The Modernization of Cosmetics Regulation Act (MOCRA) is transforming the cosmetic industry by establishing stricter safety, manufacturing, and reporting requirements for personal care products in the U.S. At The Agyekum Group, we help brands, ingredient suppliers, and manufacturers navigate these new FDA regulations with expert MOCRA compliance consulting, product safety assessments, and regulatory submissions.

Our MOCRA services include:

✔ Safety Substantiation – Ensuring your cosmetic formulations meet the new FDA safety and documentation requirements.

✔ Adverse Event Reporting – Developing compliant systems for mandatory reporting of serious adverse events.

✔ Good Manufacturing Practices (GMP) Compliance – Aligning your manufacturing processes with FDA-enforced GMP standards.

✔ Labeling and Registration Support – Assisting with product listing, facility registration, and labeling compliance.

✔ Toxicology & Risk Assessments – Conducting thorough ingredient safety reviews to comply with MOCRA’s safety substantiation standards.

As the MOCRA enforcement deadline approaches, we ensure your brand remains compliant, mitigating risks and streamlining regulatory processes. Stay ahead of evolving FDA cosmetic regulations with expert guidance from The Agyekum Group.

California’s Proposition 65 (Prop 65) requires businesses to warn consumers if their products contain chemicals known to cause cancer, birth defects, or reproductive harm. This regulation applies to a wide range of consumer goods, including cosmetics, personal care products, food, beverages, household items, electronics, furniture, textiles, and industrial products. Non-compliance can result in hefty fines, legal action, and restrictions in the California market.

At The Agyekum Group, we help manufacturers, retailers, and distributors navigate Prop 65 regulations to ensure their products meet California’s stringent safety and labeling requirements.

Our Prop 65 Compliance Services:

✔ Toxicological Risk Assessments – Evaluating chemical exposure risks across all consumer product categories.

✔ Safe Harbor Level Analysis – Determining whether a product’s chemical content exceeds allowable exposure limits.

✔ Ingredient & Material Reviews – Helping reformulate or reduce Prop 65-listed chemicals to minimize compliance risks.

✔ Warning Label Compliance – Ensuring packaging, websites, and marketing materials meet California Prop 65 warning requirements.

✔ Regulatory Guidance & Legal Support – Assisting with Prop 65 enforcement actions, defense strategies, and settlements.

Whether you manufacture, distribute, or sell products in California, Prop 65 compliance is crucial to avoiding penalties and protecting your brand’s reputation. Let The Agyekum Group guide you through compliance with expert regulatory consulting and scientific risk assessment services.