When Big Pharma develops a new prescription medication, the regulatory authorities, such as the US FDA, set regulatory guidelines for not only the claims made by the company but also for the manufacturing standards. Every ingredient used to manufacture a pill or injectable must be listed in the package insert and must be tested during the three or phases of clinical trials.

©Daily Mail UK, 2013

In general, if a pharmaceutical company makes any changes to the ingredients, even something as simple as a binder in the pill, it must re-file with the regulatory authorities for clearance to do so. Even if a manufacturer changes equipment or a process, without changing the the ingredients, it is required to file those changes with the FDA, and they may not proceed with the change.

The same is not true of so called “natural health products.” In fact, according to a study published in BMC Medicine, the majority of herbal products on the market contain ingredients that are not listed on the product’s label. Furthermore, these companies (let’s call them Big Herbal) often substitute some of the ingredients with cheaper, untested alternatives and fillers.

The researchers used a technique called DNA barcoding technology, which is a taxonomic method that uses a short genetic marker in an organism’s DNA to identify it, even if it is mixed in with DNA from other organisms, to examine the ingredients in 44 herbal products from 12 companies in Canada.

Results:

Only two of the companies provided authentic products without substitutions, contaminants or fillers.

Overall, nearly 60% of the herbal products contained plant species not listed on the label.

Only 50% actually contained the plant claimed on the label.

About 32% substituted another plant.

About 20% contained contaminants of a variety of non-plant sources.

About 20% contained fillers.

Yes, you read that right. Of the 44 herbal products studied, only about half actually contained the plant product that was claimed on the label. Moreover, the 20% that used fillers used rice, soybeans and wheat (probably GMO, ironically).

Lead author Steven Newmaster, an integrative biology professor and botanical director of the Guelph-based Biodiversity Institute of Ontario (BIO), home of the Canadian Centre for DNA Barcoding stated that, “contamination and substitution in herbal products present considerable health risks for consumers. We found contamination in several products with plants that have known toxicity, side effects and/or negatively interact with other herbs, supplements and medications.”

For example, one product that was labelled as St. John’s wort, a plant with claimed anti-depression activity (unless the research is done in Germany, the evidence is very weak), actually contained another plant, Senna alexandrina, which has strong laxative properties, and with chronic use, can cause diarrhea and liver damage, along with negatively interacting with immune system in the colon. So, you could take this medication in the hope (as farfetched as that is) of treating your depression, but end up going to the hospital because it harms several organs.

Or the other example of a Ginkgo biloba, which is claimed (and solidly refuted by science) to treat certain neurological deficits such as Alzheimer’s disease, was contaminated with black walnut, a serious danger to people with nut allergies. So, another product with absolutely no benefit to humans, but may actually be danger.

And let’s not forget the fillers like rice, soybeans or wheat, which may be a worry for individuals who may be allergic to these ingredients, or, in the case of wheat, may be sensitive to gluten (which is incredibly rare).

With all of this data, the authors concluded:

Most of the herbal products tested were of poor quality, including considerable product substitution, contamination and use of fillers. These activities dilute the effectiveness of otherwise useful remedies, lowering the perceived value of all related products because of a lack of consumer confidence in them. We suggest that the herbal industry should embrace DNA barcoding for authenticating herbal products through testing of raw materials used in manufacturing products. The use of an SRM DNA herbal barcode library for testing bulk materials could provide a method for ‘best practices? in the manufacturing of herbal products. This would provide consumers with safe, high quality herbal products.

There is so little evidence that any of these supplements do anything for you. There is little evidence that Big Herbal, a US$142 billion worldwide market (and highly profitable because they’re not regulated and don’t have to do any clinical research to support their nonsensical claims), actually is concerned about your health, only about making profits. But there is growing evidence that some of these products do more harm than even the claimed benefit.

And more evidence that Big Herbal has ethical issues that if they ever showed up in Big Pharma, there would be worldwide clamoring for criminal prosecution. Time for the same outrage against Big Herbal.

Key citations:

Linde K, Berner MM, Kriston L. St John’s wort for major depression. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD000448. doi: 10.1002/14651858.CD000448.pub3. Review. PubMed PMID: 18843608. Impact factor=5.72.

Newmaster SG, Grguric M, Shanmughanandhan D, Ramalingam S, Ragupathy S. DNA barcoding detects contamination and substitution in North American herbal products. BMC Medicine 2013 Oct;11:222. doi:10.1186/1741-7015-11-222. Impact factor=6.68.

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