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Home :: Professional / Government Regulation / Product Fact Sheets / Eye Products

EYE PRODUCTS

Below are three short articles on eye products, the first is on the safe use of eye cosmetics, the second is on eyelash dyes, and the third one is on permanent eyelash/eyebrow dyes and tints.



U. S. Food and Drug Administration
FDA Consumer
July 1980


SAFE USE OF EYE COSMETICS

Mascara, eye shadow, and eyeliner are intended to make women more attractive. One thing they shouldn't do is harm the eyes.

Yet each year many women suffer eye infections from cosmetics. In rare cases, women have been temporarily or permanently blinded by an eye cosmetic. When an eye cosmetic is bought in the store, it is almost always free from bacteria that could cause eye infections.

The reason these products do cause infections is that they are not adequately preserved against microorganisms or are misused by the consumer after they are opened. Poor preservation or misuse of an eye cosmetic can cause dangerous bacteria to grow in the product. Then, when the cosmetic is applied to the area around the eye, it can cause an infection.

The Food and Drug Administration, which is responsible for assuring that cosmetics are harmless, has taken numerous steps to make sure that eye cosmetics are free from contamination when they reach you, and that they contain preservatives to inhibit the growth of bacteria. The cosmetics industry generally makes products which will not harm you. Nevertheless, FDA urges you to follow these eleven tips on the use of eye cosmetics:

  1. Discontinue immediately the use of any eye product that causes irritation. If irritation persists, see a doctor.
  2. Recognize that your hands contain bacteria that, if placed in the eye, could cause infections. Wash your hands before applying cosmetics to your eyes.
  3. Make sure that any instrument you place in the eye area is clean.
  4. Do not allow cosmetics to become covered with dust or contaminated with dirt or soil. Wipe off the container with a damp cloth if visible dust or dirt is present.
  5. Do not use old containers of eye cosmetics. If you haven't used the product for several months, it's better to discard it and purchase a new one.
  6. Do not spit into eye cosmetics. The bacteria in your mouth may grow in the cosmetic and subsequent application to the eye may cause infection.
  7. Do not share your cosmetics. Another person's bacteria in your cosmetic can be hazardous to you.
  8. Do not store cosmetics at temperatures above 85 degrees F. Cosmetics held for long periods in hot cars, for example, are more susceptible to deterioration of the preservative.
  9. Avoid using eye cosmetics if you have an eye infection or the skin around the eye is inflamed. Wait until the area is healed.
  10. Take particular care in using eye cosmetics if you have any allergies.
  11. When applying or removing eye cosmetics, be careful not to scratch the eyeball or some other sensitive area.



U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Cosmetics Fact Sheet
February 7, 1995



EYELASH DYES

1933 marked the beginning of a congressional controversy over the need for new and stronger food and drug laws. At the time, FDA had no authority to move against a cosmetic product called Lash Lure that was causing allergic reactions in many women. Two women, in fact, had suffered severe reactions to the product; one woman became blind and the second woman died.

The new Food, Drug and Cosmetic Act was passed in 1938 and "Lash Lure" was the first product seized under its authority.

Consumers should never dye their eyebrows or eyelashes. An allergic reaction to the dye could prompt swelling, inflammation, and susceptibility to infection in the eye area. These reactions can severely harm the eye and even cause blindness. FDA prohibits the use of hair dyes for eyebrow and eyelash tinting or dyeing, even in beauty salons and other establishments.

FDA has continuously warned the public about the use of coal-tar dyes on the eyebrows or eyelashes, stating that such use could cause permanent injury to the eyes, including blindness.

Eyelash and eyebrow dyes should not be confused with temporary colorings used around the eyes, such as mascara, eye shadow, eyebrow pencils and eye liners which contain colors that have been approved by FDA for use in the eye area.



U.S. Food and Drug Administration
FDA Fact Sheet
T92-31: July 14, 1992



FDA WARNS AGAINST USE OF "PERMANENT" EYELASH/EYEBROW DYES AND TINTS

The Food and Drug Administration today reissued its long-standing warning against "permanent" eyebrow and eyelash dyeing. The Food, Drug, and Cosmetic Act of 1938 prohibits the marketing of hair dyes for eyelash and eyebrow tinting or dyeing because this practice has been known to cause severe eye injuries and even blindness.

These dyes should not be confused with temporary coloring products used around the eyes--such as mascara, eye shadow, eyebrow pencils and eye liners--which can be used safely.

FDA's new warning was prompted by a recent report from the New York City area of an injury possibly associated with eyebrow and eyelash tinting. An informal FDA survey of beauty salon advertisements in the Washington, DC area following the report from New York indicates that some establishments are promoting "permanent" eyebrow and eyelash dyeing or tinting services.

Consumers should be aware that there are no natural or synthetic color additives approved by FDA for dyeing or tinting eyelashes and eyebrows--either for use in beauty salons or in the home. In fact, the law requires all hair dye products to include instructions for performing patch tests before use to identify for possible allergic reactions, and to carry warnings about the dangers of applying these products to eyebrows and eyelashes.

The health hazards of permanent eyelash and eyebrow dyes have been known for more than 60 years. These dyes have repeatedly been cited in scientific literature as capable of causing serious reactions when placed in direct contact with the eye. In two famous cases in 1933, a woman who used eyelash dye died, while another woman became blind in both eyes after suffering weeks of intense pain.

Despite these warnings, however, some beauty salons and other establishments apparently continue to promote this use of hair dyes. This practice most often occurs during the summer months as a means of retaining eyebrow and eyelash coloring after outdoor activities such as swimming.

As recently as 10 years ago, FDA issued an import alert against the importation of foreign eyebrow and eyelash dye products. Although FDA's quick action helped to limit the distribution of these products, some injuries did occur.

To protect the public health, FDA will continue to work to prevent the importation and marketing of eyebrow and eyelash dyes. In addition, the agency will intensify its work with state and local health officials and the cosmetics industry to combat the misuse of hair dye products.


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