FAQ

Are Homeopathic Medicines Regulated?

A: Yes. Homeopathic Medicines are regulated under the Natural Health Products Regulations (NHPR). These regulations ensure that products licensed by Health Canada for sale to the public must meet quality standards as well as being safe when used as labelled and that claims are only permitted when information is submitted that satisfies the evidence requirements. Homeopathic Medicines have to follow the NHPR like all Natural Health Products in order to be granted and retain their licenses.

Q: Are Homeopathic Medicines used by many people?

A: Yes. According to the most recent World Health Organization report on the progress of traditional and complementary medicines, homeopathy is used by the populations of 100 out of its 134 member-states. In Canada, the government has pointed out that according to a 2010 public opinion poll on natural health products, about 70% of Canadians regularly use such products to maintain their health and to prevent minor health problems. More recent data showed that between 3 and 5 million Canadians use a homeopathic medicine in a typical year.

Q: If that many people use Homeopathic Medicines why do some people say that these products don’t work?

A: While many opinions are expressed in support of the value of Homeopathic Medicines (such as experts in integrative medicine, complementary medicine practitioners, patients etc.) there are some who do not believe that there is value for those who choose to use them. These people tend to base their opinion on a much narrower view of evidence. For these people, therapeutic value can only be assigned through a very few types of evidence that is typically used to assess higher risk therapeutic products. This narrow field of vision obscures all the opportunities to assess whether a product works or not.

The mere fact that so many people use Homeopathic Medicines and repeat their purchases based on successful outcomes is testament to the wisdom of applying a broad range of information (such as traditional documentation) to enable the licensing of traditionally used remedies such as Homeopathic Medicines.

Certainly, Homeopathic Medicines have a long history of safe use to ensure that those who make the choice to use them are well protected from harm. Given the lower risk profile of these medicines, a wide variety of information can be used by regulators to assess the claims made on the product label.

Q: Is there any modern scientific evidence that demonstrates that Homeopathic Medicines work?

A: Yes. There is a growing body of evidence that supports Homeopathic Medicines. Some people deny the existence of peer-reviewed evidence, but they would be ignoring the facts. While there are long-standing documents that support claims that are authorized for products in Canada and by other competent regulatory authorities, the emergence of new types of evidence gives greater support for the reliability of these traditional references and provide the possibility of novel claims.

To learn more about the state of research in Homeopathy please follow this link.

Q: Is it necessary for consumers to know the type of evidence used to approve health claims on various self-care products?

A: Consumers aren’t expected to know what the regulatory details are for licensing products under the NHPR. Knowing what type(s) of evidence used to validate the claim on the label is not required for the person selecting or using a product safely or successfully. In fact, all products regulated by government have a variety of standards which manufacturers must adhere to for their products to be used properly and consumers are not expected to have this level of knowledge before they can make a purchase.

Canadians expect that self-care products on the store shelves or available online have been granted market access by Health Canada only after meeting the regulatory standards. The standards applied are based on the relative risk a product may pose. So those with higher risks require higher standards of evidence for their claims and those with lower risks may use a broader array of evidence to support their application for a license to sell.

Consumers face decisions about product selection daily. Research shows that they are guided by friends, family and healthcare practitioners when they are selecting a product for the first time. After that, a successful outcome has the most influence over repeat purchases. Knowing the basis for an individual product’s license bears no relationship to these selection behaviors and is an artificial construct with respect to safety and a successful product experience.

There is no data that would demonstrate that a lack of knowledge about the types of evidence for each product type would change the outcomes expected by the person choosing a particular product.

However, there is a principle of informed choice that was envisioned by the government when it introduced the NHPR. Therefore, those products that are traditionally used for specific purposes and which use the precleared information sources set out by government rather than product-specific clinical trial data, carry a statement about the traditional use. For such medicines, the label must include statements like “traditionally used for” to distinguish this from a product which uses other types of information to support a label claim.

For Homeopathic Medicines there is an additional statement required on cough, cold and flu products for children under 12. These packages carry the following on their label: “This claim is based on traditional homeopathic references and not modern scientific evidence” or “These claims are based on traditional homeopathic references and not modern scientific evidence”.

While knowledge of the types of evidence has no relationship to the outcome experience for consumers, the addition of statements for traditionally used products may contribute to informed choice.

Q: Are Consumers confused about wat they find in the aisles of pharmacy?

A: There are over 50,000 self-care products licensed for sale as self-care products in Canada. With such an abundance of products to choose from there is bound to be some who find this challenging. This is not restricted to Homeopathic Medicines as there are fewer of these products on the shelves than any other category.

 Given the vast array of choices, consumers have developed behaviors that help them in making a product selection for their health needs. For first time purchases, people rely on the recommendations of friends and family who have had a positive result from a product or have asked a healthcare practitioner who they respect. They also refer to the information on a product label. For subsequent purchase decisions they rely on their own past experience with the product. If they had success, then they will likely repeat the purchase the next time they have a need. If not, they start their search as if it where the first time.

A consumer who chooses a Homeopathic Medicine instead of another type of product would find that they are not putting themselves at an increased risk as these are amongst the safest of all products on the shelves. On the other hand, a person who chooses another product when they intended to select a Homeopathic Medicine, may find that they are at greater risk than if they had not made an error in selection.

Q: Should Homeopathic Medicines be sold alongside other self-care products?

A: Yes. Store shelves are well planned to facilitate the search process for self-care products. If products for similar use were scattered in the store, then the consumer is less likely to be able to make an informed choice. They would be inhibited from comparing labels, prices and other relevant information required to make a final selection.

While products are grouped together in stores by their intended purpose, the products within a section of the store are not mixed randomly. Homeopathic Medicines are usually found together as are herbal and other traditionally used products.

Q: Where can I learn more about how Traditional Medicines like Homeopathic Medicines are regulated in Canada?

A: You can read more details on how these products are regulated and the standards of evidence by following this link.