NAD cites Green Willow Tree for overstatement of Thyodine effects
NEW YORK The National Advertising Division of the Council of Better Business Bureaus on Wednesday recommended that Green Willow Tree discontinue certain advertising claims for its Thyodine dietary supplement product, including that its product is a “safe, all-natural hormone,” and that “Thyodine helps to stimulate the thyroid gland to produce normal amounts of thyroid hormone again.”
In its defense, Green Will Tree maintained that Thyodine includes vitamins, amino acids, minerals, supplemental glandulars and other ingredients that have been generally accepted in the scientific and medical community as beneficial to, and supportive of, thyroid function.
However, NAD determined that the advertiser’s claims go beyond the simple message that Thyodine contains ingredients that have been shown to help support a healthy thyroid.
The company, in its advertiser’s statement, noted that it does not “fully agree with the conclusions.”
However, the company said that it would adjust advertising for Thyodine to “attempt to meet the recommendations submitted … by NAD.”
The claims were challenged by the Council for Responsible Nutrition, a trade association of dietary-supplement manufacturers.
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.
Perrigo files FDA application for OTC generic of Monistat
ALLEGAN, Mich. Perrigo on Monday announced that it has filed an abbreviated new drug application for over-the-counter miconazole nitrate vaginal cream, 2 percent and Suppository, 1.2g, a generic version of Monistat 1 Combination Pack.
Monistat 1 Combination Pack is an antifungal medication indicated for the treatment of vaginal yeast infections, and had sales of approximately $50 million through food, drug and mass merchandisers for the 12 months ended March 2008, as measured by Information Resources, Inc., Perrigo reported.
According to Perrigo, McNeil challenged Perrigo’s ANDA with a suit filed Friday alleging patent infringement in the United States District Court for the District of New Jersey to prevent Perrigo from proceeding with the commercialization of its product.