My answer hasn’t changed since yesterday—none.
This time, instead of looking at risk/benefits based on effectiveness, efficacy, and potential negative health impacts from the active ingredients, I want to point a general problem with the manufacturing of those products sold as supplements.
- Preliminary studies
- Clinical trials
- Review of clinical trials
- Filing a New Drug Submission to the Therapeutic Products Directive
- The TPD performs a thorough review of the submitted information, sometimes using external consultants and advisory committees.
- The TPD evaluates the safety, efficacy and quality data to assess the potential benefits and risks of the drug.
- The TPD reviews the information that the sponsor proposes to provide to health care practitioners and consumers about the drug (e.g. the label, product brochure).
- If, at the completion of the review, the conclusion is that the benefits outweigh the risks and that the risks can be mitigated, the drug is issued a Notice of Compliance (NOC), as well as a Drug Identification Number (DIN) which permits the sponsor to market the drug in Canada and indicates the drug’s official approval in Canada.
- In addition, Health Canada laboratories may test certain biological products before and after authorization to sell in Canada has been issued. This is done through its Lot Release Process, in order to monitor safety, efficacy and quality.
One of the important things to note here is that the production of the drug is included in the process from the stage of clinical trials throughout the ongoing life cycle of the drug.
While natural products that don’t make specific therapeutic claims are relieved of any of the regulations around proving benefits, in theory they are required to follow Good Manufacturing Practices and be monitored by Health Canada. In practice, these requirements are not followed with nearly the same rigour as for pharmaceuticals.
A recent study published in the journal BMC Medicine calls into question the manufacturing process used by the makes of substances marketed as natural products.
DNA barcoding detects contamination and substitution in North American herbal products. Steven G Newmaster et al
Herbal products available to consumers in the marketplace may be contaminated or substituted with alternative plant species and fillers that are not listed on the labels. According to the World Health Organization, the adulteration of herbal products is a threat to consumer safety. Our research aimed to investigate herbal product integrity and authenticity with the goal of protecting consumers from health risks associated with product substitution and contamination.
We used DNA barcoding to conduct a blind test of the authenticity for (i) 44 herbal products representing 12 companies and 30 different species of herbs, and (ii) 50 leaf samples collected from 42 herbal species. Our laboratory also assembled the first standard reference material (SRM) herbal barcode library from 100 herbal species of known provenance that were used to identify the unknown herbal products and leaf samples.
We recovered DNA barcodes from most herbal products (91%) and all leaf samples (100%), with 95% species resolution using a tiered approach (rbcL + ITS2). Most (59%) of the products tested contained DNA barcodes from plant species not listed on the labels. Although we were able to authenticate almost half (48%) of the products, one-third of these also contained contaminants and or fillers not listed on the label. Product substitution occurred in 30/44 of the products tested and only 2/12 companies had products without any substitution, contamination or fillers. Some of the contaminants we found pose serious health risks to consumers.
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.
A person could debate the phrasing of this that suggests the usefulness of the products, but that was yesterday’s post. are these substitutions due to sloppiness or outright fraud? The paper makes no assumptions, and does it really matte to consumers? We are still faced with dangerous goods.
The takeaway message for today is that right now, you cannot trust these manufacturers to ensure that the products they sell, and many consume, contain the ingredients they claim. This of course, makes any claims of usefulness completely nonsensical.
Imagine the consequences should Merck, Pfizer, or the makers of generic products be identified of such deception. There would be immediate calls for complete product recalls, a plethora of law-suits, and warnings from prescribers. In the natural products world, there will be no such immediate response; it will be business as usual for the manufacturers and the purveyors of these products.
Maybe I’m wrong, and this study will be promoted as strongly on CAM websites as it has been on mainstream medical sites and news outlets. I’m not holding my breath.