鈥淣atural Health Products鈥� encompass a large variety of substances, ranging from vitamins and herbal supplements to homeopathic 鈥渞emedies.鈥� Because there is much confusion about how these products are regulated, and about the claims that are made on their behalf, Health Canada is holding consultation sessions across the country with a view towards updating the rules that apply to marketing 鈥淣atural Health Products.鈥� Along with colleagues, I attended the event in Montreal and had a chance to make a couple of comments.
According to a Health Canada spokesperson, such products are low risk and therefore can be more loosely regulated than prescription drugs. I expressed the view that risk should not even come into the equation until efficacy has been demonstrated. Once that has been established, one can look to see if the benefits outweigh the risks. But any risk聽is too great if there is no evidence of benefit.
I also commented on Health Canada鈥檚 assigning a DIN-HM (drug identification number-homeopathic) to homeopathic "remedies." This is an official government designation, leading consumers to assume that safety and efficacy has been demonstrated. This is not the case. There is no requirement to prove that such products actually work, only that they have been historically listed in some homeopathic pharmacopeia. Of course, homeopathic products are safe enough since they essentially contain nothing, but nothing also describes the evidence of efficacy. The DIN-HM is especially misleading given that prescription medications are assigned a DIN based on a proper risk-benefit analysis.
Actually homeopathic "remedies" can pose a risk by misleading people into believing that they are effective. Such products should not be assigned a Health Canada number. They should be labeled "homeopathic placebo pills." If manufacturers so desire, they can even put on the label that the contents have been demonstrated by scientific trials to be effective placebos. Studies show that placebos can work even if people are told they are taking a placebo.
Currently Health Canada requires that companies wishing to market a natural health product apply for a 鈥淣atural Product Number (NPN).鈥� 聽Submissions are expected to provide 鈥渆vidence,鈥� but this can range from anecdotal accounts to traditional use to proper studies. Furthermore, there is a huge backlog in processing applications and many products have received 鈥渢emporary exemptions鈥� allowing them to be sold without further scrutiny.
Obtaining an NPN is not difficult. It is edifying to examine the specific case of 鈥淐hewpods,鈥� candy-like chewables that claim to 鈥減rovide beneficial effects on energy, concentration and ability to recuperate.鈥� The rationale is that delivery of the active ingredients through the oral mucous membrane bypasses the digestive tract and enables a smaller quantity of active ingredients to be absorbed more quickly for greater effect.
The theory of oral absorption is sound, and many medications, with nitroglycerin for angina being a prime example, are designed to enter the bloodstream by this route. Whether transport through the mucous membranes of the mouth is viable depends on a number of factors including the relative solubilities of the substance in oil and water, with a greater oil solubility being a requirement. The potential of the chemical to bind to mucous membranes and the pH of the saliva are also important. Exactly what technology Chewpod employs to enhance absorption through the mucus membrane of the mouth isn鈥檛 clear, although there is a claim about 鈥減ersonalized action that balances saliva pH.鈥� Since the normal pH of the saliva is in the 6-7 range, and that is also the range where mucosal absorption is the most effective, there doesn鈥檛 seem to be any need for 鈥渂alancing.鈥� In any case, the evidence provided for faster absorption by means of the technology being used is based on experiments with aspirin and acetaminophen, not the ingredients in Chewpods.
Of course, what interests consumers is not the technology involved in active ingredient delivery, but whether the ingredients deliver the goods. One would think that the issuing of a 鈥淣atural Products Number (NPN)鈥� by Health Canada would guarantee that efficacy has been demonstrated, but one would be wrong! The evidence required is minimal, and in the case of products that have several ingredients, there is no requirement for any proof that the product as a whole is beneficial. For example, the 鈥淪leep and Restore鈥� version of Chewpods contains the sleep-inducing hormone melatonin as well as 5-hydroxytryptamine (5-HTP), a precursor to serotonin, the neurotransmitter associated with mood. The dosages, however, are way less than those that have shown any efficacy in clinical trials. Nevertheless, just their presence is enough to get an NPN. There is no requirement to show that the supplement itself lives up to the advertising.
The 鈥淔ocus and Action鈥� version of Chewpods claims 鈥渢hat product helps to temporary relieve symptoms of stress such as mental fatigue and sensation of weakness, that it helps support cognitive function such as mental focus and mental stamina, that it provides antioxidants and that it helps the body to metabolize carbohydrates, proteins and fats.鈥� Justification seems to be based on the supplement containing the stimulant caffeine as well as an extract of rhodiola, which, at least according to some studies, reduces fatigue. The thin support for metabolizing carbohydrates, proteins and fat comes from the inclusion of vitamins A and B6, which play a role in numerous biochemical reactions.
Now for some numbers. The amount of caffeine (30 mg) is less than that in a cup of coffee, the vitamin A content at 80 mcg is about one-tenth the recommended daily allowance, and the 72 mg of rhodiola extract, also the source of the over-hyped antioxidants, is way less than what has been shown to have any benefit in placebo-controlled trials. There is no harm in trying Chewpods, but remember that Health Canada鈥檚 NPN on the label does not mean it has been shown to be effective. And that is something to chew on.
Natural product regulations are sorely in need of updating but it is a complex undertaking because sound science is not the only factor that enters the picture. Industry lobbying against tightening regulations is extensive, which is understandable given that the dietary supplement market is huge and many companies try to get in on the game by torturing data until it succumbs to their desires. An estimated 40 billion dollars are spent each year in North America on vitamins, minerals, herbal products and various esoteric fruit and animal extracts that purport to keep our bodies running smoothly in face of an avalanche of 鈥渢oxic chemicals鈥� unleashed by Big Pharma, Big Food, Big Agro and Big Beauty. Of course, the dietary supplements never contain 鈥渃hemicals,鈥� they only contain 鈥渘atural鈥� substances that are portrayed as the secret to health. Advertisements feature trim, attractive bodies brimming with vigour, thanks to nature鈥檚 gifts. Never mind that those gifts may not contain what the label indicates, that they may be adulterated with real pharmaceuticals, or that the 鈥渆vidence鈥� provided is on such a shaky platform that a little scientific jiggle leads to its collapse.
