Using Adverse Event Reports to Monitor Cosmetic Safety
A Conversation with Linda Katz
It’s not an exaggeration to say that everyone uses cosmetics.
“Every person uses some cosmetic product on a given day, be it shampoo, mouthwash, a moisturizer or deodorant,” says Linda Katz, M.D., MPH, director of the FDA’s Office of Cosmetics and Colors. Cosmetics are more than just makeup. They make up a broad category of products that, by law, are intended to, among other things, cleanse or alter appearance.
FDA monitors cosmetics on the market to ensure that they are safe for consumers. One way in which FDA finds out about a safety issue is when an adverse event report (AER) is filed by a consumer, manufacturer, or health care professional. An adverse event could be any problem experienced when using a cosmetic product.
On Tuesday, Dec. 6, 2016, FDA announced that it is making public certain data that the agency’s Center for Food Safety and Applied Nutrition (CFSAN) receives about adverse events associated with the use of its regulated products, which include cosmetics. The goal of CFSAN’s Adverse Event Reporting System (CAERS) is to collect data on some of the problems reported when using these products.
Dr. Katz talks about some of the safety issues involving cosmetics, how FDA is responding to them, and how consumers interested in safety data about cosmetics can best use information in the CAERS database.
Q: What are some of the cosmetic products that have generated the most AERs?
The most frequently reported adverse events for cosmetic products go into the general categories of hair care (including shampoos, conditioners, hair smoothing products, and hair dyes) and skin care products. In addition, we receive more reports for leave-on than rinse-off products. In more recent years there are a number of products that have been the subject of multiple reports.
Q: Could you talk a little more about some of those products?
WEN by Chaz Dean has generated the largest number of AERs associated within the category of cosmetic hair cleansing products. We are investigating reports of hair loss, hair breakage, balding, itching and rash reported to be associated with the use of these hair-care products and have posted information on fda.gov to alert consumers and health care professionals about adverse events reported for these products. We sent a letter to health care professionals, and published similar letters in dermatology journals, asking them to report patient problems encountered with the use of WEN cleansing conditioners. We had been following WEN for a few years but the reports of adverse events to FDA were sporadic. As we investigated and communicated with the companies and consumers, there was an increase in number of AERs we received. This year, we received more than 1,100 adverse event reports about WEN products following our consumer advisory and request for information.
It’s important to understand that FDA does not have the authority to require mandatory reporting of adverse events related to cosmetics. For this reason, we only became aware during inspections of manufacturing and distribution facilities that Chaz Dean, Inc., and Guthy Renker, LLC, had received more than 21,000 complaints from consumers about the WEN products. Consumers who have reached out to us about cosmetic issues have been shocked that a manufacturer can receive thousands of complaints about injuries from cosmetics and yet is not required to pass that information along to FDA.
Not having mandatory reporting of adverse events by manufacturers often means that we’re just seeing the tip of the iceberg in CAERS. People in general don’t report adverse events unless they have a significant health problem or have spent a lot of money on the product. We only glimpse a very small amount of what’s actually out there in the real world.
Q: What is the reason for the recent increase in adverse event reports related to talcum powder?
We have received about 1,000 AERs over the past few years, prompted in part by class action lawsuits that suggest ovarian cancer might be tied to the use of talc in powder. In 2014, FDA denied a citizen’s petition asking that a warning label be put on talcum powder warning of a possible link to ovarian cancer. We did not find such a link in our review of the scientific literature at the time. However, in part because of the continuing influx of AERs associated with talcum powder, we are taking another look at the latest scientific literature and are beginning our own laboratory research study to determine if such a link between talc and ovarian cancer, not found in earlier research, might now be determined.
Q: FDA has also posted information about certain tattoo inks. What is the issue there?
Tattoo inks have been an ongoing concern because of the potential for microbial contamination, with potentially dangerous bacteria entering the product either at the manufacturing plant or in the tattoo parlor. Adverse events reported to FDA include rashes and infections that require treatment with antibiotics. There are many different kinds of bacteria involved, and we have helped facilitate voluntary recalls to get certain tattoo inks off the market. FDA has developed many consumer information articles that focus on all safety aspects of tattooing. In addition to microbial concerns, FDA also has concerns about what is in individual inks that may be injected into the skin.
Q: Besides not being able to require reporting of adverse events for cosmetics, what are some of the other limits on FDA’s oversight of cosmetics?
We do not have the legal authority to approve cosmetics products and their ingredients, other than color additives, before they go on the market.
Under the Federal Food, Drug, and Cosmetic Act, the tools that FDA uses to regulate cosmetics are much more limited than those for other FDA-regulated products, such as drugs and medical devices. For example, cosmetics manufacturers are not required to register their facilities with the agency, or follow what’s known as Good Manufacturing Practices (GMPs) to ensure adherence to quality standards. Additionally, unlike certain other regulated products, including food and dietary supplements, FDA cannot require companies to recall products if problems are identified.
Q: Why are the lack of required facility registration and adherence to GMPs obstacles for FDA?
We are hampered in tracking down tainted products in situations like these by the lack of a facility registration requirement. For example, with tattoo inks, we don’t know the number of manufacturers, who they are, where they are, and what they make. With other regulated products, the agency knows who the manufacturers are because they are required to register.
We have voluntary cosmetic registration but we estimate that it covers only a fraction of what is marketed. If a problem comes in and we don’t have any information on file about the product, it is much more difficult to quickly identify the nature of the hazard.
The lack of required GMPs can make it difficult for FDA to identify problems with manufacturing that could cause a product to be unsafe. FDA may not discover that a product is unsafe until we receive an AER.
Q: How many adverse event reports have been submitted for cosmetic products?
In 2015 and 2016 we received 2,085 and 3,576 adverse event reports, respectively, for cosmetic products. This is a dramatic increase from previous years. For example, only 445 reports were submitted in 2014. There are a couple of reasons for this. There are the high-profile cases that generated many reports and FDA’s commitment to education and outreach has raised awareness of the need for consumers and health care professionals to report adverse events involving cosmetics.
Q: Can you tell me more about adverse event reports and what they might mean?
The information comes to CAERS through FDA’s MedWatch Safety Information and Adverse Event Reporting Program, which is the gateway for reports about all FDA-regulated products.
This is raw data and the reports have not been verified. But they are important because it’s one of the few tools FDA has to monitor possible safety problems with cosmetics. The reports need to be interpreted with caution. If you’re considering using a particular product, the database can give you some general information about what kinds of problems, if any, other people have reported experiencing. It’s information – not proof.
Another cautionary note: When it comes to adverse event reports, quantity doesn’t necessarily mean quality. We don’t just go by the number of the complaints, although that’s certainly a factor. We’re also motivated by the nature of the reports.
Q: What has FDA been doing to determine if these reports are signaling a real safety concern, and if so, to take action to protect the public?
We constantly monitor adverse event reports and even if there are just a few, we may start reviewing the relevant scientific literature. The next step is often to work with FDA’s Office of Compliance to arrange for an inspection of the manufacturing facilities. Depending on what we find during an inspection, we can issue warning letters advising a company that we have observed violations of the law. While we can’t require recalls, we have been very successful in working with companies to facilitate voluntary recalls. We also sometimes communicate with the public about potentially unsafe products, which can be an incentive for companies to work with us on finding a solution.
We can detain a product that might be unsafe or inappropriately labeled, or place it on an import alert. We also have the option of working with the Department of Justice on legal action.
We also monitor the market for products that are distributed as cosmetics but make claims that they will alter the structure or function on the body, which is not a claim that a cosmetic can legally make. For example, we have sent warning letters to the makers of certain skin-care products for this reason.
Q: What kinds of reports do you think would be most useful for FDA to receive with respect to cosmetics, and who should do the reporting?
We welcome reports from consumers and health care professionals that are as specific as possible about the adverse event, including the name and contact information of the person who had the reaction, as well as demographic information, such as age, gender, and ethnicity, to help determine if particular groups are especially affected. We also need information on any medical treatments and outcomes, as well as on the product believed to have caused the adverse event, including where the product was purchased and what it was used for. It is especially important to have any identifying information about the product, such as the batch and lot numbers, to locate the manufacturer and, if necessary, to help facilitate a recall. We would also welcome submissions from the cosmetic industry, but our focus in making the CAERS database public is to increase the number of reports from people who have experienced an adverse event, as well as from health professionals.
Q: How will making the CAERS database public strengthen FDA’s oversight of cosmetics?
We’re hoping that this increased transparency will result in more detailed and complete reports that will help us to more rapidly identify red flags about a possible safety issue with products we regulate. Anyone can report a safety or quality issue with an FDA-regulated conventional food, cosmetic or dietary supplement. To do so, visit fda.gov.