Following implementation of the Hemp Farming Act, part of the Agricultural Improvement Act of 2018 (aka the “2018 Farm Bill”), public interest in hemp-derived products has increased rapidly. To aid industry in potential future marketing of cannabidiol (CBD) in food and/or dietary supplements across the US, ToxStrategies has been conducting systematic safety evaluations and testing programs to support future regulatory submissions. Specific areas of experience include assessment of CBD manufacturing conditions and toxicological safety, to support future Generally Recognized as Safe (GRAS) determinations or New Dietary Ingredient Notifications (NDINs), as well as the safety profile of naturally occurring CBD in hemp food products.
ToxStrategies has extensive knowledge of available data on cannabinoids and other hemp-derived products, including systematic screening of more than 4,500 safety-related studies and publication of a literature review protocol for the systematic mapping of published literature on CBD. In addition, ToxStrategies continues to monitor regulatory developments in the area of hemp-derived products and participates in relevant trade associations, such as the Council for Responsible Nutrition (CRN) and the Association of American Feed Control Officials (AAFCO).
ToxStrategies provides expertise in exposure assessment and scientific program management, including:
Regulatory Submissions
- GRAS determinations
- NDIN submissions
Scientific and Regulatory Support
- Contaminants
- Consumer complaints
- Food intake assessments
- Food, beverage, and ingredient recalls
Literature Collection and Evaluation
- Literature search and review
- Data gap analyses
- Systematic reviews and literature mapping
- Narrative reviews and assessments (e.g., hazard profile dossiers, toxicology monographs)
- Database development and maintenance (e.g., tools for managing literature)
Good Laboratory Practices (GLP) and Non-GLP Study Design and Monitoring
- Contract Research Organization (CRO) identification and cost analysis
- Assessment of laboratory qualifications
- In vitro and in vivo study design and management
- Identification of representative sample(s)
- Test material certification
- Protocol development
- Preparation and review of study reports
- Exposure data collection
- Exposure modeling
- On-site sampling/monitoring
- Exposure assessment relative to California Proposition 65
Biopharmaceutical/Pharmaceutical
- Proof-of-concept studies
- Nonclinical studies to support manufacturing changes
- Risk-based strategy to support use of new materials in clinical trials
- Changes in formulation or route of administration
- Veterinary and animal feed additives expertise
- Ingredient safety and contaminants
- New regulatory requirements
- Feasibility evaluation as animal food ingredients
- Target animal safety studies