Conference on Self-Regulation of Functional Foods
WASHINGTON--A conference will be held here to discuss the development of a third-party review process for substantiating claims used for nutritional products, including dietary supplements, functional foods and nutraceuticals. Co-sponsored by the Research-based Dietary Ingredient Association (RDIA) and the Life Sciences Research Office (LSRO), industry leaders, academia, government agencies and scientific organizations will attend the conference, which will be held Nov. 13 and 14. According to RDIA, the main purpose of the conference is to create a regulatory environment for functional foods, ingredients and dietary supplements that will assure consumers that the products they buy have met safety and efficacy standards. This process will be modeled on food and food ingredient safety reviews already established by LSRO. To find out more about this conference, call LSRO at (301) 530-7030.
Boy's Case Illuminates Patients' Rights
NEW YORK--Thomas Navarro's battle against a rare brain cancer has reached the hearts of many, and has begun to reach the major media and the floor of Congress. Most recently, the New York Post featured Navarro's struggle on the cover of its Aug. 25 edition, and Congress has taken the ball with recent hearings on patients' rights and a promise to fast track the Thomas Navarro FDA Patient Rights Act (H.R. 3677), which was sponsored by Rep. Dan Burton (R-Ind.) and cosponsored by 36 other representatives.
The 5-year old Navarro and his parents have undergone a year-long uphill struggle against government officials who have moved vigorously to block the family from seeking a second opinion for the boy, who was marked for chemotherapy and radiation treatment last September. The parents, Arizona residents Jim and Donna Navarro, were told of the drastic and dangerous side effects commonly associated with this treatment in children. Grassroots consumer organization Citizens For Health noted that such conventional treatments have never been approved for use on children by the Food and Drug Administration (FDA).
In lieu of chemotherapy, the Navarro's wanted to explore a complementary treatment by Dr. Stanislaw Burzynski of Texas, who has logged 74 FDA-approved clinical trials with a 90-percent cure rate. Despite the success of the treatment, the FDA turned the tables on Burzynski and prevented the treatment from being used. When the Tucson, Ariz. doctors advising for chemotherapy caught wind of the Navarro's efforts to seek complementary treatment, they contacted child welfare officials, and the parents were told that their efforts could result in their losing Thomas and his younger brother for neglect and that manslaughter charges could also result should Thomas die under complementary or unapproved care.
The family has since gotten support from Beth Israel hospital in New York, as well as from ex-presidential candidate Alan Keyes and Republican Presidential nominee George W. Bush. For more information on the Navarro's plight and how to help the boy and other such patients, visit www.citizens.org.
NEWS IN BRIEF
Gates Foundation Donates $20 Million for Vitamin Research
BALTIMORE--The Bill & Melinda Gates Foundation granted $20 million to Johns Hopkins University to study the effect of vitamin and mineral supplementation on the populations of poor countries. The study will be conducted over a five-year period and will focus on finding the most effective combination of nutrients for women and children's health. Research is being planned in countries such as Nepal, Bangladesh, India, Ghana and Zanzibar. For additional information, visit www.glf.org.
ImmunoLin™ Maker Changes Name
AMES, Iowa-- AMPC Inc. has changed its name to Proliant Inc. Its three divisions also adopted the new name, and under the Proliant umbrella, AMPC Inc. becomes Proliant Ingredients; LG Labs becomes Proliant Health; and AMPC Biologicals becomes Proliant Biologicals. For more information, call (515) 296-7100 ext. 2535.
CoQ10 Product Earns Orphan Drug Status
WESTBURY, N.Y.--The Food and Drug Administration (FDA) has granted Orphan Drug designation to Tishcon's UbiQGel, a coenzyme Q10 product, for the treatment of Mitochondrial Cyopathies, a dibilitating disease of the mitochondria. As a result, FDA can award Tishcon seven years of exclusive marketing of the product following successful completion of clinical trials, which are to begin this fall. For more information, call (800) 201-4443.
New Web Sites
Symbiotics Inc. and BlueBonnet Nutrition Corp. both recently released new Web sites. Symbiotics' renewed site is now located at www.symbiotics.com and features in-depth information regarding colostrum. Bluebonnet's first site is located at www.bluebonnetnutrition.com and will contain useful information on the company's products as well as the greater nutrition industry
Vitamin E--Natural vs. Synthetic?
LAGRANGE, Ill.--The Antioxidant Panel of the Food and Nutrition Board of the Institute of Medicine at the National Academy of Sciences reported that natural source vitamin E can be twice as potent as the synthetic version. The group noted that synthetic E contains substances not recognized by the body as vitamin E. For more information, contact Cognis at (708) 579-6150.
Correction
In the "Products" section of the September issue of HSR:Health Supplement Retailer, the phone number for Himalaya USA should have read (800) 869-4640. We apologize for the error.
Clarification
The July issue of HSR:Health Supplement Retailer should have noted on page 36 that the study on MSM sponsored by Greenville, Pa.-based Carolwood Corp. used the company's patented Lignisul MSM. We regret the omission.
FTC Takes Action Against Rexall's Cellasene
BOCA RATON, Fla.--On July 20, the Federal Trade Commission (FTC) filed a lawsuit against Rexall Sundown Inc. for its Cellasene product, an herbal dietary supplement purported to eliminate cellulite. According to the FTC, Rexall's marketing of Cellasene as a product that is clinically proven to eliminate cellulite is false and unsubstantiated and misleading to consumers.
FTC reported that Rexall had no clinical evidence to support claims that Cellasene "fights cellulite from the inside," but the company had a different opinion.
"The Commission's action completely ignores the sound scientific research into the effectiveness of Cellasene," said Debbie DeSantis, senior vice president of product development at Rexall. "Cellasene was designed and formulated by one of the world's leading herbal/pharmaceutical extract companies with foremost expertise in cellulite research." According to Rexall, the product was studied in two clinical studies in Italy and was the subject of more research in France. The company cited the product's safety and efficacy record in Europe, where it has been on the market for six years. FTC has been asking Rexall to document Cellasene's effectiveness since its 1999 introduction to the American market. According to DeSantis, Rexall has "tried on numerous occasions" to give FTC the documentation, but FTC has "shown no interest in allowing any scientific dialogue among government and industry experts."
FTC charges that Cellasene, which contains ginkgo biloba, grapeseed extract and other herbs, is making false claims in its advertising. In the lawsuit, FTC asks that Rexall stop making the efficacy claims and reduce the price to consumers; notably, it does not ask it to stop selling the product.
Rexall is a wholly-owned subsidiary of the Dutch company, Royal Numico, N.V., which also owns brands such as Met-Rx, GNC and Enrich. For more information, visit www.ftc.gov, www.rexallsundown.com or www.numico.com.
Class Action Suit Filed Against NBTY
BOCA RATON, Fla.--The law firm of Cauley & Geller filed a class action suit against NBTY (NASDAQ:NBTY) on behalf of NBTY shareholders. It alleged that NBTY violated federal securities laws by misrepresenting its financial status and potential for future growth for the period of Jan. 27, 2000 to June 15, 2000.
Among the allegations are that: sales at NBTY's Vitamin World stores are down; the value of the British Pound negatively impacted the sales at its UK-based Holland & Barrett stores; and its "vertical integration" efforts were not at all beneficial. Due to these factors, its stock traded at artificially inflated prices. According to Cauley & Geller, insider trading was exposed and stock prices plummeted when the facts were revealed.
Cauley & Geller (www.classlawyer.com) will represent those who are interested, but noted that other law firms can do the same. The action, number 00-CIV-4402, was filed in the U.S. District Court for the Eastern District of New York. For a copy of the action, write to the Court at Two Uniondale Ave., Uniondale, NY 11553.
FDA: Cholestin to be Regulated as Drug
DENVER--An appeals court issued an opinion on July 21 that would once again allow the Food and Drug Adminstration (FDA) to regulate Cholestin, a dietary supplement that lowers cholesterol, as a drug. Cholestin is produced by Pharmanex Inc., a division of Nu Skin Enterprises Inc.
In 1999, the FDA banned the import of a red yeast rice powder, which contains the active compound mevinolin, and is used to make Cholestin. The FDA found that mevinolin was identical to a synthetic drug called Mevachor, which is marketed by Merck & Co. The agency maintained that it should be classified as an unapproved drug and proceeded to ban the powder.
Last May, U.S. District Court Judge Dale Kimball (Utah) determined that the FDA's ban was illegal under DSHEA, and that Pharmanex's Cholestin fit the definition of a "dietary supplement." Therefore, he ruled it could not be regulated by the agency as a drug. According to Kimball's interpretation of the law, the FDA can regulate finished products as drugs, but not the ingredients of finished products.
Most recently, the 10th Circuit Court of Appeals in Denver said that Kimball's ruling was in error and restored the FDA's ability to regulate Cholestin as a drug. It said the law's intent was ambiguous although "linguistically possible," and it determined that the FDA interpretation [that the definition applied to ingredients and finished products] was "not arbitrary, capricious, or manifestly contrary to the statute." Therefore, to apply a single interpretation--that it applies only to finished products--"would be to restrict its scope so as to render it a meaningless limitation."
It also found that "deference is particularly appropriate in the instant case, which involves important questions of public health and safety." Due to this deference, there are still unresolved arguments, so the case will be sent back to district court. For more information, visit www.nuskin.com or http://www.courts.state.co.us/ctappeals/coacas00.htm.
Wild-crafted St. John's Wort Better?
WASHINGTON--According to research conducted at Cornell University, wild-crafted St. John's wort may flourish in adverse environments, including when it is attacked by insects. Researchers reported that the amount of hypericin, an active compound in the plant, can increase when the plant is attacked by insects. Currently, most manufacturers use commercially grown St. John's wort.
Research funded by the U.S. Department of Agriculture's (USDA) Agricultural Research Service and Foreign Agricultural Service found that a pesticide-free plant grown in the wild increases its levels of chemicals to combat insects, which in turn increases hypericin levels.
The amount of hypericin varies from plant to plant, thus manufacturers may see differences in potency levels from batch to batch. Ongoing research is focusing on how pre-harvest conditions, light, moisture levels, altitude and latitude affect the final product.
The research was presented Aug. 15 at the annual American Phytopathological Society meeting in New Orleans. For additional information, visit www.usda.gov.