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Federal Statement on DHA

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Chapter 5
Federal Statement on DHA

On July 1, 2003, the Food and Drug Administration (FDA) released information about dihydroxyacetone (DHA), the tanning ingredient in today’s sunless products. This statement came in the shadow of the booming sunless craze and after countless questions were raised about sunless booths and handheld sprayers.

Why Does The FDA Care About DHA?

According to the July statement, the Food, Drug, and Cosmetic Act (FD&C Act), Section 721, authorizes the regulation of color additives, including their uses and restrictions. Specifically, these regulations are found in Title 21 of the 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.

DHA is listed in the regulations as a color additive for use in adding 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 The Sunless Process?
When using products containing DHA as a spray or mist, it may be a challenge to avoid exposure in a manner for which DHA was not originally approved, including contact with the area of the eyes, lips or mucous membrane, or even internally. Because of this, the FDA suggests consumers ask 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 FDA says that the consumer is not protected from the use of sunless products. In this case, the FDA suggests that the consumers request measures to protect their eyes and mucous membranes and prevent inhalation.

What Does This Mean For The Technician Applying Sunless?

Sunless airbrush technicians must take extra care in informing clients to avoid breathing the sunless product during the application process. Consumers also should try to avoid direct application of the product into the eye area as described above, and use a lip balm or other barrier product on the lips and in the nostrils to avoid contact with the mucous membrane.

The FDA’s cautious opinion on DHA most likely stems from relying on limited information found in the product’s Material Safety Data Sheet (MSDS) originating in 1973. From its original use as a topical substance, DHA was listed with three “risk numbers”: R36, R37 and R38.

  • R36 Irritating to eyes.
  • R37 Irritating to respiratory system.
  • R38 Irritating to skin.

These risk numbers are based on pure forms of DHA with no other additives considered such as water and so on. To put this into perspective, the purist form of many cosmetic ingredients fall under the same risk numbers.

To best take advantage of the bronzing effects of sunless products in its newest form, prudent sunless airbrush/HVLP technicians should use care when offering sunless in a spray or mist application.

  • Have your clients avoid getting this and other tanning products directly into their eyes. Disposable eye protection may be a good option.
  • Protect their lips with lip balm or petroleum jelly.
  • A nose filter can be used to protect the mucous membrane and also to provide inhalation protection.
  • Disposable undergarments can be used to protect the more private mucous membranes.
  • Ensure proper ventilation for staff and clients in the sunless application area of your salon. An overspray booth or overspray fans with filters should be set up to remove overspray in the air. Spray equipment should not be set up near intakes for the salon’s ventilation system.
  • Although sunless solution contains no known toxins, the repeated inhalation may cause irritation, as it would be with any substance. Common sense would dictate prudent technicians wear a filtering mask while spraying clients.

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