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Publication

title

Commentary on New Natural Health Products Regulations

DATE

July 31, 2003

EXPERTISE

Life Sciences

Marking an end to well over five years of discussion, debate, consultation and legislative drafting, on June 18, 2003, the Canadian government published new Natural Health Product Regulations[1] (the "NHP Regulations").  The NHP Regulations, which will be administered by the Natural Health Products Directorate of Health Canada (the "NHPD"), bring products such as vitamins and minerals, herbal products and homeopathic medicines under a single regulatory regime.  While all natural health products will now be considered to be "drugs" for the purposes of the Food and Drugs Act , the NHP Regulations provide for a single, tailored regime to ensure the safety, efficacy and quality of these natural health products, while at the same time allowing for an appropriate range of health claims.

WHAT IS A NATURAL HEALTH PRODUCT?

There are two components to the definition of a natural health product ("NHP"):  a substance component and a functional component.  Substances that will be considered to be NHPs include homeopathic medicines, traditional medicines, plants, plant material, algae, bacteria, fungi, certain vitamins,2 amino acids, essential fatty acids, minerals and probiotics.3  However, the NHP Regulations do not provide a definition of either "homeopathic medicine" or "traditional medicine", leaving such important definitions to be defined and interpreted through guidance documents to be published by the NHPD.  Drugs required to be sold under prescription are excluded from the NHP Regulations.

The functional component is met if the substance is manufactured, sold or represented for use in:

  1. the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans; or
  2. restoring or correcting organic functions in humans; or
  3. modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health.

Substances that modify organic functions merely as a by-product of use, as an example, should not fall into the definition of NHPs if they are manufactured, sold or represented for other purposes.  It is worth noting that these functional criteria mirror those in the definition of a drug under the Food and Drugs Act, except for the fact that they are limited to humans.  Any substances intended to maintain or promote the health of animals will still, presumably, continue to be treated as drugs.

WHO IS DIRECTLY AFFECTED BY THE NHP REGULATIONS?

The NHP Regulations will govern the sale, manufacture, packaging, labelling, importation for sale, distribution and storage of all NHPs.  A manufacturer is defined as a person who fabricates or processes an NHP for the purpose of sale, but does not include a pharmacist or other health care practitioner.  A distributor is defined as a person who sells an NHP to another person for the purpose of further sale by that other person.

The background materials published by the NHPD suggest that it is not the intention of the NHP Regulations to regulate growers of products or health care practitioners (e.g., pharmacists, herbalists or traditional Chinese medicine practitioners) who compound products at the request of a patient.  Nor do the NHP Regulations aim to regulate the practice of complementary and alternative health care practitioners or the practice of traditional aboriginal medicine.  No guidance has been provided, however, as to the distinction between the manufacture and sale of NHPs on the one hand, and the compounding and distribution of compounded products by complementary or alternative health care practitioners.

WHAT DO THE REGULATIONS MEAN FOR THE NHP INDUSTRY?

In addition to the definition of an NHP, the key aspects of the NHP Regulations are:

  • Product licensing - no NHP may be sold without a product licence, and each product will be assigned a product number, designated as either "DIN-HM" in the case of homeopathic medicine or "NPN" for all other NHPs.
  • Site licensing - renewable site licences will be required for any person who manufactures, packages, labels or imports NHPs.[4]  The renewal period will vary from one to three years, depending on how long the licensee has held the site licence.  It is unclear whether site licences previously held for a "drug" product will be considered when determining the renewal period.
  • Good Manufacturing Practices ("GMP") - the NHP Regulations cover compliance with product specifications (including purity, quantity per dosage of medicinal ingredients, potency[5] and test methods), requirements for premises, equipment, sanitation programs and operations associated with manufacturing, packaging, labelling and storage, storage conditions, employee qualifications, quality assurance and record-keeping.[6]
  • Clinical trials - provisions similar to those currently applicable to drugs are included in the NHP Regulations.
  • Standard labelling and packaging requirements - current NHPs on the Canadian market may require substantial label revisions.
  • Adverse reaction reporting - NHP licence holders will be required to provide case reports relating to serious adverse reactions to the NHP that occur inside Canada, as well as reports relating to serious unexpected adverse reactions that occur inside or outside Canada.7  Annual reports are also required.

The provisions of the Food and Drug Regulations will no longer apply to NHPs unless otherwise indicated in the NHP Regulations.  As a result, both NHPs that have previously been regulated as food products and those that have previously been regulated as drug products will now be governed by the same regime.  For NHPs that have been historically treated as food products, this will likely mean far more stringent regulation of the manufacturing and distribution process, including the requirement to obtain pre market approval, something that is currently only required for novel foods.  The new classification will include the ability to make a broader, more dynamic range of health claims, provided those claims can be substantiated.  Unfortunately, no guidance is given as to what level of evidence will be required in order to support a claim. Presumably, an NHP claim will require less evidence than would be required for a drug product; how much less evidence will be required is unclear.

For NHPs that have to date been considered to be drug products, the introduction of the NHP Regulations may mean a less rigorous regulatory examination of the product prior to sale.  Again, less evidence may be required than in the past for health claims related to the NHP.  However, some of these products may now lose intangible market value if the credibility of the product, established under the current Food and Drug Regulations and evidenced by the assignment of a Drug Identification Number ("DIN"), is diminished and the product is perceived to be in a class of products that are less safe and effective than traditional drugs.  For manufacturers and distributors who have already undertaken all of the work necessary to meet the standards currently prescribed for drug products, the requirement to switch out to a NHP product number may prove to be a competitive disadvantage.

HOW WILL PRODUCT LICENCES BE ISSUED?

In order to obtain a product licence for an NHP, an applicant will need to complete and submit a detailed application including information regarding the natural health product.  Provided all of the required information is submitted, applications for product licences will be granted or rejected within 60 days of submission.[8]

No information or guidance has been provided in the NHP Regulations or policy documentation with respect to the cost of product licences or other administrative regulatory compliance.  Most Health Canada departments have instituted cost recovery programs, and there is little reason to believe that the NHPD will not act accordingly.  However, at the moment, the administrative costs that may be expected to be incurred by NHP licence holders remain unknown.

HOW MUCH TIME DOES THE INDUSTRY HAVE TO COMPLY?

The NHP Regulations will come into force on January 1, 2004.9  If the NHP is currently sold as a drug with a DIN, compliance is delayed until December 31, 2009, provided that the drug continues to be sold in full compliance with the Food and Drug Regulations.  Even if product licences are obtained for these drugs prior to December 31, 2009, compliance with GMP requirements may be delayed for lots or batches manufactured, packaged and labelled before January 1, 2006, provided that all activity relating to the lot or batch has been conducted in accordance with GMP requirements under the Food and Drug Regulations.

The NHP Regulations include general transition provisions for delayed compliance until December 31, 2005, with site licensing and GMP requirements for products on the market before January 1, 2004, provided that all applicable activity is conducted in accordance with the requirements of the Food and Drug Regulations.  The NHP Regulations will clearly result in a manifest change to the manner in which natural health products are sold in Canada.  The lengthy transition periods will, in all likelihood, be necessary to allow both the NHPD and companies affected by the NHP Regulations sufficient time to take the necessary steps, or to put in place the necessary regulatory infrastructure to meet the new regulatory requirements.

CONCLUSION

Prior to the introduction of the NHP Regulations, NHPs were sold as either food or drugs.  For those sold as food products, the NHP Regulations introduce more stringent safety and efficacy requirements, but also allow for broader health claims to be made.  For those NHPs previously sold as drugs, more limited evidence may now be required to establish safety and efficacy and to support health claims.  However, the new evidentiary standards are unspecified, and it is unclear what information will substantiate claims for NHPs.  Minimal guidance may be found in the FAQ published by the NHPD10 suggesting that "the product must be safe for consideration as an over-the-counter (OTC) product ? available for self care and self selection."

  2. Schedule 1 to the NHP Regulations lists the following vitamins:  biotin, folate, niacin, pantothenic acid, riboflavin, thiamine, vitamin A, vitamin B6, vitamin B12, vitamin C, vitamin D and vitamin E.
  3. Extracts or isolates of plants, plant materials, algae, bacteria and fungi, and synthetic duplicates of certain of the listed substances will also be considered to be natural health products.
  4. Site licences are not required if the activity relates solely to a clinical trial.
  5. Potency specifications are applicable only if representations relating to potency of the medicinal ingredients in the NHP are shown on the product label.
  6. All non-imported NHPs must be manufactured, labelled, distributed and stored in accordance with the GMP requirements; imported products may be manufactured, packaged, labelled, distributed or stored, as the case may be, in accordance with requirements that are equivalent to those set out in the NHP Regulations.  Equivalence criteria are not specified.
  7. In each instance, reports are due within fifteen days of the licence holder becoming aware of the event.
  8. The 60-day turnaround on product licence applications will not take effect until July 1, 2004.
  9. Section 6 of the NHP Regulations, which requires the Minister to dispose of applications for product licences within 60 days if all required information is presented, will not come into effect until July 1, 2004.

©OGILVY RENAULT 2003 - All Rights Reserved

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Penny S. Bonner


pbonner@ogilvyrenault.com
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Martha A. Healey


mhealey@ogilvyrenault.com
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