Frequently asked questions about quality and regulation of herbal products

Following the official launch of the Herbal Quality Campaign (HQC), ANH-Intl responded with a press release that redresses the balance and corrects misinformation spread by the HQC. Below, we have put together a set of questions that are uppermost in consumers’ minds while this issue is in the public eye.

1) Is current enforcement of the THMPD adequate?
2) How can herbal food supplements be of the same or similar quality to herbal medicines registered under the THR scheme, when the former aren’t assessed by the MHRA?
3) Haven’t there been many examples of poor-quality herbal products that have endangered the public? Surely effective policing of the THMPD would remove these from sale?
4) Are recent rulings by the European Court of Justice preventing the MHRA from enforcing the THMPD properly?
5) Are small herbal firms in danger of going out of business if the MHRA does not step up enforcement of the THMPD?
 

1) Is current enforcement of the THMPD adequate?

The HQC contends that enforcement of the Traditional Herbal Medicinal Products Directive (THMPD) by the UK medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), is inadequate and implies that public safety is being put at risk as a result. In the UK, THMPD-registered herbal medicines are issued a Traditional Herbal Registration (THR) number, confirming that the product meets the THMPD’s standards of safety and quality. The HQC contends that, because non-THR-registered herbal products remain on UK shelves, the MHRA is not policing the THMPD thoroughly.

There are multiple routes by which herbal products may legally reach UK shelves. Apart from full (drug) marketing authorisation, ‘established use’ provisions and practitioner-prescribed products, many herbal products can legitimately be sold as botanical food supplements.  It is these food supplements that are in the cross-hairs of the HQC. The THMPD is specifically for registration of manufactured herbal medicines designed for treatment of mild, self-limiting conditions without any oversight from a trained practitioner. Before the THMPD came into full force on 1st May 2011, many unbranded herbal products were sold in the UK under a specific exemption of the 1968 Medicines Act (Section 12(2)). While this exemption expired and has been replaced by the THMPD, the different eligibility and technical requirements of the THMPD mean many unregistered medicines previously sold under the Section 12(2) exemption cannot access the THR scheme. Some manufacturers and suppliers have chosen to re-categorise products previously sold under the Section 12(2) exemption as food supplements – a perfectly legitimate option, provided that food supplement product and labelling requirements are met. This includes avoiding any medicinal claims or therapeutic indications. 

It appears that the HQC want to see the MHRA target companies selling botanical food supplements, and force them either to apply for THRs or remove their products from the market.  Such evaluation would require a case-by-case evaluation by the MHRA to determine if products that selling as food supplements fulfil the MHRA’s interpretation of the definition of a medicine. However, the government authority charged with overseeing the legality of food supplements is in actual fact the Department of Health, so the MHRA’s opinion would only become relevant where a food supplement was deemed to fulfil all criteria that would classify it as a medicine, rather than as a food supplement.

2) How can herbal food supplements be of the same or similar quality to herbal medicines registered under the THR scheme, when the former aren’t assessed by the MHRA?

The HQC contends that, since non-THR-registered herbal products have not been reviewed for safety and quality by the MHRA, they are intrinsically of lower quality compared with those products with THRs. However, food supplement legislation means that it is an offense for products to not meet the description and contents given on their packaging.  This ensures that the vast majority of botanical food supplements sold in the UK are of high quality, albeit they may or may not be standardised for particular active ingredients.  If they are, this tends to be clearly stated on the label, and products that are not standardised are not necessarily of lower quality.  Many non-standardised products, for example, focus more on providing a full spectrum of active ingredients found within the whole plant materials present.  In this sense, they are more like foods than they are like medicines, where the benefits appear to be linked to a synergy between the spectrum of active ingredients contained.

It’s also worth bearing in mind that food supplements have been shown to be safer than conventional foods at normal exposure levels. Furthermore, since botanicals are devoid of therapeutic indications, they do not legally require product information leaflets (PILs) to be included with the product, in contrast to THR-registered products. However, where precautions are relevant, these are required to be stated on label and good practice among food supplement producers ensures this is the case, with very few exceptions. As such, the HQC criticism that botanicals’ lack of PILs makes them intrinsically lower quality, and by implication less safe, is in our view unfounded.

3) Haven’t there been many examples of poor-quality herbal products that have endangered the public? Surely effective policing of the THMPD would remove these from sale?

In fact, notably few genuine safety concerns have been linked to food supplements. Those rare cases are usually due to the manufacturers failing to follow traditional preparation methods, or arise because the products have been spiked or contaminated with pharmaceuticals.  Either way, food supplement law as it stands is sufficient to remove such products from the shelves. If a manufacturer markets a black cohosh product, for instance, that contains dangerously high levels of active ingredients (in this case, particular triterpene glycosides), no change in the law or policing of the law is needed to take it off the market.

An oft-quoted example of an herbal product that has damaged public health is that of the Chinese herb, Aristolochia fangchi. The most commonly cited case of injuries relate to a case in Belgium in 1990, after Aristolochia was prescribed as part of a slimming programme by medical doctors.  The doctors prescribed a cocktail of drugs in addition to Aristolochia and other herbs, and 135 patients suffered severe kidney damage (nephropathy) as a result, with a proportion going on to develop cancer. Interestingly, three court cases have failed to prove that Aristolochia was responsible for the problem, but the perception remains that Aristolochia was the sole culprit. The most likely explanation for the cases of kidney nephropathy seems now to involve the fungal toxin ochratoxin, along with amphetamine-like drugs prescribed in the slimming ‘cocktail’ provided by the doctors.  Whatever the actual reason, the case was tragic and one important lesson that has been learned is that herbal products that have potential toxicity, such as Aristolochia, should never be used outside of their traditional context.  It should be noted that traditional preparations containing Aristolochia, used in both traditional Chinese medicine (TCM) and Ayurveda, are never associated with kidney nephropathy, because the water decoction process used in their production ensures that potentially harmful aristolochic acids are substantially reduced in concentration.

It should also be noted that the MHRA and other European medicine authorities have reacted accordingly to cases of kidney toxicity associated with aristolochic acids and so have banned Aristolochia EU-wide.  This shows what regulatory action can be taken when there is suggestive evidence of harm, even if not conclusively proven.

4) Are recent rulings by the European Court of Justice preventing the MHRA from enforcing the THMPD properly?

No. In fact, the European Court of Justice (ECJ) has tried to bring some clarity to the confused and complex issue of the food–medicine borderline, otherwise known as: when is a substance a food and when is it a medicine? The relevant ECJ rulings state that a product or substance can only be deemed medicinal after weighing up in its entirety, including the dosage of active ingredients (posology), their consequent likely pharmacological actions and the presentation of the product.  The MHRA is perfectly aware of this reasoning, discussing it in the MHRA’s Guidance Note No 8, “A Guide to What is a Medicinal Product”.  Legal uncertainty around the food–medicine borderline causes some to assume that all herbal products used for healthcare purposes are medicinal.

5) Are small herbal firms in danger of going out of business if the MHRA does not step up enforcement of the THMPD?

Smaller firms, like Rutland Biodynamics, which have managed to negotiate the THMPD minefield and obtain THRs for their products – while ensuring their products remain free of artificial ingredients, stabilisers or polymers – are very rare. The vast majority of companies with wide THR-approved product ranges are large phytopharmaceutical firms, such as the German companies Schwabe Pharma and Bionorica. These companies appear to be upset that, having invested large amounts of money into their THRs – and seemingly having been promised by the MHRA that only THR-approved products would be legal for sale in the UK – some of their competitors are able to remain on the market as food supplements. 

For the reasons given in the answer to Question 1, above, enforcement of the THMPD is not the issue, and additional enforcement by the MHRA is unlikely to have the effect desired by the HQC. If the companies have been badly advised concerning the THMPD’s ability to remove competition from the marketplace, that is unfortunate. However, no-one is likely to go out of business: companies like Schwabe and Bionorica are simply too large, Rutland sells a wide variety of products apart from its THR-certified ones, and there are vanishingly few other small companies with THRs that could possibly be endangered.

The real answer is reform of the THMPD, to make it appropriate for the type of herbal products used by all herbal traditions and not just Western herbal medicine – or, more accurately, phytopharmaceutical medicine. In addition, a separate legal framework for practitioner-prescribed products is needed, along with an open and realistic food supplement regime. Such a regulatory landscape would include space for all types of herbal product, and initiatives like the HQC, which trumpets public safety while aiming at monopoly, would be unnecessary.

Related ANH-Intl news stories:

ANH-Intl feature – Frequently Asked Questions about EU herbal registrations and bans: http://www.anh-europe.org/news/frequently-asked-questions-about-eu-herbal-registrations-and-bans

Shoddy study casts doubt on herbal products’ safety information: http://www.anh-europe.org/news/shoddy-study-casts-doubt-on-herbal-products-safety-information

Natural healthcare proven amazingly safe – once again: http://www.anh-europe.org/news/natural-healthcare-proven-amazingly-safe-–-once-again

 

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ANH Nurture Traditional Medicinal Cultures campaign page

Updated: 2 Feb 2012

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