
FDA Offers Tips For Sunless Use
by Rick Mattoon Why does the FDA care about DHA?
On July 1, 2003, the Food and Drug Administration
(FDA) released information about dihydroxyacetone (DHA), the primary ingredient
behind the explosive sunless craze. This statement came in response to many
questions about the proper use of sunless booths and handheld airbrush tanning
systems. Salons and spas that offer sunless services should educate their
employees about this important issue.
Why does the FDA care about DHA?
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, 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. The FD&C Act prompted the FDA to clarify what it deemed proper “external
use.”
The regulations list DHA 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. The CFR defines area of the eye as “the area
enclosed within the circumference of the supraorbital 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 spa and salon staff?
When using products containing DHA as a spray or mist, sunless
airbrush technicians must avoid exposure to parts of the body for which DHA is
not approved, including the area of the eyes, lips, or mucous membrane, or even
inhalation. Because of this, the FDA suggests to consumers to ask the following
questions when considering spas 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 consumer request measures to protect their eyes
and mucous membranes and prevent inhalation.
What does this mean for the spa or salon offering sunless tanning?
Staff should 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. They should use a lip balm or other barrier product on the lips
and in the nostrils to avoid contact with the mucous membrane. Barrier creams
and specially designed air-filtration devices are available through sunless
product distributors and manufacturers.
The FDA’s cautious opinion on DHA most likely stems from
information found in the products’ dated Material Safety Data Sheet (MSDS).
DHA was first approved for cosmetic use in 1973. From its original use as a
topical substance, DHA was listed with three risk numbers—R36, irritating to
eyes; R37, irritating to the respiratory system; and R38, irritating to the
skin.
The risk numbers are based on pure forms of DHA with no other
additives considered, i.e., water. To put this into perspective, the purist form of many cosmetic
ingredients typically fall under the same risk numbers.
To best take advantage of the bronzing effects of sunless
products in its newest form, prudent spa owners and staff should revert to
common sense when it comes to offering sunless in a spray or mist form. Have
clients avoid getting this and other tanning products directly into their eyes.
Assure proper ventilation for staff and clients in the sunless application area
of your spa. And, avoid contact with the mucous membrane of the mouth and nose
by using a barrier product in the nostrils and on the lips.
For more information about proper sunless use, you can review
the Sunless Airbrush Technician Course found at
www.tanningtraining.com or talk
to your sunless distributor or manufacturer.
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