You break out in a head-to-toe rash after applying a sunless tanning lotion. Your son’s skin is red and blotchy after he gets his face painted at the school carnival. Your daughter’s scalp is burned after using a hair relaxer.
If you’ve had a negative reaction to a beauty, personal hygiene, or makeup product, the Food and Drug Administration (FDA) wants to hear from you.
After the Food and Drug Administration (FDA) approves a product and it is on the market, FDA continues to monitor unexpected and undesirable side effects (adverse events) of that product.
Health care professionals and consumers may report side effects, product quality problems, product use errors, or therapeutic failure with the use of medical products to FDA's MedWatch Adverse Event Reporting program either online, by regular mail, by fax, or by phone.
From morning until night—styling our hair for work to showering before bed—Americans depend upon personal care products. Most are safe, but some cause problems, and that’s when FDA gets involved.
“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.”
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.” But the legal definition includes items that most Americans might not ordinarily think of as cosmetics, including:
face and body cleansers
moisturizers and other skin lotions and creams
baby lotions and oils
hair care products, dyes, conditioners, straighteners, perms
hair removal creams
perfumes and colognes
face paints and temporary tattoos
permanent tattoos and permanent makeup
What to Report
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. 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.
When you contact 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; and
when and where the product was purchased.
And be sure to give 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, says that information is important because it 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 the same product or similar ones. FDA scientists will use the information to determine if the product has a history of problems and represents a public health concern that needs to be addressed.
If you file a consumer report, your identity will remain confidential.
"Cosmetics are usually safe, but when they aren't, consumer reporting is essential so FDA can take action when appropriate,” Katz says. Those actions could—depending upon the product and the problem—range from issuing a consumer safety advisory to taking legal action.