NYC DERMATOLOGIST COMMENTS AS F.D.A. Unveils New Rules About Sunscreen Claims
News from certified plastic surgeon Dr. Ariel Ostad about sunscreen 'Claims'
NYC DERMATOLOGIST COMMENTS AS F.D.A. Unveils New Rules About Sunscreen Claims
After 33 years of consideration, the Food and Drug Administrationtook steps on Tuesday to sort out the confusing world of sunscreens, with new rules that specify which lotions provide the best protection against the sun and ending claims that they are truly waterproof. The F.D.A. said sunscreens must protect equally against two kinds of the sun’s radiation, UVB and UVA, to earn the coveted designation of offering “broad spectrum” protection. UVB rays cause burning; UVA rays cause wrinkling; and both cause cancer.
The rules, which go into effect in a year, will also ban sunscreen manufacturers from claiming their products are waterproof or sweat proof because such claims are false. Instead, they will be allowed to claim in minutes the amount of time in which the product is water resistant, depending upon test results. And only sunscreens that have a sun protection factor, or SPF, of 15 or higher will be allowed to maintain that they help prevent sunburnand reduce the risks of skin cancerand early skin aging.
The rules have been under consideration since 1978, when most beach lotions were intended to encourage tanning, not protect against it. But federal regulators said they had yet to decide whether to end an SPF arms race in which manufacturers are introducing sunscreens with SPF numbers of 70, 80 and 100 even though such lotions offer little more protection than those with an SPF of 50. Still, dermatologists said they were thrilled.
“Now, we’ll be able to tell patients which sunscreens are best,”says board certified NYC dermatologist Dr. Ariel Ostad.
The rules will transform the $680 million domestic market for sunscreens, which has been growing rapidly because of an aging population and growing worries about skin cancer. And the final regulations are a stark change from a proposal the agency released in 2007, which would have created a star-based system for UVA protection. Under that system, sunscreens would have provided an SPF number for UVB protection and one to four stars for UVA protection.
The agency received more than 3,000 comments on that proposal, with many asserting that allowing products to offer differing levels of protection against UVB and UVA rays would be confusing. So the agency ditched the stars and instead will tell manufacturers that if they wish to label their products as offering “broad spectrum” protection they must make their defense against UVB and UVA radiation proportional.
Dr. Ostad feels that this ruling simplifies things for consumers. “All they’re going to need to do is pick an SPF number and then make sure that its broad spectrum.”
Any product that fails to offer proportional protection or has an SPF of 2 to 14 must include a warning that the product has not been shown to help prevent skin cancer or early skin aging. The new rules will standardize the testing that manufacturers must conduct for UVA protection.
The agency had proposed allowing manufacturers to use SPF numbers no higher than 50, but that remains only a proposal for which the agency will seek further comment. In particular, the government is asking whether there are special groups of people who would somehow benefit from having a product with an SPF of more than 50.
“Right now, we don’t have any data to show that anything above 50 adds any value for anybody,” says Dr. Ostad.
More than two million people in the United States are treated each year for the two most common types of skin cancer, basal cell and squamous cell, and more than 68,000 receive a diagnosis of melanoma,the most deadly form of the disease. Sunscreens have not been shown to prevent the first case of basal cell carcinoma, but they delay reoccurrences of basal cell and have been shown to prevent squamous cell and melanoma.
The F.D.A. announced that it was re-examining the safety of the roughly 17 sunscreen agents approved for use in the United States, although it has no information to suggest that they are not safe. Tuesday’s announcement will do nothing to speed the approval of more sunscreen agents. There are roughly 28 such agents approved in Europe and 40 in Japan, and some in the industry complain that the best ingredients have yet to reach American shores.
Some consumer and environmental groups have expressed concern that the ingredients in some sunscreens have been made so microscopic that they could be absorbed through the skin into the body, but Dr. Ostad feels that the F.D.A.’s own tests had found no cause for such concerns.
The agency is also asking for more information about sunscreen sprays to ensure that consumers get adequate quantities from spray bottles and to explore what happens when those products are inhaled. The new regulations will do nothing to prevent the most common problem with sunscreens lotions, which is that consumers fail to use enough of them. The rules become effective in one year, although manufacturers with less than $25,000 in annual sales will have two years to comply. In view of this new ruling and the summer season Dr. Ostad shares his facts on Sun Protection.
Everything You Need to Know About Sun Protection
With virtually hundreds of sun protection options available at your local drugstore or department store, Dr. Ostad notes there are several important ingredients one should look for when seeking full spectrum coverage and protection:
Micronized Zinc Oxide: For broad spectrum UV protection (including UVA rays). This also has soothing effects for skin irritations, and antimicrobial properties
Titanium Dioxide: An excellent absorber of sun rays (both UVA and UVAB rays), it provides long-term UV-protection and is water resistant
Niacin: This ingredient is clinically shown to visibly improve skin tone, texture and hyper-igmentation
Vitamin E: Helps heal and protect the skin
Dr. Ostad also would like to educate the consumer regarding some chemicals found in over the counter sunscreens; which ingredients would be best for your skin and what to watch out for; and what to look for, for the best sun protection.
Know Your SPF: Dr. Ostad says it is important to use at least SPF 30 regardless of your skin type or color. According to Dr. Ostad, “sunscreens should be applied to exposed areas 15 to 30 minutes before going outdoors.” When using sunscreen, Dr. Ostad also notes to pay special attention to your face, ears, hands and arms, which are sometimes forgotten or not properly covered. One ounce, about the amount in a shot glass, is considered the amount needed to cover the body properly – don’t skimp on your sunscreen! Dr. Ostad adds that it is also a known fact that any SPF over 30 is negligible in protection.
Your Daily Dose of Vitamin D: Many people tout the sun’s ability to help our body absorb vitamin D. According to Dr. Ostad, “it is important to get 20 minutes of direct sun per day, which will allow our bodies to absorb the normal level of vitamin D needed.” You should be careful to avoid the sun during the hours of 10am – 3pm, when the sun is strongest.
Detecting Skin Cancer
Dr. Ostad recommends people have a thorough skin exam every year to detect and prevent the three major types of skin cancer: basal cell carcinoma, squamous cell carcinoma, and malignant melanoma. According to Dr. Ostad, “you can also look at your own skin spots regularly and be very attentive to any changes or growth. A melanoma can be effectively treated if detected early.” Some melanomas can occur in areas that are covered by hair or clothing, making them difficult to self-examine.
The ABCD’s of Moles & Melanoma
Most people have some skin marks, such as freckles, moles, birthmarks. Some of these marks may be the signs of skin cancer. Warning signs of melanoma include:
Asymmetry:Melanomas are usually characterized by an irregular and asymmetrical shape. This means that one half of the spot does not match the other half.
Border:The edges of the old mole may turn scalloped or rough. New skin spots with undefined borders may also appear.
Color:Existing or new fast growing moles with uneven coloring (various shades of brown or black, colorless areas) are the first signs of skin cancer. These spots may later become red, blue or white.
Diameter: Early melanoma spots usually are greater than 6mm in diameter.
Original article citation:
The New York Times
Published: June 14, 2011