MoCRA is here. Are you ready?
July 18 2024 – Essential Labs
Essential Labs: Important Information for Cosmetic Resellers
As of July 1, 2024, the Modernization of Cosmetics Regulation Act (MoCRA) has become implemented. Essential Labs is not liable for the legal obligations associated with their customers selling cosmetics, we are only liable for ours. However, we strongly advise our customers to obtain at least a basic liability insurance policy if they plan to resell products. We also recommend testing any products you purchase from us, especially if you’re adding other ingredients to them. While we stand by the quality of our products, once the container is opened, we cannot be held accountable for it, as we cannot truly verify how it has been handled or stored.
Facility Registration
All U.S. cosmetic products must be produced in FDA-registered facilities. Essential Labs' facility number (FEI) is 3003887109, located at 2211 Nw Nicolai, Portland, OR 97210.
Small Business Exemptions
Small businesses with annual sales under $1 million may be exempt from some requirements, except for products posing higher risks, such as those used near the eyes or intended for internal use.
Good Manufacturing Practices (GMPs)
By the end of 2025, cosmetic products must be manufactured according to FDA-issued GMPs. Essential Labs, which implemented cGMP in 2005, will ensure all products meet these standards.
Registration and Listing
Facilities that manufacture or process cosmetic products for U.S. distribution must register with the FDA and renew their registration every two years. Companies must also provide annual product listings.
Adverse Event Reporting
Companies must report serious adverse events to the FDA within 15 days and maintain records. Serious adverse events include those leading to death, hospitalization, significant disability, or disfigurement.
Safety Substantiation
Manufacturers must ensure the safety of their products through testing, research, or other evidence. Essential Labs provides third-party testing results for newer products and evidence for older ones.
Customer Compliance Responsibilities
Our customers are responsible for complying with all federal, state, and local regulations throughout the entire lifecycle of the product. Essential Labs can provide Safety Data Sheets (SDS) and Certificates of Analysis (CoA) for products we manufacture and sell. We urge all customers to seek legal counsel to ensure their products meet all applicable regulatory requirements.
Labeling and Packaging
Cosmetic products must comply with FDA and state labeling requirements, including country-of-origin labeling. Packaging must be safe and compliant with regulations.
General Definitions
Definition of Cosmetics
According to the FD&C Act, cosmetics are defined 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.” Cosmetics categories include:
- Baby products such as shampoos and lotions
- Bath preparations such as bath oils and bath soaks
- Eye makeup preparations such as eyeliner and mascara that doesn’t make claim to hair growth
- Fragrance preparations such as cologne and perfumes
- Hair preparations such as conditioners and styling products
- Makeup preparations such as foundations and blushes
- Manicuring preparations such as nail polishes and cuticle oils
- Oral products such as mouthwashes or toothpastes that don’t claim to whiten teeth
- Personal cleanliness products such as shower gels and deodorants
- Shaving preparations such as shaving cream and aftershave splash
- Skin care preparations such as creams and lotions
- Suntan preparations such as tanning lotions and oils
- Tattoo preparations
Some traditional soap products fall outside the FD&C Act definition of cosmetics, but many are still regulated as cosmetics, especially if they claim to moisturize or deodorize. Products intended for animal use are not regulated by the FDA but by the Consumer Product Safety Commission.
Cosmetic Tools and Accessories
Tools and accessories designed to enhance appearance, such as hair dryers, nail clippers, and makeup brushes, are regulated by the Consumer Product Safety Commission, not the FDA. Essential Labs sells a few supplies and packaging options.
Cosmetics as Drugs or Medical Devices
Some cosmetic products may be treated as drugs or medical devices if they are intended to treat or cure diseases or affect the body's structure or function. Examples include:
- Skin Disease treatments such as Acne, Psoriasis, etc;
- Antiperspirants
- Sunscreen products even once that claim a protection without a qualifying SPF number.
- Dandruff and thinning hair treatments
- Hair removal device.
Regulations to Know About
Legal Requirements for Cosmetics
Cosmetics must meet various federal and state regulations, including manufacturing standards, safety reporting, and registration/listing with the FDA. Labels must include an identity statement, quantity of contents, manufacturer details, material facts, warnings, and ingredient lists
FDA Approval for Cosmetics
Cosmetics do not require FDA approval, but they must comply with all relevant regulations, including ingredient restrictions, manufacturing practices, and labeling requirements.
Cosmetic Product Ingredient Statement
FDA Form 2512 is frequently requested when selling in certain markets. This form is not a requirement by the FDA but can be helpful. The form should be filled out by the individual brands as the information requested is regarding the final retail product.
Big Box Store Regulations
Before selling to major retailers, ensure compliance with their specific regulations.
State Requirements
Some states have additional licensing and registration requirements beyond federal ones. Check with your local commerce department for specifics.
Claim Verification
All product claims must be truthful and substantiated. Claims about treating diseases or affecting the body's structure may classify a product as a drug. The FTC regulates cosmetic advertising and requires all claims to be supported by scientific evidence.