I recently attended IQPC Cosmetic Compliance event, which brought together industry experts from cosmetic companies, regulators, and industry associations to discuss latest challenges and innovative ideas for the future. Of the many topics discussed, here were the three highlights every cosmetic company should be aware of.
The Struggle is Real: Keeping Up with Changing, Diverse Regulations
If you do business in the U.S. you know the cosmetic regulations are quite light unless you cross the “claims line” into over the counter (OTC) drugs. With FDA cosmetic regulations stagnant since the 1970’s, most agree that it’s time for the FDA to modernize regulations to meet consumer expectations for safety and quality.
Jennifer Martin, Director Regulatory Affairs from Colgate-Palmolive, used her keynote presentation to compare two of the many cosmetic and personal care legislative proposals that are currently being reviewed in Congress: the Hatch and Feinstein-Collins bills. The significant differences between them include their approach to FDA recall authority, user fees, and ingredient reporting. These areas are covered by the Feinstein-Collins bill and omitted from Hatch.
Also discussed was the long overdue regulatory modernization that happened in the OTC area this past July. The OTC monograph system is charged with ensuring safe and effective over the counter drugs, which many cosmetics and personal care products such as sunscreen and fluoride toothpaste fall into. This system had not been updated in over 40 years.
Carolyn Hermann, Deputy General Counsel from the Consumer Healthcare Products Association, outlined how the new legislation will transform the outdated monograph system by increasing FDA resources and streamlining the regulatory process to ensure faster safety label changes and enable innovation.
In contrast, European cosmetic regulations were hailed by attendees as the “gold standard”. China and Latin America have also adopted much of the European requirements. The differing regulations complicate compliance for global companies. Several attendees expressed the desire to see a harmonization of European and U.S. cosmetic regulations in the future, but acknowledged there were currently no concrete plans to do so.
Tread Carefully: Managing Claims and Labeling
Claims were top of mind for many conference attendees and the focus of a joint presentation by Kapal Dewan, FDA Cosmetics Division Team Lead and Kristin Hartzell, Director Product Quality and Regulatory Affairs at e.l.f. Cosmetics.
Claims determine HOW your product will be regulated. It’s a fine line between a cosmetic and an OTC drug - cleanses vs removes redness, moisturizing vs anti-inflammatory, softens vs treats eczema. Claims made on any marketing collateral, including website, social media, posters, and packaging, must meet applicable regulations. A product that does not meet the requirements is considered misbranded and must be removed from market until corrected. FDA regularly sends out warning letters after reviewing websites, advertisements, and other labeling and requires a corrective action response within fifteen working days, spurring a frenzied rush to respond at recipient companies.
In addition to ensuring your claims don’t cross “the line”, substantiating your claims is a critical activity under EU cosmetics regulations. The topic of claim substantiation was explored in a presentation by Emily Perez, Associate Principal Scientist from L’Oreal. Perez explained that claims can be substantiated through clinical observations, consumer perception, and laboratory test data such as moisture retention. It was clear to the audience the importance of developing and maintaining clearly defined methods, analysis, and results with supporting evidence to substantiate any claims.
It Doesn’t Have to Be This Hard: Using Technology to Simplify Compliance
Veeva’s own Bruce Beilfuss, vice president of strategy for consumer goods, was also a featured speaker and shared his expertise on why market pressures are compelling companies to modernize their regulatory compliance approach and decrease product time to market to stay competitive.
Bruce highlighted that there’s no need to continue struggling against Excel trackers, siloed legacy software, and limited visibility. Upgrading to modern digital infrastructure is possible and he has seen many customers improve real-time collaboration across teams, departments, and locations, while improving visibility and responsiveness to regulatory changes by market, country, and product. Many of the challenges outlined in the presentation resonated with the attendees and they were excited at the possibility of having all regulatory and quality data in one single location to increase compliance, visibility, and efficiency.
Agility Comes to Cosmetics
Overall, I found the Cosmetic Compliance event a worthwhile gathering of regulatory and quality practitioners dedicated to understanding and improving their work and the industry as a whole. I left inspired by the participants eagerness to learn the latest and best strategies for producing high quality, compliant products.
And where does your company stand? Are you trying to get more new products, into more markets, faster? While maintaining compliance and avoiding employee burnout?
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1 For more information on this topic, we encourage you to consult this legal overview.