DOES THE FDA REGULATE COSMETICS?

I hear time and time again..."The FDA doesn't regulate cosmetics." 

"Beware! Beauty products are unsafe and unregulated."

False and false.

 

In the U.S.., to ensure the safety of cosmetic products, the U.S. Food and Drug Administration (FDA) regulates the cosmetics industry. Using science-based information, the FDA has broad regulatory authority under the Food, Drug and Cosmetic Act (FD&C Act) passed by Congress in 1938 and amended many times since.

Here is where the confusion occurs. Unlike drugs, the FDA does NOT approve cosmetics (see Cosmetic vs. Drug). It is the legal obligation and responsibility of the manufacturer to assure that their cosmetic product is safe when used under customary conditions and that the product is appropriately labeled. The law states that it is illegal to sell adulterated or misbranded cosmetics.

What is an adulterated cosmetic?

An adulterated cosmetic is one that...

  1. contains any poisonous or harmful ingredient, which may be harmful when the product is used as described on the label.
  2. contains any filthy, putrid, or decomposed substance.
  3. is packaged, prepared or manufactured in unsanitary conditions where it may be contaminated with microbial organisms or any substance that renders the product harmful to the consumer.
  4. is packaged in a container that is composed of poisonous or harmful substances that renders the product harmful to the user.
  5. is not a hair dye but contains an unsafe color additive as determined by the FD&C Act.

What is a misbranded product?

The FD&C Act defines a misbranded product as ont that...

  1. contains misleading or false information on the label.
  2. does not contain the name and place of the business of the manufacturer, packer or distributor on the label, the quantity of contents in terms of weight or measure.
  3. does not contain any prominently displayed required information in an easy to read and understood fashion by an ordinary individual under customary condition of use.
  4. is packaged in a misleading container.
  5. is a color additive and does not fulfill the packaging and labeling requirements of such color additives.
  6. has packaging and labeling in violation of the Poison Prevention Packaging Act of 1970.

The FDA has the right to enforce any of these regulations. FDA inspectors can inspect any cosmetic manufacturing plant or office at any time without notice. The FDA has the authority to:

  • Restrict or ban cosmetic ingredient usage for safety reasons.
  • Mandate warning labels on cosmetic products.
  • Issue warning letters to manufacturers, packagers or distributors.
  • Seize illegal products.
  • Stop unlawful activities.
  • Prosecute violators of these laws.
  • Collaborate with companies to implement product recalls.

Although the FDA doe not "approve" cosmetics, the FDA absolutely regulates the industry. Enjoy your cosmetics!