Last December marked the first major amendment to the FDA’s cosmetics authorities in 85 years: the Modernization of Cosmetics Regulation Act of 2022, also known as “MoCRA.”
The goal of the legislation is to ensure that cosmetic product manufacturers provide assurances that cosmetic products are safe.
While beauty companies have long strived to produce safe, effective products for consumers, the legislation introduces safety standards that the entire industry must adopt.
But like most legislation, it can be hard to digest and break down the steps that companies can take to ensure compliance.
While the legislation will continue to morph over the next few years with additional guidelines, there are three things that all beauty companies can do to prepare for what’s passed—and what’s next—when it comes to modernizing.
First, they must digitize to modernize, second they must reimagine the role of quality, and third, they must rethink how they collaborate internally.
1. Digitize to Modernize
When reading between the lines of this legislation, the easiest way for beauty companies to prepare for this modernization act is to digitize. In the beauty industry, there are still an incredible amount of manual processes and siloed or inaccessible data.
With MoCRA, there is a greater emphasis on the product label disclosure, especially product ingredients and fragrance allergens. One of the challenges to beauty companies benchmarking their current progress against MoCRA requirements is a lack of visibility and connectivity of data.
Today, many companies manage product, packaging and supplier data in disparate systems, which makes it difficult to centralize, analyze or take action. Many companies pass this data back and forth across teams, suppliers and contract manufacturers through spreadsheets and emails, which can lead to incorrect product listings or mislabeling. The need to have live, digital data when it comes to ingredients, formulas and product listings will be critical.
Some beauty companies are ahead of the curve and have started to digitize their product and packaging specifications using Specification Management software to enable business outcomes, such as faster speed to market. It’s also important that companies manage safety substantiation documentation and those that do this in a cloud-based system instead of relying on employee desktops or hard drives will be set up for long-term success.
Having digitized data makes searching and reporting easier for teams,and cosmetics executives can rest knowing the right information is readily available if the FDA comes calling.
Digitizing, centralizing and standardizing data across teams creates a strong foundation for companies to respond and comply with other elements of MoCRA. Having data available at all times will help companies navigate FDA enforcement authorities, which according to the act, enable them to “access and inspect records relating to a cosmetic product if it reasonably believes that a product or its ingredients are adultured and present a threat of serious adverse health consequences.”
Being able to immediately pull up all the data required quickly—ranging from safety documentation to facility registrations to product ingredients—will be critical.
2. Reimagine the Role of Quality for Adverse Event Reporting
Another key element of MoCRA is the concept of adverse event reporting, which requires companies to provide a specific phone number and U.S. contact on the packaging for consumers to report issues. Adverse event reporting data must be maintained by beauty companies for six years and any reports made kick off required notifications to the FDA.
Typically, the role of quality and compliance documentation is heavy on the front-end of product development and manufacturing. Now it will be even more important for quality teams to track consumer complaints, maintain these records and correctly associate each to products and packaging component data. Providing this data in a controlled, digital feedback loop to regulatory, product development and packaging teams will also be crucial if changes to products are required.
If not managed appropriately, the act states that the FDA now has mandatory recall authority if it determines that there is a reasonable probability that a “cosmetic is adulterated or misbranded and exposure to the product will cause serious adverse health consequences or death.”
Therefore, companies must be proactive, organized and audit-ready when it comes to managing their product data and customer complaints related to adverse events.
3. Collaborate Across Internal Teams
MoCRA compliance isn’t relegated to one department—it’s going to require a team effort.
It’s critical that product, packaging, quality, regulatory and supply chain partners are on the same page when it comes to product ingredient listings, facility registrations, adverse event reporting and more to avoid recalls and negative impacts to the end customer.
The only way to do this is to break down communication silos in organizations and provide the visibility teams need to navigate these new compliance requirements.
For example, if a product ingredient changes, the packaging team needs to be notified to update the labeling accordingly.
This can only happen if teams are actively collaborating and operating out of a single source of truth for all of their data. By digitizing, reimagining quality, and collaborating, beauty companies can prepare for the current—and respond faster to future—requirements from MoCRA legislation.
Tom Preston is VP of business development at Specright, the first purpose-built platform for Specification Data Management. Before that, he spent nine years in the beauty industry, most recently at Avon, as the executive director of NPED Centers of Excellence and Global Productivity.
