Wednesday, March 11, 2009

Herbal Products "Standardization": Boon or a Bust?

Recently I wrote one of the large herbal extract producers and asked them to be more conscientious about the parallels they draw between their products and published research on other companies' products. I received a somewhat nasty reply from their Medical Director, and I think that it shows how the dietary supplement industry dumbs itself down in order to produce what they consider to be "standardized" products. The short version is that this doctor claims that everybody does it, and therefore it is OK by her.

Let's take one particular plant as a case in point, the beautiful little Arctic bush called Rhodiola rosea. This company produces a Rhodiola extract which is sold in a black tar-like liquid form inside a capsule. There are about fifty brands of Rhodiola on the market, and this company is probably in the top ten. Now, as a guy who has sampled every single one of them, I can tell you that I do NOT get that "Rhodiola feeling" when I take their capsules. So, when I saw that they were using another company's clinical trials to back up their claims, I investigated further.

I found that the company with all the clinical trial data standardizes their formula to the actual ingredients ratio in the plant. This differs -- significantly -- from the "standardization" that the firm I wrote uses, in which only one of the plant's biochemicals is identified, where it is labeled "Rosavins at 3%" on the bottle. Other companies use a 3% Rosavins/1% Salidrosides figure, which is similar. What makes this company unique is that they use the published literature of other companies to promote their benefits, when those other products are not "standardized" in the same way.

So, to use an analogy, if you were going to the store to buy a 12-Pack of Budweiser, you'd be pretty sure of what you are getting in the box. You'd be getting what God and man determined should be in a twelve pack of beer. On the other hand, how would you feel if you were to go out to buy an extract of a plant that had twelve phytochemicals in it, and yet when you brought it home and tried it, you got different results than you expected? Back to the beer analogy, when you looked inside, there were only one or two bottles of beer in that 12-pack!

Do you think it is right for a company to highlight the clinical trials of another when the two products are not identical? There's nothing wrong with making comparisons when the published literature describes a product with a similar standardization. But when X product does not in any way resemble product Y, it's just not right to promote X as having the capabilities of Y.

Industry standardization, if done like this one, is like "standardizing" our education in the USA so that every child comes out with a 3rd grade education. Who needs it!



PeterB said...

Hi Dave, I "met" you the other day on Usenet's mha and thought I would stop by. Your post on natto and nattokinase, I thought, was very balanced. Anyway, as a user of natural medicine, I have probably talked to every mftr I've ever purchased from, and there are quite a few of them. I've used 3 brands of rhodiola, can't say any of them gave me the "zap" I might have liked, but I always felt that it would depend on one's existing health, level of activity, and so on. What concerns me in your comment is that the standardization figures themselves might be misleading. The problem you uncovered is hopefully an isolated case (there are, I believe, good companies that won't play loose with the facts), but what do you think is the reliability of standardized formulas generally? Are you aware of any lab analysis done to verify the concentrations of "active" ingredients (whereas some think doing so is itself an adulteration of the herb, but that's a whole other topic), as that would be very useful to know. Anyway, thanks for your blog. Be well.

Dave Jensen said...

Hello Peter,

Thanks for your post. I recall our brief meeting on the wild west of the Internet, the "usenet."

A part of this problem will go away in June of this year, when new GMP's are passed along to the customers and HPLC analysis of label claims must be done by manufacturers (an expensive and, according to the FDA, important procedure). A future blog post from me will describe this change and the consumer will end up picking up the cost. All supplement products will become more pricey as a result.

The other part of the problem, which I'd call "Stolen Science," won't go away. That's the issue here -- where one company is using another company's science to promote their claims. I don't think that resolves with new rules of analysis. I think that's probably a company philosophy -- and to tell you the truth, everyone does indeed do it, as this company wrote me. Thanks for visiting.


Anonymous said...

Hi Dave,

Thanks for your response and sorry for the delay. I have always felt that GMP was a double-edged sword, however the net benefit of this new rule will hopefully outweigh the additional cost to consumers.

Usenet newsgroup discussions are conflicted, I think, due to the presence of industry using these channels to acquire mind share. The practice is called "astroturfing" and is associated with a PR project underwritten by the media groups of industry. I publish a "Warning" post to mha describing this behaviour (with links that document the activity) and how to detect it. Anyway, thanks again for your informative website, I will make it a staple read as time allows.