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What are NHPs (and what are not)?

NHPs are defined as: "substances or combinations of substances consisting of molecules and elements found in nature, and homeopathic preparations, sold in dosage form for the purpose of maintaining or improving health and treating or preventing diseases/conditions".

Health Canada, recently formed a new division called the Natural Health Products Directorate (NHPD). They expand the above by including a Function and a Substance component to the definition.

1. The Functional component states that an NHP is one that is used to:

a. diagnose, treat, or prevent diseases/conditions;

b. restore or correct organic function;

c. modify organic functions, such as modifying those functions in a manner that maintains or promotes health;

d. for sale as an OTC (Over-The-Counter) product; and

e. for self care and self selection by the public.

2.The Substance component states that an NHP is one that is included in the NHPD list, such as:

a. a plant or plant material (incl. extracts)

b. an alga, bacterium or fungus;

c. vitamins & minerals;

d. probiotics, amino acids & enzymes; and

e. essential fatty acids.

3. A NHP includes (but is not limited to):

a. Traditional Herbal Medicines (THMs);

b. Traditional Chinese Medicines (TCMs);

c. Ayurvedic (East Indian) Medicines;

d. Native North American Medicines;

e. Homeopathic Medicines (HMs);

f. Aromatherapy products;

g. Cosmetics which have bio-active ingredients; and

h. Food Supplements or Beverages which contain NHPs (i.e.: sports drinks or coffees containing Echinacea, ginseng, maca, guarana, etc.)

4. What is excluded from the definitions of a NHP?

a. Drugs requiring a prescription;

b. Radiopharmaceuticals;

c. Biologics, such as anterior pituitary extracts;

d. Injectables; and

e. Antibiotics.

Why were new regulations required?

"These regulations are intended to provide Canadians with ready access to natural health products that are safe, effective, and of high quality, while respecting freedom of choice and philosophical and cultural diversity".

Until now, the unique nature of NHPs has not been appropriately regulated. NHPs tended to be under-regulated as foods or over-regulated as Drugs.

As such, if health claims were made on the product label or in advertising, they were regulated as Drugs and required a DIN (with the corresponding strict regulations). However, if no claims were made they were regulated as Foods by the Canadian Food Inspection Agency (CFIA). As Foods, there was no product review nor approval required. Also, manufacturing and quality standards were only voluntary.

The NHPD was formed to create regulations half-way between Foods & Drugs.

What are the highlights of the new regulations?

1. Regulatory controls will not unduly restrict the consumers’ free access to and choice of safe, effective, and clearly labeled products.

2. NHPs are obliged to meet certain minimum standards for safety and quality with increased standards for Quality Control and Finished Product testing to ensure what is listed on the label is actually in the bottle.

3. Manufacturers, packagers, importers, and distributors of NHPs located in Canada are obliged to hold valid Site Licenses, which attest to continued compliance with GMP standards specific to NHPs.

4. These GMP standards must include specific quality control and testing for products.

5. GMP inspection activities will be performed by the NHPD consistently and on a regular basis by inspectors knowledgeable about the products.

6. Products will be evaluated, commensurate with their potential risk.

7. Risk assessments will be made in light of a broader range of reference sources other than just conventional Western drug evaluations.

8. Product labels will be standardized to be complete, accurate, and informative and must include Warnings, Contraindications and Side Effects.

9. NHPs are allowed to make health claims.

10. These claims must be supported by reasonable evidence (such as traditional references, scientific publications, professional consensus, or other evidence).

11. A pre-market approval process to Licence products has been implemented.

12. There will be post-market surveillance to monitor the risks and benefits (which is based on the margin of safety of the product and any reported adverse reactions).

How will these new regulations impact industry & consumers?

1. Standards, by their very nature, level the playing field, affording small and/or new NHP companies the same credentials as large ones. This also gives a NHP company in Edmonton the same or superior credentials for sale of NHPs in Canada as its competitors in California, Japan, or Europe.

2. Industry will benefit by having a clear set of regulations, thereby reducing confusion as to the appropriate regulatory category their product falls into;

3. Increased consumer confidence that the products they purchase have been manufactured under strict Risk Management programs and are therefore safe, efficacious and of high quality;

4. Industry will be able to provide consumers with more information about their NHPs as companies will now be required to state key information on their product labels including Health Claims;

5. Industry will benefit from an improved corporate image among regulators, customers, and the public both in Canada and abroad;

6. Manufacturers with a Site Licence will be able to bid on contracts, where as those who do not will be out of the running;

7. The regulations will eventually serve to minimize trade barriers;

8. The implementation of Good Manufacturing Practices (GMP) will establish and clarify responsibilities, procedures, policies, & records; and

9. Increase shareholder confidence.

What are the possible consequences of failing to comply with these regulations?

1. Compliance Inspections will involve samplings and analyses at points of importation, manufacture and at retail outlets.

2. For non-registered products, the NHPD will take corrective actions in a timely manner.

3. These corrective actions are based primarily on a risk-based approach. Responses to Non-Compliance may involve the following:

a. Voluntary product detention or disposal;

b. Product recall;

c. An order to stop sale and/or seizure;

d. A Customs look-out and/or alert;

e. Import refusal;

f. Suspension / cancellation of Licences;

g. Formal Hearings; and/or

h. Fines and/or jail time.

Who do these new regulations apply to, and who is exempt?

1. The regulations apply to the sale of NHPs in Canada, for human use, and apply only to:

a. Manufacturers

b. Packagers;

c. Labelers;

d. Importers; and

e. Distributors of NHPs.

2. Who is Exempt?

The regulations do not apply to:

a. growers, testers & retailers;

b. Natural Practitioners, such as Aboriginal Healers who may prepare medicines (as long as the product is prepared for an individual patient only); and

c. Supplies of raw materials.