PCPC/FDA Briefing: VOCs, CBD, PFAs, Talc and the Safe Cosmetics Act

VOCs, CBD, 1,4-dioxane, talc, inclusion, transparency, PFAs in cosmetics, formaldehyde, allergens and elements of the Safe Cosmetics Act are among the top current areas of focus for the Personal Care Products Council (PCPC) and the U.S. Food and Drug Administration’s (FDA’s) Center for Food Safety and Applied Nutrition (CFSAN).

These and other industry concerns were highlighted during the PCPC’s virtual summit, held May 11-13, 2021.

VOCs, Cannabis, 1, 4-Dioxane and Packaging

VOCs: During the session, Tom Myers, executive vice president of legal and general counsel for the PCPC, emphasized the many challenges the personal care industry is facing. “This is the busiest time on the regulatory front, with California and New York leading the way.”

Myers described current initiatives including collaborations with the California Air Resources Board (CARB) to set emission level standards for products such as dry shampoos, fragrance and other sprays—which, for some companies, means reformulation. “The PCPC was able to limit some categories and levels,” he noted.

In addition, he underlined what he believes was perhaps the biggest achievement in this collaboration: ensuring the goals set forth in the regulation are achievable from a technical perspective. He added the PCPC will continue working with CARB on VOC rulemaking.

See related: Will VOC Limits Change for Fragrance, Hair Care?

Cannabis: California’s Proposition 65 also appeared on Myers’s challenges for the industry, especially in light of the state’s Jan. 3, 2020, listing of both cannabis (marijuana) smoke and delta-9-tetrahydrocannabinol (THC) as reproductive toxins requiring warning labels. “Cannabis smoke is not a concern to cosmetics,” he said, “but THC is, as it [may be present in] CBD, which is a potential ingredient for use in cosmetics.”

However, he added, “The Office of Environmental Health Hazard Assessment (OEHHA) stated dermally applied products do not require a Prop 65 warning for ‘trace and unquantifiable’ levels of THC, which can be present in CBD.”

1, 4-Dioxane: On the East Coast, Myers emphasized limits set by the state of New York for 1,4-dioxane levels due to concerns over human health and its persistence in the environment. In personal care and household products, the limit is 2 ppm as of Dec. 31, 2022 and 1 ppm by Dec. 31, 2023. In cosmetics, the maximum allowed is 10 ppm, as of Dec. 31, 2022.

Note the state defines cosmetic and personal care product differently and therefore set limits for each. Cosmetics are as defined per the Food, Drug & Cosmetics Act, while personal care product is defined as “any product intended for cleaning or cleansing part of the body, such as the skin and hair, and including but not limited to, hair shampoo, hair conditioner, soap, bath gels and other bath products…”

“New York is the first [state] of its kind to set these limits for cosmetics and personal care and will [require] reformulation,” he said. Myers emphasized that PCPC is working to ensure this law, like others, is fair and equitable.

Packaging: On the environmental front, Myers see the next big area of concern being plastics and packaging. “Our industry is the most forward-leaning on packaging [in part because the] consumer demands it,” he said. Also, he added that personal care companies have made incredible strides in this area but there are regional rules to follow.

On the environmental front, Myers see the next big area of concern being plastics and packaging.

Transparency, Inclusivity and the Science of Beauty

Transparency: Lisa Powers, executive vice president of public affairs and communications, underscored the PCPC’s efforts to ensure member companies are clear in their communications with consumers. “Now more than ever, trust is vital and [communication must occur] in a clear, authentic and transparent manner…The PCPC has made great efforts to ensure its member companies … understand the importance of communicating transparently.”

Inclusivity: In addition, she highlighted the “historic movement within the past year toward social equity” and focus to eliminate discrimination due to, for example, hair textures and styles. “We are firmly committed to finding approaches to shape a more inclusive future,” she said, adding the PCPC aims to create a “safer and more beautiful world.”

Science: Furthermore, “safety and science continue to be in the spotlight especially in the past year with the focus on public health. We firmly believe in the science of beauty—everyone has the right to know what is in their products but also to understand them, to make informed choices.”

Moving forward, Powers see the cosmetics and personal care industry’s resilience and ability to be the force for change. “We want to foster justice and equity,…and address diversity, equity and inclusion—and we are committed to these goals,” she said.

Finally, she commended the industry for pulling together in the face of the pandemic. “We felt the impact [of the pandemic] but we continued giving back…We are a generous industry and it will continue to give back [to us] in the future.”

See related: 5 Cosmetic Giants Combating COVID-19

VCRP, Talc, PFAs, Formaldehyde, Allergens and CBD

Within the past year, as might be expected, the FDA was heavily focused on COVID-19 and food safety, but also honest labeling in cosmetics, according to Susan Mayne, director of CFSAN. She underscored several current cosmetic initiatives, including: the voluntary cosmetic registration program (VCRP), talc, PFAS in cosmetics, formaldehyde, allergens and CBD.

VCRP: Mayne reiterated how the VCRP works, encouraging companies to register their manufacturing/packaging location and cosmetic formulations in commercial distribution in the United States. “Cosmetic companies can participate in both parts of the program or only one,” she explained.

As previously reported, the VCRP assists the agency in carrying out its responsibility to oversee cosmetics marketed in the United States. Since product filings and establishment registrations are not mandatory, voluntary submissions provide the best estimate of information available about cosmetic products and ingredients, their frequency of use, and businesses engaged in their manufacture and distribution. The information provided also supports the Cosmetic Ingredient Review expert panel in its assessment of cosmetic ingredients to ensure they are safe for use.

Talc: “The FDA continues in its efforts to monitor cosmetics containing talc for asbestos,” Mayne noted, reiterating the March 2019 safety alert issued by the FDA regarding positive asbestos findings in some products, which were voluntarily recalled. In March 2020, the FDA released final reports from sampling data showing that 43 samples tested negative for asbestos while nine tested positive.

Challenges currently faced by the Safe Cosmetics Act include increasingly sophisticated ingredients with the potential to cause structure and function effects in the body.

The agency formed an ad hoc interagency working group to obtain scientific data on topics related to testing methodologies, terminology and criteria that can be used to characterize and measure asbestos and other potentially harmful “elongate mineral particles” that may present as contaminants in talc. It also continues its sampling efforts. “The final results will be released late in 2021,” said Mayne. “If testing reveals asbestos, the public will be made aware of it and the FDA will work with companies to address the issues.”

PFAs: Per- and polyfluoroalkyl substances (PFAs) in cosmetics are also of concern to the FDA, although numbers reported in the VRCP indicate the number of formulations containing any of the 21 types of PFAs has decreased. “Science continues to advance in this area and will continue to collaborate and conduct research on the gaps,” said Mayne. She added the FDA created a web page about PFAs to help the public better understand these materials.

Formaldehyde: According to Mayne, since 2010, the FDA has been assessing formaldehyde for potential effects including sensitization and causing cancer. It continues to do, as shown by a recent report warning consumers that hair-smoothing products can release formaldehyde. “The FDA [also] has communicated with the public to understand how to look for formaldehyde in products,” Mayne said.

Allergens: The FDA also is focused on potential cosmetic allergens, i.e., monitoring adverse events, researching mechanisms of action and assessing whether consumers understand them—and the best approaches for outreach. The agency is working with trade associations regarding labeling and public health concerns and encouraging voluntary compliance with labeling. A web page regarding allergens in cosmetics also was developed to educate the public and create awareness.

CBD: While CBD appeared on Mayne’s list of FDA priorities, she unfortunately did not get into specifics at this time.

See related: Into the Weeds; Walking the Regulatory Line of CBD in Cosmetics

Safe Cosmetics Act

Finally, Mayne outlined elements and challenges posed by the currently proposed Safe Cosmetics Modernization Act. The primary elements include:

• Mandating the registration and listing of products and ingredients;
• Giving explicit authority to establish GMPs by regulation;
• Mandating serious adverse event reporting;
• Mandating access to records including consumer complaints during routine or for-cause inspections;
• Mandating recalls;
• Requiring the disclosure of known cosmetic allergens on product labels;
• Requiring ingredient reviews; and
• Requiring sufficient resources to implement these protections.

The challenges currently faced include the FDA’s limited legal authority, competing agency priorities, and the significant changes occurring over the past 15 or more years. Regarding the latter, Mayne points to companies manufacturing more globally; utilizing animal alternatives for testing; and developing increasingly sophisticated ingredients with the potential to cause structure and function effects in the body (i.e., nanotech, “active” ingredients, microbiome and probiotic products, CBD, etc.).

See related: Microbiome Claims; Should Pre-, Pro- and Postbiotic Skin Care Be Regulated?