Sometimes patients are confused about this topic: aren’t the supplements (vitamin, minerals, fatty acids etc) drugs too? Don’t they “treat” diseases too? What’s the difference between them?
Let’s start with the definition of a drug first.
According to Health Canada, drugs include both prescription and non-prescription pharmaceuticals; biologically-derived products such as vaccines, blood derived products, and products produced through biotechnology; tissues and organs; disinfectants; and radio-pharmaceuticals. According to the Food and Drug Act, a drug includes any substance or mixture of substances manufactured, sold or represented for use in:
- the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical state, or the symptoms thereof in man or animal
- restoring, correcting or modifying organic functions in man or animal, or
- disinfection in premises in which food is manufactured, prepared or kept
Natural health products, such as vitamin and mineral supplements and herbal products for which therapeutic claims are made are also considered drugs at the level of the Food and Drugs Act; however, these products are regulated as natural health products under the Natural Health Products Regulations and not as drugs under the Food and Drug Regulations. They are seen as a sub-set of drugs now.
Another important theoretical distinction in the eyes of the authorities is this:
- Drugs are considered unsafe until proven safe
- Dietary supplements are considered safe until proven unsafe
Based on this conceptual difference, FDA and Health Canada consider new drugs to be unsafe until they are proven safe through clinical trials. And they must approve any new drug before it can be legally sold in the US or Canada. Clinical trials are studies done under well-controlled conditions on human volunteers. They are expensive. These tests must be done on all drugs – even those that are sold over the counter (without a prescription). The Health Canada approval process requires that the drug be proven in a series of clinical trials. These studies must show “substantial evidence” that the drug is both safe and effective for each of its intended uses. This level of scrutiny does not apply to natural health products. Manufacturers of supplements are not required to test new ingredients or supplements in clinical trials.
Under the Natural Health Products Regulations in Canada, which came into effect on January 1, 2004, natural health products (NHPs) are defined as:
- Vitamins and minerals
- Herbal remedies
- Homeopathic medicines
- Traditional medicines such as traditional Chinese medicines
- Probiotics
- Other products like amino acids and essential fatty acids
Natural Health Products must be safe to use as over-the-counter products and not need a prescription to be sold. Vitamins and minerals are regulated as a sub-set of drugs because they are considered to be natural health products.
A quick search in the Drug Product Database for vitamins, mineral and other so perceived “natural products” will reveal this: vitamin A, D, Folic acid (vit.B9), vit.K1, vit.K2 all have this duality – they are dietary supplements that become drugs at certain dosages specified in the law.
Vitamin A, for example, requires a prescription when a practitioner recommends that a patient take more than 10,000 international units (IU) per dose or in the total daily intake. Similarly, vitamin D becomes a drug when taken at more than 1,000 IUs/day; vitamins K1 and K2 require a prescription at more than 0.120 mg per day.
Folic acid (vit.B9) also “behaves” like a drug when used “in oral dosage form containing more than 1.0 milligram of folic acid per dosage form or, where the largest recommended daily dosage shown on the label would, if consumed by a person, result in the daily intake by that person of more than 1.0 milligram of folic acid”.
Why is this important? For naturopaths who commonly incorporate recommendations for supplements and vitamins as part of their practice, this is extremely important. In order to do so at the levels noted above (where the vitamin becomes a drug), a naturopath must first have successfully completed the Ontario Therapeutic Prescribing course and examination. It is fairly common for naturopaths to recommend high dose vitamins to patients; however, naturopaths who recommend patients take vitamins at levels that are above the limits and who have not completed the necessary course and exam will have breached the regulation and are subject to prosecution by the College for professional misconduct.