Regulatory Compliance

Home / Regulatory Compliance

Regulatory Compliance

Keeping up with the latest developments in the dynamic field of chemical product regulation is a challenge for many organizations. With state, domestic, and international regulatory requirements often out of sync, it’s essential to understand how to navigate this complex landscape to avoid violations and enforcement actions. Does your organization know which product categories require pre-market approval or formal registrations? Are there mandated post-market reporting requirements for your products? We understand that navigating these regulatory demands can be stressful and challenging. Miles Consulting is here to guide your organization through the process, ensuring that your products are safe, compliant, and market-ready.

Modernization of Cosmetics Regulation Act of 2022 (MoCRA)

If you are a manufacturer, packer, or distributor of cosmetic products in the United States, understanding and adhering to the latest requirements of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is essential. The MoCRA legislation has transformed many previously voluntary industry practices—such as adverse event reporting—into mandatory obligations, aligning U.S. standards more closely with global FDA regulations.

Under MoCRA, the FDA now has enhanced authority to ensure consumer safety, including the right to access and copy certain records, such as safety documentation, and the ability to issue cosmetic product recalls when necessary. Compliance with these regulations is critical not only for legal adherence but also to maintain consumer trust and product integrity.

We offer a range of services to support your compliance journey, including:

Formal Safety Assessments (Safety Substantiation): Ensuring all products meet FDA standards for safety and efficacy.
Standard Operating Procedures (SOPs): Developing customized, MoCRA-compliant SOPs for consistent and compliant product manufacturing and handling.
Regulatory Support: Navigating FDA communications, recall procedures, and other regulatory requirements.

Our expert guidance can help your company meet these evolving standards, ensuring your products are both safe and market-ready. Reach out today to discuss how we can assist in maintaining compliance and building a foundation for long-term success in the cosmetics industry.

PROPOSITION 65

If your organization currently sells products in California or intends to enter this market, ensuring compliance with California’s stringent regulations, such as Proposition 65 (the Safe Drinking Water and Toxic Enforcement Act of 1986), is essential. Non-compliance can lead to significant fines, legal issues, and negative media exposure that may harm your brand reputation.

At Miles Consulting, we specialize in helping companies navigate these complex regulatory waters. Our services include:

Comprehensive Compliance Assessments: Understanding the nuances of Proposition 65, including Safe Harbor Levels such as No Significant Risk Levels (NSRL) and Maximum Allowable Dose Levels (MADL), to ensure your products meet California’s strict safety standards.
Product Testing and Analysis: Determining whether your products contain any of the chemicals listed under Proposition 65 and ensuring levels are within allowable limits to prevent enforcement actions.
Strategic Compliance Planning: Developing customized strategies to address any potential risks and prevent costly penalties that could impact your bottom line.

Whether you’re aiming to prevent potential violations or establish a proactive compliance framework, we’re here to guide you. Reach out to Miles Consulting today to protect your business and uphold consumer trust as you grow in the California market.

MENSTRUAL PRODUCT RIGHT TO KNOW ACTS

Menstrual products are increasingly subject to regulatory scrutiny due to their critical impact on women’s health. As a manufacturer or distributor in this sector, understanding and adhering to the additional regulatory requirements for these products—which are classified as medical devices in many states—is essential.

Miles Consulting is here to be your trusted partner in navigating this complex regulatory landscape. Our team offers in-depth expertise to help ensure your menstrual products meet all relevant compliance standards, including:

Regulatory Guidance and Compliance Support: Understanding state-specific requirements and the classification of menstrual products as medical devices, which may include safety testing, ingredient transparency, and labeling standards.
Product Safety and Efficacy Assessments: Ensuring your products align with health and safety standards aimed at protecting consumers.
Strategic Compliance Planning: Developing a tailored compliance roadmap to keep your company ahead of regulatory changes, avoiding potential penalties, and safeguarding your brand reputation.

Let Miles Consulting assist in fortifying your commitment to consumer health and regulatory compliance. Together, we can navigate these evolving requirements and establish a foundation of trust and safety for your products.