FDA Requests Notifications for Adverse Reactions to Cosmetics

The US Food and Drug Administration (FDA) has requested that consumers notify the agency 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 request. She continued, “So, consumers are one of FDA’s most important resources when it comes to identifying problems.”

The message outlined the types of products to which the agency was referring, in some cases including product categories not associated with the term cosmetic, such as permanent makeup, hair removal creams, perfumes and nail polishes, among others.

The FDA's request encourages consumers to report any product whose use results in a rash, hair loss, infection, etc.—even if the user did not follow product directions. In addition, the FDA requested that products having a bad smell or unusual color be reported, as this could signal contamination, or items whose labels are incomplete or inaccurate.

Consumers were instructed to report any problems with cosmetics to MedWatch6, the FDA’s problem-reporting program, and were asked to include information such as their contact information; their age, gender and ethnicity; 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 identify trends.

While this call to action to consumers could assist product developers in identifying rare instances of adverse reactions or avoid future product recalls, it also could open the floodgates for consumer alarm based on isolated occurrences.

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