MONDAY, June 26, 2017 – If you buy a new eyeshadow or shampoo, assume these products are safe and don't cause rashes – or worse.
However, new research has shown that this is not always the case. And because cosmetics are severely under-regulated in the U.S. and there is no fixed system to determine if personal care products are harmful to your health, the study may never tell you about a problem with a product.
A complaints database from the US Food and Drug Administration contained only 5,144 adverse events related to cosmetics between 2004 and 2016, according to the lead author of the study, Dr. Steve Xu. He is a dermatologist at Feinberg School of Medicine at Northwestern University in Chicago.
"Here is a $ 400 billion industry with millions of products and lots of controversy, but we only had about 5,000 adverse events in 12 years," said Xu. "This is very, very little reported."
Only one case shows how poorly reported health problems related to cosmetics are, Xu said.
In 2014, the FDA launched an investigation into a shampoo / conditioner called WEN after receiving 127 customer reports of problems including hair loss, brittle hair, bald patches, itching, and rashes, Xu and colleagues said in their report ,
In the course of the investigation, the FDA learned that the manufacturer of WEN, Chaz Dean Cleansing Solutions, had received 21,000 complaints about hair loss and scalp irritation privately.
Cosmetics manufacturers are not required to report health-related complaints to the FDA, Xu said. For this reason, the FDA did not know that there was a problem with the product until consumers complained directly to the agency.
Because of this case, the FDA decided in December 2016 to first make a database of complaints about adverse events publicly accessible, which is maintained by its center for food safety and applied nutrition, Xu said. The database serves as a repository for consumer complaints related to food, supplements and cosmetics.
"It was really a great opportunity for us to see what the database would tell us," said Xu. "Unfortunately, it wasn't much."
The complaints averaged 400 per year and thus far below expectations, since the controversy surrounding cosmetics regularly occurred.
Complaints more than doubled between 2015 and 2016, increasing from 706 to 1,591 reported adverse events. However, this increase is due to a FDA public appeal calling on consumers and dermatologists to report health issues related to WEN, Xu said.
"We saw the increase in reports that followed this call to action," said Xu.
Hair care products received the most complaints in the database, followed by skin care products, the investigators found. Most health problems related to rashes, hair loss and other dermatological problems. However, more serious illnesses such as cancer or severe allergic reactions have also been reported.
According to applicable law, the cosmetics industry is largely self-regulated, said Dr. Doris Day, dermatologist at Lenox Hill Hospital in New York City.
"It is up to companies to monitor all of these products themselves and I think the market is monitoring them in many ways when things are not going well," said Day.
Xu said he was not an alarmist who believed that cosmetics should go through the same test as a new drug or medical device.
"By nature there is less risk for cosmetic products," said Xu. "Having a clinical trial for every moisturizer on the market is a little inconvenient and ridiculous."
But new laws could provide the FDA with better tools to respond to bad products, Xu said.
For example, the FDA cannot currently mandate a harmful cosmetic recall, and manufacturers are not required to share consumer complaints with regulators, Xu said.
The European Union is much more proactive in regulating consumer cosmetics, said Xu.
"You banned more than 1,000 chemicals. We only banned 10," said Xu. "They have been very active in chemical safety and have burdened manufacturers with proving the safety of their cosmetic products."
In the meantime, consumers can protect themselves by being more conservative when using abrasives such as facial scrubs or aggressive products that contain glycolic, salicylic, or retinoic acid, Day said.
"They attract too much or layer too many of these products on top of one another," Day said. "If you apply it to damaged skin, like tanned or burned skin or broken skin. Or if you use it too often – they think once a day is good, five times a day is better."
People who are concerned about a product should do a "patch test" and apply it to a small area on the inside of their forearm, Day suggested.
"This is not a very sensitive area. If it responds there, it is more likely to be a real allergic reaction," she said.
The study was published online on June 26 in JAMA Internal Medicine.
To report a complaint about a cosmetic product, visit the United States Food and Drug Administration.
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Published: June 2017