Report Bad Products To FDA

You break out in red rashes after using a sunscreen. Your daughter gets itchy and blotchy after applying makeup. That expensive hair relaxer your wife loves burned her scalp.

Who do you complain to … the store that sold the product to you, the manufacturer who made the item, or do you and your family suffer in silence?

If you’ve had a negative reaction to a beauty, personal hygiene, or makeup product, the U.S. Food and Drug Administration wants to know your story.

Why? FDA action could save others from suffering the same fate.

Every day 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 Dr. Linda Katz, 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.”

Defining Cosmetics

The federal Food, Drug, and Cosmetic Act defines “cosmetics” as products 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
•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

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.

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

When you contact FDA, include the following information in your report:

•Name and contact information for the person who had the reaction;
•Age, gender, and ethnicity of the product’s user;
•Name of the product and manufacturer;
•Description of the reaction—and treatment, if any;
•Healthcare provider’s name and contact information, if medical attention was provided;
•When and where the product was purchased.

FDA scientist Wendy Good advises to give the age, gender, and ethnicity of the person who had the reaction.

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, according to the FDA.

“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.

Safety Comes First

While WMB generally believes in smaller government and limited controls, we see consumers benefiting from interaction with the FDA.

Privacy concerns should take a back seat when the public’s safety is put at risk.

The FDA serves the public interest in a watchdog role. However, it needs good information to do its job and protect consumers.

As always, WMB advocates consumer activism. Nothing will be achieved by our silence.

Ken Cocuzzo

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