quality-controlIntroduction
Quality control refers to processes involved in maintaining the quality or validity of a product. Regardless of the form of herbal preparation, some degree of quality control should exist. Without quality control, there is no assurance that the herb contained in the bottle is the same as what is stated on the outside. One of the key solutions to the quality control problem that exists in the United States is for manufacturers and suppliers of herbal products to adhere to quality control standards and good manufacturing practices. Unfortunately, repeatedly the industry fails and continually has to defend itself as the result of companies taking shortcuts.

With improvements in the identification of plants by laboratory analysis, consumers should at least be guaranteed that the right plant is being used. Consumers, health food stores, pharmacists, herbalists, and physicians who use or sell herbal products should ask for information from the suppliers of herbal products on their quality control processes.

Too few manufacturers practice to complete quality control and good manufacturing practices – though many more claim that they do.

A new study published in Biomed Central details how widespread the problem is within the herbal product industry.

Background Data:
Before the 1980s, the quality of the extract produced often was difficult to determine because many of the active principles of the herbs were unknown. However, advances in extraction processes, coupled with improved analytic methods, reduced this problem of quality control. In particular, the development of standardized herbal extracts was a major advance in quality of herbal products. Not surprisingly, the introduction of extracts that were guaranteed to contain a “standardized” level of active compounds or key chemical marker led to a renaissance in the use of and appreciation for the healing power of plants.

My feeling is that regardless of an herb’s form, it should be analyzed to ensure that it contains active components or key markers at an acceptable standardized level. More accurate dosages can then be given allowing for more consistent clinical responses.

New Data:
Researchers from the University of Guelph in Toronto, Canada, tested the authenticity of 44 herbal products from a total of 12 companies using DNA barcoding techniques. All of these products and brands are available to consumers in both Canada and the United States. The results were extremely alarming as most of the herbal products tested were of poor quality, including considerable product substitution, contamination and use of fillers.

Most (59%) of the herbal products tested contained species of plants not listed on the labels. Some (33%) of the authenticated herbal products also contained contaminants and or fillers not listed on the label. Some of the contaminants were of unrelated species from entirely different plant families. For example, in one case a product labeled as St. John’s wort was substituted with senna, an herbal laxative that is not meant for prolonged use. In another example, black walnut was substituted for Ginkgo biloba.

Some of the herbal products also contained fillers that were not listed on the labels. Hidden sources of soy, wheat by-products, or other fillers may be an allergen issue for some consumers and all ingredients, including fillers are required to be listed on dietary supplement labels.

Only two of the twelve companies produced authentic, uncontaminated products.

Not surprisingly, the researchers concluded: “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.”

Commentary:
Am I surprised by these findings in this study? Absolutely NOT, this sort of finding is expected when companies forego important quality control systems in search of higher profits. Every company selling products on the marketplace claims to employ what are referred to as Good Manufacturing Practices – but in most cases, these claims are simply not true.

Studies like this recent one highlight one of the continued issues that plague the natural product industry. There are still too many low quality or bogus products out there. In the study above, only two of the twelve companies were shown to produce “authentic” products. Although no companies were named, I guarantee you with the quality control systems that Natural Factors in place that it was one of these two companies producing legitimate products.

As Director of Product Development at Natural Factors, let me highlight some of the key aspects of the Quality Control Systems in place:

  • We test every single lot of raw material we receive and every batch we produce against its specifications.
  • Certified by the United States Pharmacopeia (USP), NHPD of Health Canada, and the Therapeutic Goods Administration of Australia.
  • State-of-the-art sophisticated testing methods including HPLC, TLC and Mass Spectrometry.

The bottom line is that you can ALWAYS trust products from Natural Factors when it comes to quality.

My final comment relates to the appropriateness of DNA barcoding with natural products. These sorts of analytical techniques are those used by crime scene investigation units. They do not account for possible DNA contributions from soil bacteria, bees and other insects, plant viruses, or minute levels of other plants. There are better laboratory techniques to use for quality control.  DNA barcoding does not tell you how much of these contaminants are in the product even if in meaningless levels.

Even prescription drugs are allowed cross-contamination levels in the parts-per-million range because it is safe (and unavoidable), how can the authors hold supplement manufacturers to cross-contamination levels that are possibly in the parts per billion range when there are even less safety concerns? It is a double-standard that is not expressed in the article.

Reference:
Newmaster SG, Grguric M, Shanmughanandhan D, et al. DNA barcoding detects contamination and substitution in North American herbal products. BMC Med. 2013 Oct 11;11(1):222.

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