HEALTH

CRN comments on data on male cardiovascular health and vitamins C, E

BY Michael Johnsen

WASHINGTON The Council for Responsible Nutrition on Sunday commended research to be published in the Nov. 12 issue of the Journal of the American Medical Association. While that research concluded there appears to be no prevention of cardiovascular events in male physicians supplementing with vitamins E and C, it did not wholly discount the possible benefits of supplementing with vitamins E or C, either.

“We commend the researchers for undertaking this important prevention trial which sought to confirm positive results demonstrated by earlier observational trials on these antioxidant vitamins. Although the results did not demonstrate an overall benefit, the results also do not discount the earlier epidemiological data showing that people with high intakes of vitamins E and C may have a lower risk of cardiovascular disease,” stated Andrew Shao, vice president of scientific and regulatory affairs for CRN. “Nutrition research is extremely complex, and doesn’t always provide clear-cut answers. This study raises an interesting set of scientific challenges as to why the benefits found in observational studies have not been confirmed in this kind of trial.”  

Shao acknowledged that this research could be frustrating for consumers, however. “The truth is, we don’t have conclusive scientific evidence in the form of randomized, controlled trials that demonstrate exactly how to prevent cardiovascular disease. We do know there are some well-known practical approaches—like not smoking, maintaining a healthy weight, consuming a diet with a variety of foods, regular exercise, seeing your physician and responsible use of vitamin supplements,” he said. “[But] consumers should not take vitamins expecting that vitamins alone will prevent cardiovascular disease … they should continue to take vitamins for the general health benefits they provide.”

“This important study is another in a series of clinical trials that generally have failed to confirm hopes of identifying a strong preventive effect of vitamin E, vitamin C or other antioxidants in relation to cardiovascular disease, commented Annette Dickinson, consultant and past-president of CRN. “These results do not of course negate other evidence of benefits for vitamin E and vitamin C for other conditions, including immune function, mental acuity and eye health. Consumers would be well advised to ensure adequate intakes of all essential nutrients through a good diet plus use of a multivitamin, and selected other nutrients including vitamins E and C, vitamin D, calcium, and EPA and DHA omega-3 fatty acids.”

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Glucorell, Anafit settle FTC deceptive advertising claims

BY Michael Johnsen

WASHINGTON Two marketers of dietary supplements that purportedly prevented and treated diabetes have settled Federal Trade Commission charges that they engaged in deceptive advertising practices, FTC reported Thursday.

According to the FTC’s complaint, GlucorelFTCd  and Anafit, both based in Orlando, Fla., made false and unsubstantiated claims that two dietary supplements, Insulow and Glucorell R, were effective for preventing and treating diabetes.

The order contains a judgment of $493,545, which is the total amount the defendants received in sales for Glucorell R and Insulow between January 2005 and May 2008. However, the entire judgment is suspended due to their inability to pay. If it is determined that the financial information given to the FTC was untruthful, then the full amount of the judgment will automatically become due.

Along with statements in their ads such as “Insulow may be the only thing between you … and a needle,” the defendants also made unsubstantiated claims that Insulow prevents or reduces the risk of developing Type 2 diabetes,  is an effective treatment for Type 1 and Type 2 diabetes, lowers high blood sugar levels, prevents or reverses insulin resistence, increases fat loss and decreases insulin-related obesity and enables diabetics to reduce or eliminate the amount of drugs and insulin required to keep blood sugar levels healthy and reduce insulin resistance, according to the complaint. The FTC also alleged that the defendants falsely advertised that all of these claims except the last had been proven by clinical studies.

For Glucorell R, the defendants’ advertisements allegedly claimed that Glucorell R is effective for treating Type 2 diabetes, prevents or reduces the risk of developing Type 2 diabetes and is effective in treating and preventing cancer. According to the complaint, the defendants also falsely advertised that the last two Glucorell R claims were proven by clinical studies.

According to papers filed with the court, Glucorell has been primarily responsible for packaging, distributing and selling Insulow, and has marketed both supplements; while Anafit has been responsible for packaging, distributing, selling and marketing only Glucorell R.

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Prestige Brands Holding posts Q3 1 percent net revenue gain

BY Michael Johnsen

IRVINGTON, N.Y. Prestige Brands Holdings on Thursday posted net revenues of $88.1 million for its second quarter ended Sept. 30, up 1 percent, primarily from increases in Cleary Eyes and Little Remedies brands in the over-the-counter sector, the company reported and the introduction of two products—Chloraseptic Allergen Block and Little Allergies Allergen Block.

Little Remedies grew 37 percent in the quarter, Mark Pettie, Prestige chairman and chief executive officer, told analysts during a conference call. The growth can be attributed the introduction of Little Noses Saline Mist, which delivers nonmedicated pediatric cough-cold relief in a new form, he said. “This product supplements our existing nasal spray business and is providing considerable incremental growth in the expanding pediatrics saline segment.”

Little Remedies also has benefited from dual placement in one of Prestige’s major drug customers. “Early returns on this program indicate strong incrementality for this customer and we expect continued success will make for a compelling selling story with other customers,” Pettie said.

Also helping to drive growth for Little Remedies was last month’s industrywide voluntary label change of children’s medicines marketed for use in children under age 4. “This change has allowed us to get our two voluntarily withdrawn SKUs reinstated in a number of accounts. But it came too late to influence the seasonal cough-cold resets in the majority of our customers. As a result, there will be a modest benefit to Little Remedies in fiscal ’09, but broad reinstatement will not be possible until the fiscal year ’10 cough-cold season,” Pettie said.

Pettie also noted that the company’s wart remover category continues to be down, slightly. “The cryogenic of the wart remover category took a rather steep price reduction as our fiscal year and the summer wart season began,” Pettie explained. “During our fiscal first quarter the Compound W Freeze Off business in particular was significantly depressed by the fact that our new, lower-priced eight application products did not get into certain retailer’s sets until late in the quarter, with some of that transition carrying into Q2. … We [had] projected that in the second quarter, wart care revenues would continue to be down versus one year ago due to the significant cryogenic segment price declines but that we would see meaningfully improved performance relative to Q1. That has proven to be the case, as the pricing came into line and we restored advertising support to Compound W.”

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