A Consumer Update from the FDA
Using ultraviolet (UV) tanning lamps, like those used in indoor tanning beds, increases the risk of skin damage, skin cancer and eye injury, according to the Food and Drug Administration (FDA) and numerous other health organizations.
According to the American Cancer Society, melanoma—the deadliest form of skin cancer—accounted for 75,000 cases of skin cancer in 2012.
According to the American Academy of Dermatology, indoor tanners are 75 percent more likely to develop melanoma than those who have never tanned indoors, and the risk increases with use.
To help protect consumers from the risks of indoor tanning, FDA is proposing changes in its regulation of sunlamps. The proposals are to enhance oversight of these devices, and to require labeling to include a recommendation designed to warn young people under the age of 18 not to use these devices.
This is due to concerns about long-term effects of exposure to dangerous UV rays. Because the effects add up over a lifetime, UV exposure in children and teenagers puts them at greater risk for skin and eye damage later in life.
FDA regulates sunlamp products (including tanning beds and booths) both as medical devices and radiation-emitting products. Manufacturers of sunlamps must comply with FDA regulations regarding these devices.
Based on new risk information and recommendations from experts at an earlier FDA Medical Device Advisory Committee meeting, the agency is proposing to reclassify these devices from Class I to Class II. FDA can exert more regulatory control over Class II devices, notes FDA medical device expert Neil Ogden.
For example, sunlamps would have to undergo premarket review and comply with requirements relating to performance testing, software validation and biocompatibility. “We believe the reclassification will not only strengthen oversight of sunlamp products, but also will ensure that consumers are better informed about and protected from this sort of exposure,” he explains.
In addition, FDA is proposing that manufacturers add a label to the sunlamp warning young people not to use these devices. The World Health Organization, the American Academy of Pediatrics, the American Academy of Dermatology, the American Medical Association and other organizations have previously supported what the FDA is now proposing: a recommendation that minors refrain from indoor tanning.
The proposed order will be published in the Federal Register at www.regulations.gov and FDA will take public comments for 90 days.
FDA also is proposing that sunlamp product labeling include a warning that people who are repeatedly exposed to sunlamp products see their health care professional on a regular basis to check for possible skin cancer.
Skin Cancer Risk
“There is increasing evidence that tanning in childhood to early adult life increases the risk of skin cancer, including melanoma,” says FDA dermatologist Markham Luke, M.D.
In fact, according to an overview of studies recently published in the journal Pediatrics, melanoma is the second most common cancer in women in their 20s and the third most common cancer in men in their 20s in the U.S. Luke adds that many experts believe that at least one cause is the increased use of sunlamp products by U.S. teenagers and young adults.
The overview in Pediatrics suggests that doses of UV-A ultraviolet radiation emitted by high pressure tanning units may be up to 10 to 15 times higher than that of the midday sun, an intense exposure not found in nature.
UV-A rays penetrate to the deeper layers of the skin and are often associated with allergic reactions, such as a rash. This is not to say that tanning outdoors is a safe activity. WHO has classified all UV radiation as carcinogenic (cancer causing).
Practices to Avoid
FDA’s proposal seeks to provide a reasonable assurance of safety and to make prospective users of sunlamps aware of the risks they face. Certain practices involving sunlamps are especially dangerous. These include:
- failing to wear goggles—this can lead to short- and long-term eye injury.
- starting with long exposures (close to the maximum time for the particular sunlamp), which can lead to burning. Because sunburn takes 6 to 48 hours to develop, you may not realize your skin is burned until it’s too late.
- failing to follow manufacturer-recommended exposure times on the label for your skin type (some skin types should not tan with UV radiation at all, for example those with skin that burns easily and doesn’t readily tan).
- tanning while using certain medications or cosmetics that may make you more sensitive to UV rays. Talk to your doctor or pharmacist first.
This article appears on FDA’s Consumer Update page, which features the latest on all FDA-regulated products.
May 7, 2013
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Related Consumer Updates
FDA Consumer Update
Inked and Regretful: Removing Tattoos
That tattoo on your arm of a former flame—the one that seemed like a great idea years ago—is kind of embarrassing today. And your spouse is not too crazy about it either.
You may not know that FDA considers the inks used in tattoos to be cosmetics, and the agency takes action to protect consumers when safety issues arise related to the inks.
At the other end of the tattoo process, FDA also regulates laser devices used to remove tattoos.
FDA has cleared for marketing several types of lasers as light-based, prescription devices for tattoo lightening or removal. A Massachusetts company recently received FDA clearance to market its laser workstation for the removal of tattoos and benign skin lesions.
According to a poll conducted in January 2012 by pollster Harris Interactive, 1 in 8 (14%) of the 21% of American adults who have tattoos regret getting one.
And the American Society for Dermatologic Surgery (ASDS) reports that in 2011, its doctors performed nearly 100,000 tattoo removal procedures, up from the 86,000 performed in 2010.
Unfortunately, removing a tattoo is not as simple as changing your mind.
Artists create tattoos by using an electrically powered machine that moves a needle up and down to inject ink into the skin, penetrating the epidermis, or outer layer, and depositing a drop of ink into the dermis, the second layer.
The cells of the dermis are more stable compared with those of the epidermis, so the ink will mostly stay in place for a person’s lifetime. Tattoos are meant to be permanent.
An effective and safe way to remove tattoos is through laser surgery, performed by a dermatologist who specializes in tattoo removal, says FDA’s Mehmet Kosoglu, who reviews applications for marketing clearances of laser-devices.
Lasers Used for Decades
“Laser” stands for Light Amplification by Stimulated Emission of Radiation. Kosoglu says that pulsed lasers, which emit concentrated light energy in short bursts, or pulses, have been used to remove tattoos for more than 20 years.
However, it can be a painstaking process. “Complete removal, with no scarring, is sometimes not possible,” Kosoglu notes.
“Complete removal, with no scarring, is sometimes not possible”
There are also do-it-yourself tattoo removal ointments and creams that you can buy online. “FDA has not approved them, and is not aware of any clinical evidence that they work,” says Luke.
In addition, Luke says that tattoo removal ointments and creams may cause unexpected reactions, such as rashes, burning, scarring, or changes in skin pigmentation in the process.
How Does It Work?
With laser removal, pulses of high-intensity laser energy pass through the epidermis and are selectively absorbed by the tattoo pigment. The laser breaks the pigment into smaller particles, which may be metabolized or excreted by the body, or transported to and stored in lymph nodes or other tissues, Kosoglu explains.
The type of laser used to remove a tattoo depends on the tattoo’s pigment colors, he adds. Because every color of ink absorbs different wavelengths of light, multi-colored tattoos may require the use of multiple lasers.
Lighter colors such as green, red, and yellow are the hardest colors to remove, while blue and black are the easiest.
Does It Hurt?
“That depends on a person’s pain threshold,” Kosoglu says. Some people compare the sensation of laser removal to being spattered with drops of hot bacon grease or snapping a thin rubber band against the skin. A trained dermatologist will be able to adjust the treatment to the patient’s comfort level.
Generally speaking, just one laser treatment won’t do the trick. According to the American Academy of Dermatology, the procedure requires multiple treatments (typically six to 10) depending on a tattoo’s size and colors, and requires a few weeks of healing time between procedures. Some side effects may include pinpoint bleeding, redness, or soreness, none of which should last for long.
Luke says that these laser devices are cleared for use by, or under the supervision of, a health care professional. The removal procedure requires using the correct type of laser, understanding the reaction of tissue to laser, and knowing how to treat the area after the procedure.
“If you have any concerns about having a tattoo removed, it’s a good idea to consult your dermatologist, who is knowledgeable about laser treatments,” Luke concludes.
The ASDS has a list of dermatological surgeons who specialize in tattoo removal.
Consumers are asked to report adverse (negative) reactions from tattoos, as well as problems with tattoo removal, to FDA’s MedWatch.
This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.
January 30, 2013
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The practice of tattooing has been around for thousands of years. These days, 21% of adults in the United States report having at least one piece of permanent artwork on their bodies.
Many people who receive these lasting tributes – to loved ones, to pop culture, to religion, or to whatever they’re into – generally know what to look for when selecting a reputable tattoo parlor.
Does the artist wear gloves?
Does the tattoo shop sterilize their equipment?
Did the artist open a sterile needle in front of you?
Are things like inks and ointments portioned out for individual use?
If the artist can pass this mental checklist, most people feel pretty safe.
One question few people may consider, however, is “What exactly went into that ink you’re about to inject into my skin?” And even if the question was asked, there’s no guarantee that the artist could answer with any great certainty.
Concentrated tattoo inks may be made from products that were never intended to be used for tattoos. Tattoo ink manufacturers may use products such as calligraphy ink, drawing ink, or even printer ink to make the products eventually used for tattooing.
These manufacturers often sell their products online, and while their states may require them to hold a business license, there is no regulation or oversight of the product itself.
Tattoo photo by courtesy of Michal Zacharzewski
The Importance of Water
While the thought of sharing ink with your office printer might be unsettling all on its own, a key ingredient of concern is the water that is used to either create the tattoo ink product or to dilute the product in the tattoo parlor.
Artists will often use water to dilute concentrated inks in order to get the specific shade the client requests. They may also use pre-diluted “gray washes,” which are black inks blended to produce different color intensities.
Some tattoo artists and tattoo ink manufacturers may believe that using distilled or reverse osmosis (a filtration method that removes large particles) water is sufficient to safely create or dilute tattoo ink products, but this is not the case.
Any kind of non-sterile water can contaminate the ink with potentially harmful germs, which can lead to infections in those tattooed with the ink.
This was the case earlier this year, when public health officials in New York received reports of non-tuberculous Mycobacterial (NTM) skin infections in at least 14 people who had been tattooed with the same pre-diluted gray ink.
In January of 2012, the Monroe County Department of Public Health received a report from a dermatologist that a patient had developed a persistent rash on his arm after being tattooed by a local tattoo artist.
Biopsy and culture confirmed that he was suffering from an NTM infection, and the tattoo artist reported that other clients had complained of similar reactions.
The artist noted that the rash seemed to follow the lines created by a pre-diluted gray ink and wasn’t present on areas of the tattoo that were created with other colors.
This was an important observation because NTM infections typically don’t spread—the rash-like infection is usually localized to the area that was exposed.
Using a list of all of the clients the artist could remember tattooing with the same gray wash, the health department was able to identify 18 additional infections, 14 of which were confirmed to be NTM infections.
The Ink Thins – The Plot Thickens
After being notified of the situation in New York, CDC issued a public health alert to try to identify additional tattoo-associated NTM skin infections.
Two previously identified clusters were discovered in Washington, one in Iowa, and one in Colorado, and all were related to inks likely contaminated by non-sterile water either during the manufacturing process or during dilution by the tattoo artist just prior to tattooing a client.
Contamination of tattoo ink products by non-sterile water is an ongoing problem, and this group of identified clusters may represent a snapshot of what we could expect to find at any given time.
Until tattoo ink manufacturers and tattoo artists fully understand the dangers of using non-sterile water to manufacture or dilute tattoo ink, these infections will continue to occur, and they can be far more serious than just an annoying rash.
NTM skin infections are very hard to treat, and often require 4-6 months of treatment with drugs that can cause serious side effects.
While some people’s infections may resolve just from treatment with medication, others may require multiple surgeries to remove infected tissue and may lead to significant scarring.
So what should people do?
Because tattoo inks are injected directly into people’s skin, CDC recommends that ink manufacturers produce sterile inks.
To protect their clients, tattoo artists should do the following:
- Don’t use inks or other products that are not intended for tattooing
- Don’t dilute ink before tattooing; if dilution is needed, use only sterile water
- Don’t use non-sterile water to rinse equipment (for example, needles) during tattooing
- Use aseptic technique during tattooing (e.g., maintain hand hygiene, use clean disposable gloves properly)
To reduce their risk of infection, consumers should:
- Use tattoo parlors approved/registered by their local jurisdictions
- Request inks that are manufactured specifically for tattoos
- Ensure that tattoo artists follow appropriate hygienic practices
- Be aware of the potential for infection after tattooing and promptly seek medical care if skin problems occur
A Consumer Update from the U.S. Food and Drug Administration
Consumers should not to use skin creams, beauty and antiseptic soaps, or lotions that might contain mercury, U.S. Food and Drug Administration officials warn
The products are marketed as skin lighteners and anti-aging treatments that remove age spots, freckles, blemishes and wrinkles, says Gary Coody, national health fraud coordinator in the Food and Drug Administration’s Office of Regulatory Affairs.
Adolescents also may use these products as acne treatments, adds Coody. Products with this toxic metal have been found in at least seven states.
The products are manufactured abroad and sold illegally in the United States—often in shops in Latino, Asian, African or Middle Eastern neighborhoods and online.
Consumers may also have bought them in another country and brought them back to the U.S. for personal use.
“If you have a product that matches these descriptions (and others listed below), stop using it immediately,” says Coody.
Signs and Symptoms of Mercury Poisoning
- changes in vision or hearing
- memory problems
- numbness and tingling in hands, feet or around mouth
“Even though these products are promoted as cosmetics, they also may be unapproved new drugs under the law,” says Linda Katz, M.D., director of FDA’s Office of Cosmetics and Colors. FDA does not allow mercury in drugs or in cosmetics, except under very specific conditions, which these products do not meet.
“Sellers and distributors should not market these illegal products and may be subject to enforcement action, which could include seizure of the products and other legal sanctions,” says attorney Brad Pace, J.D., of the Heath Fraud and Consumer Outreach Branch within FDA’s Center for Drug Evaluation and Research.
Dangers of Mercury
“Exposure to mercury can have serious health consequences,” says Charles Lee, M.D., a senior medical advisor at FDA. “It can damage the kidneys and the nervous system, and interfere with the development of the brain in unborn children and very young children.”
You don’t have to use the product yourself to be affected, says FDA toxicologist Mike Bolger, Ph.D. “People—particularly children—can get mercury in their bodies from breathing in mercury vapors if a member of the household uses a skin cream containing mercury.” Infants and small children can ingest mercury if they touch their parents who have used these products, get cream on their hands and then put their hands and fingers into their mouth, which they are prone to do, adds Bolger.
How to Protect Yourself
- Check the label of any skin lightening, anti-aging or other skin product you use. If you see the words “mercurous chloride,” “calomel,” “mercuric,” “mercurio,” or “mercury,” stop using the product immediately.
- If there is no label or no ingredients are listed, do not use the product. Federal law requires that ingredients be listed on the label of any cosmetic or drug.
- Don’t use products labeled in languages other than English unless English labeling is also provided.
- If you suspect you have been using a product with mercury, stop using it immediately. Thoroughly wash your hands and any other parts of your body that have come in contact with the product. Contact your health care professional or a medical care clinic for advice.
- If you have questions, call your health care professional or the Poison Center at 1-800-222-1222; it is open 24 hours a day.
- Before throwing out a product that may contain mercury, seal it in a plastic bag or leak-proof container. Check with your local environmental, health or solid waste agency for disposal instructions. Some communities have special collections or other options for disposing of household hazardous waste.
Tracking Skin Products Containing Mercury
Investigations in the past few years by FDA and state health officials have turned up more than 35 products that contain unacceptable levels of mercury.
FDA continues to add mercury-containing skin products to its import alerts, which authorize the agency’s field staff to refuse admission of shipments of these products.
But this is only a partial solution, says Coody. “Many of these products are coming into the country through channels we can’t easily track, such as international mail and personal baggage.
That’s why it’s so important for consumers and sellers to know about the dangers of possible mercury poisoning associated with the use of these skin products.”
Texas health officials say samples of face cream they tested contained mercury up to 131,000 times the allowable level. And a teenager in southern Texas who used a mercury-containing skin cream was recently hospitalized for mercury poisoning.
In Northern California, a 39-year old woman had more than 100 times the average amount of mercury in her urine and had symptoms of mercury poisoning, according to the California Department of Public Health.
For three years, the woman and her husband had been using an unlabeled mercury-containing face cream that was brought into the U.S. from Mexico by a relative.
Several other family members who did not use the cream, including a four-year-old child, also had elevated levels of mercury in their bodies.
Virginia, Maryland, and New York have also seen cases of elevated mercury levels in people exposed to skin products containing mercury.
In Minnesota, 11 of 27 imported skin products taken from store shelves contained mercury . Photos of some illegal mercury-containing products are shown here:
This article appears on FDA’s Consumer Update page, which features the latest on all FDA-regulated products.
March 6, 2012
For More Information
- Minnesota Department of Health: Skin-Lightening Products Found to Contain Mercury (includes product photos)
- Texas DSHS Warns of Mercury Poisoning Linked to Mexican Beauty Cream (includes product photos)
- California Department of Public Health – Health Alert: Mercury Poisoning Linked to Use of Face Lightening Cream
- Virginia Department of Health: Mercury in Skin Creams
- Maryland DHMH Issues Consumer Alert Regarding Face Cream Containing Mercury (includes product photo)
- Mercury Exposure Among Household Users and Nonusers of Skin-Lightening Creams Produced in Mexico — California and Virginia, 2010
By William E. Scott
“Bugs,” the two year old boy said as he pointed to an irritated patch of skin on his face. Mary Leitao looked closer, and although she found no visible insects, she was startled to find colored fibers sprouting from her son’s skin. It was a summer evening in 2001 that would change the lives of the Leitao family for years to come.
A medical researcher turned stay-at home mom, Leitao had never seen anything like it and neither had her husband, Edward, an internist at South Allegheny Internal Medicine. Mary Leitao took her son to be examined by numerous doctors, but none provided a satisfactory explanation. Many suggested that it was a form of psychosis called “delusional infestation” or the conviction of being infected with parasites.
Believing instead that she had discovered a new disease, Leitao named the condition Morgellons and in 2004 established a non-profit organization called the Morgellons Research Foundation (MRF).
Through the efforts of the MRF, the CDC (Centers for Disease Control and Prevention) conducted a three-year government study to research Morgellons.
The results, released last week, indicated that there was no diseased organisms or parasites present in the 115 case-patients.
The protruding fibers were found to be mostly skin fragments or clothing fibers stuck to the skin.
According to the report, the physical ailments were manifestations of “delusional infestation.”
From a recent article in WebMD, individuals with delusional infestation tend to be hyper-aware of normal body sensations and interpret them as medical illness. The article notes, “This stress has real physical effects on the body and leads to a spiral of worsening physical symptoms…”
The suggestion that thoughts and stress can be manifested as physical maladies may be counterintuitive to anatomy-based medicine, but research increasingly supports the idea. For instance, The Washington Post reported, “Nocebos[inert pills provided with a negative expectation] often cause a physical effect, but it’s not a physically produced effect,” said Irving Kirsch, a psychologist at the University of Connecticut in Storrs who studies the ways that expectations influence what people experience.
The CDC study, published by the open-access journal PLoS One, is available online.
The CDC also has an information page about Morgellons Disease.
The idea that the condition may be more mental than physical has always been unpopular among those who identify themselves with the disease. It has impelled them to fight on two fronts – working to gain credibility and help from the medical community and fighting the unfortunate stigma of mental illness. With the significant setback of the CDC report, how many may be wondering, what next?
I have compassion for those suffering from Morgellons. No one should have to live with the painful symptoms or the mental anguish of feeling isolated, abandoned and uncared for. Yet, perhaps it’s time to consider the mental nature of the condition. Yet, perhaps it’s time to consider the mental nature of the condition. But I’m not proposing psychotherapy – but a spiritual approach.”
For instance, in the recent Jan. 29 issue of the Concord Monitor, a woman describes her recovery from disease as she changed her thought to a more prayerful perspective. Shifting thought away from the body to seeking a greater understanding of her spiritual nature worked for her.
As the mental factors of many diseases become more widely understood, spiritual treatments, such as Christian Science, that focus on thought can be a valuable resource. The MRF website reports that fear and hopelessness are common among those who suffer from Morgellons. Working spiritually to lessen and eliminate these unhealthy mental states may be the best next step.
This article first appeared on Blogcritics.
A retired architect, Bill Scott writes about spirituality and health for Blogcritics.org and also serves as the Christian Science Committee on Publication for Washington State.
Beginning next year, sunscreen labels must indicate whether they provide protection against the full spectrum of the sun’s skin-damaging ultraviolet radiation or not.
Under the new rules announced today by the U.S. Food and Drug Administration (FDA), only those products that pass the agency’s test for protection against both ultraviolet A (UVA) and ultraviolet B (UVB) rays can labeled as “Broad Spectrum” and claim to help prevent sunburn, reduce the risk of skin cancer, and reduce the risk of early skin aging.
Both UVB and UVA radiation contribute to sunburn, skin cancer, and premature skin aging. Sunburn is primarily caused by UVB radiation.
Products that have sun protection factor (SPF) values between 2 and 14 may be labeled as Broad Spectrum if they pass the required test, the FDA said, “but only products that are labeled both as Broad Spectrum with SPF values of 15 or higher may state that they reduce the risk of skin cancer and early skin aging, when used as directed.”
“We want consumers to understand that not all sunscreens are created equal,” Lydia said Velazquez, PharmD, in FDA’s Division of Nonprescription Regulation Development.
Any product that is not Broad Spectrum, or that is Broad Spectrum but has an SPF between 2 to 14, will be required to have a warning stating that the product has not been shown to help prevent skin cancer or early skin aging, the FDA said.
Minor & James Medical, a multi-specialty physician group located in Seattle, Bellevue and Mercer Island, recently added dermatology to its list of specialties.
New Minor & James Medical dermatologist, John M. Knox, M.D., is board certified in dermatology and specializes in skin cancer and all conditions affecting the skin, hair and nails.
The dermatology division will be located at the First Hill Medical Building at 515 Minor Ave. in Seattle. The dermatology clinic is open Monday through Thursday from 8 a.m. to 5:30 p.m.
For more information or to schedule an appointment:
- Call 206-386-9540.
Although this is Melanoma and Skin Cancer Detection and Prevention month, to protect yourself against these common cancers you should take time every month to check your skin for new or changing moles, says Dr. Don Kern, a dermatologist at Seattle’s Polyclinic.
While sun protection and avoidance of peak hours are the best ways to prevent skin cancer, early detection is your next line of defense and can offer the best chance for successful treatment, says Dr. Kern.
Often a loved one can more easily notice suspicious moles or growths in hard to see places, like the back of your thighs, middle of your back, behind your ears, buttocks, and the back of your neck.
“Although your wedding vows didn’t say so, checking your partner for new or changing moles should be among the promises you make,” Dr. Kern said..
If looking at moles solo, mirrors can make it possible to check out otherwise “blind spots” for growths, said Dr. Kern, and be sure to check the soles of your feet, back of arms and even between your toes.
How can you identify a suspicious mole from a benign mole?
Dr. Kern suggests that you use the ABCDs to help determine if the growth might be cancerous. If you notice a mole that exhibits any of the following features, it should be examined by a physician.
- Asymmetrical shape? A common mole should by symmetrical, whether it’s oval or round.
- Border is irregular or poorly defined? The border of a noncancerous mole should be smooth like a balloon—not jagged like the coast of Maine.
- Color of the mole is varied? Two shades of a color counts as two colors in this case.
- Diameter greater than 6 mm? The diameter shouldn’t be larger than a pencil eraser.
But even if the mole doesn’t display any of the ABCDs, it may still need to be examined by a physician, said Dr. Kern. “Most moles appear on our skin by early adulthood, and once a mole develops, it shouldn’t change in size, shape, height, or color. If you notice a new mole or a growth that appears to be growing or changing, get it looked at.”
Skin cancer affects the lives of more and more people each year; but with better awareness, diligent screening, and prompt treatment, outcomes can be greatly improved for many people, he said.
The Polyclinic is made up of more than 160 physicians, including internal medicine, family medicine, OB/GYN, pediatrics, and 23 additional medical and surgical specialties. Since its inception in 1917, The Polyclinic’s mission has been to promote the health of its patients through high-quality, comprehensive and personalized care. For more information, visit www.polyclinic.com.
You break out in a head-to-toe rash after applying a sunless tanning lotion. Your son’s skin is red and blotchy after he gets his face painted at the school carnival. Your daughter’s scalp is burned after using a hair relaxer.
If you’ve had a negative reaction to a beauty, personal hygiene, or makeup product, the Food and Drug Administration (FDA) wants to hear from you.
Photo: Patti Adair
From morning until night—styling our hair for work to showering before bed—Americans depend upon personal care products. Most are safe, but some cause problems, and that’s when FDA gets involved.
“Consumers are one of FDA’s most important resources when it comes to identifying problems.”
The federal Food, Drug, and Cosmetic Act defines “cosmetics” as products that are intended to be applied to the body “for cleansing, beautifying, promoting attractiveness, or altering the appearance.” But the legal definition includes items that most Americans might not ordinarily think of as cosmetics, including:
- face and body cleansers
- moisturizers and other skin lotions and creams
- baby lotions and oils
- hair care products, dyes, conditioners, straighteners, perms
- hair removal creams
- nail polishes
- shaving products
- perfumes and colognes
- face paints and temporary tattoos
- permanent tattoos and permanent makeup
What to Report
Katz says consumers should contact FDA if they experience a rash, hair loss, infection, or other problem—even if they didn’t follow product directions. FDA also wants to know if a product has a bad smell or unusual color—which could signal contamination—or if the item’s label is incomplete or inaccurate.
When you contact FDA, include the following information in your report:
- the name and contact information for the person who had the reaction;
- the age, gender, and ethnicity of the product’s user;
- the name of the product and manufacturer;
- a description of the reaction—and treatment, if any;
- the healthcare provider’s name and contact information, if medical attention was provided; and
- when and where the product was purchased.
And be sure to give the age, gender, and ethnicity of the person who had the reaction, says FDA scientist Wendy Good, Ph.D. Good, who analyzes reports about problems with cosmetics, says that information is important because it can help scientists spot trends.
When a consumer report is received, FDA enters the information into a database of negative reactions. Experts then look for reports related to the same product or similar ones. FDA scientists will use the information to determine if the product has a history of problems and represents a public health concern that needs to be addressed.
If you file a consumer report, your identity will remain confidential.
“Cosmetics are usually safe, but when they aren’t, consumer reporting is essential so FDA can take action when appropriate,” Katz says. Those actions could—depending upon the product and the problem—range from issuing a consumer safety advisory to taking legal action.
This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.
Though it’s often portrayed as a scourge of the teen years, acne can affect people of all ages.
According to the National Institutes of Health (NIH), about 80 percent of people between the ages of 11 and 30 have outbreaks of the skin disorder at some point.
“Many see their acne go away by the time they reach their 30s,” says Jane Liedtka, a medical officer at the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER). “But for some, acne persists into their 40s and 50s.”
Do not use any skin products made by Clarcon, the U.S. Food and Drug Administration (FDA) warns.
Some skin sanitizers and skin protectants produced by Clarcon Biologial Chemistry Laboratory, Inc. of Roy, Utah have been found to contain “high levels of disease-causing bacteria”, the FDA said.
“Some of these bacteria can cause opportunistic infections of the skin and underlying tissues. Such infections may need medical or surgical attention, and may result in permanent damage,” the FDA said.
“Findings from the FDA’s recent inspection of the Clarcon facility are particularly concerning because the products are promoted as antimicrobial agents that claim to treat open wounds, damaged skin, and protect against various infectious diseases,” the FDA said.
The recalled products are marketed under a number of brand names.
Among the products that the FDA says should be immediately discarded are:
- Citrushield Lotion
- Dermasentials DermaBarrier
- Dermassentials by Clarcon Antimicrobial Hand Sanitizer
- Iron Fist Barrier Hand Treatment
- Skin Shield Restaurant
- Skin Shield Industrial
- Skin Shield Beauty Salon Lotion
- Total Skin Care Beauty
- Total Skin Care Work
Clarcon is voluntarily recalling the products identified as contaminated by the FDA.
To learn more:
The U.S. Food and Drug Administration (FDA) is warning consumers not to use a water-based face paint product after the paints were linked to skin reactions in children.
“The FDA has learned of a cluster of adverse events in children exposed to various colors of the face paint. All exposures occurred on the same day at an organized event and included rashes, itchiness, burning sensation, and swelling where the face paints were applied. Significant microbial contamination was indicated in most of the products in testing by an FDA laboratory,” the FDA said in a product alert. Continue reading
A nail polish remover sold as Personal Care non-acetone nail polish remover, conditioner enriched with gelatin has been recalled after reports the product caused chemical burns to the fingers of two users.
“Any person who purchased a bottle of Personal Care non-acetone nail polish remover, conditioner enriched with gelatin is urged to return it to the store of purchase for a refund,” the manufacturer said in a release announcing the nationwide recall. Continue reading
The psoriasis drug Raptiva is being withdrawn from the U.S. market after reports that three patients on the drug had developed a serious brain disease called progressive multifocal leukoencephalopathy (PML) that is almost always fatal.
A third patient on Raptiva died of a progressive neurological disorder but it is not known whether the disease was PML.
It is thought that there are 2,000 patients in the U.S. on the drug. Continue reading