EFSA ephedra opinion ‘significant step forward’ in EU botanical regulation: Consultant
“Ephedra herb and its preparations in food supplements may result in exposure to total ephedra alkaloids or ephedrine which falls within or may exceed the therapeutic dose ranges for the individual ephedra alkaloids or ephedrine, respectively, in medicinal products,” EFSA’s Food Additives and Nutrient Sources added to Food (ANS) panel wrote in its opinion.
“Such an exposure could lead to severe adverse effects, which may be enhanced by the combination with caffeine.”
Here, Italian-based botanicals expert Luca Bucchini, PhD, details why he thinks EFSA’s ephedra stance shows real progress in its herbal safety assessment methodologies...
This is a long, well-reasoned and well-researched opinion, and is a significant step forward from the yohimbe non-opinion [where it could not determine the safety of the supposed aphrodisiac herb].
We have now a baseline: A botanical that can be deemed of significant concern across the EU.
Few had doubts that ephedra herbs would fall in this category (though it should be noted that it could be found on Amazon in the EU, but not in the US, until recently).
The welcome news is that EFSA has been able to reach a clear conclusion, defining unequivocally what is not acceptable for botanicals.
“…enough to be of concern”
It's an important development that the ANS Panel has applied efficiently and innovatively the EFSA 2009 guidance on the safety of botanicals.
The Panel did say that there is insufficient data (level A), as in the case of many botanicals, but did reach a conclusion that ephedra belongs to a further subset in level A: Insufficient data to conclude on safety but enough to be of concern.
They have thus avoided paralysis using adverse events and clinical data to draw their conclusions. This is a bit unconventional but not without precedents.
They have also pointed to where problems may lie for botanicals that are normally considered safer: Lack of standardisation of extracts, pertinent studies with the relevant extracts and limited exposure data as relevant but missing data.
The botanicals industry should take note. The experts also did not hesitate to consider data obtained on individual compounds, and I would say that the line, "only data on the entire preparation are relevant" still heard from a minority in the industry is looking increasingly weak and perhaps counter-productive.
On the other hand, as in the the yohimbe opinion, they did make reference to medicinal uses, and the therapeutic range. However, in this case, I believe they more clearly stayed within EFSA's remit: Food safety, and not that of defining what is a medicine and what is a food supplement. In fact, they have used the information from medicinal uses to derive food safety conclusions.
EFSA 'can do' botanicals...
One may ask: Is this the beginning of a EU-wide negative list of botanicals? I would say not. However, EFSA has now shown that it can apply its methodology of botanicals in a way that is meaningful for regulators and consumers. Thus, EFSA may be asked again by the European Commission to review the safety of specific botanicals, and may now return opinions more quickly: This will support harmonisation and coherent enforcement.
The potential weakness is a reference to estimated exposure levels. It makes sense scientifically but leaves a gap to be closed by regulators (is ephedra safe at lower levels?). Regulators may have preferred an opinion where there is no known safe level. It will be interesting to watch how the opinion is translated into regulation and enforcement.
Regardless, considering the recent approved hydroxyanthracene health claim opinion, EFSA is proving its ability to assess botanicals and to sort out the ‘bad guys’. This strengthens the case of those who want EU-wide harmonised regulation of botanicals, and weakens the case of those who think EFSA ‘can't do’ botanicals.
It remains to be seen how the risk assessment approach used in this case is going to be reconciled with tradition-based approaches, or with the qualified presumption of safety (QPS) EFSA itself is also working on.
Luca Bucchini PhD, MPH, is the managing director of Italian-based Hylobates Consulting.
