"If your company manufacturers such products you are hopefully already in full compliance with the final monograph for acne drug products which requires specific warnings and statements," said Diesch, an attorney specializing in the cosmetics field at law firlm Greenberg Traurig.
"FDA is now suggesting that manufacturers also warn new users to first test the acne product on a small area of skin for 3-days before using as directed."
On the back of this, Diesch believes that there are two clear actions that companies manufacturing and marketing OTC acne treatments need to take:
1) Make sure they are in compliance with the final monograph issued by the FDA
2) Update their labels to incorporate the new precaution
The new warning focusing on allergic reactions that are known to happen as the result of using certain acne treatment formulations that contain the active ingredients benzoyl peroxide or salicylic acid, which the FDA wants to draw to the public's attention.
Between 1969 and the start of 2013, 131 reports from both consumers and manufacturers of allergic and hypersensitivity-related adverse reactions associated with these products were received by the FDA, and the regulatory body notes that about 42% of these reactions occurred within minutes to 24 hours of use.
Brands which manufacture such products - which are available as gels, lotions, face washes, solutions, cleansing pads, toners and face scrubs - include Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, and Clean & Clear, according to the FDA.
The FDA’s new warning, published on the regulatory body’s site, comes with the aim of educating consumers of the risks that some of these products can pose.
“There is currently no mention of the possibility of these very severe allergic reactions on the product labels,” says Mona Khurana, M.D., a medical officer at FDA, explaining the motivation behind the body’s new consumer warning.
“It’s important that consumers know about them, and that they know what to do if they occur,” she confirms.
As Diesch notes, the agency is now encouraging manufacturers to use the drug label to advise consumers how to test the product’s safety before using it for the first time.