Expertise

The US FDA Modernization of Cosmetics Regulation Act of 2022 commonly known as MoCRA establishes the legal framework for placing a cosmetic product on the US market.
Are you MoCRA compliant?
We can help!
Choose ToxEssential to meet regulatory and safety requirements for Canada, EU & UK. Contact us today!

Is it a drug? Is it a cosmetic? What is the risk?
We can help you classify your product and ensure compliance with the US FDA monograph or the Modernization of Cosmetics Regulation Act (MoCRA) of 2022. OTC drug monographs are a kind of “recipe book” covering ingredients, doses, formulations, labeling and testing. Products conforming to a monograph may be marketed without FDA pre-approval.

The Federal Hazardous Substance Act (FSHA), the regulatory frameworks in the US, is administered by the Consumer Product Safety Commission (CPSC). It requires household products that contain hazardous substances to be labeled with cautionary statements. However, the CPSC does not provide specific examples of consumer products and some products are regulated by other federal agencies e.g., pesticides are regulated by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)

Enacted in 1988, the Labeling of Hazardous Art Materials Act (LHAMA) requires “art material products” to undergo a toxicological assessment and certification by a toxicologist at least every 5 years.

Is your product safe and compliant? Ask us!

ToxEssential can help identify gaps in the available data and recommend steps to mitigate them. In cases where additional testing is required, ToxEssential can design the required study, select expert laboratories, and ensure the reports meet ISO 10993 requirements and Regulatory standard. We focus on in vitro and in vivo biological testing, chemical characterization and toxicological risk assessments which aligns with Regulatory Agencies' expectation worldwide.
Contact us to learn more!