CE.way Regulatory Consultants provide essential OTC services for businesses seeking to expand their product portfolios into the USA. We offer the required skills, knowledge, and expertise to navigate the complex regulatory landscape governed by the US Food and Drug Administration (FDA) and other relevant authorities.
Why are we offering this additional service?
In the USA, the FDA classifies products as cosmetics when they are intended to clean, beautify, or promote attractiveness, or when they alter appearance without affecting the body's structure or functions. However, when a cosmetic product claims to treat or prevent a disease or affect the body's structure, it may be classified as a drug or an Over-the-Counter (OTC) drug. This classification subjects the product to more stringent regulations.
This distinction requires a thorough and robust understanding of the regulatory framework (Ref: 21 Code of Federal Regulations (CFR) Subchapter C and Subchapter D).CE.way provides crucial services to manufacturers and brand owners to ensure compliance with these regulations.
Examples of OTC products include:
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.
By offering OTC consultancy services, we enable brands to focus on product innovation while CE.way manages the regulatory compliance framework, ensuring products are successfully listed with the FDA and thereby enabling success in the US market.
