鈥淏ach Rescue Remedy鈥� features a Natural Product Number (NPN) issued by Health Canada so one would naturally assume that it will relieve stress and nervousness as the label claims. If you have an earache, you might go for 鈥淓ar oil鈥� that claims to relieve pain with extracts of mullein, garlic, calendula and St. John鈥檚 Wort. It too has an NPN. So does 鈥淲ild Rose Herbal Detox鈥� that claims to detoxify the colon and kidneys with its 24 ingredients extracted from the likes of dandelion, burdock, licorice, buckthorn, raspberry and radish. But if you believe that these products will deliver the goods they promise because they have been granted an NPN, you would be wrong.
Natural products are not regulated the same way as prescription or even non-prescription medications. Given that they are intended to treat some sort of health issue, shouldn鈥檛 they be subjected to the same regulations as drugs? Health Canada thinks not. The over 90,000 natural supplements that have been granted an NPN range from vitamins and probiotics with reasonable evidence of benefit in some situations to nonsensical liver detoxes that totally lack any scientific support.
Bringing a prescription drug to market requires the submission of data obtained from extensive laboratory experiments, animal studies and human placebo-controlled clinical trials. If the studies and trials demonstrate that benefits are significant, and greatly outweigh risk as judged by Health Canada experts, a Drug Identification Number (DIN) is granted. A consumer can then assume that the drug has made it to the market based on proper scientific evidence and is likely to be of use. An NPN, despite being issued by Health Canada, is quite different and only means that the government has assessed the product and approved it for sale. What 鈥渁ssessed鈥� means in this context can have quite different meanings.
Herbal supplements, milk thistle being an example, can be granted an NPN based on nothing other than traditional use. The only criterion is that the label has to say 鈥渢raditionally used in Herbal Medicine as a liver protectant.鈥� Of course, just because a substance has been used traditionally does not mean it has been used effectively, but if there were a risk it would likely have been noted. Bach Rescue Remedy introduced by British physician Edward Bach a century ago serves as an other example.
Bach was a traditionally trained physician who became disenchanted with the way medicine was being practiced and began a search for novel healing methods. Then in 1930, at the age of thirty, as he was walking through a field of flowers glistening with dew, he had an epiphany. Somehow Bach surmised that the spiritual essence of a flower was transferred to the dew when the flower was exposed to the sun, and that this dew had healing properties. This remarkable insight came to Bach, as he maintained, through 鈥渋nspiration.鈥� To sense a flower鈥檚 specific therapeutic potential, all he needed to do was hold a petal in his hand.
Bach then went on to develop his healing essences by exposing flower petals floating in a glass bowl filled with spring water to sunshine. He claimed that in this fashion the flower鈥檚 spiritual energy was transferred to the water, a few drops of which could then be used for healing purposes. The placebo response can be very powerful and many of Bach鈥檚 patients claimed to have benefitted from the treatment. That, along with the unlikelihood that such flower extract could cause harm was enough 鈥渆vidence鈥� to obtain an NPN from Health Canada.
By contrast, if a company wants to market a probiotic as a natural health product and claim that it 鈥渟upports gut flora,鈥� then it has to submit evidence that the product contains specific bacterial strains that have been found to affect the microbiome and that the product contains at least a minimal number of viable colony forming units (CFUs). Information also has to be provided about dosage and conditions for which the probiotic can be used. For safety, it is enough to refer to monographs or published papers that have documented the use of probiotics without turning up any significant problems.
A claim about a specific health benefit such as 鈥渂uilding stronger bones,鈥� as made by the manufacturer of AlgaeCal, requires a higher degree of evidence. This supplement classifies as a natural health product because the minerals in contains, calcium being the significant one, are sourced from algae. A natural health product has to come from a natural source that can be a plant, a mineral, an animal, bacteria, algae or fungi. Synthetics are allowed as long as they are identical to the natural version. Vitamin C for example is produced synthetically but is equivalent to the natural version so it is allowed. AlgaeCal also contains vitamin D which also can be classified as natural. Vitamin D2 (ergocalciferol) is typically derived from plant sources like yeast or mushrooms, while Vitamin D3 (cholecalciferol) is sourced from animal products, most commonly lanolin in sheep's wool.
The producer of AlgaeCal did fund clinical studies that showed a 1.3% gain in bone density in postmenopausal women after one year. Not a spectacular result. It should also be kept in mind that the relevant end point for such studies would be reduction in bone fractures, not changes in bone density. Increased bone density does not necessarily translate to reduced fractures. Furthermore, the studies were not placebo controlled and there was no demonstration that this product is superior to the dozens of cheaper calcium-vitamin D supplements on the market.
Basically, when it comes to the regulation of natural health products there are no hard and fast rules about evidence required. Low risk products require a smidgen of evidence while products that claim to treat, relieve or prevent some condition have to provide a higher degree of evidence but that can fall far short of the randomized, double-blind placebo-controlled trials mandated for drug approval. The granting of an NPN is not a proof of significant efficacy but does at least confirm that when used according to directions the product is likely to be safe. Nevertheless, every year there are thousands of adverse reactions reported.
Although there is much to criticize about the regulation of natural health products in Canada, the situation is far worse in the U.S. where there is no requirement to submit any safety or efficacy data before marketing a product. The Food and Drug Administration (FDA) can remove a product once an issue arises but does not have to approve the sale of a product. It does mandate, though, that any claim of benefit has to be accompanied by the statement that 鈥渢his product is not intended to diagnose, treat, cure, or prevent any disease.鈥� That prompts the obvious question, so what then is it intended to do? The cynical answer would be, make money for the producer.
When looking to take a natural health product, the appropriate question to ask would be whether that specific product at the recommended dose has been subjected to any trials that have shown benefit. Not whether some of its ingredients at some dose under some condition were reported to show some benefit in some experiment. The answer will usually be no. Bach Rescue Remedy will not rescue anyone from anything.
