Natural health products "minimalist" regulatory system urged by Canadian advisory panel.

CANADIAN NATURAL HEALTH PRODUCTS "MINIMALIST" REGULATORY FRAMEWORK recommended by the Advisory Panel on Natural Health Products in a final report to the Canadian Federal Standing Committee on Health. The advisory panel, created in May 1997 by Health Canada's Therapeutic Products Program to help develop a revised policy for regulating natural health products, "felt strongly that federal government regulation of [natural health products] should be permissive rather than the prescriptive, its interventions minimalist unless potential risks to the public warrant greater intrusion by the state," the report states. The committee is distributing the report to interested parties and plans to make recommendations for a regulatory framework for NHPs in the fall.

No regulatory structure is in place in Canada for natural health products. "Existing regulatory controls for pharmaceuticals are too stringent and cumbersome for NHPs, while regulations for foods are inadequate," the report states. "The effect of the excessively stringent regulations is that product approval for marketing is expensive and slow -- if attainable at all. This places NHP vendors at a disadvantage in the competitive North American market. Consequently, products are often sold without adequate labeling information, smuggled into a black or gray market, or not sold at all," the report says.

Natural health products need a "separate regulatory category and framework that reflects their unique characteristics, while ensuring that consumers are fully informed," the panel concludes. The group defines NHPs as "substances or combinations of substances consisting of molecules and elements found in nature, and homeopathic preparations, sold in dosage forms for the purpose of maintaining or improving health and treating or preventing diseases/conditions."

Examples of natural health products include "homeopathic preparations, vitamins, minerals, enzymes, co-enzymes, co-factors, herbs or botanicals, animal source substances, and a variety of molecules extracted from natural substances such as amino acids, polysaccharides, peptides, naturally occurring hormones and precursors as well as naturally occurring molecules synthesized by chemical or biological means," the panel says. The 18-member advisory panel includes representatives from consumer groups, growers, retailers, exporters and importers, manufacturers, traditional and orthodox medicine practitioners and pharmacists.

In connection with the NHP definition, the panel suggests changes to the "Drugs" definition in Canada's Foods and Drugs Act. Currently the definition is "Any substance or mixture of substances manufactured, sold or represented for use in: the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals; restoring, correcting or modifying organic functions in human beings or animals; or disinfection in premises in which food is manufactured, prepared or kept." The "Drugs" category ought to be renamed "Therapeutic Products in Dosage Form," the panel suggests, with dosage forms including capsules, tablets, injectable substances, oral solutions, topical preparations (i.e., creams, liquids, ointments and patches), suppositories and inhalants, the panel suggests.

The definition of "Therapeutic Products in Dosage Form" would be enlarged to add intended use of products in the maintenance of wellness and would be divided into two categories, "Pharmaceuticals" and "Natural Health Products," the report proposes. Pharmaceuticals would comprise pharmaceutical medications, biologics and radiopharmaceuticals and conventional medical devices, the panel suggests. "Functional foods and substances sold in bulk, such as herbs used by practitioners of Traditional Chinese Medicine, are not covered because they are not marketed in dosage form," the report explains.

The advisory panel also recommends three types of claims be permitted for natural health products -- structure/function, risk/reduction and treatment claims.

Structure/function claims report the effect of a product on a structure or function in the body and are based on the maintenance of good health, the panel notes, listing as an example, "Calcium builds strong bones." Risk/reduction claims relate product use to a reduction in the risk of developing a disease or abnormal physiological state, the panel says, noting "the product may alter a recognized major risk factor or factors of a disease or abnormal state; or...it may affect a body function or system so as to improve the body's capacity to resist the disease or abnormal state. For example, garlic decreases the risk of cardiovascular disease."

Treatment claims "report the effects of a product on the actions of a specific disease or its symptoms," such as "St. John's wort is useful in the treatment of mild to moderate depression." The panel disagreed over whether NHPs could be marketed without health claims, with the majority in favor of the idea. Such a policy would be necessary, at least during an interim period, while a backlog of existing products pass through the initial licensing procedure, the report adds. The panel also calls for an "enforcement mechanism to protect against product displays that imply false or unsubstantiated claims."

Standards of evidence supporting the claims also should be broader than those accepted for pharmaceuticals, the panel urges. In addition to double-blind clinical studies, product monographs and published standards, the advisory panel believes other sources must be considered for acceptance, provided they have been approved by the advisory groups of the regulatory authority. These sources include: other clinical evidence, traditional or culturally based references, published literature other than mainstream scientific journals and professional consensus. "Because NHPs and their active components cannot be patented, panel members felt that the federal government should provide incentives to research new claims for NHPs," the report declares.