Uncertainties

This is a discussion paper. It does not reflect the views of the Committee. It should not be cited.

195.               The following uncertainties have been noted:

• Dietary supplement labels often do not list the full scientific name/specie of G. cambogia nor the part of the plant that the extract(s) is/are derived from. This represents an uncertainty as it does not allow accurate determination of the components of the food product (including food supplements).
• G. cambogia products have inconsistent labelling. Some are simply marketed as G. cambogia or G. cambogia extract without describing whether it is HCA nor the standardised HCA content. This poses an issue for both exposure and risk assessment as the HCA content is unknown.
• The percentage of standardised HCA in G. cambogia extract or the salt form of HCA in food supplement products is not always disclosed and there is inconsistency in labelling of said products. Depending on the amount of concentrate and the form of HCA salt, the toxicological profile could potentially be different.
• G. cambogia (and/or its extract; HCA) is more commonly present in MIDS that have other active compounds that may or may not be fully disclosed, which does not allow for a comprehensive risk assessment.
•  If G. cambogia (and/or its extract) is present in MIDS there is a potential synergistic effect of the mixture, the potential risk(s) of which is unknown.
• Consumers may use more than one HIDS and/or in combination with prescription drugs. Incorrect dosing is also possible should the consumer not follow the manufacturers’ instructions.
• Considerations for the presence of contaminants such as heavy metals, extraction solvents (from the manufacturing process), pesticides or any other chemicals that could pose a risk to health have not been considered in this assessment.
• Case reports in the literature are limited to certain brands and formulations of G. cambogia and may not always provide the holistic state of the consumer: granularity on duration of exposure and dose, health status of the consumer (e.g., do they have suspected liver injury or immunocompromised or any other, fasting or non-fasting, physically active or not active), concomitant with other drugs or MIDS. Thus, identification of sensitive population and establishment of a mode of action for the toxicity observed in these cases is always not possible.
• Possible drug-drug interactions have been reported in some case-studies (e.g., anti-depression (serotonergic drugs), drugs affecting the liver). However, there is little scientific information to be able to fully assess this potential risk. Furthermore, it is unknown if other types of medication can cause adverse drug interaction.
• The long-term safety of G. cambogia (and/or its extract; HCA) has not been established.