Similar to the Food Safety Modernization Act of 2011 (FSMA), the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) introduces significant changes in the Beauty and Personal Care sector, aligning it more closely with FDA oversight akin to other industries.
At Astro Pak, our advanced precision cleaning and passivation techniques are uniquely poised to assist the cosmetics industry in navigating these new regulations. With proven expertise in adhering to FDA protocols across various sectors, we offer valuable insights and solutions for complying with MoCRA’s guidelines. This includes our electropolishing and mechanical polishing processes and bioburden remediation strategies, ensuring the highest standards of product safety and quality.
The similarities between MoCRA and FSMA’s new regulations also establish and codify current Good Manufacturing Processes (cGMP) as well as making compliance with these guidelines binding. The provisions of the law are scheduled to start on July 1, 2024. Additionally, other provisions of the regulations will have a gradual implementation, continuing until the end of 2025.
MoCRA: Shaping Cosmetic & OTC Regulations
MoCRA defines cosmetic products as a “preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product.” (FDCA § 604(2)). Over-the-counter (OTC) drugs that make cosmetic claims, such as makeup or moisturizers marketed with sun-protection qualities, or anti-dandruff shampoos and similar products do not come under MoCRA as they are already regulated under provisions concerning OTC drugs. However, MoCRA’s regulations do apply to fragrance allergen warnings and professional use stipulations on these products labeling, as discussed later.
While some provisions and regulations won’t be fully implemented for all manufacturers before 2026, the changes to the industry begin taking effect by the end of this year as MoCRA gives the FDA more authority and oversight over what has been voluntary guidelines. This empowers the agency to access and copy selected documentation, including safety records, under specific conditions. Additionally, the FDA now has the authority to compel mandatory recalls where previously, a company could decline to recall a product.
Coming in 2024
There are some key requirements that come into force by the middle of 2024:
– Any establishment that manufactures or processes cosmetic products for the U.S. market will have to register their facility with the FDA by July 1, 2024. This includes all overseas companies. This information will include the facilities’ name and physical address as well as telephone and email contact information. A current draft guidance seeks to further refine and clarify the statute and it is possible that a DUNS number may be included as required information by the end of the two-year period. Overseas facilities will have to appoint a U.S.-based point of contact.
Facilities solely engaged in distribution, warehousing, labeling, relabeling, packaging or repackaging cosmetic products are exempt from having to register. New facilities coming online after June 2024 are required to be registered within 60 days after they begin manufacturing or processing cosmetics. For contract manufacturers, only a single registration is required by either the facility itself, or for the company who owns the products. This registration must be renewed every two years and updated within 60 days if there are any changes to the registration.
– While MoCRA doesn’t require a pre-market approval for cosmetics, it does require that the party responsible for the product must list the product itself along with the product ingredients with the FDA. The responsible party can be the manufacturer, distributor, or packer of the product and the list of ingredients must include any colors, flavors or fragrances. Similar to food items, the ingredients must be identified by their common names, or the name used in the Code of Federal Regulations (21 CFF Part 701.30).
In addition to the product name as it appears on the label and the ingredient list, the FDA also requires the Facilities Registration information mentioned above. The company will also need to note which cosmetic category the product falls under, and if the FDA has already assigned the product a listing number, that will need to be listed as well.
Any product already on the market will need to be listed with the FDA by December 29 and new products introduced after that day must be listed within 120 days of its initial marketing. Unlike the Facilities Registration, the product listing must be renewed annually. If the product formulation hasn’t changed within the year, the process will be simplified. Multiple cosmetics which have identical formulations but only minor variations such as color, flavor, fragrance or the amount of ingredients can be put under a single listing.
It is important to note that the FDA’s previous Voluntary Cosmetic Registration Program (VCRP) was discontinued on March 27, 2023 and that any information provided to that program will not be transferred to the MoCRA registration system.
Good Manufacturing Practices (GMP)
– Just as the FSMA codified GMP for the food and beverage industry, MoCRA also makes compliance with GMP mandatory for cosmetic manufacturers. The FDA has stated that it will be crafting these new GMP regulations with an eye on simplified versions for smaller businesses to minimize economic impact. The overall regulations are expected to align with ISO 22716 and other existing national and international standards. Under the current schedule, the expected date for the proposed rule is December 29, 2024, with finalization one year later. However, given that the deadline for enforcement of MoCRA has been pushed back six months, it is likely that these scheduled dates will also move back half a year.
After the date of finalization of this rule, failure to comply with the GMP conditions when manufacturing or processing a cosmetic will mean that the product will be considered adulterated. A determination that a product has been adulterated can result in the FDA removing the product from the market and bringing legal action against the product’s responsible parties.
Substantiation of Safety
– Going hand-in-hand with listing ingredients and GMP, the responsible parties for a product will now be required to ensure its safety but also maintain records that substantiate the claim. This requirement may significantly impact the industry compared to the pre-MoCRA voluntary standards. The text of MoCRA includes the term “adequate substantiation of safety.” As with other aspects of MoCRA, the FDA is still developing the guidance that will govern how a product can be substantiated to be “safe”. In the interim, it is reasonable to believe that the new guidance regarding determining that a product’s safety will not deviate too far from the text found in the Cosmetic Labeling Guide (21 CFR 740.10) which states, “The safety of a cosmetic may be considered adequately substantiated if experts qualified by scientific training and experience can reasonably conclude from the available toxicological and other test data, chemical composition, and other pertinent information that the product is not injurious to consumers under conditions of customary use and reasonably foreseeable conditions of misuse.” Once the guidance is finalized, however, any product that does not meet the standards will be considered adulterated.
– This builds upon the FDA’s existing Cosmetics Labeling Guide (21 CFR Part 701), expanding it in three key areas starting in July 2024:
Professional Use Cosmetics Labeling
Specific labeling will be required on cosmetic products intended for “professional use” by licensed professionals such as barbers, cosmetologists, estheticians, and nail technicians. In addition to the information found on the labels intended for general consumers, additional wording must be presented in a clear and prominent manner stating that product may only be used or administered by licensed professionals.
The contact information for the product’s responsible party will be included on the label. Such information will include U.S. address, website, email address, phone number or other method of contact to convey an adverse event report associated with the product. (see Adverse Event Reporting, below)
Fragrance Allergens Disclosure
Currently scheduled for implementation in early 2025, additional information will be added to labels to disclose each fragrance allergen in the product. Currently such fragrance ingredients are listed as “Flavor” or “Fragrance”. The FDA has until June 29, 2024 to draft a list of specific fragrance allergens, although this deadline may also be moved back in light of the other delays. After the list is created, it will undergo a 180-day public review and comment period. Failure to disclose a fragrance allergen can provoke an enforcement action by the FDA should the agency deem that omission to be a case of misbranding.
Adverse Event Reporting
– Under MoCRA, manufacturers or other responsible parties will be required to maintain records of “adverse events” for six years, or three years for smaller businesses. Additionally, any “serious adverse events” (SAE) MUST be reported to the FDA within 15 days of receiving that report. Although MoCRA doesn’t specifically define “adverse events”, it outlines types that require FDA reporting, including:
- (A) results in:
- a life-threatening experience
- inpatient hospitalization;
- a persistent or significant disability or incapacity;
- a congenital anomaly or birth defect;
- an infection; or
- significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance), other than as intended under conditions of use that are customary or usual; or
- (B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described in (A) above.
It is under this aspect of MoCRA where the FDA’s new authority to issue a mandatory product recall is most likely to come into play. Related to this, is another new authority that MoCRA grants the agency; the FDA can, under certain conditions, access, copy and retain certain records relating to a cosmetic product. Safety records are among those documents that the FDA can look at.
Currently, the only way to submit an SAE report is by using Form 3500A and sending it along with any provided images of the event along with the product’s label by mail. However, the process for submitting these reports and supporting documentation electronically is being developed. Should the FDA become aware of potential severe adverse events related to a product on its own, it can send a request to the product’s responsible party for information which much be provided to the agency within 30 days.
A trio of other aspects; Asbestos in talc-containing products, Per-and Polyfluoroalkyl Substances (PFAS) and Animal Testing will also be addressed by the FDA under MoCRA.
Under the schedule that would have begun enforcement at the end of this year, the FDA was also to have completed work on a proposal establishing standardized testing for the detection of asbestos within talk-containing cosmetics. The final rule was to be published six months later, in June of 2024. However, this schedule has likely also been pushed back six months.
After being considered “inert” for many years after their introduction in the 1940s, PFAS have been found contribute to a number of cancers, miscarriages and other health issues. Their lack of breaking down – also known as “forever chemicals” has been increasingly viewed as problematic. As part of MoCRA, the FDA has been authorized and directed to conduct further studies and assess the continued use and safety, as well as the associated risks of these chemicals in cosmetic products. The findings of this assessment are scheduled be released to the public around the end of 2025.
While animal testing of cosmetics will remain unchanged under MoCRA, the legislation does include language reflecting Congress’ view that it should no longer be used as routine testing and that, in most cases, it should be phased out by the industry.
Exemptions and Exceptions
Even with MoCRA’s scheduled December 29, 2023 date for commencement of enforcement was pushed back six months, its Preemptive Provision came into effect earlier this year. It overrides any state or local laws governing facilities registration, product listing, GMP, safety substantiation, adverse event reporting, records and recalls. However, it doesn’t supersede state laws that ban or limit certain cosmetic ingredients, nor does it prevent enforcement of existing state laws mandating the reporting of specific cosmetic ingredients. Respective examples of such laws would be California’s California Toxic-Free Cosmetic Act and California Safe Cosmetic Act.
MoCRA also reduces the compliance burden on “small businesses” which are defined as having gross annual cosmetics sales of less than $1M USD over the prior three years. Specifically, these businesses:
- Do not have to register facility with FDA
- Do not have to list products with FDA
- Must substantiate the safety of their products
- Do not need to meet GMP regulations at this time
- Must comply with labeling standards, including U.S.-based point of contact information, indications professional use and presence of fragrance allergens
- Adverse event reporting documentation must be retained for three years rather than six.
However, there are exceptions to the exemptions. No matter the size of the business, facilities or responsible persons are still required to comply fully with MoCRA if the products fall into any of the following categories:
- Cosmetic products come into with the eye’s mucus membrane under normal use
- Injectable cosmetics
- Cosmetics intended for internal use
- Cosmetics intended to alter the consumer’s appearance for more than 24 hours under normal use, without the consumer having to remove the product.
Where a cosmetic product is also a drug, then it generally falls under Chapter V: Drugs and Devices of the Federal Food Drug & Cosmetic Act (FD&C), but not Chapter VI: Cosmetics’ cosmetic requirements. As a result, the products and their manufacturers do not have to comply with MoCRA’s facility registration, product listing, GMPs, safety substantiation, record keeping and mandatory recall points as these are covered by the other regulations – some of which are more stringent. Compliance with the fragrance allergen and professional use portions of MoCRA’s labeling requirements will still be required. However, if a facility manufactures or processes both cosmetic products and cosmetic/drug combination products, then it must comply with all of MoCRA’s regulation.
The FDA’s authority to access documents related to a product is not unlimited. Cosmetic recipes or formulas, financial and pricing data are not required to be turned over. Access to data on personnel, research and sales is limited to portions dealing with qualifications, safety substantiation and shipping dates which may be needed in identifying issues with the product.
As has been covered earlier, MoCRA gives the FDA the power to compel a recall of a product. It also has the power to demand access to records about a product and especially any documentation regarding safety.
For the FDA to rapidly respond to a potential health risk caused by a cosmetic product, the agency also has the authority to suspend the registry of a facility involved in production or processing. This is similar to the authority in gained with the FSMA which allows it to shut down a food factory if it has reasonable probability that the facility might be the source of adverse health conditions and that those issues may also extend to other products being manufactured or processed there.
A facility with a suspended registration may not produce any further cosmetic products until the FDA reinstates it. In most cases, the FDA will provide prior notice and the option of an informal hearing with the responsible party before suspending a facility’s registration. If the FDA finds that the health issues originated at the facility, further action may be taken which can range depending on the seriousness of the issue.
A Changed World
Like 2011’s FSMA did for the food industry, MoCRA will dramatically change the operational rules governing the cosmetics industry. Coming 73 and 84 years respectively, from the original FD&C Act, the two pieces of legislation set safety standards that were viewed as long overdue by Congress and advocates. Instead of viewing these as burdensome obstacles, they present opportunities for fair competition, eliminating location-based exceptions. MoCRA also offers the promise of reduced chances for unwanted negative publicity surrounding a product-related health scandal – and related financial impacts – by giving guidance on current best safety practices. Among those GMP standards is guidance on to best ensure that a facility’s equipment is maintained in a manner where product safety is key. These same practices also help ensure the reliability of the processing equipment and allowing it to have a longer productive lifespan. Partnering with Astro Pak can assist with complying with MoCRA’s GMP requirements, reducing the challenges of navigating this new world.