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.
Colgate-Palmolive launches toothpaste for sensitive teeth in Canada
TORONTO Colgate-Palmolive Canada has introduced its new Colgate Sensitive Pro-Relief toothpaste, which is positioned as the first and only toothpaste clinically proven to deliver instant and lasting sensitivity relief, according to the company.
The toothpaste is made with the company’s patented Pro-Argin formula, a technology that plugs the channels that lead to sensitive tooth nerves, thereby blocking the transmission of heat, cold, air and pressure that stimulate pain receptors within teeth.
"Sensitivity is more than just an inconvenience; it’s a common condition that can cause unwanted pain," stated William DeVizio, VP global technology for Colgate-Palmolive. "Colgate Sensitive Pro-Relief can be directly applied to a sensitive tooth, using your fingertip to gently massage for one minute, to deliver instant relief from sensitivity. And regular brushing with Colgate Sensitive Pro-Relief toothpaste builds a long-lasting protective barrier that acts like a seal against sensitivity."
Colgate Sensitive Pro-Relief currently is available at major retailers across Canada.
Unilever expands hair care business with Alberto-Culver acquisition
LONDON and ROTTERDAM, Netherlands Unilever is significantly boosting its hair care portfolio by acquiring Alberto-Culver for $3.7 billion in cash.
Alberto-Culver’s TRESemme and Nexxus styling and conditioning brands will complement Unilever’s Suave, Dove and Sunsilk. The deal makes Unilever the world’s leading company in hair conditioning, the second-largest in shampoo and the third-largest in styling. It significantly enhances Unilever’s hair care presence in the United States, Canada, the United Kingdom, Mexico and "Australasia," all of which will be significant hair care markets for years to come. In skin care, Alberto-Culver’s portfolio also includes such brands as St. Ives and Simple.
The acquisition, which is subject to regulatory approval, is expected to deliver significant synergies and, excluding restructuring costs, will be accretive to EPS in the first full year.
"Personal care is a strategic category for Unilever and growing rapidly. Ten years ago it represented 20% of our turnover, strong organic growth has driven it now to reach over 30%, with strong positions in many of the emerging markets," stated Paul Polman, Unilever CEO. "Organic growth remains the cornerstone of energizing ambition to double the size of Unilever whilst reducing overall environmental impact. Bolt-on acquisitions, such as Alberto-Culver, supplement organic growth and add powerful new brands to our portfolio."
Alberto-Culver generated sales of nearly $1.6 billion and EBITDA of more than $250 million for the 12-month period ended June 30. It has operations in nine countries, six manufacturing facilities and employs roughly 2,700 people.