Regulation of herbal drugs: a pragmatic public health approach?BMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g4156 (Published 24 June 2014) Cite this as: BMJ 2014;348:g4156
- Anthony R Cox, lecturer in clinical pharmacy1
- 1Pharmacy, Pharmacology and Therapeutics Section, College of Medical and Dental Sciences, University of Birmingham, Birmingham B15 2TT, UK
McCartney’s view that the regulation of herbal products leads to the potential for non-evidence based herbal preparations being given a cloak of scientific credibility ignores the counter-argument that such regulation is an important public health measure.1
Increasing concerns about the safety of herbal drugs, including cases of serious renal toxicity and cancer linked to the use of Aristolochia,2 were noted by regulators.3 Adulteration with heavy metals, dangerous herbs, and prescription drugs was common.
The regulation of herbs on the basis of a “traditional use” rather than proved effectiveness is “bizarre” only if the fundamentalist view that regulation can never be used pragmatically for the public good is taken. The risks to patients from unregulated herbal preparations means a scheme that reduces the risk of adulteration carries a public health benefit, even in the absence of known efficacy. Differing licensing requirements for prescribed drugs and herbal products do not reflect dual standards of evidence; a herbal product licence is an admission that the product has no proved efficacy.
Users of licensed herbal products can at least be assured that they are avoiding the worst excesses of unregulated herbs.4 We may not be able to protect the wallets of those foolish enough to use these products, but we can at least try to protect their livers.
Cite this as: BMJ 2014;348:g4156
Competing interests: I worked from 2002 until May of 2014 for a regional centre of the Medicines and Healthcare Products Regulatory Agency’s Yellow Card scheme.
Full response at: www.bmj.com/content/348/bmj.g3194/rr/697477.