P&G adds updated versions of DayQuil, NyQuil with vitamin C
CINCINNATI Procter & Gamble recently combined the multi-symptom relief of its DayQuil and NyQuil brands with more than 150 percent of the recommended value of vitamin C in DayQuil Plus Vitamin C and NyQuil Plus Vitamin C respectively.
The idea is that while consumers are seeking cold symptom relief, they can take something to help boost their immune system in one remedy. Last cough/cold season, Bayer Healthcare followed a similar line of thinking with its introduction of Alka-Seltzer Plus Immunity Complex, effervescent get-better tablets that contain all supplements, however, as opposed to a supplement and OTC combo.
Bayer did however recently launch a supplement/OTC combination product, Bayer With Heart Advantage, which contains 81 mg of aspirin and 400 mg of phytosterols. That product generated a warning letter from the Food and Drug Administration on Oct. 28, in which the agency suggested that supplement/OTC combinations may run afoul of regulations. “The FDA considers these products new drugs and thus they must undergo the FDA’s drug approval process,” Mike Chappell, the FDA’s acting associate commissioner for regulatory affairs, said. Speaking to the Bayer products, FDA noted that the solution is labeled as being a combination of a drug and a dietary supplement, but when a drug and a dietary supplement are combined in a single tablet, the product is regulated by FDA as a drug.
That’s not to suggest that P&G is marketing a product without FDA approval. Under its OTC drug monograph system, FDA allows some drugs to be marketed without first obtaining agency approval, the agency noted. These drugs must comply with applicable monographs as well as the indications for which the drugs can be marketed.
Glucorell, Anafit settle FTC deceptive advertising claims
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.
Prestige Brands Holding posts Q3 1 percent net revenue gain
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.”