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Herbal Product Services

Clinical

Trials

483-Warning Letters

Quality Management Systems

Labeling and Health Claims

Medical Writing

There are two major legislative measures that affect the regulation of herbal products in the US: the Dietary Supplement Health and Education Act (DSHEA) of 1994 and the Food Safety and Modernization Act (FSMA) of 2011.  When wading through the regulations mandated  by these legislative acts, it is important to understand where your product falls between the dietary supplement classification and the general food classification.

Dietary supplements are defined as products taken by the mouth that contain a dietary ingredient intended to supplement the diet.  Foods are defined as articles used for food or drink by humans or other animals, chewing gum, and articles used for components of any such article.  Dietary supplements can be in many different dosage forms such as tablets, capsules, softgels, gelcaps, gummies, liquids, powders and bars if they do not market the product as a conventional food or sole item of a meal or diet.  It is important to understand the differences between these definitions and distinguish your product as either a food product or a dietary supplement, with your marketing and labeling verbiage.  This will help determine which regulations your manufacturing and labeling practices need to be compliant with.

Whether you are preparing your company for cGMP, responding to a 483 or warning letter, or developing your quality management system, BRC Consulting is an expert in the field of herbal products 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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