FDA MoCRA Cosmetics Updates: What you Need to Know to Stay Compliant

17/08/2024

Background on the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) marks a significant change in the cosmetics industry, representing the most substantial expansion of the FDA’s regulatory authority since the Federal Food, Drug, and Cosmetic (FD&C) Act of 1938. This new legislation introduces comprehensive requirements aimed at improving the safety, transparency, and accountability of cosmetic products in the U.S. market. Compliance with MoCRA is now essential for both domestic and international brands to maintain market access and uphold consumer trust.

As MoCRA’s regulations take effect, the need for strict compliance is greater than ever. Companies must navigate these new standards not only to avoid penalties but also to remain competitive in a crowded market. Whether your brand is based in the U.S. or operates internationally, understanding and adhering to MoCRA’s requirements is critical for long-term success.

Key changes introduced by MoCRA includes:

⭐️Facility Registration: Mandatory registration of all facilities involved in manufacturing or processing cosmetics products distributed in the United States, no matter it is in US or international. FDA has the authority to suspend a facility’s registration if the agency determines that a cosmetic product manufactured or processed by the registered facility and distributed in the U.S. has a reasonable probability of causing serious adverse health consequences or death to humans, and the agency has a reasonable belief that other products manufactured or processed by the facility may be similarly affected because of a failure that cannot be isolated to a product or is sufficiently pervasive to raise concerns about other products manufactured in the facility.

⭐️Product listing: Mandatory Requirement for all marketed products to be listed with the FDA, including ingredient details.

⭐️Good Manufacturing Practices (GMPs): Enforcement of standardized GMPs across all cosmetic manufacturing facilities

⭐️Adverse Event Reporting: Obligation to report any serious adverse events to the FDA within a set timeframe. The responsible person must also provide certain additional information, such as new medical information, received within one year of the initial report. FDA will also have access to adverse event reports during an inspection.

⭐️Safety Substantiation: Mandatory proof of safety for every cosmetic product marketed in the U.S.

⭐️Record inspection: MoCRA amends the FD&C Act to provide that FDA inspections of facilities that manufacture or process cosmetics shall extend to certain records and information, such as safety substantiation and adverse event report information, when the applicable standard for records inspection applies.

⭐️Mandatory Recall Authority: If FDA determines that there is a reasonable probability that a cosmetic is adulterated or misbranded and use of, or exposure to, the cosmetic will cause serious adverse health consequences or death, FDA has the authority to order a mandatory recall if the responsible person refuses to do so voluntarily.

⭐️Labelling for professional-use: requires certain labelling for cosmetic products that are intended to be used only by licensed professionals, requires cosmetic product labels to include certain contact information through which the responsible person can receive adverse event reports. Contact information must include: domestic address, phone number or electronic contact information, which may include a website

⭐️.Labelling of Fragrance Allergens Rule: FDA to develop regulations to identify fragrance allergens that must be disclosed on cosmetic labels, taking into consideration international, state, and local allergen disclosure requirements.

New regulations regarding talc, asbestos: FDA to develop regulations to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products and

Report on PFAS in cosmetics: The FDA will release a report summarizing the safety assessment of per- and polyfluoroalkyl substances (PFAS) in cosmetic products.

Key Term:

⭐️Cosmetic product: a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product.

⭐️Facility: any establishment (including an establishment of an importer) that manufacturers or processes cosmetic product distributed in the United States.

carve out include for certain beauty shops and salons, certain retailers, hospitals, public health agencies, trade shows, certain research and testing facilities, and
establishments that solely perform one or more of the following with respect to cosmetic products: labelling, relabelling, packaging, repackaging, holding, and distributing.

⭐️Responsible person: The manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of the cosmetic product.

⭐️Adverse Event: any health-related event associated with the use of a cosmetic product that is adverse.

⭐️Serious Adverse Event: an adverse event that

(A) results in:
- death;
- 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.

Source:https://www.fda.gov/

These changes present both challenges and opportunities for cosmetic brands, especially those outside the U.S. looking to enter the market. OCM Vietnam Corporation is uniquely positioned to help our clients navigate these regulatory shifts with confidence.

As a professional cosmetics OEM/ODM manufacturer, OCM Vietnam Corporation offers comprehensive services, including product development, formulation, testing, packaging, labeling, and regulatory compliance. Our team of experts is dedicated to helping you meet the requirements of the U.S. market while delivering the highest quality, service, and value.

If you are interested in partnering with OCM for your cosmetics compliance and innovation needs, please contact us today. We look forward to discussing how we can help you achieve your goals.