Mar 23 2022
The U.S. Food and Drug Administration cautions that you should avoid skin creams, beauty and antiseptic soaps, and lotions that contain mercury.
The manufacturer or distributor of a cosmetic is legally responsible for ensuring that a marketed product is safe when consumers use it according to the directions in the labeling or in the customary or expected way. FDA can take action against the manufacturer of a cosmetic on the market if we have reliable information to show that a cosmetic does not meet the legal requirement for safety.
The law treats color additives differently. Unlike other cosmetic ingredients, color additives, other than coloring materials used in coal-tar hair dyes, must be approved by FDA for the specific intended use before they are permitted in any cosmetic.
How will you know if mercury is in the cosmetic, especially one that’s marketed as “anti-aging” or “skin lightening”? If the words “mercurous chloride,” “calomel,” “mercuric,” “mercurio,” or “mercury” are listed on the label, mercury’ is in it—and you should stop using the product immediately.
The products are usually marketed as skin lighteners and anti-aging treatments that remove age spots, freckles, blemishes, and wrinkles. Adolescents may use these products as acne treatments.
Federal law requires that ingredients be listed on the label of any cosmetic or nonprescription drug. In addition, FDA does not allow mercury in drugs or in cosmetics, except under very specific conditions where there are no other safe and effective preservatives available – conditions that these products do not meet.
Sellers and distributors who market mercury-containing skin whitening or lightening creams in the U.S. may be subject to enforcement action, including seizure of products, injunctions, and, in some situations, criminal prosecution.
Dangers of Mercury
Exposure to mercury can have serious health consequences. The danger isn’t just to people who use mercury-containing products but also to their families. When you use these products your family might breathe mercury vapors or might become exposed by using things like washcloths or towels contaminated with mercury.
Some people – including pregnant women, nursing babies and young children – are especially vulnerable to mercury toxicity. Babies may be particularly sensitive to the harm mercury can cause to their developing brains and nervous systems. Newborns who nurse are vulnerable because mercury is passed into breast milk.
Tracking Skin Products Containing Mercury
In the past few years, FDA and state health officials have discovered numerous products that contain mercury, and there have been cases in which people exposed to such products have had mercury poisoning or elevated levels of mercury in their bodies.
FDA has an import alert in place that lets our field staff know that the agency has enough evidence or other information to refuse admission of shipments of mercury-containing skin products.
Additional note
: Does the phrase "Natural" on the label mean "safe" for the product?
Choosing ingredients from sources the manufacturer considers “organic” or “natural” is no guarantee that they are safe. Manufacturers are still responsible for making sure their products are safe when used according to the directions in the labeling, or in the customary or expected way. Some testing may still be needed.
Manufacturers can use safety data that is already available on individual ingredients and on products with similar formulations.
Cosmetic ingredient suppliers often have safety data on their products.
Safety data may be published in scientific journals (sources include PubMed and TOXNET).
Additional Test
Manufacturers may also need to do toxicological testing to fill in any gaps in the information that’s available. Toxicology or other testing methods may be necessary to determine the safety of each ingredient and the finished product. Animal testing is not a specific requirement for marketing a cosmetic; however, it’s important for all testing to be scientifically sound.
To learn more, see “Microbiological Methods for Cosmetics.”
If a manufacturer does not have the technical expertise to determine the best way to ensure that a product is protected from contamination, the company may want to work with a consultant.
FDA can and does inspect cosmetic manufacturing facilities to assure
cosmetic product safety and determine whether cosmetics are adulterated
or misbranded under the FD&C Act or FPLA.
If you have any questions about FDA regulation of OTC Drugs and Cosmetics,
Registration and labeling compliance... , please CONTACT US.
Office 1-909-493-3276
Email ask@provisionfda.com
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