FDA Cosmetics Director: ‘Sporadic’ WEN AERs Make Case For Mandatory Reporting
This article was originally published in The Rose Sheet
Executive Summary
In a Q&A posting, FDA Office of Cosmetics and Colors Director Linda Katz offered perspective on how the division handles adverse event reports and makes a case for mandatory AE reporting. She also explains how FDA reacted when WEN-related AERs began rolling in.
Without mandatory reporting of serious adverse events associated with cosmetics, reports FDA receives represent just the “tip of the iceberg” of adverse events experienced, according to Office of Cosmetics and Colors Director Linda Katz.
In a Dec. 8 question and answer posting on FDA’s website, the official held up WEN Cleansing Conditioner and associated hair-loss AERs as a prime example, suggesting that if mandatory reporting were in place the agency could have addressed the issue sooner.
Reporting of serious adverse events would be mandatory under the two cosmetics modernization bills pending in Congress, the Personal Care Products Safety Act, S. 1014, and Cosmetic Modernization Amendments of 2015, H.R. 4075.
Katz’s posting followed a Dec. 6 release of 12 years’ worth of AER data for cosmetics, dietary supplements and food from the Center for Food Safety and Applied Nutrition’s Adverse Event Report database, information previously available only through Freedom of Information Act requests. (Also see "Cosmetics Adverse Events Under Spotlight In FDA Transparency Push" - HBW Insight, 7 Dec, 2016.)
According to Katz, OCAC has been following reports of hair loss, hair breakage, balding, itching and rash associated with WEN products for a few years, “but the reports to FDA have been sporadic.”
FDA received its first AER associated with WEN in 2011 for an event experienced in 2010. But it was followed by intermittent reports, and the agency wasn’t inclined to take action until the number increased.
The agency only became aware of 21,000 adverse events reported to WEN parent company WEN by Chaz Dean Inc. and distributor Guthy-Renker LLC in 2014 when it began inspecting its facilities.
Following outreach to consumers and health care practitioners in July, FDA received more than a thousand WEN-related AERs by Sept. 30. (Also see "Consumers, Health Practitioners Heeded FDA’s Call For WEN-Related AEs" - HBW Insight, 15 Nov, 2016.)
The disparity in reporting numbers could justify the need for mandatory AERs for cosmetic products, Katz suggested.
“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,” she said.
However, consumers are often reluctant to report such matters themselves, and generally don’t report AEs unless the issue is significantly impacting their health or they have spent a lot of money on a product, the director explained.
As it stands now, “we only glimpse a very small amount of what’s actually out there in the real world,” Katz maintained.
That glimpse is still important to the agency though, as the report data is one of the few tools FDA has to monitor cosmetic safety problems, she said.
“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.”
Registration, GMPs Needed
In the Q&A, Katz explained how FDA handles safety issues within the confines of the current system.
FDA constantly monitors AERs, and even just a few reports could prompt the agency to review scientific literature on the subject, she said.
If an issue is suspected, FDA will work to complete an inspection of a firm’s manufacturing facilities. An inspection that turns up violations could lead to a warning letter.
FDA can’t order cosmetic recalls, but “we have been very successful in working with companies to facilitate voluntary recalls,” Katz explains.
Further, FDA will sometimes reach out directly to consumers if it has concerns about product safety, “which can be an incentive for companies to work with us on finding a solution.”
That was likely the track used in the WEN case. After FDA went public with its request for consumer information related to the products, WEN and Guthy-Renker representatives met with the agency in “continued cooperation.” (Also see "WEN Attorneys Meet With Top FDA Officials In ‘Continued Cooperation’" - HBW Insight, 21 Oct, 2016.)
The agency can also take other enforcement actions such as detaining a product, issuing an import alert, or working with the Department of Justice, if needed.
Products marketed as cosmetics but making drug claims continue to be on FDA’s radar, Katz noted, emphasizing that the agency monitors structure/function claims and issues warning letters accordingly.
However, the current regulatory system for cosmetics has its shortcomings. The director noted that the agency sometimes struggles to regulate cosmetics without mandatory facility registration, good manufacturing practices or ability to recall products.
She cited the example of tattoo inks, conveying FDA’s concern for potential microbial contamination by bacteria entering the products during manufacturing or in tattoo parlors, as well as by concerns for individual ink ingredients. The agency has received tattoo ink AERs for rashes and infections.
The agency is “hampered in tracking down tainted products” without knowing “the number of manufacturers, who they are, where they are, and what they make,” Katz says.
“With other regulated products, the agency knows who the manufacturers are because they are required to register.”
While many cosmetics firms voluntarily register their products with FDA, those represent only a fraction of cosmetics on the marketplace, which leaves FDA without needed information if a problem arises, according to Katz.
Further, without binding GMPs for cosmetics, it makes it harder for the agency to recognize issues on the manufacturing side of things that could lead to an unsafe product, she adds.
Another Look At Talc
Katz also notes that the agency has received approximately 1,000 AERs in the past few years associated with talc products, “prompted in part by class action lawsuits that suggest ovarian cancer might be tied to the use of talc in powder.”
Johnson & Johnson has been mired in numerous lawsuits alleging a link between feminine-hygiene use of its talcum powder products and ovarian cancer. (Also see "J&J Talc Verdict Spells Opportunity For Plaintiffs, Talc-Free Powder Market" - HBW Insight, 29 Feb, 2016.)
While the agency has studied talc products in the past, its focus has largely been on asbestos in talc, and not on a link to ovarian cancer. (Also see "FDA: No Asbestos Found In Talc Products Sampled, But Results Limited" - HBW Insight, 19 Mar, 2012.)
In 2014, the agency denied a 2008 Citizen Petition from the Cancer Prevention Coalition that asked FDA to require warning labels on talcum powder cautioning that talc is possibly associated with ovarian cancer. (Also see "Petition against cosmetic talc" - HBW Insight, 26 May, 2008.)
FDA’s denial was in part because the agency “did not find such a link in our review of the scientific literature at the time,” Katz explained.
However, due to continued submission of talc-related AERs, “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.”
Transparency Push
Katz states that she hopes the new level of transparency will help the agency receive “more detailed and complete reports,” which in turn can aid in efforts to quickly identify “red flags” regarding safety issues in cosmetics, echoing statements made in CFSAN Director Susan Mayne’s blog post on the topic.
The cosmetics director emphasized that report quantity is beneficial, but report quality is important to FDA too.
“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.”
FDA seeks reports from consumers and health professionals that offer specific information regarding the AE at hand, including:
- name and contact information of person who had the reaction
- demographic information such as age, gender and ethnicity
- medical treatments undertaken and outcomes
- product purchase location
- product identification information such as brand name, batch and lot numbers
While the agency welcomes AER submissions from industry members, the intent of making the CAERS database public is to increase reports from consumers themselves and from health professionals, Katz adds.
In 2015 and 2016, FDA received 2,085 and 3,576 cosmetic AERs, respectively. The figures represent a dramatic jump from 2014, when only 445 AEs were reported to the agency.
Katz attributed the increase to the high-profile cases such as WEN and talc that generated the influx.
The most frequently reported cosmetics-related AERs fall in the hair care and skin care categories, and the agency receives more reports for leave-on products than for rinse-off.