SOPs Consistent with MoCRA Now Available at discount!
Email ralph.fucetola@gmail.com with "MoCRA SOPs" in Subject Line
Yes, you must have SOPs for your Cosmetic Products…
Last year Congress adopted the first comprehensive amendment to the cosmetic laws since 1938. The Modernization of Cosmetics Regulation Act of 2022 — MoCRA — empowers FDA by making mandatory various previously ‘voluntary’ requirements for cosmetics sold to Americans. In summary:
Mandatory facility and product registration
Adherence to cosmetics Good Manufacturing Practices (GMPs)
Adverse event reporting
Safety substantiation
Additional labeling requirements
New enforcement powers and records access for FDA
The new law goes into effect on December 29, 2023. FDA expects to have an online registration system by then. I will be working closely with my clients to make sure their cosmetic products meet the new standards.
Once MoCRA takes effect registration will no longer be voluntary but will be required for every cosmetics manufacturing facility, regardless of where it is located.
FDA defines cosmetics at “Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)”
“…by their intended use, as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance" [FD&C Act, sec. 201(i)]. Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, cleansing shampoos, permanent waves, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product. “ https://www.fda.gov/cosmetics/cosmetics-laws-regulations/it-cosmetic-drug-or-both-or-it-soap#Definecosmetic
Email me at ralph.fucetola@gmail.com with “Cosmetics” in the subject line to get started. Each of your cosmetic products must be registered. This is immediately important for all cosmetic-label-owners and for manufacturing facilities that handle cosmetics.
See also: www.ProfessionalSafetyDossier.com
Additional Notes:
1. All cosmetic products will have to register with FDA, providing:
Place of manufacture
Product category
Ingredients (fragrances, flavors & colors)
FDA will assign a product listing number.
2. FDA will propose a Good Manufacturing Practices rule within 2 years.
3. Adverse Event Reporting, defining AER:
“death, a life-threatening experience, inpatient hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect, infection, significant disfigurement (serious or persistent rashes, second or third degree burns, hair loss, or persistent or significant alteration of appearance), or an event which requires medical intervention to prevent the health outcomes listed above.”
4. FDA web page about MoCRA: https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022
5. FDA Cosmetic GMP Guidance: https://www.fda.gov/media/86366/download?attachment
6. FDA MoCRA site: https://www.fda.gov/cosmetics/registration-listing-cosmetic-product-facilities-and-products
