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- Public Notices
Q: You have written columns about reporting a drug’s side effects to the FDA. What about bad reactions to cosmetics?
A: Yes, if you’ve had a bad reaction to a beauty, personal hygiene or makeup product, the Food and Drug Administration (FDA) wants to hear from you. 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 people 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
+ nail polishes
+ shaving products
+ perfumes and colognes
+ face paints and temporary tattoos and
+ permanent tattoos and permanent makeup.
Consumers should contact the FDA if they experience a rash, hair loss, infection, or any 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, the FDA’s problem-reporting program, on the Web (www.fda.gov, click on MedWatch and Begin) or by calling 800-332-1088.
When you contact 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 health care provider’s name and contact information, if medical attention was provided; and
+ when and where the product was purchased.
When a consumer report is received, the 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.
Richard P. Hoffmann, Pharm.D., has been a pharmacist for more than 40 years. Send questions to him at 2960 E. Coventry Court, Hernando, FL 34442.