Are herbal medicines really useful?
Canada supports the determination by the World Health Organization (WHO) that the use of medicinal plants is important in the health care system of any country. Hundreds of herbal products are legally available on the Canadian market.
In recent weeks, Canadian consumers and practitioners have expressed concerns about regulations of and accessibility to herbal medicines in Canada. In response to these concerns, a panel will be established to review the regulatory framework for herbal products. Consultations with herbal and traditional medicine specialists, consumers and other stakeholders will also occur.
Have herbs been reclassified so that they now require a DIN or GP?
Under the legislation, if a manufacturer wanted to sell a medicinal herb or market a herb with drug claims, it has always required a Drug Identification Number (DIN) or General Public (GP). If a product defined as a drug under the Food and Drugs Act was sold without a DIN or GP, it was not in compliance with Canadian law.
Why is it necessary for the government to introduce regulation in this area?
Regulations to ensure the safety, effectiveness and quality of drugs have existed for a long time. The number of unlabelled and incorrectly labelled herbal remedies for sale has increased as the interest of Canadians in herbal remedies has grown. Health Canada applies the Food and Drugs Act and Regulations fairly to all the industries it regulates. It is vital that the products that Canadians use are safe.
What is the difference between a food and a drug?
In Canada, the Food and Drugs Act and Regulations set requirements for the production and sale of food and drug products. All products intended for ingestion, that is, taken by mouth, must be regulated as either a "food" or a "drug".
Canada has stringent regulations to ensure the safety, effectiveness and quality of drug and food products. This federal legislation defines "drug" as a substance that will restore, correct or modify a body function. A drug is also a substance that is sold or represented for sale as a treatment, prevention or cure of a disease, disorder or abnormal physical state. This means that if a product has one of these purposes or a manufacturer makes explicit or implicit claims that a product will achieve one of these purposes, it must be treated as a "drug". Alternatively, a food is something that is normally expected to be consumed for its nutrient value.
What is the DIN and GP?
These numbers are located on the label of any drug product that has been approved for sale. It indicates that a product has undergone -- and passed -- a review of its formulation, labelling, and instructions for use.
Several hundred herbal products which fall under the “drug” category, have been authorized for sale on the Canadian market and display the DIN, or GP, issued by the Therapeutic Products Programme of Health Canada.
When is an herbal product regulated as a drug?
When an herbal product is offered for sale to treat or prevent diseases or symptoms, or when it has one of these purposes, it is regulated as a drug under the Food and Drugs Act. An herbal product can be sold as a nonprescription medicine provided it is in compliance with the Act and its Regulations.
Any herbal product in a form used by the consumer and which is intended for medicinal use requires a DIN or GP prior to sale. The presence of drug indications on labelling or advertising materials is evidence that a product is intended for medicinal use.
In the case of unfinished products like bulk herbs, which are to be sold for further processing, different restrictions apply than for finished products. For example, the DIN requirements do not apply to raw materials.
What is the importer's responsibility?
It is the importer's responsibility to ensure that all finished products coming into Canada comply with Canadian requirements. If an importer plans to bring something into the country, it is up to the importer to know whether or not it is a controlled, prescription, or restricted drug. Goods may be refused entry to the country if there is no evidence of a valid DIN or GP.
Will the Controlled Drugs and Substances Act affect the availability of herbs in Canada?
No. It will regulate drugs already classified as narcotic and controlled drugs in Canada, including some substances that are subject to international drug trafficking control conventions such as opium and cocaine. This Act, when enforced, will in no way affect the availability of herbs offered for sale in Canada.
How are herbal remedies approved as therapeutic products?
Approval of herbal remedies is based mostly on traditional herbal references, provided they are not known to be unsafe when used to treat minor illnesses. Some manufacturers may wish to market herbal products to treat more serious ailments. If so, they must provide scientific and clinical evidence to support specific indications. These products are in the minority.
Can you assume that if an herbal product has been used for centuries it is safe?
Not necessarily. For example, Belladonna, an herbal ingredient used over the centuries as a sedative and for asthma, is also referred to as Deadly Nightshade. Consuming as few as three of the bright red berries of this invasive garden weed can be fatal. Recently, both Stephania tetranda and Magnolia officinalis caused severe kidney damage in Belgium where these products were illegally available: the kidney damage has resulted in over 50 patients requiring either chronic dialysis or kidney transplant. Import and compliance alerts have been issued in Canada to ensure these products are not illegally imported and sold.
While these three herbal ingredients are just examples, many reports are available in both the traditional and current literature where incorrect parts of a plant or the incorrect use of a plant for an otherwise treatable disease have resulted in tragic outcomes.
Cost Recovery:
How does cost recovery affect manufacturers and importers?
Since January 1995, all drugs have been subject to cost recovery fees, including herbs.
Is Health Canada introducing new licensing requirements on herbal product manufacturers and importers? Is there a cost?
Herbal medicines have been subject to Good Manufacturing Practices (GMP) for a long time and inspections to assure facilities meet these requirements. As of July 1997, Health Canada regulations require an annual “establishment license” to reflect that a manufacturer or exporter meets this standard.
The intent of the “establishment licensing” and GMP framework is to ensure uniform requirements for all persons wishing to fabricate, package, import, distribute, wholesale or test drugs in Canada. The Establishment Licensing Fees Regulations (1056) were published in Canada Gazette
Part I, on April 12, 1997. A 30 day comment period follows for the proposed regulations. Comments received will be shared with the expert advisory panel for use in developing options for an appropriate regulatory framework.
The Therapeutic Products Programme has recognized from the first, however, that while cost recovery fees may be fully justified on the basis of costs incurred, if the full cost were to be charged to some clients it would result in severe adverse economic impact and/or a disincentive to market necessary products. Fees are based on either the costs of the services provided (e.g. drug submission evaluation) or the market value of a right or privilege (e.g. annual fees for the right to sell a drug product). It is for this reason that “establishment licensing” fees have been capped at 1.5% of total sales.
Consultation with stakeholders on “establishment licensing” regulations and fees was extensive with a wide variety of stakeholders.
Is there a list of banned herbal products? Which herbs are not acceptable as drugs with or without claims?
Certain herbs are not acceptable as drugs or as ingredients in drugs. If they are encountered at Customs in a form that is likely to be used for those purposes, entry will be refused. Health Canada revises its lists of products presenting health hazards continuously, as additional information regarding the safety and pharmacological action of any herb becomes available. Consumer safety is the bottom line. Health Canada regulations are intended to ensure that:
(1) the sale of herbal products and their consumption in accordance with label directions will not pose a health hazard to consumers;
(2) any measures that may be taken to protect the health of consumers will not place unnecessary restrictions on freedom of choice; and
(3) herbal products which should be available as drugs are treated in that manner.
When are herbs acceptable as food?
In general, an herbal ingredient is acceptable as a food when it can be consumed as desired without ill effects. In fact, many herbal products are currently sold as food in Canada. As with any food in the marketplace, the sale of herbal products as foods is subject to Section 4 of the Food and Drugs Act, which states:
4. No person shall sell an article of food that
(a) has in or on it any poisonous or harmful substance;
(b ) is unfit for human consumption;
(c) consists in whole or in part of any filthy, putrid, disgusting, rotten, decomposed or diseased animal or vegetable substance;
(d) is adulterated; or
(e) was manufactured, prepared, preserved, packaged or stored under unsanitary conditions.
What is the official definition of a drug?
All therapeutic products in Canada are regulated under the Food and Drugs Act and some also by the Narcotic Control Act (soon to be replaced by the Controlled Drugs and Substances Act). The definition of a drug in the Act is:
"drug" includes any substance or mixture of substances manufactured, sold or represented for use in:
(a) the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical state, or its symptoms, in human beings or animals, or
(b) restoring, correcting or modifying organic functions in human beings or animals.
Under this definition, herbal remedies and other complementary medicines are quite clearly drugs.
Regulation A.01.040 to the Food and Drugs Act prohibits the importation for sale of any drug, the sale of which would be in violation of the provisions of the Act and regulations. Active ingredients which may be restricted are listed in any of the schedules to either the Food and Drugs Act and Regulations or the Narcotic Control Act.
For more information, importers and/or manufacturers are encouraged to discuss any concern with their regional Health Canada offices.