Canadian regulation of herbal products

Like the United States, Canada, has developed systems to regulate herbal products. In Canada, some herbs are considered foods, some are considered drugs and some may considered both. Where an herbal product falls

232 Appendix: The herbal regulatory system is very much dependent on its history of use, its dosage and its presenta-

tion. In some cases these criteria are clearly stated, whereas in many oth- ers the dividing line is obscure.

For herbal products that are presented as therapeutic agents the clas- sification is clear. Unlike the United States, which passed the DSHEA to regulate these products as a subset of foods capable of making mild claims, Canada took a decidedly different route and set out to regulate these products as a subset of drugs and allowed drug-like claims to be made for these products. The Natural Health Products Regulations came into effect on January 1 st , 2004 and regulate all herbal remedies as well as vitamins and minerals, homeopathic medicines, traditional medicines,

probiotics and other products like amino acids and essential fatty acids. 18 These products are called Natural Health Products (NHPs). Herbs that are not presented as having therapeutic effects are not nec- essarily exempt from regulatory scrutiny. This is especially true for herbs that have not been commonly used as foods in Canada (which inciden- tally, sums up the vast majority of herbs). These herbs would be considered novel foods and would still require a very stringent safety evaluation prior to gaining market approval.

NHPs, unlike dietary supplements, are also required to undergo a pre-market safety evaluation. But, because they make claims, NHPs must also undergo quality and efficacy evaluations prior to going to market. NHPs are not, however, subject to all the provisions set out for drugs in the Canadian Food and Drug Regulations and are subject to a simpli-

fied evaluation process. 18 The authority that evaluates and regulates these products is known as the Natural Health Products Directorate (NHPD). 18 Because NHPs are not limited to a dosage form, they can be in typical supplement forms such as capsules, pills, tablets, powders and liquids, as well as in more conventional food forms such as bars, gums, wafers or beverages. Some topical creams, lotions and toothpastes are considered NHPs. Products that require that they be delivered by puncturing the der- mis (i.e. injectables) cannot be NHPs.

The definition of a Natural Health Product essentially consists of two parts: a structure component and a function component. The structure component refers to the medicinal ingredient or ingredients in the NHP, and includes “herbal remedies, traditional and homeopathic medicines and materials derived from plants, algae, bacteria fungi, or non-human animal material, amino acids, essential fatty acids, probiotics, minerals, several vitamins and synthetic duplicates of the natural ingredients”. 18

The function component is the requirement that these products are “sold or represented for the use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symp- toms in humans, restoring or correcting organic functions in humans, modifying organic functions in humans, such as modifying those

Appendix: The herbal regulatory system 233 functions in a manner that maintains or promotes health.” 18 Simply put,

NHPs can and must make drug-like claims or structure function claims. When used in NHPs, there is essentially no distinction between the two; both are considered NHP claims.

NHP claims can be divided into two categories: traditional use claims and non-traditional use claims. Traditional use claims are for products that have been used within a cultural belief system or healing paradigm

for at least 50 consecutive years. 18 Unlike other jurisdictions with similar traditional use clauses, under the Canadian regulations, the cultural system is not limited to the local population. Thus, the demonstration of the traditional use of the product in another culture or country other than Canada is acceptable.

Non-traditional use claims are for those claims that do not meet the requirements of traditional use claims. These claims need to be supported by scientific evidence and the review and approval of the claim is done by the NHPD during the product licensing procedure.

Product licensing is the pre-market approval step that all NHPs must go through prior to legal sale. Following the review process, those products deemed acceptable by the NHPD in terms of safety, quality and efficacy would be given a product license and a Natural Product Number (NPN) or, in the case of homeopathic medicines, a Drug Identification Number for

Homeopathic Medicine (DIN-HM). 18 The standards of evidence required to demonstrate safety, quality and efficacy will vary between products. The amount and type of evidence will be dependent on the nature of the product and the type of claim being used.

Products can consist of combinations of medicinal ingredients. The applicant is required to justify the use of such a combination and ensure that there are no safety concerns with the combination of the ingredients. Basically, four types of product license applications that can be made: a compendial application, a traditional claim application, a non-traditional claim application and a homeopathic medicine application.

Among the NHP product license application types, the compendial Application is the simplest and most restrictive. These applications are for products that contain a single medicinal ingredient that is the subject of an official NHPD monograph. For products containing more than one medicinal ingredient, the NHPD has published several product monographs that can also be used for compendial applications; however these monographs are very limited in scope and number. The NHPD has stated that as more information is obtained and reviewed, more monographs will become available for use.

The monographs provide specific details including, but not limited to, the medicinal ingredient’s proper name, common name, and source. Additionally, the monographs specify the route of administration, the dose, quality specifications for the product, and duration of use for any

234 Appendix: The herbal regulatory system appropriate subpopulation. Products that are applying for a compendial

application must conform to these specifications. The monographs also indicate a recommended use or purpose for the ingredient, as well as risk information associated with the ingredient. An applicant may make alterations to the wording of these elements, but cannot alter their meaning. If the product matches the required criteria as set out in the monograph, a compendial application can be made and the monograph can be used as the sole source of evidence for the safety and efficacy of the product. NHPD has stated that compendial products will be reviewed within 60 days of the date upon which the directorate receives a complete submission. 18

As noted above, traditional claims need to refer to the medicinal use of the product for 50 consecutive years. To qualify for a traditional use claim, the product needs to be prepared in the traditional manner described in

the submitted evidence. 18 The evidence must include at least two independent references (i.e. references that do not cite the same source, or each other, as the main source of information regarding the traditional use) that support the recommended conditions of use or one acceptable phar- macopoeia reference.

Applicants for a nontraditional claim must submit a nontraditional claim application. The amount of evidence needed to for these applications will vary with the product. At a minimum, two independent pieces of evidence supporting the product’s safety and efficacy is required. The NHPD places importance on the type and level of evidence submitted in the application. To obtain a license, the evidence submitted must support the safety of the product and the claim that is being made. Different types of claims would require different levels of evidence.

All manufacturers, packagers, labelers and importers of natural health products are required to hold a site license. The site license will specify exactly which of the previously listed activities the applicant is allowed to do with respect to NHPs. In order to obtain a site license the applicant must demonstrate that they are in compliance with the good manufactur- ing practices (GMP) requirements set out in the regulations.

The NHP regulations are still relatively new. Health Canada and the NHPD are currently doing the first major review of the system. They are looking over the results and issues that have surfaced since the implementation of the regulations.

Among the issues to address is the large delay experienced in the pro- cessing and issuing of product licenses. A major component of the delay is the time required to process the backlog of license applications cre- ated by implementation of a new regulatory regime. The NHPD started on day one with zero licensed products and as many as 40,000 applications. When the backlog is completed, action on applications is expected to proceed in a more timely fashion. The NHPD has implemented and

Appendix: The herbal regulatory system 235 continues to implement procedures it believes will help streamline the

process. Some of these proposed procedures aim to address some of the concerns that manufacturers have brought forth. These include the need for better guidance and information on exactly what type and amount of evidence applications required to substantiate claims and increasing the quality and quantity of published monographs. The NHPD has also introduced new on-line ingredient and product databases. These databases provide limited information on both ingredients and products that have been approved for sale. As more information is gathered the NHPD hopes to significantly expand the information available in the databases.

A major innovation that is hoped to significantly improve the efficiency of product license reviews is the use of the NHP On-line System. This system, which is currently undergoing pilot studies, will allow for the support of electronic preparation and submission of license applications. It is hoped that through the implementation of these initiatives that product licensing process can be improved in terms with respect to time, efficiency and costs.

Another major concern among manufacturers and consumers is the proposed fees associated with the regulation of NHPs. The NHPD had stated that user fees would be required to cover a portion of the costs of its operation. So far, no fees have been charged. Recently Health Canada has set out a proposed cost recovery program that has drawn concern and anger among manufacturers and consumers. The proposed program is being heavily debated and the eventual outcome is anxiously awaited.

Canadian regulation of herbal products