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Limit Lead Levels in Lipsticks-FDA

Limit Lead Levels in Lipsticks-FDA

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  • The U.S Food and Drugs Administration (FDA) has turned a critical eye to the lead levels in cosmetics like lipsticks and eye shadows.
  • The manufacturers will be capable of limiting lead content in cosmetic products to 10 ppm, if they follow good manufacturing practices.

In a new draft guidance, the U.S Food and Drug Administration has suggested to limit the use of lead in cosmetics such as lipstick, eye shadow and shampoo that are marketed across the U.S.

Cosmetics used in the US should be marketed according to the Federal Food, Drug and Cosmetic Act and other laws.


Limit Lead Levels in Lipsticks-FDA

Cosmetics, unlike drugs do not need to win pre-market approval from the FDA. Only the color additives, when used as an ingredient in cosmetic require pre-market approval.


According to the U.S. Environmental Protection Agency, lead is a naturally occurring element found in small amounts in the earth's crust. It can be toxic to humans and animals causing health issues.

Apart from ingestion, lead can be absorbed through the skin as well. It can accumulate over time and affect almost every organ and system.

Exposure to lead can lead to various cardiovascular diseases, kidney issues and reproductive issues in children. Lead exposure in pregnant woman could cause premature birth or reduced growth of the fetus.

Though no amount of lead is considered safe, certain amounts are not considered "elevated" to cause health risk.

According to the Centers for Disease Control and Prevention, for adults, blood lead levels equal to or greater than 10 micrograms of lead per deciliter of blood are considered elevated and for children it is half this amount.

New FDA Suggestion

As per the new guidance a maximum of 10 parts per million of lead in lipsticks, lip glosses and lip liners, as well as externally applied cosmetics, such as eye shadows, blushes, body lotions and shampoo are allowed.

The new guidance, excludes the hair dyes that contain lead acetate as an ingredient or to topically applied products classified as drugs.

The new FDA draft guidance is not a rule that must be followed, it is only a suggestion, said David C. Steinberg, founder of Steinberg & Associates, Inc, a consulting company for the personal care industry which specializes in US regulations for cosmetics and cosmetic chemistry.

"Although most cosmetics on the market in the United States generally already contain less than 10 ppm of lead, a small number contained higher amounts, and we are aware that some cosmetics from other countries contain lead at higher levels," the FDA said on its website.

The FDA analyzed 685 products and found that more than 99% of the products contain levels of lead that are at or below FDA's recommended maximum level of lead.

If the amount of lead present is below 10 parts per million level, it will not result in detectable levels of lead in the blood, even if absorbed or swallowed while using cosmetics.

"The agency also encourages manufacturers of lipsticks and other cosmetic products to follow or continue to follow manufacturing practices that allow them to achieve levels of lead lower than 10 ppm whenever feasible." the FDA said in its website.

The manufacturers will be capable of limiting lead content in cosmetic products to 10 ppm or less if they are careful about selecting their ingredients and follow good manufacturing practices.

Source: Medindia

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