diva
06-29-2003, 09:49 AM
http://www.cfsan.fda.gov/~dms/cos-tan4.html
Quote:
U. S. Department of Health and Human Services
U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Cosmetics and Colors
June 2003
DHA-Spray Sunless "Tanning" Booths
FDA has received questions about the safety and legality of sunless "tanning" booths, in which consumers receive an application of the color additive dihydroxyacetone (DHA) in the form of a mist or spray in commercial spray "tanning" booths to achieve the appearance of a tan. The following information is intended to address such inquiries.
What does the law say about color additives, and DHA in particular?
The Food, Drug, and Cosmetic Act (FD&C Act), Section 721 authorizes the regulation of color additives, including their uses and restrictions. These regulations are found in Title 21, Code of Federal Regulations (21 CFR), beginning at Part 70. If a color additive is not permitted by regulation or is used in a way that does not comply with the specific regulation(s) authorizing its use, it is considered unsafe under the law. Such misuse of color additives causes a cosmetic to be adulterated.
DHA is listed in the regulations as a color additive for use in imparting color to the human body. However, its use in cosmetics - including sunless "tanning" products - is restricted to external application (21 CFR 73.2150). According to the CFR, "externally applied" cosmetics are those "applied only to external parts of the body and not to the lips or any body surface covered by mucous membrane" (21 CFR 70.3v).
In addition, no color additive may be used in cosmetics intended for use in the area of the eye unless the color additive is permitted specifically for such use (21 CFR 70.5a). The CFR defines "area of the eye" as follows:
"the area enclosed within the circumference of the supra-orbital ridge, including the eyebrow, the skin below the eyebrow, the eyelids and the eyelashes, and conjunctival sac of the eye, the eyeball, and the soft areolar tissue that lies within the perimeter of the infra-orbital ridge." (21 CFR 70.3s)
What does this mean for DHA spray "tanning" booths?
When using DHA-containing products as an all-over spray or mist in a commercial spray "tanning" booth, it may be difficult to avoid exposure in a manner for which DHA is not approved, including the area of the eyes, lips, or mucous membrane, or even internally.
Consequently, FDA advises asking the following questions when considering commercial facilities where DHA is applied by spraying or misting:
- Are consumers protected from exposure in the entire area of the eyes, in addition to the eyes themselves?
- Are consumers protected from exposure on the lips and all parts of the body covered by mucous membrane?
- Are consumers protected from internal exposure caused by inhaling or ingesting the product?
If the answer to any of these questions is "no," the consumer is not protected from the unsafe (and thus illegal) use of this color additive.
Quote:
U. S. Department of Health and Human Services
U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Cosmetics and Colors
June 2003
DHA-Spray Sunless "Tanning" Booths
FDA has received questions about the safety and legality of sunless "tanning" booths, in which consumers receive an application of the color additive dihydroxyacetone (DHA) in the form of a mist or spray in commercial spray "tanning" booths to achieve the appearance of a tan. The following information is intended to address such inquiries.
What does the law say about color additives, and DHA in particular?
The Food, Drug, and Cosmetic Act (FD&C Act), Section 721 authorizes the regulation of color additives, including their uses and restrictions. These regulations are found in Title 21, Code of Federal Regulations (21 CFR), beginning at Part 70. If a color additive is not permitted by regulation or is used in a way that does not comply with the specific regulation(s) authorizing its use, it is considered unsafe under the law. Such misuse of color additives causes a cosmetic to be adulterated.
DHA is listed in the regulations as a color additive for use in imparting color to the human body. However, its use in cosmetics - including sunless "tanning" products - is restricted to external application (21 CFR 73.2150). According to the CFR, "externally applied" cosmetics are those "applied only to external parts of the body and not to the lips or any body surface covered by mucous membrane" (21 CFR 70.3v).
In addition, no color additive may be used in cosmetics intended for use in the area of the eye unless the color additive is permitted specifically for such use (21 CFR 70.5a). The CFR defines "area of the eye" as follows:
"the area enclosed within the circumference of the supra-orbital ridge, including the eyebrow, the skin below the eyebrow, the eyelids and the eyelashes, and conjunctival sac of the eye, the eyeball, and the soft areolar tissue that lies within the perimeter of the infra-orbital ridge." (21 CFR 70.3s)
What does this mean for DHA spray "tanning" booths?
When using DHA-containing products as an all-over spray or mist in a commercial spray "tanning" booth, it may be difficult to avoid exposure in a manner for which DHA is not approved, including the area of the eyes, lips, or mucous membrane, or even internally.
Consequently, FDA advises asking the following questions when considering commercial facilities where DHA is applied by spraying or misting:
- Are consumers protected from exposure in the entire area of the eyes, in addition to the eyes themselves?
- Are consumers protected from exposure on the lips and all parts of the body covered by mucous membrane?
- Are consumers protected from internal exposure caused by inhaling or ingesting the product?
If the answer to any of these questions is "no," the consumer is not protected from the unsafe (and thus illegal) use of this color additive.