Cannabis Product Services
FDA is currently evaluating the regulatory framework that applies to hemp-based CBD products. Until this regulation is implemented, FDA has determined that hemp-based CBD products cannot be marketed as dietary supplements in the US. However, the FDA still expects that manufacturers of CBD products maintain the quality standards outlined with Good Manufacturing Practices (cGMP). CBD companies that are marketing CBD products with medical claims or claims related to structure and/or function of the body are considered in violation of the law and are being issued Warning Letters (483) by the FDA and the Federal Trade Commission (FTC).
It is very important for hemp-based CBD companies to maintain compliance with cGMP regulations and compliance with the labeling requirements in order to avoid receiving a 483 Warning Letter from FDA. The most common warning letters being sent to hemp-based CBD companies are for infractions regarding adulterated products and misbranding. A product is deemed adulterated by FDA when the manufacturer is not compliant with cGMP regulations. A product is deemed misbranded if the marketing and/or labeling of the product does not comply with regulations.
Whether you are preparing your company for forthcoming regulations, responding to a 483, or developing your quality management system, BRC is an expert in the field of cannabis regulations and can help.