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Hydroxycitrate complex (update)
The current compositional guideline for "hydroxycitric acid and hydroxycitrates derived from Garcinia quaesita" has recently been revised by the Therapeutic Goods Administration (TGA). TGA also amended the draft compositional guideline to include a new Australian approved name (AAN) "hydroxycitrate complex". The new AAN more appropriately identifies the hydroxycitric acid and the associated salts, calcium hydroxycitrate, potassium hydroxycitrate and sodium hydroxycitrate, derived from the rind of G. quaesita. Instead of selecting individual AANs for hydroxycitric acid and each of the associated salts, sponsors may now simply select hydroxycitrate complex as an ingredient when lodging an application for a listed medicine in the Electronic Listing Facility.
Hydroxycitric acid, potassium hydroxycitrate, sodium hydroxycitrate or calcium hydroxycitrate originally appeared as ingredients suitable for use in listed medicines in a Listing Notice published in the Commonwealth of Australia Special Gazette on 10 November 1999.
In the absence of a suitable monograph, TGA (in consultation with the sponsor of the original application) develops a draft compositional guideline to describe any newly approved ingredient for use in listed medicines. In August 2002, TGA distributed a draft compositional guideline to industry for "hydroxycitric acid and hydroxycitrates derived from G. quaesita". TGA subsequently received a number of requests from industry to clarify the original compositional guideline. In consultation with industry, TGA has updated the draft compositional guideline for "hydroxycitric acid and hydroxycitrates derived from G. quaesita" by:
- revising the AAN through the AAN Committee to hydroxycitrate complex, which includes the sodium, potassium and calcium salts; and
- amending the specifications in the draft compositional guideline to hydroxycitrate complex (including the salts, calcium hydroxycitrate, potassium hydroxycitrate and sodium hydroxycitrate), to assist sponsors in the appropriate characterisation of this substance.
In amending the draft compositional guideline to hydroxycitrate complex, TGA sought comment from raw material suppliers on the appropriateness of the specifications to adequately describe the substance available to Australian sponsors for incorporation into therapeutic goods. Raw material suppliers queried the use of only G. quaesita in the compositional guideline since a number of international suppliers quote G. cambogia as a source of hydroxycitric acid. TGA currently recognises G. quaesita as an ingredient suitable for use in listed medicines for supply in Australia. According to botanical taxonomy sources, G. cambogia could be one of several separate species: quaesita, zeylanica or hanburyi. Neither G. zeylanica nor G. hanburyi are currently approved for use in listed medicines. TGA recommends that sponsors who intend to include this herbal ingredient in a listed medicine should approach the supplying company for appropriate botanical authentication of the herb before purchase, to confirm the correct botanical species.
After finalising the draft compositional guideline for hydroxycitrate complex, TGA intends to advise affected sponsors of the possible need to:
- implement an ingredient name change in their products within an agreed time-frame; and
- express the equivalence of hydroxycitric acid content contained in the ingredient.
A copy of the compositional guideline for hydroxycitric complex is available. Consultation on the draft compositional guideline for hydroxycitric complex closed on 8 July 2005.