LexisNexis Reed Tech was pleased to sponsor, present, and attend the recent IBA (International Beauty Association) Cosmetics Convergence Spring Symposium. In addition to having great conversations with our industry peers, we attended many educational sessions, especially those concerning the new MoCRA regulations, and are happy to share some highlights in this post. For more information about MoCRA requirements and deadlines, please contact [email protected]. To learn more about IBA and their upcoming events, please visit their website.

MoCRA: Status Update and Practical Learnings

Don Frey and Meredith Petillo kicked off the symposium with an overview of MoCRA (The Modernization of Cosmetics Regulation Act of 2022). Giving attendees a detailed look at the MoCRA timeline, they were careful to note that many areas of the regulation are already in effect! These areas include: adverse event tracking and serious adverse event reporting; professional use labeling; mandatory recall authority; and records access. Technically, product data listings and facility registrations are in effect as well, though the enforcement is delayed. It is important to note, enforcement has not been delaying for any other parts of this regulation. Additionally, a proposed rule for Labeling of Fragrance Allergens, with a comment period, is expected this June.  The speakers noted, and Reed Tech agrees, that the “banner headline is do not delay!” as July 1^st is creeping up closer and closer.

In addition to the current regulations set forth by FDA, Industry can also expect a Good Manufacturing Practices (GMP) Proposed Rule (with a final rule one year later) on December 29, 2024. The speakers noted that IBA, along with other industry groups, is working alongside the FDA to make sure new rules will work well with other global Health Authorities, especially the EU, with the goal that product batches can still be split and separate sets of paperwork will not be required.

After discussing the timeline, the speakers jumped into another very important topic: bottlenecks. The first bottleneck that they identified is the learning curve needed to understand how to use the Cosmetics portal. Since you need to educate yourself on the system, or engage an experienced third-party vendor like Reed Tech, before you can even begin trying to make submissions, it is recommended that you get started sooner rather than later.

Another bottleneck is the Facility Registrations. They must be completed before any product listings can be done. Typically, product listing will be of a much higher volume and much more time consuming than the product listings so do not wait until the last minute. These Facility Registrations also require an FEI number.

The final bottleneck that was highlighted is the numerous optional fields in both the Facility Registrations and Product Data Listings. These fields can make the portal exceptionally difficult to navigate. Additionally, you will find little caveats, such as UNI codes are optional but the upload feature in the portal is not available without the inclusion of UNI codes. However, the speakers caution that it may be prudent to only include what is required so less potential changes will be required in the future. To help navigate these bottlenecks, it is recommended that you consider partnering with third party experts. Reed Tech can help!

The next topic in this session was the Small Business exemptions. To require for the small business exemptions, you must have a revenue of under $1M over the course of the past three years and the cosmetic in question must not alter the appearance for more than 24 hours or come into direct contact with the mucus membrane of the eye. If you are not sure if you are exempt, the speakers recommend you should eye on the side of caution. And while you are not currently required to prove you are exempt, it is recommended that you have rationale prepared and on hand.

Some final thoughts: As does FDA and Reed Tech, IBA highly recommends utilizing electronic submissions to make the process more digestible. IBA also recommends addressing clarity between brands and contract manufacturers as MoCRA may change how you work together. It would be prudent to have written agreements and clear communication, defining responsibility and assigning accountability. Finally, IBA reminds attendees that this is not a project that can be completed by service providers at the last minute, so you will need to submit your information and data to your third-party service provider as soon as possible.

Breakout Check-In with Gary Saner, Reed Tech

Gary Saner is a subject-matter expert at LexisNexis Reed Tech and industry-regarded SPL authority who chairs the SPL Technical Committee and has been involved in SPL pilot programs for FDA and other Global Health Authorities. Gary presented a quick break-out session at the IBA Cosmetics Convergence Spring Symposium to ensure everyone had the MoCRA highlights. He walked through the requirements and discussed new provisions that give FDA a few more “tools in their toolbox” to monitor and enforce safety and efficacy. Next Gary explains when and how to best comply. Below is a brief summary.

The highlights

• Currently past due (if not done): safety substantiation, professional use label, adverse event reporting
• July 1, 2024: Product listing and facility registrations enforcement begins
• Product listings need to be completed annually; facility registrations need to be completed every two years

The 4Cs of Gary: How to effectively comply

• Create a plan
• Construct environment
• Collect data
• Complete submission

As Gary noted, Reed Tech can be your trusted partner to help build your strategy – including regulatory consulting, gap analysis, project planning, technical help, listing and registration services and more. We can go so far as to help complete your submissions and act as a US agent. You could expect a high level of hand-holding and hypercare to get you started—followed by support and guidance in years to come. For more information about working with Reed Tech, please reach out to us at [email protected].

Compliance and Enforcement Risks: MoCRA, Sustainability and Retailer Requirements

Leading into this presentation, our IBA host stated “I feel like I’m in a game of dodgeball,” which seemed to resonate with many attendees as they try to navigate the new FDA Cosmetic Requirements. As such, it was the perfect introduction for the conversation on compliance and enforcement risks presented by Angela Diesch, Kurt Kober and Allyn Stern. We will summarize this information at a high level. For more specific information, please reach out to [email protected] so we can connect you with a regulatory specialist.

Adulteration: New definitions have been added to adulteration under MoCRA, including product composition.

• “manufactured or processed under conditions that do not meet GMP requirements of section 364b”
• “cosmetic product, including each ingredient, does not have adequate substantiation for safety, as defined in section 364d(c) of this title”

These new definitions do not have the requirement that injury needs to be caused for adulteration.

Misbranded:

• False or misleading in any particular
• Doesn’t include: name and place of business statement; net content statement; or domestic address or domestic phone or electronic contact info for reporting an adverse event
• If technical labeling requirements are not prominent and not likely to be read and understood by the ordinary individual under customary conditions of purchase and use
• If container is made, formed or filled as to be misleading
• If a color additive, doesn’t comply with section 379e
• Doesn’t comply with FDA cosmetics regulations

Recalls:

To be expected if there is a probability that that the product is adulterated or misbranded AND use or exposure will cause serious adverse health consequences or death.

FDA will first offer the opportunity for voluntary recall before issuing a mandatory recall. FDA can force the responsible persons, by order, to immediately cease distribution. However, the speakers do not foresee a significant increase in recalls because, for the most part, companies are already doing voluntary recalls when suggested by the FDA.

Summary

This concludes the highlights of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) coverage at the 2024 IBA Cosmetics Convergence Spring Symposium. The key takeaways remain that time is running out, manufacturers should begin taking action immediately and it is prudent to engage an experienced third party provider, like Reed Tech, to assist not only with preparation and submission, but also analysis and planning.

Reed Tech is currently offering a free MoCRA readiness assessment to qualifying companies. Fill out the form here or contact us at [email protected] or 215-557-3010 to begin your MoCRA compliance now!