CIR Panel’s ‘Ethereal’ Role In Cosmetics Regulation Not Clarified By MoCRA

While other legislative proposals to update US cosmetics regulations would have included FDA ingredient review or codified reviews from the CIR Expert Panel for Cosmetic Ingredient Safety, the Modernization of Cosmetic Regulations Act of 2022 does not. Panelists, industry and FDA reps discussed implications for CIR at the 5-6 March meeting of the group’s independent expert panel.

The Modernization of Cosmetic Regulations Act of 2022 does not create a framework for systematic cosmetic ingredient review at the US Food and Drug Administration, as other cosmetics reform proposals would have, but does include new requirements for substantiating the safety of cosmetic products.

Arguably that could make the work of Cosmetic Ingredient Review’s independent Expert Panel for Cosmetic Ingredient Safety all the important.

But MoCRA, signed into law as part of an omnibus federal spending bill in December 2022, does nothing to formalize the expert panel’s role as it relates to US regulations and industry compliance. The group’s safety assessment reports have been widely respected and followed by industry members since its formation in 1976, and the FDA serves as a liaison to the panel, providing input to steer its work and often making ingredient review requests.

Dr. David Cohen, chief of allergy section/contact dermatitis at New York University School of Medicine, noted during the group’s 6 March meeting that although the FDA participates as a non-voting member, the Expert Panel for Cosmetic Ingredient Safety is not quite an FDA-associated entity.

“It lives in an ethereal space, the CIR,” Cohen mused. “You'd think that if there were mandatory assessments and someone said, ‘We recognize the expertise of the panel’ … then it would sort of take a little bit of the vagary out of what we’re doing.”

In 2015, Congress proposed a public-private partnership between CIR and FDA, but a year later FDA said it would not support such an association, calling the proposal “inappropriate” and potentially raising “significant appearance concerns and resource issues.” (Also see "FDA Balks At CIR Public-Private Partnership In FY 2017 Budget Request" - HBW Insight, 15 Feb, 2016.)

In another effort that fizzled, the Personal Care Products Council advocated in 2017 for CIR to be a certified third party for ingredient safety assessments for FDA. (Also see "PCPC Hatching Proposal For CIR Role In FDA Ingredient Review" - HBW Insight, 7 Mar, 2017.)

Pre-MoCRA bills to update FDA’s oversight of cosmetics would have established a cosmetic ingredient review program at the FDA or codified reviews from the CIR panel. However, such proposals proved contentious among stakeholders, impeding progress. (Also see "US House Cosmetics Hearing: Preemption, FDA Ingredient Review Could Be Regulatory Reform Snags" - HBW Insight, 5 Dec, 2019.)

Preemption proved another sticking point. MoCRA’s preemption terms are limited, notably allowing states and local governments to continue banning or restricting ingredients as they see fit on the basis of safety concerns.

"I would assume it gives greater credence to CIR and its findings because, as qualified experts in your fields, making safety findings about these ingredients and the use of these products helps to substantiate their safety.” – Tom Myers

Even without a formal bridge between CIR and FDA, it is expected that industry will be able to leverage CIR safety assessments to comply with new MoCRA requirements for safety substantiation.

MoCRA puts the onus on companies to adequately substantiate the safety of their cosmetic products using “tests or studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable certainty that a cosmetic product is safe.”

In a presentation to the CIR panel on MoCRA, Tom Myers, EVP legal and regulatory affairs for the Personal Care Products Council, said it’s possible FDA will elaborate on what “adequate” substantiation means in the context of MoCRA.

As matters stand currently, “It seems to me that there's potential opportunity for companies to continue to utilize findings from the CIR expert panel as qualified experts to essentially support the safety of their products and ingredients,” Myers said.

However it shakes out, Myers emphasized that the CIR expert panel’s work will continue to be held in high regard.

“I think the work that you're doing is obviously extremely important and continues to be valuable to companies of all sizes,” he said. “So what constitutes an adequate substantiation of safety – I don't know how that necessarily changes it. I would assume it gives greater credence to CIR and its findings because, as qualified experts in your fields, making safety findings about these ingredients and the use of these products helps to substantiate their safety.”

Uncloaking Fragrance And Flavor Components

Expert panelists also considered if they and the medical community may be alerted to potential cosmetic ingredients of concern under MoCRA.

They noted that the law requires companies to provide FDA with a full list of flavor or fragrance ingredients if the agency has reason to believe a fragrance or flavor component caused or contributed to a serious adverse event, which MoCRA requires to be reported. But such information ostensibly would not be made public, as MoCRA provides for any trade secret or confidential commercial information obtained in the process to be protected.

“That doesn't really help the physician trying to work with a patient to figure out what the heck the problem was that caused it,” said Dr. Donald Belsito, a dermatologist at Columbia University’s Irving Medical Center, who serves as one of the panel’s team leaders.

“Without a physician knowing what that specific ingredient or the ingredients are, it's not possible to make an evaluation,” he continued. “It's an issue for dermatologists getting component information, and it doesn't sound like this bill is going to help us.”

Cohen similarly questioned what FDA will do with fragrance or flavor component information when it receives it, given that there’s no liaising between the agency and the patient or physician.

Myers pointed out that under MoCRA, FDA has new authority to order a product recall based on information it receives. “That's an avenue that they can take to protect the public.”

Prashiela Manga, deputy director of the Center for Food Safety and Applied Nutrition’s Office of Cosmetics and Colors, suggested the data will be used to understand patterns across safety signals.

“For these cases where they may request fragrance or flavor information, I think the goal would be for trending and tracking to see if those are popping up in multiple cases rather than just maybe a deep dive into an individual case,” she said.

Thomas Gremillion, a liaison to the panel representing the Consumer Federation of America, questioned if adverse event reports could be helpful to the panel to match up what ingredients are associated with adverse events.

Dr. Linda Katz, director of the Office of Cosmetics and Colors, noted that they are made public on the agency’s website without personally identifiable information, but they are product-related and not associated with specific ingredients.

She further noted that AE reports reaching FDA from consumers and other individuals tend to contain “a lot of noise,” and “oftentimes it’s difficult to discern what may have caused the problem.”

Once the AE reporting requirement for cosmetic companies comes into effect at the end of 2023, “some of the data may be better, but it's still going to be somewhat difficult to be able to [determine] causality based on some of the information that we would get.”

Taking The V Out Of VCRP

Under MoCRA, cosmetics firms must register their facilities and product information with FDA.

Myers suggested that without significant additional funding to implement MoCRA provisions, the agency could leverage existing systems to provide a framework for compliance – eg, the current Voluntary Cosmetic Registration Program.

“The ‘V’ is gone and we’ll figure it out,” Myers said.

Belsito asked if MoCRA would change the panel’s past reports, which have been prioritized and built around formulation and use data voluntarily submitted through the VCRP.

CIR executive director Bart Heldreth noted the data CIR uses “has always been a live data stream,” in that CIR staff requests data from FDA each year and gets a “snapshot” of ingredient use.

“I don't think that really changes how we proceed forward,” he said. “It just means that maybe that data that we pull from what currently is told by the VCRP may be more reliable, more exact than representative.”