Aptean PLM Lascom Edition
Navigating MoCRA: A Deep Dive into the New Requirements and How PLM Software Supports Compliance
Explore Aptean’s Cosmetic Solutions
It’s often said that change is the only constant, and the truth in that statement has been evident in the U.S. cosmetics industry over the past several decades. The market continues to grow in order to meet mounting demand, which has led to a proliferation of brands. Looks that were once in vogue are now distant memories and the product characteristics that consumers desire today are quite distinct from those that were valued in the past. As far as regulatory compliance, though, the status quo has been the same since 1938, when the original Federal Food, Drug and Cosmetic Act (FDCA) was passed. The “requirements” it laid out for cosmetics manufacturers, packers and distributors were little more than guidance, with the only mandate being that finished products must be safe when used in accordance with labeling. Business registration, official product listings and even recalls were all voluntary. But December 29, 2022, marked the beginning of a new paradigm. That’s the day the Modernization of Cosmetics Regulation Act (MoCRA) was signed, which significantly expands the authority of the Food and Drug Administration (FDA) to oversee the industry and enforce higher standards in documentation and product safety. That means more change is in store for your cosmetics company, and both due diligence through research and preparations for the new requirements are in order. Failure to do so could result in steep consequences for your organization for any violations of MoCRA. These may include costly mandatory product recalls, class-action lawsuits, penalty fees and even complete business closure. As a leading solutions provider committed to the industry, we’re here to help with a thorough explanation of which companies are subject to MoCRA regulations, what the bill entails and a timeline for enforcement. We’ll also highlight how a purpose-built product lifecycle management (PLM) can facilitate adherence to MoCRA standards and help protect your business from the risks of noncompliance.
Whitepaper | Navigating MoCRA: A Deep Dive into the New Requirements and How PLM Software Supports Compliance
2
Determining the Applicability of MoCRA for Your Business As outlined in the bill, MoCRA’s new requirements apply to all U.S.-based manufacturers, packers, importers and distributors of finished cosmetic products. Additionally, international businesses that market cosmetics products in the U.S. are also subject to MoCRA’s stipulations. There is one major exemption for MoCRA, and that’s for small businesses that have averaged less than $1 million in average annual turnover over the previous three years. For those companies, the requirements for facility registration, product listings and Good Manufacturing Practices (GMPs) are waived. However, businesses that meet the above revenue criteria are not exempt from those MoCRA requirements if they manufacture or sell:
› Cosmetic products that regularly come into contact with the mucus membrane of the eye under conditions of customary or usual use
› Cosmetic products that are injected › Cosmetic products that are intended for internal use only › Cosmetic products that are intended to alter appearance for more than 24 hours under customary or usual conditions, and removal by the consumer is not part of customary or usual usage
Furthermore, Sec. 613 of the bill specifies that businesses covered in Chapter V of the FDCA—which include those that produce some personal care products, like sunscreen, that might be considered adjacent to cosmetics—are regulated as manufacturers of non-prescription drugs under that act and not subject to the requirements of MoCRA.
A Bit of Background on MoCRA In the intervening years between the passage of FDCA and MoCRA, the Fair Packaging and Labeling Act of 1966 did bring about one major new requirement for cosmetics businesses—that products marketed on a retail basis to consumers in interstate commerce must be honestly and informatively labeled. That, however, was far from the sweeping reform for which consumer and industry groups have advocated in the decades since. Records from a 1988 Congressional hearing show that a consensus was formed that “the [cosmetic industry’s] safety apparatus was…in dire need of repair,” but no legislation was drafted or voted on. In the more recent past, bills with intent similar to that of MoCRA were introduced—including 2017’s Personal Care Products Safety Act and FDA Cosmetic Safety and Modernization Act—but neither gained the traction necessary to be passed. The Personal Care Products Council has also called for updated regulations but it took bipartisan support in Congress for a bill of this magnitude to become law. With the passage of MoCRA, the FDA’s previous system for cosmetics business registration—the Voluntary Cosmetic Registration Program (VCRP)—has come to an end. The FDA is currently developing a new program for the now-mandatory process of business registration, with further updates forthcoming.
Whitepaper | Navigating MoCRA: A Deep Dive into the New Requirements and How PLM Software Supports Compliance
3
What Does MoCRA Mean for My Cosmetics Business?
Is your cosmetics business based in the U.S.?
Yes
Has your business had average annual turnover > $1M for the past 3 years?
Yes
Your business is likely subject to new requirements of MoCRA, including: No
Yes
Does your business market products in the U.S.?
No
No
Does you business deal in products that 1) contact the eye’s mucus membrane; 2) are injected; 3) are intended for internal use, OR 4) alter appearance for > 24 hrs. and are not manually removed?
No
1) Mandatory adverse event reporting (see Sec. 605); 2) Good Manfuacturing Pracitces (GMPs; see Sec. 606); 3) Mandatory facility registration and biennial renewal (see Sec. 607); Yes
4) Mandatory product listing (see Sec. 607); 5) Product safety substantiation (see Sec. 608); 6) New product labeling standards (see Sec. 609); 7) FDA access of business records (see Sec. 610); 8) FDA-mandated recalls (see Sec. 611)
Your business is likely exempt from MoCRA requriements.
Your business may be exempt from MoCRA requirements, but a qualified professional in your organization should review the bill (specifically Sec. 612) for confirmation.
The New MoCRA Requirements in Detail Before we dive in to take a close look at each of the major stipulations for cosmetic businesses that MoCRA establishes, it’s critical that you understand the concept of a “responsible person” as outlined in the law. The term implies that it would refer to an individual, but in fact it is actually the manufacturer, packer or distributor whose name, address, phone number and electronic contact information appear on product labels. Of course, you may find that it is optimal to assign a specific person (or team) to act as the point of contact between your company and the FDA, as that will allow those best suited to the management of MoCRA compliance and the associated documentation and procedures to take the lead. You should be sure to select someone who is qualified for the role and reachable via the contact information on your product packaging. Additionally, MoCRA defines the terms “adverse event” as any health-related event associated with the use of a cosmetic product that is adverse. It also defines “serious adverse event” as an event that results in: Death
A life-threatening experience
Inpatient hospitalization
A persistent or significant disability or incapacity
A congenital anomaly or birth defect
An infection
Significant disfigurement
Necessary medical or surgical intervention
Whitepaper | Navigating MoCRA: A Deep Dive into the New Requirements and How PLM Software Supports Compliance
4
Lastly, you should be aware of what’s on the line should you be found in violation of these requirements after the date of enforcement. The FDA will likely publish more detailed information specifically regarding MoCRA noncompliance in the future, but the probability is high that the Administration will maintain its authority to seize property and levy penalty fees of up to $100,000. And while it’s unlikely that a single instance of noncompliance would be disastrous for your business, repeated violations or the inability to provide the FDA with required records could result in penalties that add up to millions of dollars. What’s more, being forced to execute a mandatory product recall will not only cost your company a lot financially—it will also severely damage your reputation as a brand. With those basics laid out, here are the new and updated requirements in the bill:
Mandatory Adverse Event Reporting Your business’s responsible person must report all serious adverse events to the FDA within 15 days of the incident. They must also provide any new and material medical information related to a serious adverse event that is received within one year of the incident, and that must be within 15 days of the discovery of the information. Your business must also securely maintain all adverse event records, and the FDA Secretary may request a list of fragrance and/or flavor ingredients found in products that led to serious adverse events (see Sec. 605 for more).
Good Manufacturing Practices (GMPs) Your business must adhere to cosmetic GMPs as established by the FDA (which includes definitions of “adulterated” and “misbranded” products, as well as guidelines for buildings, equipment, personnel, raw materials and more). The Secretary may request records that demonstrate compliance with this requirement. There are some considerations for smaller businesses, and the timeframe for enforcement includes proposed rulemaking no later than 2 years after MoCRA’s passage, with a final rule published no later than 3 years after (see Sec. 606 for more).
Mandatory Business and Facility Registration Your existing facilities engaging in cosmetic product manufacturing, processing, packing and distributing must be registered with the FDA. Any new facilities fitting the above criteria must be registered within 60 days of its opening or 60 days after one year from the passage of MoCRA, whichever is later. These registrations must be renewed biennially, meaning every two years. Contract manufacturers producing finished cosmetics for more than one business need only file a single registration for each facility. The required information for registration is covered in the text of the bill, as is the process for facility suspensions and related hearings (see Sec. 607 for more).
Discover 6 Ways PLM Software Enhances Cosmetics NPD
Whitepaper | Navigating MoCRA: A Deep Dive into the New Requirements and How PLM Software Supports Compliance
5
Find Out How PLM Acts as a Single Source of Truth
Cosmetic Product Listing Your company’s responsible person must submit a listing for each of your business’s cosmetic products for interstate commerce. The listing must include, among other elements, a full list of ingredients, including fragrances, flavors and colors (see Sec. 607 for more).
Product Safety Substantiation Your business’s responsible person must maintain records that provide “adequate substantiation of safety” (defined as tests, studies, research, analyses or other evidence that would be considered by experts as proof of reasonable certainty that the product is safe) for every product your company deals in. There is an exemption for coal-tar hair dyes (see Sec. 608 for more).
Product Labeling Standards All cosmetics products must bear a label that includes domestic address, phone number and electronic contact information through which your business’s responsible person can receive adverse event reports. Products that are intended only for professional use must also include that disclosure. Additional guidance on labeling for fragrance allergens will be issued within 18 months of MoCRA’s passage (see Sec. 609 for more).
FDA Records Access If the FDA has a reasonable belief that a cosmetic product or an ingredient therein is likely to be adulterated or presents a threat of a serious adverse health event, the FDA Secretary may request copies of all records relating to that product. This does not extend to exact formulation or recipe specifications, financial data or personnel data (see Sec. 610 for more).
Whitepaper | Navigating MoCRA: A Deep Dive into the New Requirements and How PLM Software Supports Compliance
6
FDA-Mandated Recalls If the FDA determines that there is a reasonable probability that a cosmetic product is adulterated, misbranded or likely to cause a serious adverse health event, the FDA Secretary will provide that company’s responsible person an opportunity to cease distribution and issue a recall of that product. If they do not, the FDA Secretary can initiate a mandatory product recall. The specifics on the hearing process, order resolution, notices to persons affected and public notifications are covered in the text of the bill (see Sec. 611 for more).
Standardized Asbestos Testing for Products Containing Talc If your business produces products containing talc, another requirement is on the way. The Secretary of Health and Human Services will publish proposed regulations for standardized asbestos testing methods for product containing talc within one year of MoCRA’s passage, and final rulings will be made within 180 days of that date (see Sec. 3505).
Additional Notes on MoCRA The bill also includes a commitment on the part of the Secretary of Health and Human Services, in consultation with the National Center for Toxicological Research, to assess the use of perfluoroalkyl and polyfluoroalkyl (PFAs) in cosmetic products and the scientific evidence regarding their safety (see Sec. 3506). Furthermore, Sec. 3507 specifies that Congress discourages animal testing for cosmetic products and that businesses should phase out that practice with some appropriate allowances made.
Learn How PLM Software Facilitates Product Diversification
Whitepaper | Navigating MoCRA: A Deep Dive into the New Requirements and How PLM Software Supports Compliance
7
The Timeline for MoCRA Enforcement While the dates for initial enforcement of MoCRA’s various requirements were set with respect to the fact that cosmetics businesses can’t ensure compliance overnight, it’s a prudent move to review the timeline now and begin preparations. The phased approach that the FDA is taking will allow your company to create the records and processes necessary to satisfy each in turn and work them into your standard operating procedures.
Before 2024 By December 29, 2023, established safety substantiations for all of their cosmetic goods and put in place procedures for adverse event reporting. The FDA’s mandatory recall authority and records access provisions will be in effect as of this date, and the Administration will have also issued its proposed rulemaking for identifying asbestos in talc-containing products by this date. To get ready, you can begin to assemble the necessary information and conduct testing necessary for safety substantiations.
Mid-2024 By July 1, 2024, all applicable businesses will need to have registered both their facilities and their products with the FDA. The deadline for this requirement was originally set for the end of 2023, but the FDA revised the timeline. Additionally, the FDA will have issued its final ruling on asbestos testing for cosmetic products containing talc, as well as its proposed rulemaking for the labeling of fragrance allergens. If your business manufactures products with those components, you’ll want to make a point to check the headlines and FDA website at the beginning of the month.
Before 2025 By December 29, 2024, applicable businesses will need to ensure compliance with the new labeling standards, which by this time will also include the final ruling on fragrance allergen declaration. The FDA will have also issued its proposed rulemaking on adherence to GMPs for cosmetic companies by this time. You can prepare by studying the labeling requirements ahead of time, gathering the necessary information and modifying packaging accordingly.
Before 2026 By December 29, 2025, the FDA will have issued its final ruling on cosmetic business GMP standards, and enforcement of that requirement will begin. The FDA will also have published its re-evaluation of the use of PFAs in cosmetic products by this time, which will be significant for your business if they are incorporated into your products. You should review the GMPs as they stand now and begin making adjustments in accordance with them, study the proposed rulemaking when it is issued no later than one year prior to this date and further modify procedures as necessary.
Whitepaper | Navigating MoCRA: A Deep Dive into the New Requirements and How PLM Software Supports Compliance
8
Timeline for MoCRA Enforcement, Visualized Provision
2023
2024
2025
2026
Safety Substantiations
Adverse Event Reporting
Mandatory Recall Authority
Facility Registration
Product Listings
Standardized Asbestos Testing
Fragrance Allergen Disclosures
Labeling Standards
Cosmetic GMP Adherence
Rulemaking Proposed
Rule Finalized
Whitepaper | Navigating MoCRA: A Deep Dive into the New Requirements and How PLM Software Supports Compliance
9
How a Cosmetics PLM Can Facilitate MoCRA Compliance If that seems like a lot to prepare for, that’s because it is—but as a cosmetics industry professional, you’re used to constant change. You’ve also likely taken steps to maximize the flexibility and agility of your organization, and now that you’ve learned more about all that MoCRA entails, you can look to further equip your business with digital solutions that facilitate compliance. Among the best software for cosmetics companies that are getting ready for the new requirements are PLM systems. That’s because such a platform, when developed specifically for your industry, offers a set of features that help you manage critical data, dial in product specifications precisely, establish standardized processes and more.
› Electronic document management (EDM) – This component of PLM software can be utilized as a
unified and fully digital repository for the creation and storage of important reports, certificates and other documentation. With EDM, your employees can have easy access to product safety substantiations and specifications for registration with the FDA.
› Change management – By facilitating the process of changing formulations with both single and mass component replacement functionalities, this PLM feature makes it easier to modify your products in line with safety standards so that proper substantiation can be filed with the FDA.
› Formulation tool – With this highly flexible tool that allows for precise product formulation, you’ll have what you need to create new products that adhere to MoCRA standards. Advanced PLM solutions—like our own Aptean PLM Lascom Edition—can integrate with universal databases (like International Nomenclature Cosmetic Ingredient, or INCI) to pull material information automatically, which can aid in the product registration process.
› Manufacturing process management – Designed specifically to help cosmetics businesses create
standardized manufacturing processes and assign them to specific products following a step-by-step structure, this PLM feature can help you establish and adhere to GMPs.
› Packaging development – Since new rules for product labeling are one of the major requirements
of MoCRA compliance—and more changes may be in store once the FDA rules on fragrance allergen disclosures—you need the tools to tinker with your product packaging in accordance with updated standards. That makes this feature invaluable for companies like yours.
› Compliance module – That’s right, advanced PLM systems have an entire module dedicated to
compliance. Aptean PLM Lascom Edition provides functionalities for ingredient statement creation, allergen screening and generation of important claims and certifications. Those can help you manage records that the FDA may request, as well as your product safety substantiations.
Whitepaper | Navigating MoCRA: A Deep Dive into the New Requirements and How PLM Software Supports Compliance
10
In addition to the above, don’t forget that leading solutions like Aptean PLM Lascom Edition also serve as organization-wide platforms for collaboration, innovation and iteration. Because the cosmetics industry is so dynamic and consumer preferences are shifting by the day, a purpose-built PLM is a crucial piece of an optimized tech stack for companies that operate in this sector.
What Makes Aptean the Ideal Solution Provider Having gotten this far, you hopefully feel more informed and better prepared for this new era in U.S. cosmetics regulation. You’ve also had a chance to learn about the features of PLM systems that can make adjusting your products and processes for MoCRA compliance a much more manageable and straightforward task. We’ve highlighted a few of the ways that Aptean PLM Lascom Edition stands out from the many other systems on offer, including the availability of database integrations and features developed specifically for compliance efforts, but there’s still more to love about our software. For starters, it’s cloud ready and can be deployed on the flexible Software as a Service (SaaS) model. What’s more, Aptean is a cut above as a solution provider, as we strive to act as a partner and guide for each of our customers, assisting in the creation of an implementation roadmap and providing outstanding support. Our team has in-depth knowledge of the cosmetics industry, too, so we know the unique challenges you face and the best practices to overcome them. Finally, our reputation in the software space speaks for itself. We were ranked in the upper echelon of The Software Report’s Power 500 Software Companies list, coming in at the 30th overall spot to place in the top 10% of businesses included. That’s a demonstration of our systems’ superior performance, as well as our dedication to our clients and target markets.
As a disclaimer, this whitepaper and accompanying graphics do not constitute legal advice or assurance of compliance or exemptions. Qualified personnel within your organization should investigate the bill in its entirety (see H.R. 2617-1389, Subtitle E – Cosmetics in the published legislation) to fully understand your business’s requirements.
Whitepaper | Navigating MoCRA: A Deep Dive into the New Requirements and How PLM Software Supports Compliance
11
Are You Ready to Learn More? Contact us at info@aptean.com or visit www.aptean.com.
About Aptean
Aptean is one of the world’s leading providers of purpose-built, industry-specific software that helps manufacturers and distributors effectively run and grow their businesses. With both cloud and on-premise deployment options, Aptean’s products, services and unmatched expertise help businesses of all sizes to be Ready for What’s Next, Now®. Aptean is headquartered in Alpharetta, Georgia and has offices in North America, Europe and Asia-Pacific. To learn more about Aptean and the markets we serve, visit www.aptean.com. Copyright © Aptean 2023. All rights reserved.