US FDA Commissioner Provides Insights On Cosmetics Industry

During the Leadership Summit of the Personal Care Products Council, US Food and Drug Administration (FDA) Commissioner Robert Califf provided insights on the relationship between FDA and the beauty industry. The Summit, which opened with a welcome from with PCPC President and CEO Lezlee Westine, also included insights on the 2022 US mid-term elections. The Summit was held in Washington DC in September.

Califf, in a pre-recorded interview with Westine, discussed a wide range of topics of importance to the cosmetics industry. He also shared his vision for the Agency’s future.

Westine noted that Califf served as FDA Commissioner from February 2016 to January 2017. In 2019, he became head of medical strategy at Alphabet Inc., the parent company of Google.

President Joe Biden renominated Califf to head the FDA in November 2021. He was confirmed in February. Judging by his comments at the Summit, Califf’s time at Alphabet had a major impact on his views about the role computerization can play in the US healthcare system in general and cosmetics in particular.

“Our ability to use digital technologies in the real world to match cosmetics and other things to the needs of an individual person are just going to get better and better,” said Califf. “I think one of the most exciting things is personalized cosmetics.”

But at the same time, Califf warned that a tsunami of misinformation is having a detrimental effect on the health of US consumers.

“I actually believe that misinformation is the leading cause of death in America today. I call it an ocean of information, and most of us are out there on the internet without a compass,” asserted Califf. “So, [FDA] is going to put a lot of effort into it…We are accountable for getting people the information they need to use the products that we regulate in a safe and effective way. And so, we’ve got to take this on.”

Ironically, Califf also noted that the internet can be a source of consumer information for the cosmetics industry.

“Let’s find out what’s safe and effective. The internet enables you to have give-and-take with consumers,” he suggested. “The pharma and device industry uses it. The cosmetics industry could get the information it needs via the internet. Think how you interact. Look at the airline industry. It asks customers what they think. The real world can assess cosmetics.”

Westine noted that during his first tenure as FDA Commissioner, Califf called for modernizing cosmetics industry oversight. At the time, Califf cautioned that the oversight should not be burdensome for industry. Five years later, Westine wanted to know his current views toward possible legislation.

“People want to know who’s making the products and what’s in them,” asserted Califf.

With that in mind, he urged the industry to create a compendium of manufacturers, suppliers and ingredients. Califf also insisted that FDA have the power to issue a mandatory recall of cosmetics, if and when an issue of health and safety should arise. Califf also called for Good Manufacturing Practice (GMP) guidelines.

“We should have access to records,” he said, adding that user fees are an important mechanism within the medical device industry.

Califf commented on a range of topics. He called for fragrance allergens to be listed on product labels, and noted that animal testing remains a source of contention. Paying for all of it is a source of contention, too.

“The big players have more resources,” he admitted. “We need a different regimen for small businesses to function.”

However, like everything else in a divided US government, Califf admitted that any legislation remains up in the air. As a Duke University alum, it made sense that Califf channeled former Blue Devils Men’s Basketball Head Coach Mike Krzyzewski, when it comes to getting things done in Washington or anywhere else for that matter.

“Coach K always says that five fingers are more important than a fist,” recalled Califf. “Collaboration and working together is most important. We need that in the federal agencies and in industry.”

PCPC has collaborated for many years on the issues outlined by Califf. Karen Ross, EVP-government affairs, noted that PCPC is working on cosmetic reform through the Cosmetics Modernization Act with allied trade and other stakeholders. At the same time, PCPC is working on animal testing and anti-counterfeit issues. Finally, at the federal level, the Council is working on user fee legislation.

“We are waiting on election results,” noted Ross. “Afterwards we can see the policy to fruition.”

At the state level, Ross noted that PCPC is working closely with member companies in state capitals in Albany, NY; Sacramento, CA and Maui, HI on issues including 1,4-dioxane, PFAs and sunscreen.

At the same time Tom Myers, EVP-legal and regulatory affairs, told attendees that PCPC views key issues as ingredient bans and reporting, along with packaging and extended producer responsibility.

He noted that a straightforward mercury ban goes into effect in New York on January 1. But limits on 1,4 dioxane go into effect in December and at press time, the agency had not published any guidance. In packaging, extended producer responsibility bills are gaining strength in several states. Myers said PCPC is determined to make any EPR legislation as least-onerous as possible. But there is some good news, too. The FTC is modifying its Green Guide.

“It’s the first update in 10 years; it’s a big deal,” said Myers. “It is very important to help (industry) make environmental marketing claims, by defining terms such as ‘organic’ and ‘sustainable.’”

Packaging and other environmental issues are prevalent on the world stage, too. Francine Lamoreillo, EVP-global strategies, noted that an EU proposal on microplastics will impact the personal care industry and could become the model for other countries and even some US states.

“We are working with our partners to develop one global approach (to microplastics),” explained Lamoreillo.

Elsewhere, China remains a priority. PCPC is working with regulators to ensure that new rules and regulations under the Cosmetics Supervision and Administration Regulation (CSAR) are not burdensome and restrictive for Council members. Finally, PCPC is working to include cosmetic regulations in any cooperative arrangements within the Indo-Pacific, Latin America and EU regions.

Lamoreillo explained that these aren’t free trade agreements, but rather, cooperation arrangements with like-minded companies that seek growth through technical cooperation, taxes and supply chain resilience. It underscores PCPC’s commitment to a united international playing field.

The ultimate goal, she explained, is one global voice to have regulatory convergence, market access and improved safety and quality. To get there, PCPC is working with 12 associations from around the world.

Alexandra Kowcz, chief scientist, PCPC, provided updates on numerous environmental research projects underway. Of particular focus, is the impact of sunscreen filters in salt and fresh water environments.

“If you are a research scientist working on environmental issues, this is your time to shine,” noted Kowcz.

She applauded efforts of PCPC’s Environmental Safety Committee, which is working with other groups to develop the science necessary to demonstrate product safety. She pointed to a recent National Academy of Sciences study, funded by EPA, which reviewed the impact of UV filters on aquatic environments. Researchers concluded that there is insufficient data to ban sunscreens.

“We need to dig in our heels, do the research and conduct environmental risk assessments,” asserted Kowcz.

She called on regulators to work with formulators and their suppliers to share the data gathered from their research.

Working together is one way to ensure trust and transparency—both are critical when communicating with the consumer, too.

Lisa Powers, EVP-communications, noted that today, business has become the most trusted, credible and most able to solve problems. Citing the Edelman Trust Barometer, Powers noted:

• 
  61% of respondents said they trust business; and
• 
  77% of employees trust their employers.

The pandemic, she said, underscored the trust that the majority of consumers have in science and scientists. Powers noted that the PCPC-sponsored website, cosmeticsinfo.org, is a trusted source of information that was developed by a cross-section of experts. In fact, FDA linked to cosmeticsinfo.org regarding allergen issues.

“We are committed to being part of the solution,” said Powers. “We’re not perfect, but the companies in this room are looked upon as credible sources.”

That’s significant at a time when the country is so divided and Americans get their information in dramatically different ways, said Powers. According to Pew Research, one in 5 US adults get all their news from social media, and half get some of their news from social media. Due to these algorithms, consumers end up listening to like-minded people—which is not a good idea if one wants to understand all sides of an issue.

“PCPC monitors everything to see how it impacts our industry,” explained Powers. “Journalists use Twitter, consumers use Facebook. Our staff takes a trust-but-verify approach. We have to understand who we are talking to, who they are and what our message is. One size does not fit all. We have to be strategic.”

Algorithms can play havoc with emotions, too. Feeling fraught over the mid-term elections? Don’t blame Democrats or Republicans—blame technology. Political Analyst Bruce Mehlman, a partner with Mehlman Castagnetti Rosen & Thomas, noted that decades ago, Americans heard one trusted voice—Walter Cronkite.

“We all got the same facts,” explained Mehlman. “Today, media doesn’t inform—it influences.”

Technology has disrupted the way consumers think, feel and vote. As a result, there’s a loss of trust among voters. Historically, when one party holds the White House, the opposition gains control of Congress. Mehlman predicted that Democrats will maintain their razor-thin margin in the Senate, but lose the House of Representatives. 

More Mehlman election insights are on Happi.com 

Esi Eggleston Bracey, president of Unilever US and CEO of Unilever Personal Care North America, received the Madam CJ Walker Award for Excellence in Diversity, Equity and Inclusion (DEI). The award was presented during the PCPC Leadership Summit. It recognizes individuals in the beauty and personal care products industry who demonstrate an outstanding commitment to DEI through strong leadership and sustained efforts with a focus on workplace culture, program and policies, or through external engagement with consumers and communities. Eggleston Bracey was recognized for her dedication to advance DEI. Eggleston Bracey is widely recognized and admired across the industry as someone who leads with respect and brings fresh thinking to businesses. She champions high-impact, purpose-driven efforts like Dove’s founding of the CROWN (Create a Respectful and Open World for Natural Hair) Coalition to foster beauty inclusivity and eradicate hair discrimination through the support of the CROWN Act legislation. “This award means the world to me because the business of diversity is a team sport. Madam CJ Walker knew that it wasn’t just about her own financial success, it was about the success she bestowed on others,” said Eggleston Bracey. “The work that we do changes the narrative around beauty. So, let’s embrace it as a team sport. Let’s make this all of our award, raise the bar high, and commit to making this world more inclusive and more equitable for all people.”