Safety and Regulatory Information
October 18, 2000; Updated January 12, 2005
In their quest for the perfect tan, some people may look for a "magic pill" that will help them achieve this with minimal exposure to ultraviolet (UV) radiation. There are no such pills approved for this purpose. Nevertheless, pills bearing tanning claims continue to appear on the market. Consumers should be aware of risks associated with such products, as well as doubts about their efficacy.
The Claim: Tinting the Skin by Ingesting a Color Additive
So-called tanning pills are promoted for tinting the skin by ingesting massive doses of color additives, usually canthaxanthin. When taken at these large doses - many times greater than the amount normally ingested in food - this substance is deposited in various parts of the body, including the skin, where it imparts a color. The color varies with each individual, ranging from orange to brownish. This coloration is not the result of an increase in the skin's supply of melanin, the substance produced naturally in the skin to help protect it against UV radiation.
'Tanning Pills' Are Not FDA-Approved
Although canthaxanthin is approved by FDA for use as a color additive in foods, where it is used in small amounts, its use in so-called tanning pills is not approved. Imported tanning pills containing canthaxanthin are subject to automatic detention as products containing unsafe color additives.
Adverse Effects Have Been Reported
At least one company submitted an application for the approval of canthaxanthin-containing pills as a tanning agent, but withdrew the application when side effects, such as the deposition of crystals in the eye, were discovered. In the August 1993 issue of American Pharmacy, Darrell Hulisz, Pharm.D., and pharmacist Ginger Boles described this condition - called "canthaxanthin-induced retinopathy" - as "a common adverse effect associated with canthaxanthin use," adding: "The patient experiencing this form of retinopathy rarely is symptomatic, although decreased visual acuity has been reported."
According to the article, the condition is reversible, "although it may take 25 to 60 months for complete resolution, and deposits have been detected for up to seven years following discontinuation of canthaxanthin." Hulisz and Boles also referred to reports of "nausea, cramping, diarrhea, severe itching, and welts" associated with the use of canthaxanthin "tanning" pills.
The following article appeared in the February 1990 issue of FDA Consumer:
U.S. Court of Appeals Decision
"French Bronze" Fades Away
You no longer can order a "French Bronze tan" by dialing 1-800-544-1300. U.S. Court of Appeals Judges Irving Kaufman, Richard Cardamone, and Daniel Friedman last October rejected an appeal by a tanning pill distributor to keep her product on the market by claiming its sale was legal under the Food, Drug, and Cosmetic Act.
The distributor, Diane Alberti, was challenging an earlier order by Judge Israel Glasser of the U.S. District Court for the Eastern District of New York. At a Feb. 17, 1989, hearing, the judge had instructed Alberti to stop distributing the "special European formulae" French Bronze Tablets because they contained an unapproved ingredient.
Alberti acknowledged that each tablet contained 30 milligrams of the color additive canthaxanthin, which has not been approved for use in cosmetics. But she claimed that because small amounts of canthaxanthin are used legally in foods and drugs, the Food, Drug, and Cosmetic Act approval extended to use in cosmetics.
As a matter of "statutory construction and simple logic," the appellate court ruled that - because of factors such as varying concentrations - use of substances must be regulated separately for foods, drugs, and cosmetics. An average daily intake of canthaxanthin is only 5.6 milligrams (mostly from foods such as ketchup and salad dressings). But a person taking four French Bronze Tablets a day, the recommended dosage, would consume an additional 120 milligrams.
FDA became suspicious of Alberti's product after an investigator from the agency's Raleigh district office saw a magazine advertisement for the tablets, guaranteeing a "golden tan" in just three weeks. The tablets were available through both telephone order and a New York city mail-order address.
Andrea Latish, an investigator with FDA's New York district office, visited the New York address in January 1988 and found it to be a mail drop location. Letters sent to "French Bronze Tablets," a clerk told Latish, were forwarded to Diane Alberti, president of FBNH Ent., Inc., at 8000 Fourth Avenue in Brooklyn. Alberti distributed the tablets from her home.
Latish made an appointment with Alberti and her lawyer and learned in the meeting that Alberti ordered approximately 1,500 bottles of 80 tablets every month from the manufacturer, Universal Labs, in New Brunswick, N.J. Universal's label lists the ingredients and carries a statement that no nutritional claims are made and the ingredients are for use as a food coloring. Nevertheless, the labels also carry the name "French Bronze Tablets" and a picture of a palm tree.
Alberti developed an instruction brochure for using the pills as tanning tablets and advertised in muscle and fitness magazines. The ads claimed that the pills would help prevent skin blistering and peeling and even skin cancer because they were "Safer than UV ¢ultraviolet| radiation from the sun."
Latish inspected Alberti's home in late January 1988 and found 141 bottles - an estimated $1,615 worth of tanning pills - bearing the label "French Bronze Tablets." Laboratory analysis of samples collected during the inspection confirmed that the tablets contained 30 milligrams of canthaxanthin.
FDA's New York district compliance officer Ira Flaum then wrote FDA headquarters recommending seizure of the tanning pills, based on both the use of an unapproved ingredient and the unsubstantitated drug claims. Before sending a formal seizure request to the U.S. attorney's office in New York, FDA again inspected Alberti's home and found 192 bottles of the pills labeled "French Bronze Tablets." Alberti was continuing to receive shipments from Universal and distribute the tablets as tanning pills.
At FDA's request, U.S. marshals seized 15 cases (24 bottles each) of tanning pills from Alberti's home on June 24, 1988. The pills, valued at more than $4,000, were ordered destroyed in the October 1989 court decision.