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Cannabis Product Services

Clinical

Trials

483-Warning Letters

Quality Management Systems

Labeling and Health Claims

Medical Writing

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.

 

Clinical Trials

  • Develop and Write Clinical Trial Protocols

  • Develop and Write IRB Applications 

  • Clinical Site Audits 

483 Remediation-Warning Letters

  • Prepare for FDA Inspection- Conduct Internal Audits

  • Write and Develop effective CAPA (Corrective and Preventive Action) Plan

  • Government Representation

Quality Management Systems

  • Developing and Writing Standard Operating Procedures (SOP’s)

  • Develop and Auditing Production and Process Controls

  • Records Management

Labeling and Health Claims

  • Audit current marketing and labeling for FDA/FTC compliance 

  • Develop marketing and labeling language plan that is FDA/FTC compliant 

  • Audit current social media program for potential non-compliance

Medical Writing

  • Develop and write regulatory submissions such as:

    • IND- Research of Cannabis products​

    • GRAS- Conventional foods containing cannabis 

    • NDI - New dietary ingredient notifications

    • Structure/Function Notification- FDA notifications of structure/function claims

 
 
 
 

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