Better consumer protection

There has been much concern in recent weeks about Bill C-51 which proposes amendments to the Food and Drugs Act to modernize the regulatory system for foods and therapeutic products.

Perhaps the greatest misconception is that consumers will no longer have the freedom or choice to purchase Natural Health Products (NHPs) or that you will need a prescription in order to obtain natural health products. This is simply untrue.

To date a great deal of misinformation is being spread on the implications of the Bill including the notion that you will no longer have the choice to purchase natural health products without prescriptions. This is not the case.

Bill C-51, An Act to amend the Food and Drugs Act and its companion Bill C-52, An Act respecting the safety of consumer products, are key components of the federal government’s Food and Consumer Safety Action Plan, announced on December 17th, 2007. They represent what is essentially a three-pronged approach to food, health and consumer product safety.

The Food and Consumer Safety Action Plan was initiated in response to a rash of product recalls in 2007 and 2008, involving items such as tainted pet food, spinach contaminated with Escherichia coli, contaminated toothpaste, and unsafe children’s toys.

On January 10th, 2008, the Government of Canada issued a discussion paper outlining the key aspects of its plan and inviting Canadians to provide input. Health Canada and the Canadian Food Inspection Agency also hosted a technical consultation for key stakeholders on January 24th, 2008 to obtain their views on more specific aspects of the plan.

Under the proposed Bill C-51 there are no changes to the Natural Health Products Regulations which have been regulated as a unique category since 2004. Natural Health Products are not regulated as food or as drugs.

It has been stated that the use of the term “therapeutic product” in Bill C-51 is intended to move NHPs fully into the drug category. This is not true.

The term ‘therapeutic product’ is a general term which includes all products that claim to enhance human health including drugs, natural health products, medical devices, veterinary drugs, and blood and blood products.

The intention of Bill C-51 and the regulations is to ensure that the Natural Health Products available to Canadians remain safe and effective as Health Canada has addressed a number of health and safety issues where NHPs are concerned.

Also, where good manufacturing practices have not been respected, there have been safety issues around bacterial contamination and heavy metals, including arsenic and lead.

Under C-51, the legislation requires vigilance to ensure that tainted products are found and recalled, that what is on the label is actually in the bottle, and that health claims are supported by evidence.

There has been a perception that the increased powers around recalls, enforcement, fines and penalties are specifically targeting the NHP industry.

This is incorrect, as these powers apply to all product classes regulated under the Act. In addition, the compliance and enforcement authorities are not directed to any single group.

These new powers bring Canada up to par with other international regulators. It is accepted that most companies, including NHP companies, do comply with requests for product recalls. However, without this Bill, if companies choose not to recall, Canada will remain unable to require them to recall their products even in situations when there are clear health and safety concerns.

For NHPs, compliance and enforcement activities will continue to be guided by the Compliance Policy for Natural Health Products and will be gauged by the degree of risk of the product. On products of low risk, which includes most Natural Health Products, pharmaceutical standards of evidence are not and will not be required.

The strength of C-51 is that, as a consumer of NHPs, you will have greater assurance that the products on the market are safe and that you will continue to enjoy excellent quality and choice in health care prevention and treatment with confidence.

Furthermore, I have spoken at length with Minister Clement and his staff and have his full assurance that he will continue to consult with representatives from the Natural Health Products community to address their concerns and to ensure that under C-51, NHPs will continue to be available to you and that the number and variety of Natural Health Products will continue to grow.

In this regard, I am pleased to report that on May 23rd, Health Canada sponsored a stakeholders meeting in Kelowna on Bill C-51 in their continuing efforts to consult with the Natural Health Products community. The objectives of this interactive session were to explain the intent of the proposed legislative amendments and provide a clear description of the changes as well as identify and potentially address areas of concern early in the legislative process. The meeting also sought stakeholders’ feedback on the scope and impact of the legislative package on natural health products.

One of the suggestions made at the meeting is that the Natural Health Products be considered a category in its own right. I am supportive of this and am confident that an amendment to this effect will come before the House of Commons.

Stakeholders will have a further opportunity to share their concerns when the Bill comes before the Standing Committee on Health which will happen sometime in the fall.

For your information, the legislation can be found at:

Bill C51 Legislation

Information on the Natural Health Products Regulations can be found at:

Natural Health Products Regulations

You may also be interested in contacting 1-866-891-4542 to make a direct inquiry regarding Bill C-51 or view this following website (www.healthycanadians.ca) for more information regarding this bill. Here you will find clarification of many of the misconceptions that have caused alarm including the false contention that agents will be allowed to enter private residences without warrants.

It is important to keep an open mind. There are those within the industry who do not want to be regulated at all and who are trying to scare people. But be assured, the government is taking a balanced approach to consumer safety and is respectful of Canadians right to choice in Natural Health Products.

If you would like to discuss this or any other issue please feel free to
e-mail or telephone me at any time at [email protected] or 470-5075.

This article is written by or on behalf of an outsourced columnist and does not necessarily reflect the views of Castanet.