ADA petitions FDA to crack down on natural weight-loss claims
CHICAGO The American Dietetic Association last week filed a joint citizen’s petition to the Food and Drug Administration regarding the weight-loss claims made by marketers of dietary-supplement-containing diet aids.
“The American Dietetic Association this week is joining with three other groups in asking the U.S. Food and Drug Administration to raise the scientific standard bar for weight-loss supplement health claims,” the ADA noted in its weekly online newsletter published Friday.
The groups, which filed the petition April 17, are asking the FDA for changes in the regulation of weight-loss supplements so that manufacturers would be required, on the basis of credible scientific evidence, to obtain prior FDA approval of weight-loss claims.
Traditionally, regulating weight-loss claims made in advertising has fallen under the purview of the Federal Trade Commission. That would change, however, if the FDA were to rule that weight-loss claims are a disease state claim, as the citizen’s petition argues.
The ruling could weaken the ability of makers of natural diet aids to market their products to consumers, stacking the deck in favor of GlaxoSmithKline’s over-the-counter medicine weight-loss drug Alli, the one brand that would still be able to make weight-loss claims under those restrictions.
The move would potentially drive more of the $180.3 million in diet aid tablet sales that Alli doesn’t already control into GSK’s bucket. According to Information Resources Inc., Alli alone generated sales of $118.9 million for the 52 weeks ended Jan. 27, across food, drug and mass channels (excluding Wal-Mart), accounting for 32.2 percent of all dollars spent in the category and 13 percent of all units purchased.
GSK, according to the ADA report, is one of the companies that has signed the petition. The other petitioners are Shaping America’s Health and the Obesity Society.
The general public already assumes the FDA is governing dietary supplement diet aid claims, the ADA claims. According to ADA statistics, some 34 percent of consumers have used weight-loss products, and 46 percent believe that the FDA regulates natural diet aids for efficacy, which it does not.
Supplements gain ground in medical community
MINNEAPOLIS Nutritional supplements are gaining ground in the traditional medical community, according to an April report in the Chronicle, published by the investment banking firm of The Mercanti Group.
According to the report, consumers are increasingly moving toward alternative solutions to general wellness issues, spurred by high healthcare costs, quality of care issues and distrust of pharmaceuticals, among other reasons. In addition, supplements are gaining scientific credibility, thanks to Food and Drug Administration insistence on product quality and testing procedures, and increasing research by such federal agencies as the National Institute of Health.
“As consumers have become more interested in health and overall wellness, the market for products and services that provide a holistic approach has greatly increased,” stated author Eric Groman, a principal in Mercanti’s Los Angeles office. “Given that healthcare professionals tend to be more sensitive to product efficacy and the purity of ingredients, practitioner lines are generally characterized by high quality, and have more of a scientific foundation.”
Groman also noted that growth of nutritional supplements is much sharper in the practitioner setting compared with retail. “In this way, practitioner products generally address the quality concerns that have become increasingly important as consumers look to supplements as a way to remedy or alleviate real health problems.”
The report characterizes the $1.7 billion practitioner market as fairly fragmented and crowded. It identifies two of the leading players in the business as Metagenics, a 25-year-old company that has been a pioneer in the field of nutrigenomics, with products aimed at affecting genetic expression and that help prevent or manage chronic diseases; and Standard Process, an 80-year old company offering a full line of whole food and herbal supplements, as well as veterinary items.
Others active in the field that the report discusses are Allergy Research Group, Atrium Innovations, Designs for Health, Integrative Therapeutics, Seroyal International and Thome Research.
“The market is certainly ripe for future growth,” Groman said. “As quality and efficacy continue to be high on the list of consumer demand, and as supplements continue to gain credibility in traditional medical circles, practitioners will have a deepening impact and influence of broader activity in the market for alternative healthcare products.”
Survey prompts Westchester N.Y. to ponder dextromethorphan restrictions
WESTCHESTER , N.Y. A report published Monday stated that between 5 percent and 9 percent of 3,241 middle-schoolers have admitted consuming the cough ingredient dextromethorphan to get high, citing a Student Assistant Services study.
Westchester County is currently considering placing age restrictions on the sale of dextromethorphan, following the lead of Suffolk and Nassau counties—the two counties that make up Long Island.
The paper reported that as many as 10 adolescents have been treated at local hospitals for abusing cough medicine so far this year, according to the Long Island and Westchester Regional Poison and Drug Information Center.