Following an inspection of the La Roche-Posay website in the United States, the FDA (Food and Drugs Administration) sent a warning letter to the group L’Oréal. On what grounds? The claims given for several products made them fall outside the scope of cosmetics and become drugs. The warning was accompanied with the order to correct the different texts online… which seems to have been done.
The letter is dated February 12, 2015. It has just been published on the FDA website and is signed by the Department responsible for compliance with regulations.
L’Oréal’s management in the United States is required to take the action needed to correct the claims of several La Roche-Posay products presented online.
Two are explicitly mentioned: 'Rosalic AR Intense' and 'Mela-D Pigment Control'.
As for the Rosalic AR Intense, the FDA notes this anti-redness serum is presented as able to 'reduce visible redness and sensations of discomfort' thanks to '3 effective ingredients to help reduce redness with a long lasting efficacy'. In addition, it is rosaceaon and broken capillaries that are the most mentioned in consumer verbatim reports.
Now, as for the Mela-D Pigment Control, an anti-dark spot serum, it must be 'used to treat dark spots and discolorations', and is recommended by the brand in case of hyperpigmentation.
To the FDA, these claims 'indicate that the products are intended for use in the cure, mitigation, treatment, or prevention of disease and/or are intended to affect the structure or any function of the human body, rendering them drugs under the Act.'
Such products, considered as 'new drugs', may not …
