDE
The American Council on Science and Health has published a 46-page booklet, Growing Healthy Kids: A Parents’ Guide to Infant and Child Nutrition. The booklet can be read online (http://www.csh.org) or ordered for $5 from the council at 1995 Broadway, 2nd Floor, New York, NY 10023.
FDA POLICY UPHELD
The U.S. Supreme Court has rejected an attack against the FDA’s policy of requiring “significant scientific agreement” to substantiate health claims on supplement labels. A suit challenging the FDA had been filed by the Nutritional Health Alliance, a group of manufacturers, retailers, and consumers. The lawsuit contended that the labeling restriction amounts to an unlawful prior restraint of truthful commercial speech. However, a federal judge in New York and the 2nd U.S. Circuit Court of Appeals had upheld the regulations.
BOGUS DEVICE OPERATOR ORDERED TO STOP
The attorney general of Minnesota has obtained a judgment against Shelvie Rettmann of Prior Lake, Minnesota, an unlicensed individual who falsely represented that she could cure cancer. Her approach included treatments with a Rife Frequency Generator, a special diet, dietary supplements, foot reflexology, and a regimen of baths. The Rife device is claimed to generate radio waves that shatter “cancer-causing bacteria.” The judge prohibited Rettmann from providing health-care services or products, ordered refunds upon request to injured consumers, and imposed civil penalties of $50,000 plus the state’s attorney fees and costs. However, refunds are uncertain because Rettmann filed for bankruptcy.
COURT HALTS BREATHASURE CLAIMS
The Warner-Lambert Company, which manufactures Certs breath mints, Clorets mints and gum, Dentyne gum, and Listerine antiseptic mouthwash, has obtained a federal court order to stop BreathAsure Inc., of Calabasas, California, from continuing to claim or imply that its internal breath freshener products, BreathAsure and BreathAsure-D, get rid of bad breath for hours and give users clean, fresh breath, even after they consume onions, garlic, or other foods containing aromatic substances. Warner-Lambert had charged that taking BreathAsure capsules with water is no more effective in fighting bad breath than drinking water alone. Following the court ruling, BreathAsure removed information about its products from its Web site (http://www.breathasure.com).
COPYRIGHT 1999 Prometheus Books, Inc.
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