David Baxter PhD
Late Founder
European Union "Ban" On Herbal Products
by Steven Novella. Science-Based Medicine
May 4, 2011
Regulations have just gone into effect in the EU regarding the sale of herbal products. The regulations seem reasonable, but they have sparked near hysteria on the part of herbal sellers and advocates of ?natural? medicine. They are calling the regulation a ?ban? on herbal products, which much of the media has parroted, but it is not a true ban, just a requirement for registration.
The law was sparked by cases of toxicity from over-the-counter herbal products. For example, aristolochia is a toxic plant species that is either used deliberately or can be accidentally or carelessly substituted for other plant species. It is known to cause kidney damage ? even leading to kidney failure is some cases. Another herb, kava, has been linked to liver damage.
The new EU law, which went into effect May 1, 2011, will require herbal products to be licensed, or prescribed by a licensed herbal practitioner. In order to be licensed evidence for safety of the product must be presented. It is estimated that it will cost between 80,000 and 120,000 British pounds to get an individual herbal product licensed.
I find it interesting, and completely predictable, that sellers of herbal products are wailing that this is all a conspiracy by ?Big Pharma? to crush the little guy and steal all the herbal profits for themselves, or to ban herbal products to protect their drug profits. But this is a straw man. The real question here is the balance between marketing freedom and quality control ? but those who want to defend their right to sell herbs don?t want to discuss the real issues, apparently.
Dr Rob Verkerk from a trade organization, the ANH, is quoted as saying:
His next point if the same point that is always made against regulation ? if you make X illegal then people will just obtain X illegally or from less regulated sources. This is not specific to herbal products. There is a point there ? regulation is not easy, especially with a global market and the internet. But that does not mean we should abandon all efforts at quality control and honesty in marketing.
He concludes with an assumption that herbal products under the current scheme work for anything and have adequate quality control ? but again, that is the very issue. In fact regulations are generally not adequate to assure quality control in terms of dose and purity. And there is virtually no regulation about the claims that can be made for herbal products.
In the US the 1994 DSHEA essentially allows herbal manufacturers to make a host of pseudo-health claims without any oversight. The same is and will continue to be true in the EU. One could argue that this legislation does not go far enough to protect the public against false claims and useless products.
Others argue that this legislation will put the small producers out of business. This is exactly what patent medicine sellers complained about when the FDA was proposed. In fact all of the objections are identical to those raised against regulation of drugs. Of course, the point of the FDA was to put the mom and pop patent medicine sellers out of business ? because they were largely selling snake oil and did not have the resources to perform proper safety and efficacy testing.
Here the claims are even less relevant ? because herbal remedies are a multi-billion dollar industry, and the relative cost to get licensing is much less than getting a drug through the FDA.
What we really have here is an industry that wants to continue selling poorly regulated products with health claims and without any burden of having to prove that their products are safe or that their health claims are based upon science.
I acknowledge that there is a real political debate here, and that some people might want to favor freedom and risk over government regulation. But I object to the way the debate is often framed by opponents to regulation. Even for those who would prefer to have a free market for herbal products would likely agree that the consumer deserves accurate information in order to make informed decisions. Right now, in most markets, the consumer does not have that.
Most people I talk to about this assume that herbs are more regulated than they currently are. People want both freedom and protection, and are not always aware of the degree to which the two are at cross purposes. So if you ask them if they want freedom in the market, they say yes. And if you ask them if they want assurance of safety and honesty, they also say yes. They want the freedom to choose, but only among products that are safe and effective.
With respect to herbal remedies, however, the evidence is largely against the efficacy that is being claimed for many products. If you look at the big sellers, like echinacea and Gingko biloba, the large well-controlled studies are largely negative ? they don?t appear to work for the indications for which they are commonly marketed.
The industry has largely failed to self-regulate, and to use their profits to generate good science to back up their claims. And they consistently fight against regulation to force them to do so, and try to make it seem like they are on the side of the little guy against big corporate interests. But this is just spin ? they are just another big industry protecting their interests. If they really cared about the little guy or the consumer they would be producing good science, and keeping their claims within the evidence, rather than fighting against attempts to make them do just that.
Under most current regulatory schemes, there is a disincentive to conduct good efficacy research. Such research is a lose-lose proposition for industry. They have to spend the money to do the research. If it?s positive, it is unclear how that will benefit them since they already can make health claims (or pseudo-health claims, like the so-called ?structure function? claims under DSHEA). But if it?s negative, then they risk losing market share. The risk/benefit of doing efficacy research is simply not there, and that is probably why there is so little such industry-sponsored research into supplements. The only way to get the industry to spend some of their profits doing quality research is to make such research a requirement for entry into the marketplace.
In the end we should remember that herbs are drugs ? they have pharmacological activity, they have toxicity, an they have drug-drug interactions. How much regulation and quality assurance do we want for our drug industries (no matter what they are called)?
by Steven Novella. Science-Based Medicine
May 4, 2011
Regulations have just gone into effect in the EU regarding the sale of herbal products. The regulations seem reasonable, but they have sparked near hysteria on the part of herbal sellers and advocates of ?natural? medicine. They are calling the regulation a ?ban? on herbal products, which much of the media has parroted, but it is not a true ban, just a requirement for registration.
The law was sparked by cases of toxicity from over-the-counter herbal products. For example, aristolochia is a toxic plant species that is either used deliberately or can be accidentally or carelessly substituted for other plant species. It is known to cause kidney damage ? even leading to kidney failure is some cases. Another herb, kava, has been linked to liver damage.
The new EU law, which went into effect May 1, 2011, will require herbal products to be licensed, or prescribed by a licensed herbal practitioner. In order to be licensed evidence for safety of the product must be presented. It is estimated that it will cost between 80,000 and 120,000 British pounds to get an individual herbal product licensed.
I find it interesting, and completely predictable, that sellers of herbal products are wailing that this is all a conspiracy by ?Big Pharma? to crush the little guy and steal all the herbal profits for themselves, or to ban herbal products to protect their drug profits. But this is a straw man. The real question here is the balance between marketing freedom and quality control ? but those who want to defend their right to sell herbs don?t want to discuss the real issues, apparently.
Dr Rob Verkerk from a trade organization, the ANH, is quoted as saying:
?Thousands of people across Europe rely on herbal medicines to improve their quality of life. They don?t take them because they are sick ? they take them to keep healthy. If these medicines are taken off the market, people will try and find them elsewhere, such as from the internet, where there is a genuine risk they will get low quality products, that either don?t work or are adulterated.?
First, he begs the question that the use of herbs improves anyone?s quality of life. That is, in fact, the entire question ? are the risks worth the alleged benefits. The legislation is simply an attempt to provide a better risk/benefit for the consumer by putting into play better assurances of safety.
His next point if the same point that is always made against regulation ? if you make X illegal then people will just obtain X illegally or from less regulated sources. This is not specific to herbal products. There is a point there ? regulation is not easy, especially with a global market and the internet. But that does not mean we should abandon all efforts at quality control and honesty in marketing.
He concludes with an assumption that herbal products under the current scheme work for anything and have adequate quality control ? but again, that is the very issue. In fact regulations are generally not adequate to assure quality control in terms of dose and purity. And there is virtually no regulation about the claims that can be made for herbal products.
In the US the 1994 DSHEA essentially allows herbal manufacturers to make a host of pseudo-health claims without any oversight. The same is and will continue to be true in the EU. One could argue that this legislation does not go far enough to protect the public against false claims and useless products.
Others argue that this legislation will put the small producers out of business. This is exactly what patent medicine sellers complained about when the FDA was proposed. In fact all of the objections are identical to those raised against regulation of drugs. Of course, the point of the FDA was to put the mom and pop patent medicine sellers out of business ? because they were largely selling snake oil and did not have the resources to perform proper safety and efficacy testing.
Here the claims are even less relevant ? because herbal remedies are a multi-billion dollar industry, and the relative cost to get licensing is much less than getting a drug through the FDA.
What we really have here is an industry that wants to continue selling poorly regulated products with health claims and without any burden of having to prove that their products are safe or that their health claims are based upon science.
I acknowledge that there is a real political debate here, and that some people might want to favor freedom and risk over government regulation. But I object to the way the debate is often framed by opponents to regulation. Even for those who would prefer to have a free market for herbal products would likely agree that the consumer deserves accurate information in order to make informed decisions. Right now, in most markets, the consumer does not have that.
Most people I talk to about this assume that herbs are more regulated than they currently are. People want both freedom and protection, and are not always aware of the degree to which the two are at cross purposes. So if you ask them if they want freedom in the market, they say yes. And if you ask them if they want assurance of safety and honesty, they also say yes. They want the freedom to choose, but only among products that are safe and effective.
With respect to herbal remedies, however, the evidence is largely against the efficacy that is being claimed for many products. If you look at the big sellers, like echinacea and Gingko biloba, the large well-controlled studies are largely negative ? they don?t appear to work for the indications for which they are commonly marketed.
The industry has largely failed to self-regulate, and to use their profits to generate good science to back up their claims. And they consistently fight against regulation to force them to do so, and try to make it seem like they are on the side of the little guy against big corporate interests. But this is just spin ? they are just another big industry protecting their interests. If they really cared about the little guy or the consumer they would be producing good science, and keeping their claims within the evidence, rather than fighting against attempts to make them do just that.
Under most current regulatory schemes, there is a disincentive to conduct good efficacy research. Such research is a lose-lose proposition for industry. They have to spend the money to do the research. If it?s positive, it is unclear how that will benefit them since they already can make health claims (or pseudo-health claims, like the so-called ?structure function? claims under DSHEA). But if it?s negative, then they risk losing market share. The risk/benefit of doing efficacy research is simply not there, and that is probably why there is so little such industry-sponsored research into supplements. The only way to get the industry to spend some of their profits doing quality research is to make such research a requirement for entry into the marketplace.
In the end we should remember that herbs are drugs ? they have pharmacological activity, they have toxicity, an they have drug-drug interactions. How much regulation and quality assurance do we want for our drug industries (no matter what they are called)?
