The ugly side of beauty

Number of bad reactions caused by cosmetics has jumped dramatically in recent years

Suzan Obagi has seen it happen many times: A bride comes to her during the week of her wedding with chemical burns on her body — a bad reaction to a cosmetic product such as a chemical peel or laser device that she bought online as a last-minute treatment to look her best for the big day.

Dr. Obagi then works with the bride to determine whether the adverse event will cause scarring (discuss laser surgery), infection (antibiotics, then laser surgery if scarring) or an allergic reaction (topical or oral steroids).

“Leading up to the wedding, people let their guard down and get carried away with the cosmetics that they buy,” said Dr. Obagi, director of the UPMC Cosmetic Surgery and Skin Health Center and associate professor at the University of Pittsburgh School of the Health Sciences.

The Food and Drug Administration defines cosmetics as being anything, when applied to the human body, that aims to cleanse, beautify, promote attractiveness or alter one’s appearance. Although adverse effects may be rare and are not life threatening, they have the power to alter lives.

Dr. Obagi’s patients are not alone. A recent report published by Northwestern University’s Feinberg School of Medicine researchers found that over the past decade, the FDA has seen a significant jump in the number of adverse events reported annually — going from 155 in 2006 to 1,591 in 2016.

In 2014, the FDA received 127 complaints regarding the celebrity hair conditioner brand WEN by Chaz Dean — making up the most from one brand of the FDA’s 436 reports that year.

When the FDA started investigating this high number it found that WEN had not reported more than 21,000 adverse events ranging from scalp irritation to extreme hair loss.

“The increase of complaints was ultimately caused by WEN and shows that consumers are sensitive to FDA announcements,” said Steve (Shuai) Xu, dermatology resident at Northwestern Memorial Hospital and corresponding author of the report. “When they see others suffering from the same symptoms that they searched on

the internet, they are more likely to report.”

The revelation comes from a compilation of accumulated voluntary submissions to the FDA dating back to 2004. Thousands of reports detailing the companies and the adverse events experienced were put into a large Excel document that the FDA publicly released on its site in December called CAERS. But the FDA has acknowledged that the report is not completely accurate. This is because the average person uses several products a day — making it hard to determine if it is a single product that is causing the reaction. Additionally, many of these comments are reactionary and may be side effects from prior health issues such as alopecia areata (genetic spot baldness).

Since the FDA opened an investigation of WEN in 2014, it has received 1,386 more complaints against the company as of November 2016. Also, a class action suit filed by customers against the company was settled in October 2016, with the company setting up a $26 million to pay customer claims and other costs.

The FDA

Despite thousands of complaints, WEN products are still on the market. And, it still advertises itself as having no harsh chemicals.

“When it comes down to it, the question of what the definition of ‘harsh’ is matters,” Dr. Xu said. “It could mean anything to the company since it’s such a broad term, which is how it’s still allowed on the label — labels don’t really mean anything.”

The most common misconception consumers have about the FDA is that it can regulate and filter products that can be potentially dangerous before they hit the market. That is not the case. The only times the FDA preapproves products are when there are colored additives or the product was resubmitted as a prescription. The FDA only has jurisdiction to remove a product from shelves if it has illegal ingredients or if it makes a medical claim. Otherwise, recalls are made by the manufacturers voluntarily whether by their own decision or by the FDA’s request.

The European Union has banned more than 1,300 cosmetic ingredients while the United States has banned only 11.

“Under the law, information on cosmetic labeling, including claims, must be truthful and not misleading,” said Theresa Eisenman, spokeswoman of the FDA’s Center for Drug Evaluation and Research. “The FDA’s authority is post-market: The agency can take action against cosmetics on the market that do not comply with the laws we enforce, but the onus is on the FDA to prove that a cosmetic is adulterated or misbranded under the law.”

The reason WEN is able to claim on its label that it contains no harsh chemicals is because it is not a medical claim, Dr. Obagi said. “For example, if a wrinkle cream says ‘building collagen,’ that is a medical claim; therefore, it needs to be taken off the label or resubmitted as a prescription. However, the wrinkle cream can use ‘reduce appearance of fine lines,’ instead,” she said.

The manufacturers

Because the FDA has little authority over cosmetics, manufacturers have a lot of freedom. They can choose whether to submit reported adverse events and how many they want to send if they do submit. They also decide what is put on the label as long as it isn’t a medical claim.

Dr. Xu does not believe that the manufacturers hide adverse event reports or intend to make products that harm. It is more about what the manufacturers want to investtheir funds in.

Dr. Obaji believes that there is less knowledge than ever before about cosmetics because with the internet there are so many different purchasing outlets. Right now, the FDA is working to curtail questionable cosmetics entering the United States through internet purchases. However, it has limited power.

In 2015, California Sen. Dianne Feinstein introduced the Personal Care Product Safety Act to give the FDA the authority to recall products, make it mandatory for manufacturers to report adverse events, and conduct an annual safety review of five ingredients. Even though that has yet to become law, major cosmetic companies have already jumped on board. “Congress is the best way to modernize FDA authority,” Dr. Xu said.

But Dr. Xu believes that there is a major challenge in determining the toxicity and safety of products because there are no perfect models that test chemicals for humans. The next step, he said, is more investment in regulatory sciences for cosmetics to improve testing (both cellwise and animal-wise).

The FDA needs a middle category between retail products and pharmaceuticals, said Dr. Obaji. She suggests that there should be categories like in baseball where the most mild skin cream is “first base,” and then gradually increasing in intensity with “home” being prescription medication. “That way it would be easier because the companies don’t have to apply as a prescription if they aren’t one, the customers understand what they are getting, and both groups save money.”

In the meantime, she said, “My advice to customers is to just be smart and be careful with what they buy.”

For the most up-to-date information on product recalls, the FDA publishes a weekly report newsletter on its website, www.fda.gov.