As a self-regulated industry that’s under watchful eyes of government agencies, NGOs and consumers, ICMAD’s annual FDA Cosmetics Regulations Workshop has traditionally been a well-attended event. And that streak continued as the association hosted its 38th iteration at the Javits Center in New York City on May 9, 2019. Approximately 120 participants were on site for this all-day event, which was sponsored by the New York Society of Cosmetic Chemists, Consumer Product Testing Company, D-Lab, Regulatory Graphics Consultants, Product Integrity Laboratory LLC, The Complete Package, Coptis and Kinetik. Topics included rules and regulations, fragrance allergens, sunscreens, claims and cannabis.

ICMAD technical/regulatory committee chair Craig Weiss (Consumer Product Testing) provided opening remarks before introducing Sharon Blinkoff, counsel, Locke Lord LLP, who is ICMAD’s government relations chair. Blinkoff provided an overview of state and federal legislative changes in the cosmetics category. She noted that without nation-wide legislation, cosmetic companies are forced to deal with laws that come piecemeal from individual states, including Nevada, New York, Hawaii and California.

“Until we get to federal legislation, we are going to keep dealing with these bills,” she told attendees.

Following Blinkoff, Linda Katz of FDA addressed statutory authorities and selective priority initiatives at the agency, and provided a review of the difference between a cosmetic and drug, reminding all in attendance that “there is no legal term for cosmeceutical.”

According to Katz, adverse reporting events help FDA establish priorities and where it should spend its resources. 

“Post-market surveillance is the most important tool that FDA uses to monitor safety of cosmetic products,” said Katz.

She discussed the high-profile Clare’s recall earlier this spring when tremolite asbestos fibers were found in the brand’s cosmetics. 

Katz also discussed research projects in FDA’s cosmetics division, such as establishment of in vitro and in silico screens for safety assessment of cosmetic ingredients, such as allergens and sensitizers. According to Katz, sensitization reactions are the most common adverse events for cosmetics. In fact, 55% of cosmetics-related adverse events reported to MedWatch describe at least one sensitization/allergenicity symptom, she said.

The workshop moved easily into the next speaker's presentation: “The RIFM approach to dermal sensitization—a qualitative risk assessment (QRA) method,” which was presented by Anne Marie Api PhD, vice president, human health science, at the Research Institute for Fragrance Materials Inc. (RIFM).

According to Api, RIFM started its research inthe 1970s, and by the end of this year, it will have completed safety assessments on more than 1,500 synthetic fragrance ingredients.

Following lunch, Dr. Theresa M. Michele, director, division of nonprescription drug products, Center for Drug Evaluation and Research at FDA, presented information on newly proposed sunscreen regulations.

According to Michele, FDA is asking for data regarding sunscreens and specific ingredients because of changing use patterns over time. When rules were initially proposed, sunscreens weren’t used as a preventative measure to prevent skin cancer, she said. “Now we tell people to use them from six months old to 99 years old, every two hours.That is a very different use.”

The ICMAD workshop also offered attendees the chance to listen to expert panel sessions; one included FTC and NAD staffers who looked at recent actions in the cosmetics arena, while another covered current thinking about the concepts of “green” and “clean” in beauty.

During the “Green, Clean, What’s New” panel, Pamela Gill Alabaster, senior advisor, Carol Cone on Purpose, and managing partner, The Gill-Alabaster Group, addressed the “seismic shifts” in the beauty industry—namely e-commerce, social media and radical transparency.

In addition, she noted concerns about state legislation and activist campaigns that are both well organized and well-funded.

“Brands and companies aren’t set up to manage that many campfires across the country,” she said.

ICMAD’s 38th Annual FDA Cosmetics Regulations Workshop came to a close on a high note, so to speak, with a panel that addressed cosmetic cannabis.

Rory Radding, a partner at Locke Lord LLP, traced the history of cannabis up to the 2018 Farm Bill. He noted that cannabis had been listed in the US Pharmacopeia for almost a half century before it was dropped in 1942.

Weiss of Consumer Product Testing Company provided insight into testing this ingredient. He said that when CPTC tested 18-20 commercial CBD coils, some contained cannabis and some had THC.
           
“Industry needs to be controlled if it is going to be sold,” he said.
 
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