Unfortunately, just because it’s sold over-the-counter does not make products safe for use. In fact, there are almost 13,000 chemicals used in cosmetics and only 10 percent have been tested for safety. Although the U.S. Food and Drug Administration (FDA) has the authority to regulate ingredients in cosmetics and personal care products, they often do not exercise it.
Personal care products are allowed to reach store shelves without any prior approval by any agency. Only after a product has demonstrated harm, has been misbranded or adulterated, may the FDA take action. According to the FDA’s description of their authority over cosmetics:1
“The law does not require cosmetic products and ingredients, other than color additives, to have FDA approval before they go on the market, but there are laws and regulations that apply to cosmetics on the market in interstate commerce.
FDA's legal authority over cosmetics is different from our authority over other products we regulate, such as drugs, biologics and medical devices. Under the law, cosmetic products and ingredients do not need FDA premarket approval, with the exception of color additives. However, FDA can pursue enforcement action against products on the market that are not in compliance with the law, or against firms or individuals who violate the law.”
Compounding this situation, the FDA also has made manufacturers responsible for ensuring the safety of the products they produce and those manufacturers are not required to share the tests that reportedly demonstrate the safety of these products with any Federal agency or the public.
What does this mean for a health-conscious person like yourself? When you use body lotion, deodorant, shampoo or nail polish, you may be applying harmful chemicals to your body, even if the product claims to be nontoxic and safe.
Adverse Event Reports From Cosmetic Products Rising
According to researchers who examined data from the FDA database of adverse effects, there were an average of nearly 400 adverse events reported yearly directly to the FDA between 2004 and 2016 for personal care products, such as shampoos, lotions, tattoos and perfume.2
The number of reports surged by the end of 2016 to nearly 1,600, triggered by the FDA’s public appeal to consumers and physicians to report adverse events related to products manufactured by Chaz Dean Cleansing Conditioners under the brand name WEN.3 In their analysis of the data,4 researchers found the three personal care products that were reported most commonly were hair care, tattoos and skincare.
The products that involved the more serious health conditions were baby products. Haircare products were reported at a rate of 35 percent and skincare products represented 22 percent of the complaints. Lead author Dr. Steve Xu, dermatologist from McGaw Medical Center at Northwestern University, commented on the number of adverse effects in the study,5 saying, "You can start making a cosmetic and start selling it the next day without any kind of permission from the FDA.”
It was only in December 2016 that the FDA publicly released6 adverse event data on food and cosmetics from the Center for Food Safety and Applied Nutrition.7 Prior to this, an individual would have to file a Freedom of Information Act request to get access to safety reports. Although there were thousands of reports of adverse effects from the use of WEN haircare products, these products have not been pulled from the market.8
Although the FDA can recommend recalls, it has no authority at this time to enforce the recommendation. Sens. Dianne Feinstein (D-Calif.) and Susan Collins (R-Maine) have introduced a bill requiring greater regulation of personal care products, including skincare and haircare products.9 This bill would also give the FDA the authority to issue recalls and require better labeling and warnings from manufacturers.
While this type of regulation would help protect the consumer, Kim Harley, associate director at the University of California, Berkeley Center for Environmental Research and Children’s Health, noted it would also help the FDA learn more about the long-term effects of personal care products.10 Harley went on to say:
"When you think about harmful chemicals, you can think of two levels. You can think of acute harm and chronic exposure. Acute would be 'I use a cosmetic product, and I get this rash that's almost immediate, or hair loss or something like that.' It's an extreme reaction that's happening so close in time to when you use the product, it seems it's linked to the use of this product."
The researchers who analyzed the data of adverse events from the FDA noted there were several limitations to their study:11
- There was a lack of information in the database as to what in the product caused the adverse effect.
- It was unclear if the report was made by a consumer or by a health professional.
- It is possible the study underestimated the total number of events as reporting is not mandatory, nor are companies or manufacturers required to share the complaints they receive with the FDA.
Adverse Event Numbers Are Likely Underreported
The spike in complaints to the FDA in 2014 by WEN haircare products triggered an investigation that uncovered another 21,000 complaints made to the manufacturer.12 Both the complaints to the FDA and to Chaz Dean Cleansing Conditioners identified the same concerns with the WEN product, including hair breakage, hair loss and scalp problems.13 Xu commented on the discrepancy in adverse events reported to the FDA and the manufacturer, saying:14
"These numbers are likely underreported. We need better reporting, from both consumers and clinicians. Broadly, the hope of our paper was to continue this discussion to modernize and expand the collection of data about personal care products. If you can't measure it, you can't manage it, was our key point."
While necessary, the challenge of monitoring and regulating the cosmetic industry under the current laws is a daunting task. In a corresponding editorial published alongside the data analysis, three experts, including former commissioner of the FDA, Dr. Robert Califf, wrote:15
"For products that are used routinely, small effects over time within large populations can be almost impossible to detect without active surveillance. Even when health risks are substantial, as with tobacco products, the path to identifying and interpreting those safety signals clearly enough to justify regulatory action is often long and tortuous.
In an ideal world, sophisticated active monitoring approaches would complement — and perhaps eventually supersede — spontaneous adverse event reporting. For example, widely used internet and social media tools may offer novel ways for expeditiously collecting large amounts of data to yield a more complete picture of risks associated with commonly used products.”
As cosmetic manufacturers are not required to share health related complaints with the FDA, the agency was not aware of the extent of the problem with WEN until consumers began complaining directly to the FDA.16
As a result, the FDA opened the database of adverse event complaints for the first time in December 2016, used by Xu and his colleagues in this recent study. Xu commented on the information they gleaned from the repository of adverse event complaints:17 "That was really a great opportunity for us to see what the database would tell us. Unfortunately, it wasn't much."