At FDAPals, we specialize in providing comprehensive FDA cosmetic regulations compliance solutions. We have years of experience in helping our clients understand and adhere to all applicable regulations, from label review and registration to manufacturing and distribution guidelines.
We can provide you with detailed assistance on how to satisfy FDA guidelines, as well as ensure that your products meet all safety and manufacturing standards. Our team of experienced professionals will work with you to ensure that your products are compliant, safe, and effective for your customers
We provide a comprehensive range of FDA cosmetic regulations compliance services ( MoCRA Compliance) to meet December 29, 2023 deadline including,
1: What is MoCRA?
MOCRA stands for the FDA’s “Modernization of Cosmetic Regulations Act”, which was implemented in 2020 to update the cosmetic industry’s regulations. This law laid out requirements for labeling, production, distribution, safety testing, and other aspects of cosmetics that must be adhered to in order to remain compliant with FDA regulations. It is a major amendment to the FDA’s cosmetics regulatory framework after 85 years
2: What is the Modernization of Cosmetics Regulations ( MoCRA) Acts Requirements?
- Mandatory FDA Registration
- Mandatory Product Listings
- Adverse Event Reports
- Good Manufacturing Practices
- Record Keeping
- Safety Substantiation
- Labelling
- Declaration of Fragrance Allergens
- Standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products
3: When is MoCRA implemented from?
MOCRA was first implemented in 2020 and is currently in effect.
4: What are the new labelling requirements?
Under MoCRA, all labels must contain accurate information about the product’s ingredients and their associated risk levels, instructions for safe use and storage of the product, warnings regarding potential health hazards associated with certain ingredients or uses of the product, as well as contact information for the responsible person (e.g., manufacturer).
5: Who is the responsible person as per MoCRA 2023?
The responsible person under MOCRA is typically either a company or individual who has taken responsibility for ensuring that a cosmetic meets all applicable regulatory requirements set forth by law or regulations. This person can include manufacturers, distributors or importers of cosmetics.
6: When is MoCRA Registration Deadline?
MoCRA effective Date is December 29, 2023 ,Cosmetic companies need to register and comply with MoCRA regulation by then.
All domestic and foreign facilities must register with the FDA no later than December 29, 2023, or within 60 days of initiating manufacturing or processing operations for new facilities. Registration must be renewed biennially, and any changes to the registration information must be notified to the FDA within 60 days.
FDA Has now extended additional six months after the December 29, 2023, statutory deadline, or until July 1, 2024, to provide regulated industry additional time to comply with these requirements
7: What is the Scope of MoCRA?
The MoCRA has a wide scope, covering all aspects of the cosmetics industry, including manufacturers, importers, marketers, and distributors of cosmetic products, as well as the ingredients and manufacturing methods used.
8:What is an Adverse Event (AE)?
Any negative health event associated with the use of a cosmetic product. Cosmetic Companies are expected to maintain records of all adverse event reports
9: What is Serious Adverse Event?
An adverse event that results in death, life-threatening experiences, hospitalization, significant disability, birth defects, infections, or significant disfigurement. SAE are also to be reported under Adverse event Report
10: Who are exempt from FDA new cosmetic Regulatory Requirements ( MoCRA) ?
Cosmetic companies solely involved in labeling, relabeling, packaging, or repackaging of cosmetic products are exempt from registration.
11: Who Does MoCRA Impact?
- MoCRA primarily impacts cosmetic manufacturers, importers, packers, and distributors of finished cosmetic products.
- Some small businesses are exempt from certain requirements like Good Manufacturing Practices (GMP), registration, or listing (with some restrictions).
- MoCRA defines cosmetic products as preparations of cosmetic ingredients for use in a finished product.
- MoCRA does not apply to over-the-counter (OTC) drugs that make cosmetic claims, except for new provisions related to fragrance allergen disclosure and professional use labeling.
11: MoCRA provides new authorities to the FDA, including?
- Registration Suspension: The FDA can suspend a facility’s registration if a cosmetic product poses a reasonable risk of serious adverse health consequences. The facility cannot create new products until registration is restored.
- Records Access: The FDA can access and inspect records related to a cosmetic product if there are concerns about adulteration and serious health consequences. Certain confidential information, like recipes and financial data, is excluded.
- Recall Authority: The FDA has mandatory recall authority if a cosmetic is deemed adulterated or misbranded; with a reasonable probability of harm upon exposure.
12: How do I prepare for MoCRA Registration?
Preparing your business for compliance with MOCRA requires an understanding of both existing laws as well as any changes introduced through this act. Our team at FDApals can provide tailored guidance throughout every step of this process – from initial label review through registration assistance – so you can rest assured knowing that your business remains compliant with ease and confidence! Contact us Now to learn more!.
