Have a Bad Reaction to a Cosmetic? the FDA Wants to Hear from You

By GalTime Consumer Watchdog Mary Schwager

The FDA wants to hear from you...The FDA wants to hear from you...Have you ever bought a new face lotion and ended up covered in hives, or tried a new mascara and your eyes swelled shut just before your big date? Uncle Sam wants to hear about it! Yup, the Food and Drug Administration wants to know about your rashes, blotches, or any other adverse reaction that occurred after you used cosmetics. In fact, the FDA is relying on consumers to report this kind of stuff because most products don't require government approval before they're sold in stores.

Sound weird? Cosmetics aren't only products you buy in the makeup aisle. The federal Food, Drug, and Cosmetic Act defines "cosmetics" as products that are intended to be applied to the body "for cleansing, beautifying, promoting attractiveness, or altering the appearance." Note that the legal definition actually includes:

  • face and body cleansers
  • deodorants
  • moisturizers and other skin lotions and creams
  • baby lotions and oils
  • hair care products, dyes, conditioners, straighteners, perms
  • makeup
  • hair removal creams
  • nail polishes
  • shaving products
  • perfumes and colognes
  • face paints and temporary tattoos
  • permanent tattoos and permanent makeup

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While the FDA says most cosmetics are safe, the agency gets involved when problem arise. "Even though these products are widely used, most don't require FDA approval before they're sold in stores, salons, and at makeup counters," says Linda Katz, M.D., director of the agency's Office of Cosmetics and Colors. "So, consumers are one of FDA's most important resources when it comes to identifying problems."


Katz says consumers should contact FDA if they experience a rash, hair loss, infection, or other problem-even if they didn't follow product directions. The FDA also wants to know if a product has a bad smell or unusual color-which could signal contamination-or if the item's label is incomplete or inaccurate.

If you have any concerns about a cosmetic, contact MedWatch, FDA's problem-reporting program, on the Web or at 1-800-332-1088; or contact the consumer complaint coordinator in your area.

When contacting the FDA, include the following information in your report:

  • the name and contact information for the person who had the reaction
  • 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 healthcare provider's name and contact information, if medical attention was provided
  • when and where the product was purchased

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Be sure to also provide the age, gender, and ethnicity of the person who had the reaction, says FDA scientist Wendy Good, Ph.D. Good, who analyzes reports about problems with cosmetics, suggests such information can help scientists spot trends.

When a consumer report is received, FDA enters the information into a database of negative reactions. Experts then look for reports related to same or similar products. FDA scientists then utilize the information to determine if the product has a history of problems and represents a public health concern that needs to be addressed.

Should you file a consumer report, note that your identity will remain confidential. The FDA can take action against companies ranging from issuing a consumer advisory or taking legal action.

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