FDA warns 'wonder' wrinkle treatment maker on claims
warning letter sent by the goverment regulation body stating that
marketing claims for its anti-wrinkle treatment, StriVectin-SD,
could mean the product's status will be changed from that of a
cosmetic to a drug, reports Simon Pitman.
In a letter sent to the company on January 20, the company was given 15 days to respond to the FDA's claims that the company's products StriVectin,-SD, Stri-Vectin-SD Eye Cram, Dermalin-APg, Mamralin-ARa and TestroGel are promoted with "claims that cause the product to be drugs under section 201 of the Federal Food, Drug and Cosmetic Act."
Basic Research told CosmeticsDesign.com, "It is important to note that the FDA is not accusing Basic Research of making false claims, nor is it the FDA's position that the products in question are ineffective. Rather, this is an issue of whether or not the FDA considers the claims made on product packaging, ads, promotional materials, etc. to be 'drug claims' or 'cosmetic claims.'
"For example: According to the FDA, if a product is claimed to 'reduce fine lines and wrinkles,' it is classified as a drug. If a product is claimed to 'reduce the appearance of fine lines and wrinkles,' it is classified as a cosmetic, regardless of whether the outcome is identical."We are working and cooperating actively with the FDA to rectify any outstanding issues and arrive at an amicable solution."
Obviously if the company were to receive drug status for any of its products it would come as a severe blow to its sales in the US as it would mean a significant restriction on over the counter purchases.
The FDA defines the term 'drug' as meaning any article or product that is intended to affect the structure or function of the body.
"The labelling for your products includes several claims that demonstrate that these products are intended to affect the structure or function of the body (structure/function claims," the FDA's letter stated.
In a letter addressed to Dennis Gay, CEO of Basic Research, the FDA cited specific examples of this found on the labels for the company's products. With specific reference to Stri-Vectin-SD it emphasised the labelling claims: "StriVectin-SD's clinically proven, proprietary compounds will produce a visible recution in actually length, size, depth, feel, colour, and rough texture of your existing wrinkles and/or stretch marks," and "Reduces wrinkles by as much as 68 per cent."
Stri-Vectin-SD was originally marketed by the company as a high end remedy to help relieve the effects of stretch marks, both during and after pregnancy. The remedy proved highly effective and it was soon discovered that it was equally effective in treating facial lines and wrinkles.
According to NPD Beauty - a division of the NPD marketing information company - StriVectin is the number one selling skincare item in US department stores based on dollar sales in 2004. The product was also launched in leading markets in Europe last year and has had notable success in France, UK, Italy, Spain, Portugal and Poland.
The success of the product as an anti-wrinkle treatment has also spurned the launch of StriVectin-SD Eye Cream, which contains the same active ingredients, but is formulated specifically to treat crow's feet.
Both the Stri-Vectin products - together with Dermalin-APg, marketed as a cellulite reducing topical treatment; Mamarlin-ARa, formulated with the aim of preventing sagging breasts and TestroGel, a treatment aimed at heightening men's sex drive and reduce body fat - all comply with the FDA's current labelling regulations. The FDA said that failure to take a prompt action to correct the violations could result in enforcement action.
