The Natural Health
Products Regulations:
Implications for Practice
April 19, 2006

Overview

• What are the NHP regulations?
• Why do they exist?
• What do they say?
• What implications do they have for practise?

Jargon

•   NHP – Natural Health Product
•   NHPD – Natural Health Products Directorate
•   HM – Homeopathic Medicine
•   DIN – Drug Identification Number
•   NPN – Natural Product Number
•   DIN-HM – Natural Product Number for Homeopathic Medicines
•   CAM – Complementary and Alternative Medicine
•   GMPs – Good Manufacturing Practices

What are the NHP regs?

What are Regulations?

• Laws made not by parliament but by someone to whom parliament has delegated authority e.g. a Minister, an administrative agency or Cabinet
• Regulations must be consistent with what is allowed under Act
• Operational part of a law, providing definitions of terms used in Act, procedures and processes which must be followed or standards which must be met

What is an Act?

•   Means by which laws are made by Parliament
•   Originates as a draft (Bill) from House of Commons or Senate
•   Discussed by both Houses during First, Second and Third Readings
•   Reviewed by parliamentary committee which seeks input from public & other interested parties

The Food and Drugs Act

• Interpretations (definitions)
• Part I:  Foods, Drugs, Cosmetics, Devices
• Part II: Administration and Enforcement
• Provisions for developing Regulations under the Act
• Offences & Punishment
• Schedules to the Act

Schedules to the Food & Drugs Act/Regulations

• Schedule A: list of conditions & diseases for  which claims are prohibited
• Schedule B: list of international pharmacopoeia
• Schedule C: radiopharmaceuticals
• Schedule D: biologic drugs
• Schedule F (to the F&D Regulations): prescription drugs
• Schedules E, G & H: repealed/empty

Schedule A & Section 3 of
the Food & Drugs Act

Section 3 states that no person can label or advertise any food, drug, cosmetic or device to the general public as a treatment, preventative or cure for diseases, disorders or abnormal physical states referred to in Schedule A

Schedule A

Examples of conditions on Schedule A include:

• Arthritis
• Alopecia
• Cardiovascular disease
• Depression
• Hypertension and Hypotension
• Obesity
• Ulcer of the GI tract
• Disease of the prostate

Schedule A Revisited?

•   On Nov 19, 2005 a regulatory amendment was published in Canada Gazette Part 1 which proposes to exempt drugs (including NHPs) not listed on Schedule F from the preventative & treatment prohibitions in Section 3 of the F&D Act
•   Licensed non-prescription drugs & NHPs would be permitted to carry claims regarding prevention & treatment for Schedule A conditions (evidence must be provided!)
•   75-day comment period ended early February, 2006

Why do the NHP Regs exist?

Previous Regulations for NHPs

•   Until January 1, 2004, all NHPs in Canada were regulated as a food or a drug under the Food and Drug Regulations
•   Simplified …
  • Food: for nutrition, taste, texture, etc.
  • Drug: make claims - to treat, cure, prevent, diagnose disease or modify organic function
•   All products with real or implied claims considered drugs, and therefore required a Drug Identification Number (DIN)

History at a Glance

• Grassroots Development
• 1997 - Advisory Panel
• 1998 - Standing Committee of Health - 53 recommendations
• 2000 - Creation of the Office of Natural Health Products
• Consultations with consumers, manufacturers, practitioners, and retailers
• 2001 - Proposed NHP Regulations in Canada Gazette I
• 2003 - Natural Health Products Regulations published in Canada Gazette II June 18^th, 2003
• Came into force January 1^st, 2004

53 Recommendations - highlights

• Appropriate definition for NHPs
• Consider new regulatory authority
• Staffed by individuals with expertise and experience with NHPs
• Not delayed by process of amending Food & Drugs Act
• NHPs be allowed to make health claims when supported by clinical & scientific evidence
• Review Schedule A

Various Perspectives:

•   Consumer:
  • Access and safety; personal impact
•   Advocacy Groups:
  • Focussed information; organized positions
•   Researcher:
  • Freedom to study; pure information
•   Practitioner:
  • Freedom to practice; ensure quality of the products
•   Industry:
  • Market access; minimize negative impact
•   Government:
  • Need to satisfy all views; public safety

Consultation Results:

• Design regulations specific to NHPs, that can answer the following Qs:
  • Is it safe?
  • Is it effective?
  • Is it of high quality?
  • Do people have access?

What do the NHP regs say?

NHPD Mission Statement

To ensure that all Canadians have ready access to natural health products that are safe, effective, and of high quality, while respecting freedom of choice and philosophical and cultural diversity.

NHP Regulations

•   Definitions
•   Part 1 – Product Licences
•   Part 2 – Site Licences
•   Part 3 – GMPs
•   Part 4 – Clinical Trials
•   Part 5 – Packaging and Labelling
•   Part 6 –Transitional Provisions
•   Including, of interest:
  • Adverse Reaction Reporting
  • Standards of Evidence

To whom do the NHP Regulations Apply?

• The NHP Regulations apply to the sale, manufacture, packaging, labelling, importation, distribution and storage of natural health products (NHPs).
• Do not apply to health care practitioners who compound individual NHPs for the needs of an individual client/patient
• Retail of NHPs does not require a site licence

NHP Definition

A substance or combination of substances set out on Schedule 1, a homeopathic medicine or a traditional medicine, that 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;
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.

What is an NHP?

Schedule 1: Included Substances

•   Plant, alga, bacterium, fungus, non-human animal material
•   Extract or isolate of the above
•   Vitamins
•   Amino acids
•   Essential fatty acids
•   Synthetic duplicates of the above
•   Minerals
•   Probiotics

What is not a NHP?

• Schedule 2: Excluded Substances
• Schedule C, D of the Food & Drugs Act
• Substances under the Tobacco Act
• Schedules I-V of Controlled Drugs & Substance Act
• Substances administered by puncturing the skin
• Antibiotics

HMs Eligible for a DIN-HM 

• Medicinal Ingredient must have monograph in one of following pharmacopeia:
  • HPUS
  • HAB
  • Pharmacopée française
  • European Pharmacopeia
  • Encyclopedia of Homeopathic Pharmacopeia

HMs Eligible for a DIN-HM (cont.)

• Provided it is found in a pharmacopeia, the following substances can be licensed:
  • Substances listed on Schedule D (biologics)
  • Substances exempted from the Tobacco Act because they are subject to the Food and Drugs Act, such as homeopathic Tabacum and Nicotinum
  • Substances listed on Schedule F to the Food and Drug Regulations (Prescription Drugs)
  • Any substance derived from an animal material
  • Substances that become nosodes, isodes, sarcodes, and allersodes

Ms Not Eligible for a DIN-HM

The NHP Regulations do not apply to homeopathic medicines manufactured from substances on the following lists:

• Schedules I to V of the Controlled Drugs and Substances Act
• Schedule C to the Food and Drugs Act (Radiopharmaceuticals)
• Homeopathic medicines intended for injectable use

Product Licence Requirements

•   Ingredients (medicinal & non-medicinal)
•   Brand name
•   Recommended conditions of use (use or purpose, dosage form, route of admin, dose, duration of use, risk info)
•   Safety and efficacy info
  • Attestation to an NHPD monograph, or
  • Other data to support the safety, quality and health claims
•   Attestation to Good Manufacturing Practices

Product number (NPN or DIN-HM) issued once a product is approved for sale in Canada

•   Clearly defined criteria used by regulators to describe the amount and type of data required to evaluate product safety, claims, and quality
•   Claims must correspond to the level of evidence provided in support of the claim
•   3 types of claims allowed:
  • Structure / Function
  • Risk reduction
  • Treatment / Cure
•   Claims must reflect the balance of all available evidence

Requirements:

• all manufacturers, packagers, labellers, and importers must be licensed
• all sites in distribution chain (i.e. including distributors, wholesalers) must adhere to Good Manufacturing Practices (GMPs)
• the regulations also set out circumstances for refusing, suspending or cancelling a site licence, and an appeals mechanism

Parts 2 & 3: Site Licences & GMPs

•   This component will provide investigators:
  • clear and transparent requirements for conducting human clinical trials with NHPs 
  • methods to ensure the safety of trial participants
  • a means to test new products without a long history of traditional use, including products that have not yet received market authorization, where no other data are available, and/or for obtaining evidence to support new claims, if they wish
  • And ensure effective, appropriate and complete ethical review.
• Comparison between regulations for drugs and NHPs:
  • Very similar approach irrespective of product
  • Research Ethics Board for NHP clinical trials requires a members knowledgeable in complementary and alternative health care
  • ‘if any’ statement
  • Fewer timeline restrictions for NHPs
•    The proposed reporting system will assist Health Canada in issuing advisories, where appropriate, to the public:
  • similar to system now in place for pharmaceuticals
  • an important part of a product approval system based on risk assessment and the corresponding management of risks
•   Regulations will require product licence holders to monitor all adverse events associated with product
•   Serious and unexpected adverse reactions must be reported to Health Canada

Labelling

• Brand name
• Product number (NPN/DIN-HM)
• Dosage form
• Sterile products marked as “sterile”
• Net amount (weight, measure, number)
• Name and address of the product licence holder
• Name and address of the importer, if any
• Common & Proper Name of each medicinal ingredient
• Quantity of each medicinal ingredient per dosage unit

Labelling

• Potency of each medicinal ingredient
• Recommended conditions of use (use, route of administration, dose, duration of use, risk information)
• Storage conditions
• Lot number
• Expiry date
• Source materials of each medicinal ingredient
• Non-medicinal ingredients

Transitional Provisions

Priority Approach to
Compliance and Enforcement

What are the implications for practice??

mplications for Practice: Context

• Practice of medicine is largely the responsibility of the provinces and territories
• Most NHPs are self selected by consumers without seeking advice from a health care practitioner
• NHP Regulations intended to ensure safety of products suitable for self-care

Benefits of the NHP Regs on Practice

•   Patients have access to high quality products
•   Complete information on the labels supports them in making informed choices
•   NHP Research Program is facilitating CAM practitioners in becoming more involved in the national research agenda
  • IN-CAM- national CAM network supporting the inclusion of practitioners
  • NHP Research Society of Canada, supported by the NHPD, actively engages practitioners in research projects.
•   Through the NHP Research Program, practice/product issues are being explored as part of the directorate’s health promotion initiative

Availability of Product

• Products that do not meet HM definition may not be licenced e.g. Opium, X-ray, newly proven remedies that are not in an accepted Pharmacopeia

NHP Regulations - Review

• Original commitment to review the NHP Regulations was 3-5 years after implementation
• Timeline being moved up – review will begin within the next few months

Natural Health Products Directorate

For further information, please contact:

Natural Health Products Directorate
Health Canada
2936 Baseline Road, Tower A
Address locator 3302A
Ottawa, Ontario, K1A 0K9
Tel:    1-888-774-5555
Fax:   (613) 946-1615
E-mail: nhpd_dpsn@hc-sc.gc.ca

Web: http://www.healthcanada.ca/nhpd