FDA Proposes Sun Warnings on Sunscreens
The Food and Drug Administration proposed Wednesday that all sunscreens and tanning products be required to carry warnings about the dangers of sun exposure and that cosmetic products which only promote tanning--but do not screen against the harmful rays of the sun--display a warning that they do not protect against sunburn.
“There is overwhelming evidence that overexposure to radiation from the sun is a health hazard,” FDA Commissioner David A. Kessler said in a statement. “Consumers should not have to guess how much protection, if any, they’ll get from sunscreen and tanning products on the market.”
The proposal would require all such products to carry statements about the sun’s potential harm and their ability to protect users.
One statement that the FDA proposes to require on sunscreen products reads: “Sun Alert: The sun causes skin damage. Regular use of sunscreens over the years may reduce the chance of skin damage, some types of skin cancer and other harmful effects due to the sun.”
Sunscreens and tanning products--a $650 million-a-year market--have been growing in use in recent years as health-conscious Americans have become increasingly aware of the risks of sun exposure. These dangers include premature aging of the skin and skin cancer.
Skin cancer, in which ultraviolet radiation from the sun is considered a major contributing factor, is the most common form of cancer.
There are more than 700,000 cases annually of highly curable basal cell or squamous cell skin cancers and about 32,000 cases of melanoma, a potentially fatal type of skin cancer, according to the American Cancer Society. There will be an estimated 9,100 deaths from skin cancer in 1993, of which 6,800 will be the result of melanoma. Since 1973, the incidence of melanoma has increased by 4% every year.
“Since the late 1970s, considerable advances have been made in understanding the effects of sun radiation on the body, while the number of visits to doctors’ offices for skin cancer has increased more than 50%,” Kessler said.
The proposals, which will be subject to a six-month period of public comment, likely would not become effective for about 18 months, the FDA said.
Officials at the Cosmetic, Toiletry and Fragrance Assn., the industry group that represents most manufacturers of the products, refused to comment on the FDA action, saying that they had not yet had an opportunity to read through the proposals, “which total about 500 pages,” said one.
But the changes were applauded by the American Cancer Society as a valuable way to increase consumer awareness of skin cancer and ways to prevent it.
“The huge bulk of skin cancers, while not life-threatening, are nevertheless serious and preventable,” said Joann Schellenbach, a cancer society spokeswoman. “We have to change our attitudes about the sun and we have the tools--we just have to learn to use them better. And this will help.”
The American Academy of Dermatology has long supported the use of sunscreens--with a minimum protective factor of 15--coupled with sun avoidance and the wearing of protective clothing and wide-brimmed hats.
The regulations would require that sun protective factors in a product be limited to a maximum of 30, which is an attempt to standardize the products’ scale of protection and give consumers a basis for comparison. While there are products with factors higher than 30, the FDA said that they are not necessary for most consumers.
The factor number is an indication of the degree of protection, and relates to the period of time a user of the product can safely remain in the sun without burning. For example, if an individual without protection burns after one hour, he or she could remain in the sun for 30 hours using a sunscreen with an SPF number of 30.
The new proposals do not change the labeling requirement for ingredients. Ingredients in sunscreens are already required to be listed on the product label, according to the FDA.
The proposal also will require that labeling advise that products used on children between the ages of 6 months and 2 years provide a minimum SPF of 4, and that parents consult a physician about using sunscreen on children younger than 6 months.
Generally, the American Cancer Society recommends that children be protected from the sun because of the possible link between severe sunburns in childhood and greatly increased risk of melanoma in later life.
Unlike tanning products, which are considered cosmetics, sunscreens are classified as drugs for regulatory purposes. Thus, any product that refers to an SPF or makes other sunscreen claims would be considered a drug and subject to the sunscreen requirements, the agency said.
The FDA said, however, that--although it considers all products, including cosmetics such as lipsticks and shampoos that make sunscreen claims, to be drugs--alternative labeling would be permitted to distinguish between those products intended for everyday use and those intended to protect against prolonged and intense exposure to the sun.
