Publication
title
Natural Health Products Regulations: A Vague New Vision
DATE
February 1, 2002
EXPERTISE
Life Sciences Team
Natural health products - neither food nor drug but something new entirely? Bringing an end to years of speculation and debate, Health Canada has finally published proposed Natural Health Products Regulations. The publication of the draft regulations on December 22, 2001 marks the end of the extensive review and consultation period that formally began with the creation of an advisory panel to Health Canada, proceeded through a Standing Committee review on the regulatory status of natural health products and resulted in the 1998 release of the Standing Committee's report: A New Vision. The draft regulations create a comprehensive new regulatory regime for natural health products. They may be accessed on the Government of Canada website at http://www.canada.gc.ca/gazette/part1/pdf/g1-13551.pdf pages 112-171. Interested parties may provide comments on the draft regulations by March 23, 2002.
Natural health product definition
Although the regulations will be enacted under the Food and Drugs Act, they will be separate from the Food and Drug Regulations as are the regulations governing cosmetics and medical devices. Unless specifically provided in the regulations, the Food and Drug Regulations will not apply to natural health products.
The regulations encompass the manufacture, packaging, labelling, storage, importation, distribution and sale of natural health products. One key element of the regulations is that they will attempt to define what is meant by a "natural health product".
The regulations define a "natural health product" ("NHP") in two ways. Functionally, an NHP is a listed substance, a homeopathic preparation or a traditional medicine that is 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 humans;
- restoring or correcting organic functions in humans; or
- maintaining or promoting health or otherwise modifying organic functions in humans.
The substances listed as NHPs are:
- A plant or a plant material, an alga, a fungus or a non-human animal material
- An extract or isolate of a substance described in item 1, the primary molecular structure of which is identical to that which it had prior to its extraction or isolation
- Any of the following vitamins, their salts or their derivatives:
biotin
folic acid
niacin
pantothenic acid
vitamin A
vitamin B1 or thiamine
vitamin B2 or riboflavin
vitamin B6 or pyridoxine
vitamin B12 or cyanocobalamin
vitamin C or ascorbic acid
vitamin D
vitamin E
vitamin K - An amino acid or any of its salts
- An essential fatty acid
- A synthetic duplicate of a substance described in any of items 2 to 5
- A mineral
- A probiotic.
Certain substances, such as biologics and injectables, are specifically excluded from the definition. Also excluded from the definition are those products with a narrow margin of safety between their recommended doses and their toxic doses. (Substances in this category will continue to be regulated as drugs under the Food and Drug Regulations.)
Theoretically, the definition would allow for a full range of health claims including structure-function, risk reduction and therapeutic or treatment claims. Unfortunately, there is no indication as to the type of evidence required to support such claims. The regulations state only that information must be submitted that supports the safety and efficacy of the product for its recommended use. The guidance document on the standards of evidence for evaluating safety and claims has yet to appear for review by the general public. It is also interesting to note that the regulations contemplate that an NHP may be restricted to prescription-drug status.
Product licensing
All NHPs will require pre-market assessment and approval. Theoretically, holders of a Drug Identification Number (DIN) for existing NHPs will be expected to apply for an NHP/PSN number and the DIN will be cancelled. According to the Natural Health Products Directorate (NHPD), natural health products with DINs will be considered not to be in compliance with the Food and Drug Regulations. The regulations do not, however, describe how this transition will occur or even whether such a transition is mandatory.
The NHPD is developing a Compendium of Monographs of medicinal ingredients. A product licence application for a medicinal ingredient that is the subject of a monograph would not require any safety or efficacy data and would be disposed of within 60 days.
The regulations contain provisions permitting stop sale orders as well as licence suspensions and cancellations.
Product licence holders would be required to report, record and analyse adverse reactions.
Site licensing
A site licence will be required for all buildings in which NHPs are imported, distributed, manufactured, packaged, labelled or stored prior to sale.
Good manufacturing practices
The proposed GMPs apply to manufacturers, packagers, labellers, importers and distributors of NHPs. The GMPs are vague and outcome-based, rather than procedure-based. A GMP guidance document will suggest procedures that may be adopted to meet the GMP requirements but is not available at present.
An application for a product licence for an imported product must include an attestation, as well as evidence, demonstrating that the product will be manufactured, packaged, labelled, imported, distributed and stored in accordance with the GMP or equivalent requirements. An application for domestically-manufactured product must include an attestation that the product will be manufactured, packaged, labelled, distributed and stored in accordance with the GMP requirements. An application for a site licence must include an inspector's report that all buildings, equipment, practices and procedures comply with the GMP requirements or an audit report to the same effect signed by a person who has the technical expertise and training to do so.
Clinical trials
The regulations provide for the prior approval of clinical trials for NHPs. The requirements are very similar to the requirements imposed on clinical trials for drugs. The regulations impose obligations on sponsors in relation to good clinical practices, labelling, record-keeping and adverse reaction reporting.
Labelling and packaging
The regulations mandate that the label include, inter alia, the strength or potency of the medicinal ingredients, a qualitative list of non-medicinal ingredients and all risk information, including cautions, warnings, contra-indications and known adverse reactions associated with the use of the NHP.
Cost recovery
The regulations make no reference to the imposition of cost recovery fees. (Given the current trend toward cost recovery within federal government departments, it is not unlikely that a schedule of fees associated with the new licensing regime will be introduced in the future.)
Transitional provisions
In essence, all NHPs will have to be in compliance with the regulations within two years after their final enactment. Once the regulations are enacted, the NHPD is requesting that all those marketing NHPs in Canada notify the NHPD of that fact. All notified products, both with and without DINs, may continue to be sold pending product licensing and subject to health and safety concerns.
The NHPD is also requesting that all those involved in the importation, distribution, manufacture, packaging or labelling of NHPs for sale in Canada notify the NHPD of that fact.
Conclusion
Unfortunately, notwithstanding their five-year gestation period, the regulations are incomplete. Left unanswered are the following questions:
- which products will be excluded on the grounds of a narrow margin of safety?
- what will be the criteria for imposing prescription-drug status on NHPs?
- what will be the standard of evidence necessary to support a health claim?
- what will be included in the Compendium of Monographs?
- what evidence will be required to demonstrate that an imported NHP is in compliance with the GMP requirements?
- what will the specific GMP requirements entail?
- how extensive a review will NHPs currently holding a DIN be subjected to?
- how will PSNs replace DINs?
The extent and scope of these unanswered questions raises serious concerns for manufacturers, retailers, distributors and importers of natural health products as well as the general public. Companies that currently hold DINs for products that will now fall within the definition of an NHP may be particularly concerned, as the status of those registrations is now questionable. Companies that have been manufacturing and selling products without DINs may find that the new licensing regime imposes significant compliance costs. The new definition of an NHP lacks specificity and is likely to be of little use to the general public in assessing the quality of products at the retail level. It is doubtful that the goals and objectives of the "New Vision" contemplated by the Standing Committee in 1998 have been met. The proposed regulatory regime lacks specificity and certainty and will, no doubt, require supplementing by regulatory "guidance" and case-by-case decision-making.
Comments on the proposed regulations are to be directed to the following address by March 23, 2002:
Philip Waddington
Director General
Natural Health Products Directorate
Health Products and Food Branch
Department of Health
Address Locator 3709B
171 Slater Street, 9th Floor
Ottawa, ON K1A 0L3
Tel: (613) 952-3128
Fax: (613) 946-1615
E-mail: ONHP Consultations@hc-sc.gc.ca
Contacts
Penny S. Bonner
Toronto
416.216.6629
pbonner@ogilvyrenault.com
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Martha A. Healey
Ottawa
613.780.8638
mhealey@ogilvyrenault.com
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