Canadian Reg Presentation

Natural Health Products

Many of the products we distribute will be subject to registration with the new Natural Health Product Directorate.  Registering products will allow the manufacturer to make several approved claims as to the benefit or structure/function claims depending on what the product is, and what level of evidence is produced to support any claims.

Puresource will be required to register each of your approved products on our Site Licence in order to allow us to continue the distribution of these items.  However, the the registration of each individual product, in terms of applying and receiving approval with a product identification number, is the responsibility of the manufacturer.

Puresource will make every attempt to support all our manufacturers though this transition by providing the necessary references to the appropriate resources.  Products not registered by the dates stipulated by Health Canada will not be legal for sale in Canada, and Puresource may not be able to distribute these items at that point.

The products most affected are:

1. Herbal products and remedies previously sold as foods (including teas and supplements)
2. Any product making a health claim (including health and beauty items also)

Please choose from the following:

• Frequently Asked Questions

• Consultants

• Does your product qualify under the NHP regualtion?

Canada’s Natural Health Products Regulations  

Frequently Asked Questions (FAQs)

1. Why were the regulations created for natural health products?

In the past, natural health products (NHPs) have been sold as either drugs or foods under the Food and Drugs Act and Regulations because there was no other category under which to classify them. If classified as a drug, natural health products must adhere to the drug review process, including proof of safety and efficacy through clinical trials, and receive a Drug Identification Number (DIN) to be sold. If classified as a food, natural health products can make only very limited health claims and do not provide adequate safety information on their labels. The new regulations were created with the intention of removing the difficultly associated with the DIN application process, while allowing natural health products to make health claims that reflect the strength of evidence supporting the use of the natural product for specific health problems.

2. When are the regulations coming into effect?

June 2003 - The Natural Health Products Directorate published the new regulations in the Canada Gazette, Part II. These regulations will become law in January, 2004. Then, a transitional period that will span from 2 to 6 years ( 2 years for site licensing and 6 years for products with Drug Identification Numbers (DIN)), will follow before any penalties or enforcement will begin.

a)       By the end of two years (Jan. 2006), all manufacturers, importers, packagers and labelers must employ good manufacturing practices (GMPs) ,and have site licenses.

b)       By the end of four years (Jan. 2008), any new Natural Health Products that are on the market must have obtained a NHP product license (NPN) (i.e. a product license).

c)       By the end of six years, natural health products that currently have a product license, as a Drug Identification Number (DIN), will have transferred that DIN to a NPN or, a DIN-HM (homeopathic medicine).

3. What types of natural health products are affected by these new regulations?

Natural health products (NHPs) are defined in the regulations as vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicines (e.g. Traditional Chinese Medicines), probiotics, and other products like amino acids and essential fatty acids. Under the new regulations, the product must be safe for consideration as an over-the-counter (OTC) product. Natural health products are available for self care and self selection, and do not require a prescription to be sold. Products requiring a prescription will continue to be regulated under the Food and Drug Regulations.

 4. Who is responsible for assuring that products met the new regulations?

Manufacturers are responsible for attaining a site license, thereby using Good Manufacturing Practices (GMPs). Manufactures are responsible for attaining product licenses for their products.  Puresource Private Brands (Herbal Select/NOW Foods) have always and will use GMPs. Puresource Private Brands will assure that all SKUs attain product licenses before the regulations come into effect (January 2008). Puresource is confident that we will met all new regulation expectations for both site and product licenses. We guarantee that all Herbal Select and NOW products sold will be compliant with the new regulations in a timely manner. Puresource will require that all products distributed will comply with regulations by the dates indicated in Question 1(contact Paul to confirm). However, it is important for retailers to understand the regulations to assure they offer compliant products, and to be able to can assist customers understand the new regulations. 

 5. How will consumers know when a natural health product has been authorized for sale by Health Canada?

Once assessed by Health Canada, the product label will bear an 8 digit product license number, preceded by the letters “NPN” meaning Natural Product License Number.  The NPN on the label will inform consumers that the product has been reviewed by Health Canada for safety, quality and health claims. For homeopathics, the label will bear the designation DIN-HM.

 6. What type of "claims" will we be allowed to make, and what type of research will be required?

There are 5 levels of evidence: 1) meta-analysis of randomized controlled trials, 2) other controlled trials, 3) observational studies (case control, cohort, survey),  4) expert committee reports, opinions or experience of respected authorities, 5) traditional references.  The chart below highlights the level of evidence required for each health claim.

7. How will this affect the industry as a whole?

This is difficult to predict, as the regulations are new. The hope is that the regulations will greatly increase consumer support and confidence in the natural health products industry thereby increasing sales.  With the new additional steps required to place a product on the shelf, increases in costs and, therefore, prices are likely. Whether the number of products available will increase or decrease, can not be determined until the Natural Health Products Directorate publishes all product monographs, (i.e. reports on individual natural products and their accepted use), which is not likely to occur until January 2004.

8. Which items specifically will be at the greatest risk of being "pulled" from our shelves?

Products at greatest risk are those with safety concerns and little to no evidence (e.g. traditional or scientific), to support their effectiveness.  All products can apply for product licenses, regardless of whether a monograph has been created for that specific product. There are various levels of evidence that will be accepted by the NHPD, from traditional use evidence, to human clinical trials.  The level of the evidence provided will reflect the strength of the health claim that will be allowed on that product.

9. Will pharmacists, and "licensed" practitioners have more freedom as to what they may carry on their shelves and recommend to their customers than the "health food retailer"?

No.  The new regulations do not allow pharmacists or licensed practitioners to sell natural health products that health retailers can not. Pharmacists will be allowed to dispense drugs with DINs, and health retailers can not. This is no different than current regulations.

 10. Will products from the U.S., specifically NOW, be no longer allowed in Canada?

Products at greatest risk are those with safety concerns and little to no evidence (e.g. traditional or scientific), to support their effectiveness.  All products can apply for product licenses, regardless of whether a monograph has been created for that specific product. There are various levels of evidence that will be accepted by the NHPD, from traditional use evidence, to human clinical trials.  The level of the evidence provided will reflect the strength of the health claim that will be allowed on that product.  Specifics are not yet known.

For a copy of the new Natural Health Products Regulations as they appear in Canada Gazette II visit, http://www.hc-sc.gc.ca/hpfb-dgpsa/nhpd-dpsn/regs_cg2_cp_e.html

For more information, visit Health Canada's:

 Website: www.hc-sc.gc.ca

Email: nhpd_dpsn@hc-sc.gc.ca

Mail:  Natural Health Products Directorate
Health Canada
2936 Baseline Rd.
Ottawa, ON
K1A 0K9

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