FDA Consumer; 12/1/1986; Farley, Dixie
Tanning Salon Sees the Light
Sauntering into the Midnight Sun
tanning salon in New York City, the man says he'll take his tan straight: no goggles.
No problem. Although goggles are available, says the clerk, it's OK to just close your eyes while using this salon's
tanning units.
The "customer" disagrees, now identifying himself as an
FDA investigator, New York district office.
But the clerk still insists that goggles are unnecessary.
That incident of Jan. 22, 1986, was one of several observations that ultimately led U.S. marshals to remove, at
FDA's request, four facial suntan units from two Manhattan
tanning salons owned by Solarium Resorts, Inc., doing business as Midnight Sun.
FDA had requested the seizures because it found the units to be a health hazard and, therefore, illegal.
Some people may think that sunlamps emitting ultraviolet A (UVA) radiation--rather than ultraviolet B (UVB), produced by conventional sunlamps--are completely safe. It's true that UVA is less likely than UVB to burn the skin--provided the lamps are used as directed. But UVA radiation penetrates more deeply and, in fact, may increase the risk of other hazards, such as blood vessel damage, skin cancer, and premature skin aging. Further, unless the eyes are properly shielded with goggles, exposure to radiation from any sunlamp can burn the eyes, irritate the corneas, and increase the risk of cataracts. For this reason,
FDA requires that
tanning salons, regardless of the type of sunlamps they use, provide customers with special goggles.
The New York
FDA investigator's visit to the
tanning salon was prompted by conversations with a local newspaper reporter who was researching an article about a lack of safety in
tanning salons and specifically mentioned Midnight Sun.
FDA's inspection revealed several violations of agency regulations. The facial units lacked adequate directions for use, including required warning statements. Some units lacked goggles, and spare goggles weren't available. What's more, the facial units were wired to bypass automatic timers, so that salon operators could manually control exposure time through switches at the front desk. An
FDA performance standard requires that the user be able to control the unit and that each unit be equipped with a working timer. There were similar problems at the other Midnight Sun salon.
Despite telephone calls from
FDA to the firm's president regarding the violations, no correections were made. The company also failed to respond to a letter from
FDA notifying them of the violations.
There were no reports of injuries but, in view of the serious nature of the problem,
FDA's New York district office recommended that the
tanning units be seized. On April 29, 1986, the U.S. attorney filed a Complaint for Forfeiture in the U.S. District Court for the Southern District of New York. The four machines, valued collectively at $12,000, were removed on May 16. They were returned to Solarium after the firm, under
FDA's supervision, corrected the problems. The firm also paid the costs incurred by
FDA, as ordered by the court.
For more information about
tanning units, see
FDA Consumer: "A Careful Look into
Tanning Booths," October 1980, and
"Tanning Beds Are Not Without Drawbacks," December 1983-January 1984.
(this is not the whole article but just an excerpt)
November 2005
Fighting the Winter Blues Although some still consider phototherapy an investigatorial treatment, evidence that it may safely help seasonal affective disorder is mounting. By John D. Zoidis, MD The US Food and Drug Administration (FDA) considers light boxes Class III medical devices—the most stringent regulatory category for devices. Therefore, the FDA has not given final approval for manufacturers to market light boxes for the treatment of SAD. In 1993, the FDA entered into a “consent decree” that permits light box manufacturers to market light boxes in the United States provided that no significant therapeutic claims are made (ie, “light boxes are curative”). According to the FDA, as long as no therapeutic claims are being made by light box manufacturers, they are considered an “alternative medicine” and, therefore, may be dispensed in the United States without a prescription. Since 1997, the FDA has issued at least one warning letter to remove therapeutic claims from labeling. In 1998, the FDA convened a small, “informal” group to discuss health care policy. During this meeting, it was determined that light boxes, and their relationship to SAD, did not pose a “significant danger” to the public. In addition, the FDA is “not aware of any adverse events as a result of light box therapy.” I could give many more examples, but my point is that we do not want to make any "therapeutic claims" regarding tanning. Once you step out of the world of simple making someone look better and feel better about themselves and move over to treating medical conditions the government gets knee deep into your business and takes all of the fun out of everything.