Beauty Industry Expert, Wendy Lewis, Sheds Light On The Latest FDA Warning About Topical Acne Products

A new FDA warning about rare but severe and potentially life-threatening reactions to benzoyl peroxide (BPO) and salicylic acid (a type of beta hydroxy acid or BHA) has been issued. Both ingredients are widely considered mainstays in acne remedies.

Consumers are advised to stop using topical acne products containing these ingredients and seek emergency medical help immediately if they experience extreme allergic reactions such as feeling faint, breathing difficulties, throat tightness or swelling of the eyes, lips, face or tongue, or if they develop hives or itching.[1]

Some said that the FDA created an unnecessary panic for such an infinitesimal level of incidence of severe allergic reaction. Felipe Jimenez, PhD, Chief Scientific Officer of Envy Medical, Inc., the marketers of ClarityMD acne system, said, “Regrettably the FDA cannot provide guidance to consumers on which acne ingredients actually caused the documented severe allergic reactions, admitting that it ‘cannot determine if these reactions were triggered by the products’ active ingredients, the inactive ingredients, or a combination of both.’ Benzoyl peroxide has been used safely in topical treatments, both prescription and OTC, for decades, and there is a wealth of clinical data on its safety and efficacy in the literature.”

Many products contain these ingredients, including those made by Neutrogena, Clean & Clear and Aveeno, and range from cleansers, washes, solutions, pads, gels, creams, lotions, foams and scrubs. Even some shampoos contain salicylic acid.

In an emailed statement, acne therapy giant Johnson & Johnson wrote, “We are aware of the FDA MedWatch report regarding rare hypersensitivity reactions to certain over-the-counter topical acne products and remind consumers that it is important to always read and follow the label. Our products currently contain information for consumers about the active ingredients and instructions for safe use. We support the FDA’s efforts to educate consumers about this rare reaction and will continue to work with the agency to ensure that our labeling provides consumers with the information they need to use our products safely.”

The FDA suggests that consumers use a small amount of product for three days, and if there is no reaction, they can continue with normal use.