The letter, dated February 12th, and just published on the FDA website, highlights the fact that two products were reviewed as part of an audit that was carried out in December 2014.
The two products that were questioned as part of the review process were“Rosalic AR Intense” and “Mela-D Pigment Control”, which according to the FDA: “appear to be promoted for uses that cause the products to be drugs under section 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(C)]”.
Claims touch on the physiological
According to the letter, it is by making claims that edge towards the physiological that has again got L’Oréal into trouble.
The claims on the company’s website for the products indicate that the products are intended for the treatment or prevention of disease, and/or could affect the structure or function of the human body - in this case the skin.
For the Rosaliac AR Intense product claims, the FDA noted that the claims ‘reduces visible redness and sensations of discomfort’ and ‘formula combining 3 effective ingredients to help reduce redness with a long lasting effect’, were both questionable due to their physiological nature.
Likewise, on the same basis claims for Mela-D Pigment Control that were also noted by the FDA included ‘use to treat dark spots and discolorations’ and ‘Recommended For: Hyperpigmentation and Dark Spots’.
FDA recommendations
The FDA noted that both of the products had not been recognized as safe and effective for the claimed uses, which put them into the realms of ‘new drugs’.
The warning letter came with a reference to the new drug approval process, and also stated that the two products had been flagged up in an attempt to highlight any such claims made by L’Oréal across its brand portfolio.
It also asked the company to take swift action to rectify the current situation with respect to the specific claims highlighted in the warning letter and asked that the company notify the FDA in writing within 15 days concerning the steps it would take to identify and correct the violations.
Effective anti-aging products make claims difficult
Increasingly sophisticated and effective anti-aging products mean that claims regarding efficacy now often dip into the realms of the physiological, which during the course of the last year has seen some of the biggest players in the US anti-aging skin care category get into hot water with the FDA.
Big players, which in addition to L’Oréal, have also included Avon and Estée Lauder, have all been asked to change their labeling and marketing claims on anti-aging products because anti-wrinkle claims have been judged to touch on the physiological, therefore putting them in the drug category.
Over the past few years this has led to a crop of FDA warning letters that have been sent to a number of companies warning about unintentional drug claims, which underlines the need to audit product claims thoroughly.