MoCRA has granted the FDA greater authority to the industry than ever before. The FDA will now have the authority to inspect facilities, access records, request voluntary recalls, as well as order mandatory recalls. Due to the new regulations set to go into effect July 2024 the interactions and oversight for the FDA in the industry will drastically increase.
8 Things for Cosmetic companies to be aware of with the updated regulations…
- Register the facility. The registration is biennial, and you must notify the FDA within 60 days of changes to information. If operational after MoRCA goes into effect- 60 days of first engaging in activity require registration.
- Product Listing- cosmetic products must be listed to the FDA (within 120 days of marketing the product in interstate commerce if marketed after MoCRA). The companies will also need to update changes made to listing annually.
- The industry must operate under good manufacturing practices (GMPs)- the FDA will establish this rulemaking further in 2024.
- The industry must develop safety data for products and their ingredients.
- A domestic address and contact information on the packaging label will now be required.
- Clearly labeling allergens
- When applicable, include “for professional use” on the label.
- Maintain records and report adverse events. A company must submit to the FDA within 15 days of when a report is received. Up to a year after a report a company is required to submit new medical information regarding the event within 15days of receiving the information. Companies are also required to keep records for 6 years (3 years for small businesses)
It is important to note that the definition of a “serious adverse event” for a cosmetic product is defined differently than other uses of the term in the industry. In cosmetic products it is defined as “an adverse event that (A) results in (1) death; (2) a life-threatening experience; (3) inpatient hospitalization; (4) a persistent or significant disability or incapacity; (5) a congenital anomaly or birth defect; (6) an infection; or (7) 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 subparagraph (A).
The initial steps for a company to get ready for the implementation of MoCRA include…
- An internal assessment of existing products and compliance
- Register facility.
- Submit product listing and any adverse reporting.
- Adjust labeling to include allergen listing, contact information, and “for professional use” where applicable.
- Develop SOPs to meet MoRCA regulations.
Although registration and listing will be primarily administerial, companies are advised to develop standard operating procedures to manage the process, as well as monitor adverse events and report serious ones by qualified individuals. Companies should also be prepared to address additional MoCRA-required activities, such as identification of allergens, allergen labeling and GMPs, as the FDA engages in rulemaking on those issues.
Need assistance with preparing your facility and brand for the upcoming regulatory changes? Contact us today!