FDA: Mouth rinse products cannot have ‘prevents gum disease’ claim
SILVER SPRING, Md. The Food and Drug Administration on Tuesday issued warning letters to three companies that manufacture and market mouth rinse products with claims that they remove plaque above the gum line or promote healthy gums. According to the FDA, these claims suggested the products are effective in preventing gum disease when no such benefit has been demonstrated.
Warning letters were sent to: Johnson & Johnson (Listerine total care anti-cavity mouthwash), CVS (CVS complete care anti-cavity mouthwash), and Walgreens (Walgreen mouth rinse full action).
These mouth rinse products contain the active ingredient sodium fluoride.
The FDA has determined that sodium fluoride is effective in preventing cavities, but has not found this ingredient to be effective in removing plaque or preventing gum disease.
Under federal law, a company cannot claim its product is effective in treating a disease unless those claims have been reviewed and approved by the FDA in a new drug application or the active ingredient has been generally recognized as safe and effective for these claims in an over-the-counter drug monograph.
The FDA stated that the actions are part of the agency’s effort to curtail an increasing number of Federal Food Drug and Cosmetic Act violations among the makers/marketers of mouthwashes concerning unproven claims of therapeutic benefits.
To date, the FDA is unaware of any injuries or adverse health effects related to the use of these mouth rinse products. Consumers who have these products may continue to use the products for cavity prevention without risk of injury but should be aware that the FDA has no data to show that these products can prevent gum disease.
Skin care benefits fuel market growth
LITTLE FALLS, N.J. —A stable consumption of personal care products and increased consumer awareness of products with such skin protection benefits as anti-aging and sun care is helping to fuel the demand for personal care ingredients in the United States. That growth is expected to continue in the coming years, according to consulting and research firm Kline & Co.
The market posted 3% growth since 2005, and is forecast to grow further at a compound annual growth rate of 2.2% through 2014, according to Kline’s recently released study, “Global Personal Care Ingredients 2010: Market Analysis and Opportunities.”
Conditioning polymers are the leading product category followed by surfactants, constituting a market share of about 32% and 23%, respectively, by volume. Alkyl polyglucosides, or so-called “green” surfactants that are plant-derived, exceeded the growth of traditional surfactants by more than 2% in 2009.
Spurred by growing consumer awareness, the natural personal care end-product market has persevered through the recession registering an 8% sales gain in 2009 in the United States. Natural ingredients benefited from a strong demand for natural products, capturing a small but increasing growth in their sector. Kline believed the opportunities for growth in the naturals segment surpass the more traditional ingredients, creating a forum for innovation.
Manufacturers hit nail on head with lacquer launches
It’s no secret that the economic crunch helped to spur the sales of nail products in 2009—especially nail color—and that trend is expected to continue as women still are likely to forgo the pricey salon and embrace the do-it-yourself trend.
“The DIY trend helped drive 9% value growth in nail products in 2009. Budget-conscious women continued to give themselves at-home manicures instead of going to salons. As a result, after years of sales declines, nail products turned in a positive sales performance in 2008 and 2009. Within nail products, nail polish was the best performer with value sales growth of 11% in 2009,” stated research firm Euromonitor International in its most recent U.S. color cosmetics research report.
Looking ahead, Euromonitor expected the trend to continue, with nail products projected to experience a 2% constant value increase over the forecast period of 2010 to 2014.
Judging by the slew of new nail products coming to market, manufacturers are banking on the fact that beauty mavens are still hot on nail color. One such example is Nicole by OPI, which is looking to ring in the holiday season with new seasonal shades and special collections. Coming exclusively to Target is the new Nicole by OPI Shades to Crave Collection, which is comprised of 12 nail lacquers, ranging from glittering magenta to the darkest of blacks. Each shade has a suggested retail price of $6.99.
The company also is launching in November its new Tinsel Tips Collection at Harmon and H-E-B, as well as select Walgreens, Sears and Wegmans locations. This is a limited-edition collection featuring three mini nail lacquers with “jewel” nail decals. The gift set will have a SRP of $10 each. There also is the Holiday Magic limited-edition collection, featuring four different shades, coming to Ulta, Meijer, Harmon, H-E-B and Sears in November.
As previously reported, N.Y.C. New York Color, a Coty beauty brand, is ready for fall with its new limited edition Berry Blossom color collection that includes In A New York Minute quick-dry nail polish (SRP $1.99).
Also, POP Beauty, which is sold at Duane Reade’s Look Boutique locations and CVS’ Beauty360 stores, launched in mid-September several new products, including Nail Glams nail polish (SRP $10) in Punk’d (denim blue), Ultraviolet (purple) and De-Glaze (mattifier).