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Regulatory issues surrounding natural health products

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Regulatory issues surrounding natural health products
This Q-and-A article with Dr. Gerry Derganc, ND, regulatory and quality assurance advisor with Douglas Laboratories/Pure Encapsulations Canada, is intended to dispel myths and hopefully offer some clarity to any questions regarding the use of natural health products in daily practice.


March 23, 2011
By Massage Therapy Canada

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victoria-coleman.jpg 
Victoria Coleman


 

March 11, 2011 – Dr. Victoria Coleman is a 1994 graduate of CMCC and a B.Sc in kinesiology, specializing in Fitness Assessment and Exercise Counselling. She is currently working toward her certification in Functional Medicine. Dr. Coleman is also the president of Douglas Laboratories/Pure Encapsulations Canada.

This Q-and-A article with Dr. Gerry Derganc, ND, regulatory and quality assurance advisor with Douglas Laboratories/Pure Encapsulations Canada, is intended to dispel myths and hopefully offer some clarity to any questions regarding the use of natural health products in daily practice.

The regulation of natural health products in Canada has changed since the inception of the Natural Health Products Directorate (NHPD), a branch of Health Canada that regulates natural products. This has resulted in questions and often some confusion surrounding the incorporation of nutritional products in practice for health care providers.

Dr. Derganc graduated from the Canadian College of Naturopathic Medicine in 1999. Along with maintaining a private practice, he has held product development and regulatory positions within the natural health products industry and Health Canada.


Victoria Coleman: What is a natural health product (NHP)?

Dr. Derganc: Generally, a natural health product can be defined as a naturally occurring substance used to diagnose, treat or prevent disease, or its symptoms, in humans. Examples of NHPs include vitamins, minerals, botanical extracts, amino acids, probiotics, essential fatty acids and homeopathic medicines.

V.C.: How are natural health products in Canada regulated?

Dr. Derganc: The Natural Health Products regulations are administered by the Natural Health Products Directorate (NHPD) within Health Canada, and apply to the manufacturing, packaging, labelling and importation of NHPs for sale in Canada. The regulations include specific labelling and packaging requirements as well as good manufacturing practice standards. To be “legally” sold and imported into Canada, NHPs must undergo pre-market review and be granted product licences, which include Natural Product Numbers (NPNs), and the Canadian facilities that manufacture, package, label and import NHPs must obtain valid site licences. Note that the intent of these regulations is based on a self-care model. That is, the intent of these regulations is to cover NHPs that consumers can access without consulting a health-care provider.

V.C.: Are these regulations beneficial?

Dr. Derganc: The intent of these regulations is to provide Canadians access to a wide range of natural health products that are safe, effective and of high quality. Regarding quality, good manufacturing practices, or GMPs, are ongoing measures designed to ensure an effective overall approach to product quality control by setting appropriate standards and practices for product testing, manufacturing, storage, handling and distribution.


V.C.: What does the process of getting a natural health product licensed for sale in Canada involve?

Dr. Derganc: Obtaining a product licence, or Natural Product Number (NPN) requires submitting product specific safety, efficacy and quality evidence to Health Canada, Natural Health Products Directorate. Depending on the complexity of the product, the licensing process may take several months or longer. Once a product has been licensed, it will bear a product licence number preceded by the distinct letters NPN (which stand for Natural Product Number), or, in the case of a homeopathic medicine, by the letters DIN-HM (which stand for Homeopathic Medicine Number). This number on the label will inform consumers that the product has been reviewed and approved by Health Canada for safety, efficacy and quality.

V.C.: What are the recent developments in the NHP regulatory industry?

Dr. Derganc: Because Health Canada has not yet evaluated all natural health products currently on the market, Unprocessed Product Licence Applications Regulations (UPLAR) have recently been enacted. These incorporate the granting of an Exemption Number (EN) to eligible products in order to make them “legal” for sale and importation into Canada while the licensing process within Health Canada continues. The exemption number will be listed on the product label preceded by the letters EN.

V.C.: Is it safe to use a natural health product that does not have a Natural Product Number (NPN), Exemption Number (EN) or Homeopathic Medicine Number (DIN-HM) on the label?

Dr. Derganc: The absence of a NPN, EN or DIN-HM on the label does not necessarily mean that the product is unsafe. It means that the product has not been licensed for sale and that Health Canada has not had the chance to assess the product’s safety, its quality or the validity of its health claims. It is also possible that a licensed and/or exempted natural health product may not have an NPN or EN on the label the manufacturer has not had time to revise label texts.


V.C.: Are private practitioners legally able to sell natural health products to their patients?

Dr. Derganc: The Natural Health Products Directorate does not regulate the chiropractic, naturopathic or other regulated health-care professions. Providing there is no restriction within the practitioner’s scope of practice, regulated health-care practitioners can sell NHPs to their patients.

V.C.: Some practitioners have heard it can be less expensive to order natural health products from the United States and import them for resale. Is this legal?

Dr. Derganc: It would not be compliant with Health Canada’s Natural Health Product Regulations if an individual or business imported NHPs into Canada for the purpose of resale without a valid site licence. Any business or individual that brings into Canada an NHP for the purpose of sale is considered to be an importer. Also, retailers selling products obtained from a business that does not take responsibility as the importer and, therefore, does not have a site licence, will themselves be considered the importer and will require a site licence.

V.C.: Some practitioners have patients who question why they recommend a dose of a product that is outside the recommended dose on the label. How can they reassure these patients that the doses they are recommended are still safe?

Dr. Derganc: As mentioned previously and stated by Health Canada, “In developing the Natural Health Products Regulations, Health Canada’s intent was to cover products that consumers can select and use themselves, without the need to consult a health care provider and obtain a prescription.”

As highly trained health-care professionals, you have access to clinical experience, medical knowledge and relevant patient information, all of which allows you to make a detailed assessment and treatment plan for your patient.

Based on the expertise and opinion of the health-care practitioner, it is possible that an NHP may be prescribed for a condition other than what has been approved by the NHPD for self-care use. Also, based on the expertise and opinion of the health-care practitioner, treatment of certain conditions may require a different recommended dose from what has been approved by the NHPD for self-care use.


REFERENCES:
Health Canada Links:NHPD main page: http://www.hc-sc.gc.ca/dhp-mps/prodnatur/index-eng.phpDouglas Laboratories of Canada/Pure Encapsulationswww.douglaslabs.ca.


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