Suppliers of natural health products in Canada are up in arms over changes to national legislation they say could place pharmaceutical controls on their products.
Amendments to the country's Food & Drug Act — known as Bill C-51 — would see "natural health products," currently regulated as a separate and distinct class under Drug law in the Food and Drug Act, re-classed, along with drugs as "therapeutic products" with many new and onerous requirements including clinical trial implications.
Of major concern is just how the new legislation would supercede the 2004 regulations developed specifically for Natural Health Products.
Critics say this would see suppliers of natural health products, which they argue pose a low risk to consumers, face costly registration procedures normally reserved for drugs, which are associated with far greater dangers to health. As a result, many companies could be deterred from launching products onto the Canadian market, reducing choice for consumers, they say.
Penelope Marrett, president and CEO of the Canadian Health Food Association (CHFA), which is lobbying for a separate category for natural health products under the Act, said: "While CHFA supports the government's commitment to ensuring Canadians are provided with foods and products that are safe and effective, our members cannot support legislation that categorises natural health products as therapeutic products together with drugs.
"This bill views natural health products through the lens of pharmaceutical drugs and that is just not right for consumers. The government has a responsibility to ensure that any amended legislation recognises that natural health products are neither foods nor drugs, and that access to these important products will continue now and into the future to be available to Canadians working to achieve optimal health and well-being."
But the Canadian government played down the impact of the amendments, arguing: "Bill C-51 will not affect the way that natural health products are regulated in Canada. The Natural Health Products Regulations, introduced in 2004, will continue to operate the same way under the proposed Bill C-51. The Natural Health Products Regulations already recognise that natural health products are different from drugs, and that the evidence requirements for drugs are not appropriate for natural health products. Bill C-51 does not change this."
The amendments, which give officials greater enforcement powers and increase the penalties faced by those breaking the law, were designed to protect consumers against tainted products and misleading claims, it added. It also enabled the 'Minister' to, by order, designate a therapeutic product — either individually or by class — as a prescription therapeutic product, a clause and power worrying to industry.