In March, we tackled homeopathy websites. We had a tremendous response from our supporters and the Advertising Standards Authority are still dealing with the websites we all complained about. They are also working with the various homeopathy trade bodies to ensure they fully understand their obligations and responsibilities under the ASA's CAP Code and this is communicated to their members.
Once their members become aware of what they can — and cannot — say on their websites and other advertising materials, we expect to see a huge reduction in misleading claims being made.
The ASA gave the homeopaths a further three months to comply and change their websites:
We are giving you three months to review and amend the claims you make on your website. At three months, we will monitor compliance. We think this provides all advertisers with sufficient time to make the necessary changes. We will visit your website, along with all the other advertisers' complained about after 1 July 2011. If your website does not comply with the Code in the ways outlined in this letter we may have to take action.
Just in case the message doesn't get out properly, or some are reluctant or tardy in changing their websites, we will be focusing on them again. This won't be another ASA complaints campaign — we want to allow the ASA to take whatever action they see fit to obtain industry-wide compliance — but it will be something that we will need will need a lot of help with and we will let you know later how you can become involved.
More details nearer the time.
Again, we've had a fantastic response from our supporters and we believe we have some excellent example CST websites to send to the ASA. We will use the ones with the worst misleading claims as 'test' cases and submit the remainder to illustrate to the ASA the extent of the problem. We will also give the ASA full details of the various trade bodies that have CST members. We anticipate this will help the ASA in ensuring industry-wide complaince, as they are doing with the homeopathy trade bodies. It is hoped that these trade bodies will take responsible and decisive action to ensure their members comply with the CAP Code.
We will keep you informed of our progress.
We are working on several other projects including having discussions with the Medicines and Healthcare products Regulatory Agency (MHRA) on several topics of interest including homeopathy, herbals and another one we'd like to keep to ourselves for the time being!
This is a good time to say a bit about the regulation of herbal products.
Herbal products are significantly different from most other forms of alternative therapies in that they frequently contain pharmacologically active chemicals that can cause physiological effects in humans and other animals. They can therefore be dangerous: either intrinsically or because they have been contaminated or adulterated during or after the manufacturing process. It is therefore essential to safeguard the public that these products are regulated.
It's a long and complicated story, but a hot topic of discussion amongst herbalists — whether western, traditional Chinese or ayurvedic — is the ending of a very long transition period on 30 May. This transition period has to do with the implementation of the EU Traditional Herbal Medicinal Products Directive (2004/24/EC). We wouldn't recommend you try to understand it unless you have a penchant for such legalese, but a good, simple summary of what it means to the advertising and selling of herbal products has been produced by the EU: Q&A: Registration of Traditional Herbal Medicinal Products.
Essentially, after 30 May, it will be illegal to sell over-the-counter manufactured herbal products that are not registered by the MHRA under their Traditional Herbal Medicines Registration Scheme (THMRS). There are just over 100 licences that been issued by the MHRA and these will be the only herbal products making medicinal claims that will be allowed to be sold. Other herbal products will be allowed to be sold, but only if they are sold as food supplements, do not make medicinal claims and do not have a physiological or immunological effect.
The MHRA publish Public Assessment Reports for each of the THMRS licences they issue. It's worth looking through one of these to get an idea of what data are required to comply with the THMRS. Taking this one for a Black cohosh product as an example, the main body of the assessment comprises a scant nine pages. It includes:
No clinical efficacy data are required for registration of Traditional Herbal Medicinal Products (THMP).
No studies have been carried out to determine if drug interaction occur with this product.
The safety of the product during pregnancy and lactation has not been established, therefore it should not be used during pregnancy or lactation or by women attempting to become pregnant.
No studies on the effect of this product on the ability to drive or use machinery have been performed.
Pharmacodynamic properties: Not required.
Pharmacokinetic properties: Not required.
Preclinical safety data: The preclinical toxicology data are limited. Tests on reproductive toxicity, genotoxicity and carcenogenicity have not been performed.
However, herbalists are up in arms about this restriction, seeing it as an unwarranted intrusion into their right to freely choose to purchase whatever herbal products they wish. Essentially all the THMRS does is ensure some safety aspects of the products through Good Manufacturing Practice. No evidence of efficacy is required and the scheme is a pale imitation to the requirements that pharmaceutical companies have to comply with to obtain MHRA Marketing Authorisation. But it seems that even this two-tiered system is too much for some herbalists and many are so incensed that they have collected £90,000 to mount an eleventh-hour legal challenge against the EU Directive.
So, if we find unlicensed herbal products that are making medicinal claims for sale in May, can we complain and who to?
Unfortunately, it's not quite that simple. Although the transitional period ends on 30 May, unlicensed products that are already in the supply chain can continue to be sold until they are used up. What is not allowed is for a manufacturer or EU importer to place on the market any unlicensed product after 30 May. The full details of this can be found in the MHRA's guidance.
What this means is that we cannot be certain that any unlicensed product on a shop shelf or being sold on the Internet is illegal. Not knowing the details of a typical supply chain, it's impossible to estimate when unlicensed product placed on the market before 1 June will be used up.
However, we will be monitoring the situation and we will let you know when we think it would be a good time to do some checking. We will also keep you informed of the Government consultation to regulate herbal practitioners.
Focus of the Month
Because of all this activity and planning that's going on behind the scenes, we've decided that we won't have a Focus of the Month for May.
But don't worry, there will be plenty of opportunities to help challenge misleading claims in the near future!
The following recent ASA health related adjudications may be of interest: