Understanding Sources of Heavy Metals in Cannabis and Hemp: Benefits of a Risk Assessment Strategy
The pharmaceutical industry took over 20 years to move from the semi-quantitative monitoring of a small group of heavy metals to finally arrive at regulations for 24 elemental impurities in drug products, listed by their permitted daily exposure (PDE) limits and categorized by toxicological impact and method of administration (oral, parenteral, inhalation, transdermal). The entire premise was based on carrying out a comprehensive risk assessment study of the elements’ toxicity and the likelihood of finding them somewhere in the drug manufacturing process, which was fully documented in ICH Q3D guidelines for elemental impurities.
The cannabis industry cannot move beyond testing just four heavy metals until this type of risk assessment study is carried out. The objective of this white paper is to offer guidance as to which elemental contaminants are worthy of consideration, based on likely sources derived from the cultivation, extraction, processing, packaging and delivery of cannabis and hemp consumer products and to explore how this well-established pharmaceutical risk assessment process could be adapted by the cannabis industry.
The white paper will be broken down into four major sections outlined below:
- The pharmaceutical risk assessment approach
- Can risk analysis be adapted for the cannabis industry?
- Sources of elemental contaminants derived from cultivation practices
- Contributions from the cannabis manufacturing process
