The Consolidated Appropriations Act, recently passed by the US Congress, incorporates revisions to US cosmetics laws. The Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which has been in the works for years, is the biggest change to cosmetics legislation in recent U.S. history.
The U.S. Food and Drug Administration (FDA) can now impose stricter regulations on the cosmetics business according to MoCRA, which increases the agency’s regulatory jurisdiction over the sector. Cosmetic producers should be aware of the changes in the bill even if FDA has not yet established specific requirements. Keeping up with the latest FDA cosmetic regulations can be an overwhelming task and in this article, we will help you navigate MoCRA and FDA cosmetic regulations.
What are the FDA Cosmetic Regulations?
The FDA is responsible for regulating cosmetics in the United States and works to protect public health by ensuring the safety of cosmetics. All cosmetic products, including all ingredients used in those products, must comply with FDA rules before they can be sold to consumers. Cosmetic companies are held responsible for the safety of their products under Section 21 CFR 740, which requires them to have a reasonable basis belief that their products are safe before they can enter the market.
What are the Different Types of Cosmetics and Their Regulatory Status?
Cosmetics can be divided into four distinct categories with separate FDA regulatory statuses. The categories are Color Additives, Over Counter Drugs, Prescription Drugs and Devices, and Cosmetics/Soaps. Within each category, there are specific regulations that must be followed, such as listing all ingredients on the product label and submitting safety testing results to the FDA. Companies should thus familiarize themselves with the relevant guidelines to remain compliant with all applicable laws.
How do Companies Register their Cosmetics with the FDA?
To register cosmetics with the FDA, companies must first fill out a Cosmetic Registration Form. The form must include the company’s information and contact details, a comprehensive ingredient list, and any relevant safety testing. Once the form is complete, it must be submitted to the FDA for review and approval. Companies should also maintain appropriate records of their compliance efforts to remain compliant with all applicable regulations.
11 ways MoCRA will enhance FDA Cosmetics Regulations:
- Cosmetic Product Listing
An obligatory product listing for every cosmetic product must be submitted by companies to the FDA no later than one year following the law’s passage. Cosmetics sold after the law’s passage must include the product within 120 days of sale. Multiple cosmetic goods with the same formulations or formulations that vary only in terms of colours, aromas, flavours, or the number of ingredients, may be submitted under flexible listings.
A product listing must be renewed by businesses each year along with any revisions. Products that have not changed since their prior listing will have the option of an abbreviated listing.
- Registration of Cosmetic Facilities and Renewal
Owners and operators of facilities that produce or process cosmetic items for distribution in the United States are required to register with the FDA, and this registration must be renewed every two years. New facilities that manufacture or process cosmetic products for distribution in the U.S. after the enactment date must register within 60 days of marketing a product or 60 days after the deadline for registration, whichever is later. Existing facilities will have one year from the date of enactment to register their facility with FDA.
Facilities must now renew their FDA registration every two years and must notify the FDA of any changes to registration information within 60 days of the change.
- Cosmetic Good Manufacturing Practices (GMP)
Good Manufacturing Practices (GMPs) that are compliant with regional, national, and international standards will be enforced in facilities. GMP aims to safeguard the public’s health and guarantee that cosmetic items aren’t contaminated. With the use of this legislation, the FDA will be able to examine facilities and gain access to the information it considers necessary to confirm that GMP standards are being followed. Currently, the FDA has 3 years from the date of passage to publish a Final Rule after publishing a Notice of Proposed Rulemaking for the Cosmetic GMP.
- Adverse Event Report
The responsible party must file a report and include a copy of the label found on or inside the retail packaging if a serious adverse event involving a cosmetic product occurs no later than 15 business days after the report is received.
Within one year of the first report, a corporation is required to provide any new and significant medical information linked to the report to the FDA within five business days of receiving it.
- New Cosmetic Labeling Requirements
A domestic address, domestic phone number, or electronic contact information must be added to product labels so that a responsible party can receive complaints of adverse events.
The labels of cosmetic goods that include fragrance allergens must be updated to include the allergens. Within 18 months of the law’s passage, the proposed fragrance allergens must be published, and the final determination must be made no later than 180 days after the public comment period has ended.
Labels for professional cosmetic products must clearly and conspicuously say that the product is administered or used only by qualified professionals and that it complies with all applicable cosmetic labeling regulations.
- Additional powers to FDA in regulating cosmetics
These requirements include, among others:
- Registrations for establishments/facilities
- Product catalogues
- Reporting of adverse events
- Version control and safety monitoring
Among these abilities are:
Need help navigating the FDA MOCRA cosmetic regulations?
- Establish good manufacturing practices that are required of all manufacturers.
- Possibility of requesting documents that attest to a product’s safety Power to order a required product recall.
- Create a talc-containing product asbestos testing protocol.
- Review the PFAS (per- and polyfluoroalkyl) compounds’ safety and usage.
Overall, the Modernization of Cosmetics Regulation Act of 2022 represents a much-needed advancement in laws governing the composition, safety, and efficacy of cosmetic goods.
- Cosmetic Records Inspection
if there is a reasonable suspicion that a cosmetic product or ingredient poses a threat of substantial adverse health consequences or human death upon use, gives the FDA power to view and copy certain records pertaining to a cosmetic product.
- Cosmetic Mandatory Recall
According to the FDA, there is a good chance that a cosmetic is adulterated or misbranded, and using or being exposed to such a cosmetic will have substantial negative effects on one’s health. The Responsible Person has the option to recall the product, but if they choose not to, the FDA may impose an immediate halt to distribution and a recall of the goods.
- Record of Cosmetic Adverse Reports
Adverse event reports must be kept on file for six years, and the FDA must have access to them when conducting inspections. If FDA suspects an ingredient or combination of components has caused serious adverse effects, FDA may require a documented list of all ingredients in the product’s perfumes or tastes. Following the FDA’s request, this list must be submitted within 30 days.
- Small Business Exemptions
Some rules do not apply to small firms. The FDA classifies small enterprises as those with average annual gross sales of less than $1,000,000 over the prior three years. This shall not apply to any responsible person or facility engaged in the manufacture of cosmetic products intended for internal use, regularly coming into contact with the eye, being injected, or altering the appearance for a period of time exceeding 24 hours when used as intended or customarily would be done.
- Cosmetic Safety Substantiation
Companies are required to keep documents demonstrating sufficient safety justification for their cosmetic items. To support a reasonable certainty that a cosmetic product is safe, it must be substantiated with “tests or studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient.”
Need help understanding MoCRA or need assistance? We’re hear to help!
You should familiarize yourself with the legislation that will apply to your facility or cosmetic items. One year following MoCRA’s implementation, new required clauses take effect.
How Quality Smart Solutions can help
Need help ensuring your cosmetic ingredients are safe for use? Get assistance with your U.S cosmetic product compliance from our consultants. Contact Quality Smart Solutions today! We can help.