PCPC Chief Scientist Alexandra Kowcz welcomes attendees to the Symposium.

With the US Food and Drug Administration’s (FDA) Linda Katz as a headline speaker, the Personal Care Product Council’s Annual Science Symposium & Expo attracted a record 250 participants earlier this month at the Ritz-Carlton Pentagon City, Arlington, VA.

“It’s always great to get an update from Dr. Katz,” said Kimberly G. Norman, PhD, DABT, ERT, senior director, safety and regulatory toxicology, PCPC. “We had representatives from FDA and EPA, and dozens of regulators.”

Katz is the director of the Office of Cosmetics and Colors (OCAC) at the Center for Food Safety and Applied Nutrition (CFSAN) at the US Food and Drug Administration. She provided an update on implementation activities of the Modernization of Cosmetics Regulation Act (MoCRA) and other Agency priorities. Katz told attendees that through early July, 6,623 facilities were registered and 348,492 products listed under MoCRA.

The symposium also included speakers from EPA, member companies such as Procter & Gamble, Tri-K Industries and Unilever and researchers from the University of Maryland, American Chemistry Council, International Collaboration on Cosmetics Safety.

“That level of participation demonstrates that manufacturers are using cosmeticsdirect.com,” said Norman.

Cosmeticsdirect.com is an electronic submissions portal for the registration and listing of cosmetic product facilities and products. Registration is just one part of MoCRA that was the topic of conversation during the seminar. Norman noted she is particularly interested in adverse events reporting. As it currently stands, serious adverse events must be reported to FDA in PDF forms that can be emailed or mailed. But FDA is working on an electronic reporting system that would resemble the safety reporting portal for OTC drugs or food.

While Katz didn’t provide an update on fragrances or GMPs under MoCRA, she mentioned the FDA is concerned about consumer use of potentially harmful over-the-counter (OTC) skin products containing hydroquinone or mercury. Neither is FDA approved for OTC sale. The Office of Minority Health and Health Equity (OMHHE) created the Skin Facts! Initiative – which includes educational materials and other communications – to help consumers understand the potential risks of using these products and to help identify whether the skin products they purchase contain these harmful ingredients.

Tattoo Taboos

Katz voiced concerns about contaminated tattoo inks. In July 2024, the FDA published a study in the Applied Environmental Microbiology Journal after finding that over 30% of tattoo ink and permanent makeup product samples were contaminated with bacteria. FDA tested 75 tattoo and permanent makeup inks from 14 different manufacturers and found that 26 of the samples were contaminated with 22 different types of bacteria. The study concluded that both tattoo and permanent makeup inks may contain aerobic and anaerobic bacteria.

Tattoo ink is considered a cosmetic product and regulated by FDA. As the tattoo market soars, FDA is concerned about the prevalence of microorganism contamination. Underscoring that concern, on Oct. 25, the FDA issued final guidance to the tattoo industry on the preparation, packing and holding of tattoo inks designed to reduce the risk of microbial contamination.

FDA’s new guidance is aimed at tattoo ink manufacturers, distributors and packers. It describes situations that may result in contamination and recommends steps to prevent contamination or remediate any insanitary conditions. Specifically, the guidance lists the following examples of insanitary conditions that could result in contamination:

• Preparing or packing the inks in unsuitable facilities, such as carpeted areas;
• Uncovered packaging containers near open air ducts;
• Storing or packing tattoo ink or ink components in non-sanitized containers;
• Personnel failing to wear appropriate attire such as hairnets, lab coats, masks and/or gloves;
• Failure to equip facilities with signage for employees to wash hands and equipping facilities with restrooms, soap and water;
• Failure to properly dispose of used personnel protection clothing;
• Insanitary mixing of tattoo inks with non-sanitized utensils; and
• Storing products in places susceptible to contamination, including near dust or debris.

The FDA suggests the following nonbinding recommendations to prevent contamination:

• Testing ink and ink components for contamination (or ensuring any purchased ink components are tested by supplier);
• Ensuring the manufacturing process does not contaminate products;
• Validating any sterilization method;
• Ensuring that the cleaning method does not introduce any contamination; and
• Preventing the release of any product that tests positive for harmful microorganisms.

While these recommendations are nonbinding, they provide insight on what the FDA considers when determining whether a cosmetic product in the tattoo industry is adulterated.

Defeating Chemophobia

Scientific seminar speakers also addressed consumers growing concerns about chemicals.

“We’re in an era of chemophobia; it’s an ongoing challenge,” said Norman. “Dr. Aegean Chan gave a great presentation on scientific communication.”

Dr. Aegean Chan, center, tells attendees to keep their scientific messages focused and simple.

Chan, a dermatologist, advised attendees to keep scientific communication simple and focused on the primary message. To help consumers understand what’s in the personal care products they use every day, PCPC recommends its website, cosmeticsinfo.org. The site provides the science and safety behind nearly 2,200 cosmetics ingredients.

PCPC may have more allies in its war on chemophobia.

Norbert Kaminski, director of Michigan State University’s Center for Research on Ingredient Safety, addressed public concerns over chemical safety with insights on titanium dioxide and BPA. Now, various scientific organizations are in discussion to collaborate on making scientific communication a priority.

During the symposium, Dr. Anne Marie Api, president of the Research Institute for Fragrance Materials, Inc. (RIFM), discussed principles of effective communication. For example, RIFM uses YouTube to explain its science-based process to help ensure the safe use of fragranced materials.

Animal Testing Alternatives

Finally, Thomas Hartung, of the Center for Animal Alternative Testing (CAAT) at The Johns Hopkins Bloomberg School of Public Health, explained how artificial intelligence is transforming cosmetic safety assessment. CAAT is using artificial intelligence to predict skin sensitivity. CAAT researchers found that AI is a better predictor of sensitivity than animal models.

Hartung is an expert in animal testing alternatives. In 1996, he designed an in vitro version of a pyrogen test. Traditionally performed on rabbits, the test is designed to ascertain whether a product is clean of bacterial contamination. It took a decade for Hartung’s test to be approved. The European Union finally decided to outlaw the industry standard rabbit pyrogen test by 2026. The move could save as many as 170,000 rabbits from unnecessary suffering every year.

Ironically, earlier this year, FDA requested animal tests to ensure the safety and efficacy of sunscreen actives. For its part, PCPC and its members are committed to develop viable alternative safety assessment methods. The passage of The Humane Cosmetics Act will continue to be a priority for PCPC and its members who are dedicated to promoting ethical practices and non-animal testing methods that are humane and scientifically sound, reflecting consumer values.

The 2025 Science Symposium will take place Oct. 28 and 29, 2025 back at the Ritz-Carlton in Virginia.