FDA warns, then withdraws letter over combining vitamin C and Vicks cough-cold formulations
ROCKVILLE, Md. The Food and Drug Administration on Wednesday initially issued a warning letter to Procter & Gamble for combining the dietary supplement vitamin C with its Vicks NyQuil and Vicks DayQuil cough-cold formulations, according to published reports, and then withdrew that letter from its Web site Thursday citing that the posting was made in error.
The letter initially read: “Because the vitamin C in these products is an active drug ingredient, it is therefore both false and misleading to state that it is an inactive ingredient in these drug products.”
P&G on Wednesday claimed that its marketing of the combination product was appropriate. “P&G has clearly differentiated benefits by the NyQuil or DayQuil active ingredients versus the dietary supplement vitamin C,” stated spokeswoman Crystal Harrell.
Bayer fell under similar criticism last year with its Bayer Aspirin with Heart Advantage (since removed from the market), which contained low-dose aspirin and phytosterols. The Council for Responsible Nutrition, in a statement issued soon after that initial Bayer warning letter, stated: “CRN continues to believe that combination dietary supplement-OTC drug products have a useful and important role to play in integrated healthcare and wellness. … Our hope is that FDA will assist companies attempting to maneuver the regulatory challenges of developing products that combine these ingredients and meet the labeling and formulation requirements of both drugs and dietary supplements, as required by the law.”
CRN noted then that FDA in 1994 stated in the Federal Register that “FDA does not believe that it would be appropriate to preclude such claims [health claims and OTC drug labeling] under all circumstances. Such claims may be permissible if a firm can demonstrate that dual claims can be made in a manner that will neither misbrand the product nor create a safety problem.” Since that 1994 publishing, FDA has issued a few warning letters addressing specific combinations of supplement and OTC drug ingredients, but has never publicly reversed its view that combination products with dual labeling can be developed that would satisfy the agency’s appropriate concerns for safety.
Mentholatum Co. sponsors triathlete Belinda Granger
ORCHARD PARK, N.Y. As part of a new strategy to target the active, athletic consumer who works hard and plays hard, the Mentholatum Co. last week announced its sponsorship of 11-time Ironman triathalon winner Belinda Granger in support of its Rohto Eye Drop line.
Granger wore the Rohto logo on her jersey in pursuit of her 12th Ironman win at the 33rd annual Ford Ironman World Championship triathalon this past weekend in Kailua-Kona, Hawaii. She will continue to wear the brand’s logo in subsequent races through 2011, and her name/likeness will be incorporated across all marketing efforts for the brand, including advertising, in-store merchandising, public relations and digital media.
“Eye irritation is a daily issue for athletes, particularly for triathletes, given the intense exposure to sun, wind, water, salt, chlorine — practically every environmental element,” stated Todd Cantrell, director of the eye care and pain management divisions at Mentholatum. “We’re excited to align with Belinda because she is an extraordinary, inspiring athlete who speaks to the benefits of Rohto Eye Drops in a way that resonates with our target consumers who pursue active lifestyles.
This announcement follows the recent news of Mentholatum’s partnership with the Ironman organization to introduce a line of Ironman-branded topical pain relief products. Granger’s likeness will be used on select Ironman product packaging, as well.
CDC: Recent influenza activity exceeds average flu season rates
ATLANTA Visits to doctors for influenza-like illness continued to increase in the United States for the week ended Oct. 3, the Centers for Disease Control and Prevention announced Friday, and are higher than levels expected for this time of the year.
For patients between the ages of 5 and 49, hospitalization rates from April through October have already exceeded average flu season rates for that period.
A total of 37 states are reporting widespread influenza activity at this time and almost all of the influenza viruses identified so far are of the 2009 H1N1 influenza A viruses. Only Washington, D.C., Hawaii and Vermont reported less than regional influenza activity.