We now offer comprehensive OTC services to help businesses expand their product lines into the U.S. market. With our extensive expertise and in-depth knowledge, we guide companies through the complex regulatory framework overseen by the U.S. Food and Drug Administration (FDA) and other governing bodies.
In the U.S., the FDA categorizes products as cosmetics when they are designed to clean, enhance beauty, or alter appearance without impacting the body’s structure or functions.
However, if a cosmetic claims to treat or prevent disease or affect the body’s structure, it may be classified as a drug or an Over-the-Counter (OTC) drug, requiring compliance with stricter regulations.
This distinction highlights the need for a solid understanding of the regulatory landscape, including 21 CFR Subchapter C and Subchapter D. CE.way provides essential support to manufacturers and brand owners, ensuring full compliance with these requirements.
Anti-perspirant deodorants (OTC Monograph ID M019)
Acne products (OTC Monograph ID M006)
Products formulated with sunscreens designed to protect the skin with SPF values (OTC Monograph ID M020)
Dental products formulated to prevent tooth decay (OTC Monograph ID M021)
And many other products that impact the structure or function of the body
Through our OTC consultancy services, we enable brands to prioritize product innovation while CE.way handles the regulatory compliance process, ensuring products are properly listed with the FDA for success in the U.S. market.
Our specialized services assist companies in meeting FDA regulations through the following:
1. Product Development Guidance
We offer expertise in formulation, helping companies align their products with the appropriate monograph and select compliant active ingredients. Our guidance also ensures formulations meet requirements across all U.S. states, minimizing the need for multiple versions.
2. OTC Product Labeling
The FDA requires precise labeling, including product identity, net contents, ingredient lists, usage directions, and warnings. We ensure all products meet these labeling standards.
3. Product Claims Substantiation
Claims on product labels must adhere to the relevant monograph and be backed by scientific evidence. CE.way ensures all claims are well-substantiated, avoiding misleading information and potential legal issues.
4. Manufacturing Compliance
We provide guidance on FDA-approved manufacturing facilities, quality management systems, and adherence to Good Manufacturing Practices (GMP).
5. Adverse Event Reporting and Post-Market Surveillance
We support ongoing compliance by monitoring product performance, managing consumer feedback, through to reporting verified adverse reactions to the FDA. This protects consumer safety and brand reputation.
6. State-Specific Regulations
States like California have unique regulations, such as Proposition 65. Our consultants ensure compliance with state-specific requirements.
7. FDA Establishment Registration
We assist with the annual registration of manufacturing facilities with the FDA.
8. FDA Product Listing
CE.way ensures successful product listing with the FDA and manages its ongoing maintenance.
With our support, businesses can confidently navigate the intricate landscape of OTC regulations in the U.S. market. Our expertise safeguards brand reputation, streamlines FDA compliance, and future-proofs businesses, allowing them to focus on innovation and growth.
Need help with the cosmetics regulations and testing?
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