Salon Allergy Specialist

Salon Allergy Specialist

Tuesday, September 17, 2013

The False Safety of Sunless Tanners, DHA, and the FDA

Tanning booths and sunless tanning is a part of the industry I have chosen for my career. I have worked for salons that offered both, and I have used both. I can say that I used them rarely, because I could not sit still long enough to lay in the tanning bed, or to keep the tanning cream or spray from becoming smeared. I have also unknowingly sold sunless tanner from Aveda with the false pretense that the chemical would be safer because it came from walnut shells. I know know that this is not safer. Here is some information direct from the FDA web sight on DHA, the active ingredient in sunless tanning products.

Thank you, FDA!

What are "sunless tanners"?
Neither the laws nor the regulations enforced by FDA define the term "sunless tanner." It typically refers to products that provide a tanned appearance without exposure to the sun or other sources of ultraviolet radiation. One commonly used ingredient in these products is dihydroxyacetone (DHA), a color additive that darkens the skin by reacting with amino acids in the skin's surface.

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). The industry has not provided safety data to FDA in order for the agency to consider approving it for use on these exposure routes, including "misting" from tanning booths.
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) DHA is not permitted for use in the area of the eye. 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)
As with the lips and other areas covered by mucous membrane, the industry has not provided safety data to FDA in order for the agency to consider approving it for use in the area of the eye.

What does this mean for DHA spray "tanning" booths?
As noted above, the use of DHA in "tanning" booths as an all-over spray has not been approved by the FDA, since safety data to support this use has not been submitted to the Agency for review and evaluation, 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 unapproved use of this color additive. Consumers should request measures to protect their eyes and mucous membranes and prevent inhalation.

Has FDA received reports of adverse reactions associated with sunless tanners?

FDA has received reports from consumers stating that they have experienced adverse events associated with sunless tanning, including rashes and, primarily in the case of spray tanning booths, coughing, dizziness, and fainting. It is uncertain what, if any, ingredient or combination of ingredients in the sunless tanning products might have caused these adverse events, whether an individual's allergic reaction might have played a part, or whether factors unrelated to the sunless tanning products may have been involved, such as pre-existing medical conditions.
Under the authority of the Fair Packaging and Labeling Act (FPLA), FDA requires ingredient declarations on cosmetics sold on a retail basis to consumers. In this way, consumers can know what ingredients are contained in the products they purchase and avoid ingredients to which they may be sensitive. However, the FPLA does not apply to products used exclusively by professionals, such as those used in spray tanning booths.

Who is responsible for the safety of spray tanning booths?
The FD&C Act does not authorize FDA to approve cosmetic products or ingredients, with the exception of color additives that are not coal-tar hair dyes. Firms and individuals who market cosmetics are responsible for assuring that the products they market are safe when used under labeled or customary conditions of use and properly labeled. FDA can take action against firms and individuals who violate the law. The practice of administering such products by professionals, such as in salons, is generally the responsibility of local and state health authorities.

Consumers and healthcare providers can report adverse reactions from cosmetic products, including sunless tanners, using the contact information in Bad Reaction to Cosmetics? Tell FDA.

You can read more of this article at the FDA web sight. I included the link at the beginning of the information. I am not sure why so much of my industry is unregulated. I am more surprised by each chemical I begin to look up. I will be posting more often if the results are as fruitful as they seem to be. 

-sadly, Gina