Advisors to the US Food and Drug Administration are planning hold a public debate in the spring to discuss the pros and cons of stricter regulations on the use of tanning beds, including stronger warnings on cancer risks and reclassifying them.
According to an Associated Press report earlier today, FDA UV radiation specialist Sharon Miller said the agency doesn’t recommend the use of tanning beds at all, but:
“We know people do use them so we want to make them as low-risk as possible.”
The FDA class of a device determines the level of control necessary to assure the safety and effectiveness of the device. Class I includes devices with the lowest risk and Class III includes those with the greatest risk.
The agency currently has tanning beds as Class I devices (alongside elastic bandages, bedpans and examination gloves), indicating that they present minimal potential for harm to the user, and are generally simpler in design than Class II (eg X-ray machines, acupuncture needles, infusion pumps) and Class III devices (eg silicone gel-filled breast implants, implantable pacemakers, replacement heart valves).
Reclassifying a Class I device to Class II allows the FDA to bring in stricter controls and insist on tougher labelling about the risks. At the moment tanning beds do carry some warnings about the cancer risks, but the FDA said these are not prominent enough, and don’t state the risks strongly enough, especially to young people.
The decision to review the classification of tanning beds comes after the International Agency for Research on Cancer (IARC), a division of the World Health Organization, announced in July last year that it was re-categorizing indoor tanning devices as “carcinogenic to humans”, placing the devices in the highest cancer risk category afforded by the IARC. (Previously the agency had categorized the devices as “probably carcinogenic to humans”.)
The IARC had concluded in a review of the scientific literature that the risk of melanoma, the deadliest form of skin cancer, goes up by 75 per cent when people start using tanning beds and sun lamps before the age of 30.
They recommended, because cancer develops over a long period that can take decades, people under 18 should not be allowed to use indoor commercial tanning beds to protect them from the increased risk for melanoma and other skin cancers.
If the FDA determines that tanning beds should be reclassified to Class II, according to its own regulations, the agency must propose a rule in the Federal Register, and this must include a scientific justification and allow a period for comment.
The The Indoor Tanning Association (ITA) said there was no new evidence to support an FDA re-classification. Their president, Dan Humiston, told the Associated Press that the risk comes when people overdo it, and it’s easier to overdo it in the sun.
However, Humiston said the industry was open to the idea of changing the labels so consumers are better informed about the whole process and so “there’s no chance they could be overexposed, no chance they could get a sunburn“.
In an FDA consumer update last November, Miller said that people need to recognize that exposure to UV radiation is an “insult” that causes the skin to react. The reaction produces more melanin, which is how the skin gets darker, giving us a so-called “healthy glow” but is really a sign of skin damage.
“Over time, this damage will lead to prematurely aged skin and, in some cases, skin cancer,” said Miller.
There are two types of UV radiation that penetrate the skin: UV-B, which penetrates the top layers and causes sunburn and UV-A, which goes deeper and is often associated with an allergic reaction such as a rash. Both types of UV damage the skin and lead to skin cancer.
Tanning salons use lamps that emit both UV-A and UV-B rays.
Some states are considering bringing in laws to ban under-18s from using tanning beds, and many states require minors to have obtained parental consent or to be accompanied by a parent to gain access to a tanning salon.
However, according to one study at least, this does not seem to be having the desired effect.
The National Cancer Institute (NCI) did a study published in the September 2009 issue in the Archives of Dermatology where they hired and trained college students to pose as 15 year old fair-skinned girls who had never used a tanning bed.
They found that fewer than 11 per cent of the 3,600 tanning facilities contacted in 50 states about their practice followed the FDA recommended exposure schedule of three or fewer sessions the first week, and many sold “unlimited tanning” packages at special discount rates. And over 70 per cent said they would allow a teenager to tan every day the first week.
Of the facilities contacted, about 87 per cent required parental consent, leading the researchers to conclude that many parents were letting their teenagers use tanning beds and must be giving written consent or taking them there themselves.
Miller said parents should “carefully consider the risks before allowing their children under 18 to tan”.
The FDA’s consumer update recounts the story of one woman, Brittany Lietz Cicala of Chesapeake Beach in Maryland, who started using tanning beds at the age of 17. She stopped when she was diagnosed with melanoma at the age of 20.
“Growing up, until I started using tanning beds, my parents were very strict about me wearing sunscreen,” said Cicala.
She said she was using the tanning beds at least four times a week, and sometimes every day. She now has to undergo an all over skin exam every 3 months, and her body carries about 25 scars from all the surgeries she has had in the 4 years since diagnosis to remove suspicious growths.
Perhaps if the tanning beds she had used had been Class II devices, carrying stricter, more prominent warning labels, she would have thought twice about using them.
Source: Associated Press, FDA, MNT Archives.
Written by: Catharine Paddock, PhD