FDA Registration for Cosmetic Products and Cosmetic Establishments is voluntary and FDA does not approve cosmetic products or ingredients before they go on the market. It is the responsibility of cosmetic manufacturer to ensure the safety of its products.
As per FD&C, it is prohibited by law to distribute any cosmetic containing an ingredient that makes the product harmful when used exactly as per label directions or as per the customary use. The only exception to this rule is for coal tar hair dyes for which FDA cannot take action against as long as the product label contains a special warning statement and also contains directions for a skin test.
Color additives are permitted in cosmetics only if FDA has pre-approved them for the intended use.
FDA specifically prohibits or restricts following ingredients in cosmetics:
- Bithionol – Prohibited as it may cause photo contact sensitization
- Chlorofluorocarbon propellants – Prohibited for use in cosmetic aerosol products intended for domestic consumption
- Chloroform – Prohibited as it causes cancer in animals and is likely to be harmful to human health, too. Except for residual amounts from its use as a processing solvent during manufacture, or as a byproduct from the synthesis of an ingredient
- Halogenated salicylanilides (di-, tri-, metabromsalan and tetrachlorosalicylanilide) – Prohibited as it may cause serious skin disorders.
- Hexachlorophene – Prohibited because of its toxic effect and ability to penetrate human skin. The HCP concentration in a cosmetic may not exceed 0.1 percent, and it may not be used in cosmetics that are applied to mucous membranes, such as the lips
- Mercury compounds – Restricted to eye area products at no more than 0.0065 percent of mercury calculated as the metal and is permitted only if no other effective and safe preservative is available
- Methylene chloride – Prohibited as it causes cancer in animals and is likely to be harmful to human health, too
- Prohibited cattle materials – These materials include specified risk materials, material from no ambulatory cattle, material from cattle not inspected and passed, or mechanically separated beef
- Sunscreens in cosmetics
- Vinyl chloride – Prohibited for use as an ingredient of aerosol products, because it causes cancer and other health problems
- Zirconium-containing complexes – Prohibited in aerosol cosmetic products because of their toxic effect on lungs of animals, as well as the formation of granulomas in human skin
FDA may take action against any such cosmetic manufacturers or products on the market that do not comply with the law.
Cosmetic labels must always carry directions for use as some cosmetics are safe when used the correct way and unsafe when used the wrong way. Cosmetics must have any directions for use or warning statements needed to make sure people use the products safely. For example; some ingredients are safe on skin if washed off immediately but not if left on skin for hours or some ingredients that are safe for use on hair but not safe when used near eyes.
Liberty Management Group LTD is one of the leading FDA consulting group in the USA. LMG provides assistance with Registrations, Label compliance, and many more FDA regulations.
Namrata
FDA Regulatory Consultant
support@libertymanagement.us
Published on February 27, 2019