National Cancer Institute NCI Cancer Bulletin: A Trusted Source for Cancer Research News
June 14, 2011 • Volume 8 / Number 12

FDA Update

FDA Announces Changes to Sunscreen Labels


The Food and Drug Administration (FDA) has announced that sunscreen products meeting modern standards for effectiveness may be labeled with new information to help consumers find products that reduce the risk of skin cancer and early skin aging, in addition to helping prevent sunburn.

The regulation allows sunscreens that pass the FDA's test for protection against ultraviolet A (UVA) and ultraviolet B (UVB) radiation to be labeled as "broad spectrum." UVA and UVB radiation contribute to sunburn, skin cancer, and premature skin aging. Sunburn is primarily caused by UVB radiation.

Under the new rules, manufacturers of sunscreens labeled as broad spectrum and SPF 15 or higher may state that the products will help prevent sunburn and reduce the risk of skin cancer and early skin aging. Products that have SPF values between 2 and 14 and pass the FDA's test may be labeled as broad spectrum, but the manufacturers may not state that these products reduce skin cancer risk or early skin aging.

Any product that is not broad spectrum, or that is broad spectrum but has an SPF between 2 and 14, must carry a warning stating that the product has not been shown to help prevent skin cancer or early skin aging.

More information on sunscreens is available from the FDA online.

No Link Found between Hypertension Drugs and Cancer

After reviewing data from 31 randomized clinical trials, the FDA has concluded that angiotensin receptor blockers (ARBs)—drugs that are used to treat high blood pressure—do not increase the risk of cancer.

The FDA announced last July that it would perform a safety review of ARBs after a published analysis of five randomized clinical trials with roughly 62,000 participants found a small but statistically significant increased risk of cancer in patients taking the drugs.

The FDA's more comprehensive analysis of 31 trials with about 156,000 participants showed no increased risk of cancer among patients taking ARBs. In addition, the FDA's analysis found no evidence of an association between ARBs and cancer-related death.

For more information, see the FDA's news release.

Thermography Is No Substitute for Mammography, FDA Warns

A comparison of thermography and mammogram images (Images courtesy of the FDA) Thermography produces an infrared image (left) that shows the patterns of heat and blood flow on or near the surface of the body. A mammogram (right) is an x-ray of the breast in which a cancerous mass shows up in white. (Images courtesy of the FDA)

The FDA is advising women and doctors not to be misled by claims that thermography—a technique that uses infrared light to identify patterns of heat and blood flow near the body's surface—can be used as a stand-alone tool to detect breast cancer.

"The FDA is not aware of any valid scientific data to show that thermographic devices, when used on their own, are an effective screening tool for any medical condition, including the early detection of breast cancer or other breast disease," the agency stated in an alert issued June 2.

So far this year, the agency has issued three warning letters to practitioners and manufacturers of thermography devices for claiming that the technique can replace mammography.

"Mammography is still the most effective screening method for detecting breast cancer in its early, most treatable stages," Dr. Helen Barr, director of the Division of Mammography Quality and Radiation Programs in the FDA's Center for Devices and Radiological Health, said in a press release.

"While there is plenty of evidence that mammography is effective in breast cancer detection, there is simply no evidence that thermography can take its place," Dr. Barr continued.

Thermography devices have been cleared by the FDA for use as an adjunct, or additional, tool for detecting breast cancer. No randomized clinical trials, the gold standard for demonstrating effectiveness of a medical treatment or diagnostic test, have assessed the ability of thermography to detect breast cancer.