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FDA Requests Consumer Notification of Adverse Cosmetic Reactions

Posted: April 4, 2011

The U.S. Food and Drug Administration (FDA) has sent a message to consumers requesting them to notify it of all adverse reactions to beauty, personal hygiene and color cosmetic products.

“Even though these products are widely used, most don’t require FDA approval before they’re sold in stores, salons, and at makeup counters,” noted Linda Katz, MD, director of the agency’s Office of Cosmetics and Colors, in the administration's message. She continued, “So, consumers are one of FDA’s most important resources when it comes to identifying problems.”

The message provided a definition for what it defines as "cosmetics" and added that its definition includes many categories not associated with the term such as permanent makeup, hair removal creams, perfumes and nail polishes, among others.

The message encourages consumers to report any cosmetic if its use results in a rash, hair loss, infection, etc.—even if they didn’t follow product directions. Also, the FDA wants to know if a product has a bad smell or unusual color, as it could signal contamination, or if the item’s label is incomplete or inaccurate. Consumers were instructed to report an problems with cosmetics to MedWatch6, the FDA’s problem-reporting program, and were told to include information such as the contact information for the product's user;  the age, gender and ethnicity of the product’s user; the name of the product and manufacturer; a description of the reaction—and treatment, if any; the health care provider’s name and contact information, if medical attention was provided; and  when and where the product was purchased. Wendy Good, PhD, a scientist with the FDA, added that the age, gender and ethnicity of the product's user allows the administration to spot trends.