The FDA looks for patterns of complaints or unusual or severe reactions. The agency may conduct an investigation, and if the evidence supports regulatory action, the FDA may request removal of a cosmetic from the market.

Take the example of two popular hair relaxer products by World Rio Corp. — the Rio Naturalizer System (Neutral Formula) and the Rio Naturalizer System with Color Enhancer (Black/Licorice

After receiving complaints about these products in November and December of 1994, the FDA warned the public against using them. Consumers complained of hair loss, scalp irritation, and discolored hair.

In December 1994, the World Rio Corp., Inc. of Los Angeles, Calif., announced that it stopped sales and shipments of the product. But reports indicated that the company continued to take orders, and the California Department of Health also stepped in to stop sales.

In January of 1995, the U.S. Attorney's Office in Los Angeles filed a seizure action against these products on behalf of the FDA. By then, the agency had received more than 3,000 complaints about the Rio products.

Although most relaxers are alkaline, this product was formulated to be acidic. In the resulting consent decree of condemnation and permanent injunction, the FDA alleged that the products were potentially harmful or injurious when used as intended, that they were more acidic than declared in the labeling, and that the labeling described the products as "chemical free" when "allegedly they contained ingredients commonly understood to be 'chemicals.'"

Safer Straightening
FDA has received complaints about scalp irritation and hair breakage related to both lye and "no lye" relaxers. Some consumers falsely assume that compared to lye relaxers, "no lye" relaxers take all the worry out of straightening.

"People may think because it says 'no lye' that it's not caustic," says FDA biologist Lark Lambert. But both types of relaxers contain ingredients that work by breaking chemical bonds of the hair, and both can burn the scalp if used incorrectly. Lye relaxers contain sodium hydroxide as the active ingredient. With "no lye" relaxers, calcium hydroxide and guanidine carbonate are mixed to produce guanidine hydroxide.