FDA Proposes Priorities For Cosmetic Ingredient Review: Mica, Probiotics, CBD

Nakissa Sadrieh, director of cosmetics at FDA and the agency’s CIR liaison, floated the three potential review priorities at the CIR Expert Panel’s April 8-9 meeting in Washington. It’s the most for-cause targets proposed by the agency in recent memory, and CIR leadership noted that they pose considerable challenges.

Like many industry stakeholders, FDA clearly has cannabidiol (CBD) on its brain in the wake of the US farm bill’s passage late last year, which cleared barriers to wider marketing of industrial hemp-based consumer products.

Under the Agriculture Improvement Act signed into law by President Donald Trump in December 2018, hemp is defined as the same cannabis plant that constitutes marijuana under the Controlled Substances Act, but with no more than 0.3% tetrahydrocannabinol (THC).

CBD, a cannabinoid like THC but without the psychoactive properties, can be derived from hemp and has been linked to numerous, if still questionable, health benefits.

The compound’s reputed anti-inflammatory properties and other skin benefits have marked CBD as an ingredient of promise for the beauty industry.

Alex Kowcz, chief scientist at the Personal Care Products Council, recommended that CIR hold off on probiotics until the International Cooperation on Cosmetics Regulation produces its work on the subject, a project she described as “very extensive.”

Unilever PLC’s Schmidt’s Naturals unit reportedly has a CBD-based skin-care line in the works, signaling that mainstream global players are itching to get a piece of the action. 

“We believe CBD will be the most powerful thing to happen to personal-care products this decade,” Schmidt’s CEO Michael Cammarata told MarketWatch.

However, the company is waiting for CBD regulations to be clarified before taking the plunge.

[Estee Lauder Companies Inc.] seem to be taking a similar tack. Lauder’s Origins brand dipped into hemp seed oil with a 2018 face mask launch, touted as an "ultra-hydrating" formula that "instantly calms skin, visibly reduces irritation and de-stresses the senses." (Also see "Lauder/Origins' Hello, Calm Mask: Gateway To Bigger Cannabis Skin-Care Play? " - HBW Insight, 18 Sep, 2018.)

But hemp seed oil is a safe play compared with CBD due to the former’s historical exclusion from the Drug Enforcement Agency’s definition of marijuana. 

The big question now is how FDA will come down on CBD across the industries it oversees.

The agency has scheduled a May 31 public hearing to discuss CBD’s skyrocketing use and a proportionate regulatory response, asking “whether there are particular safety concerns that we should be aware of as we consider the FDA’s regulatory oversight and monitoring” of CBD products. (Also see "FDA Opens CBD Regulatory Path Docket, Warns Firms On Claims Missteps" - HBW Insight, 2 Apr, 2019.)

In the dietary supplements space, CBD’s use is verboten in FDA’s view due to its active role in approved drugs and its exploration in clinical drug trials before the substance reached the food and supplements markets. (Also see "FDA To Consider Regulatory Shift Making Cannabis Ingredients Officially Eligible For Use In Dietary Supplements" - HBW Insight, 28 Dec, 2018.)

That said, FDA currently is exercising discretion in its enforcement activities, concentrating on CBD supplements marketed with glaring drug or disease claims.

FDA’s stance on CBD-containing cosmetics is hazier, though the same basic principles presumably apply, at least in the interim as the agency solidifies its regulatory approach. 

In the meantime, the agency seems keen on learning whether CBD poses safety issues beyond any drug-like effects.

At the Cosmetic Ingredient Review Expert Panel’s April 8-9 meeting in Washington, CBD was one of three items recommended by Nakissa Sadrieh, director of FDA’s cosmetics program, as potential review priorities for CIR.

CIR currently is accepting comments on its 2020 review priorities, which appear in the group’s administrative memo for the April meeting. The list is virtually identical to the group’s 2019 priorities, comprising 20-some ingredients or ingredient groups with high frequencies of reported use that have yet to be evaluated by the organization’s independent experts. (Also see "CIR’s 2019 Priorities A Botanical Garden; AHPA To Stay Tuned In " - HBW Insight, 13 Jun, 2018.)

CIR’s Expert Panel also takes on ingredient reviews “for cause.” From FDA’s perspective, CBD should be one of those.

Speaking to HBW Insight after the panel meeting, CIR Executive Director Bart Heldreth recognized escalating interest in CBD safety and cosmetic product use.

“We certainly see it all over the news. You drive down the street and see little advertisement flags that they’re selling CBD everywhere,” he said.

But CIR relies heavily on FDA’s Voluntary Cosmetic Registration Program data in its review activities. At the moment, “there’s not one reported use of [CBD],” Heldreth said.

The ingredient’s uncertain regulatory status could be a factor in that. If companies are hesitant to own up to CBD use, CIR could have a hard time ascertaining concentrations and conditions of use in the cosmetics sector, impeding any review of the substance’s safety.

Probiotics? Postbiotics? Prebiotics?

FDA’s recommendation that probiotics be prioritized for CIR review poses challenges as well.

Probiotic claims on cosmetic products have spiked in recent years, but visibility is limited into exactly what ingredients are being harnessed to provide consumers with purported skin microbiome benefits.

The question, then, is precisely what CIR is expected to review.

Sadrieh noted during the meeting that cosmetics carrying probiotic claims don’t typically contain live microorganisms.

“Most products are postbiotics, which means that they lysed the cells and have taken the extract,” she said. “But sometimes they will have live microorganisms, and they can be either bacteria or they can be yeast.”

Linda Katz, who oversees the FDA’s Office of Cosmetics and Colors, has raised similar points before. (Also see "FDA Says Probiotic Cosmetics Could Be Adulterated, ‘Good’ Bacteria Or Not" - HBW Insight, 20 Sep, 2018.)

Sadrieh said an FDA working group is focused on surveying the market and pinning down definitions to separate probiotics from postbiotics and prebiotics. She suggested that CIR could employ a similar strategy.

She acknowledged the magnitude of the task. “Again there are multiple [genera] there, and within each one, like Lactobacillus, there are hundreds of them,” she said.

Alex Kowcz, the Personal Care Products Council’s chief scientist and CIR Expert Panel liaison, recommended that CIR hold off on probiotics until the International Cooperation on Cosmetics Regulation – comprising regulators from the US, EU, Canada, Japan and Brazil – produces its work on the subject.

“This [ICCR] project is very big, it’s very extensive,” she said. “This is a whole new field for us, [so] we have to really scope out what we can and cannot do – and definitions will really help us with that.”

Heldreth agreed. “I think this is likely an important area for us to look into, but I don’t think we’re ready yet.”

He suggested that probiotics could potentially be targeted for priority CIR consideration in 2021 once an ingredient list is clarified.

Talc Out, Mica In?

Mica was FDA’s final recommendation at the meeting for CIR Expert Panel assessment on a for-cause basis.

James Marks, a professor of dermatology in Pennsylvania State University’s College of Medicine, who serves as one of the CIR Expert Panel’s two team leaders, summarized FDA’s budding interest in cosmetic mica use.

“We know it’s a color additive, but it has a lot of new uses as a substitute for talc,” he said.

Cosmetic talc’s stock has plummeted of late amid reports of asbestos contamination in products aimed at young women and children. (Also see "Kids’ Cosmetics With Talc Would Require Asbestos-Free Verification Or Warnings Under Dingell Bill" - HBW Insight, 20 Mar, 2019.)

Meanwhile, Johnson & Johnson is embroiled in legal battles over allegations linking its talcum powders, contaminated or not, to cancer. (Also see "Overwhelmed J&J Talc Supplier Takes Cover Under Bankruptcy Protections" - HBW Insight, 14 Feb, 2019.)

Heldreth told HBW Insight that mica has blipped on its radar before – with more than 10,000 known uses in cosmetic products, according to FDA/VCRP data – but this was the first indication from FDA that the mineral is being used for purposes other than coloring, i.e., as an absorbent to replace talc.

CIR takes a hands-off approach to color additives used in cosmetics, which must be approved by FDA for use in cosmetics under federal food and drug law.

But if mica is being swapped in for talc as an absorbent at higher concentrations than it’s used for coloring purposes in cosmetics, the substance could merit examination, Heldreth said.

“We’ll have to look into this a little bit more down the road, and we’re doing to need information from FDA to understand how many products are using this [for non-coloring purposes] and at what concentration,” he said.

According to Heldreth, the three priority recommendations from FDA are more than CIR’s received from the agency in years.

CIR plans to finalize the proposed 2020 priority list at its Expert Panel’s June 2019 meeting.