I have established in previous posts that Forever Living do not hold the correct licences to sell products for health purposes. I detailed the laws covering the regulations for this in the UK and stated why it is important to follow these rules. Previous blog posts here and here.
But WHY don’t Forever Living hold the correct paperwork to sell their products for health purposes? Surely, if the products are as good as they say they are, a licence should be easy to come by?
A possible explanation was put forward by a Forever Living rep on her team’s facebook page-
She thinks- “The reason we can’t make medical claims is because, we as a company would need to hold a pharmaceutical certificate…If you hold one of these- you cannot sell products outside of a pharmacy”.
I disagree. It is possible to obtain a licence called a Traditional Herbal Remedy (THR) from the MHRA (The government body responsible for licencing medicines, medical equipment and herbal remedies.) Website here. This is granted for herbal remedies that are used for minor ailments such as colds that don’t require medical input. Also available are licences for products that treat symptoms of more serious conditions. Theses licences are called a marketing authorisation.
If a product has these licences, they do not need to be sold in a pharmacy. Think of the products you can buy in health food shops, or even Tesco-
These products have been through the proper channels. Evidence was produced that they were not harmful, the strength had to be proved to be consistent and contain what it said it contained. There is monitoring and reporting systems and proper information is provided to users of the products.
Importantly, as part of this registering and licencing process, it has to be shown that the natural ingredient has traditionally been used for this purpose. There is a database for products used in Europe for this purpose. I looked for the part of the database for Aloe Vera on the European Medicines Agency, who hold all the data.
Aloe Vera is allowed to be used as a traditional herbal remedy for constipation. There is adequate evidence that it has been used for this purpose for many years. Scientific studies show that it is safe for this purpose. Link to the Aloe Vera information page here. Here are the conclusions-
V. Overall conclusion Well-established use: short term use of occasional constipation.
There are no clinical studies available, which evaluate the clinical efficacy of barbados aloes and cape aloes in patients with occasional constipation. The postulated laxative effect is mainly based on pharmacological data, experts’ opinions and clinical experiences. Clinical and pharmacological data obtained on other anthranoid-containing laxatives (primarily senna leaf preparations) support the efficacy of these anthranoid-containing herbal substances for short-term use in cases of occasional constipation. The current level of evidence1 of the available scientific data for “the short term use of occasional constipation” can be identified as level IV because well-designed studies with mono-preparations of aloe are missing. The conditions determined in the pharmacovigilance actions for anthranoid-containing laxatives have to be maintained for the moment because further investigations are needed to clarify the carcinogenic risk. The results of the most recent studies are inconsistent. However, a risk was also revealed for constipation itself and underlying dietary habits. 1 As referred to in the HMPC ‘Guideline on the assessment of clinical safety and efficacy in the preparation of Community herbal monographs for well-established and of Community herbal monographs/entries to the Community list for traditional herbal products/substances/preparations’ (EMEA/HMPC/104613/2005) @EMEA 2007 24/24 The use in children under 12 years of age is contraindicated and use during pregnancy and lactation is not recommended. Traditional use Besides the use as a laxative, the use as an emmenagogue and the external use for wounds and abscess are described in most references mentioned above. But as already mentioned in the Dispensatory of the United States of America 1918, it is extremely doubtful whether aloe exercises any action upon the pelvic organs which is not attributable to its cathartic effects. There are no plausible pharmacological data for this indication, nor for haemoptysis, jaundice or gout etc. Furthermore, the preparations used are not described exactly, even for the external use In view of existing possible risks, such traditional uses cannot be recommended and referred to in the ‘Community list of herbal substances, preparations and combinations thereof for use traditional herbal medicinal products’. This is in accordance with the German pharmacovigilance actions for anthranoidcontaining laxatives.
To translate the above paragraph-
- Aloe Vera can be used as a herbal remedy for occasional constipation.
- Children under 12 must not use aloe vera.
- Pregnant and breastfeeding women must not use it. It has affected unborn rats in studies, and their fertility. (this info is from the main body of the report).
- There is insufficient evidence that aloe vera is useful as a remedy for anything other than constipation.
I have shown that it is not easy to simply obtain the relevant herbal remedy for aloe vera products for Forever Living. And that you do not need to be a pharmacist to sell it.
Maybe there is another way to obtain licencing? A company could start from scratch with clinical trials and prove that their product does what they say it does. This would take years and a lot of money. Here is a chart showing how much it costs to do one clinical trial.
This information is from this site.
So, for example, if Forever Living wanted to show that their aloe vera gel helps with asthma and pain (as has been widely reported by FL reps), it would cost $240 million to carry out the research. Then they would have to hope that the findings were in their favour. This would take years to do and there is the very real and probable risk that the product would not have the effect that is being claimed by some reps.
A lot of time and money could potentially be wasted on these studies.
Which begs the question, why bother with all the effort needed to properly test these products when your independent reps will make these claims illegally on your behalf? If they are called on it, they can be blamed as individuals and the company will be blameless because they keep telling their reps not to make false claims. Just like the above rep “our products work”. Do they? Where is your evidence?
botwatchblog 
Reblogged this on timeless vie.
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