Oy, Canada! Is a Natural Health Products Act rising?
Under Canada’s Food and Drugs Act of 1953, health or medicinal products are classified in four categories: drug, device, cosmetic, or food. Natural health products, or NHPs-including dietary supplements, certain food and beverage products (such as energy bars and fortified juices), traditional medicines (e.g., ayurvedic, Chinese, herbal), and homeopathic remedies-have been regulated as a subset of drugs. But could that change?
In November 2011, nonprofit trade association the Canadian Health Food Association (CHFA; Toronto, ON, Canada) publicly called on Health Canada to develop and enact a new law governing natural health products, thereby removing NHPs from the current Food and Drugs Act that is overseen by Health Canada and enforced by the Canadian Food Inspection Agency.
The idea of creating a separate law governing NHPs isn’t new. In 1998, the House of Commons Standing Committee on Health issued 53 official recommendations to Health Canada to more properly define and regulate NHPs, which included calling for modification of the Food and Drugs Act to account for the fact that NHPs are neither foods nor drugs and that the law should be amended accordingly.
Although the Canadian health-food industry supported the recommendations at that time, Lionel Pasen, a founding member of CHFA and head of Toronto-based Natural Health Products Consulting, said that “all indications were that getting a new law or a completely separate class of products for NHPs would take 10 to 15 years.” The best the industry could get, at that time, “was to have NHPs listed as a separate class of drugs, which is effectively where they are now.”
Still regulated as drugs, NHP regulations did undergo a significant change in January 2004, when the Natural Health Products Regulations (NHPR) came into effect. These requirements called for the Natural Health Products Directorate (NHPD) to review premarket license applications for every natural product, and site license applications for all supplement manufacturers, packagers, labelers, and companies that import into Canada. In order to receive product preapproval, supplement makers must submit evidence to NHPD documenting safety, proper manufacturing, and health-claim-supportive data. However, as the NHPD became flooded with submissions, said the Association of the European Self-Medication Industry in a June 2011 overview, “an instant backlog of applications awaiting review and decision was created...”
As of 2010, seven years after the passage of the NHPR, there was already a massive backlog of NHP product-license applications that had been filed but not yet reviewed by Health Canada. Because new products were barred from the marketplace, innovation and product introductions were frozen during this time. The industry outcry over this logjam led to the introduction of the Natural Health Products (Unprocessed Product Application) Regulations (NHP UPLAR). Under NHP UPLAR, companies could continue marketing their products, even while awaiting preapproval, if products met certain criteria and eventually underwent postmarket oversight.
However, NHP UPLAR is set to expire in February 2013, by which time NHPD will theoretically have been able to eliminate the backlog and will be able to do future reviews within a 180-day window.
According to CHFA, data from a survey conducted by Calgary, Alberta–based Ipsos Reid on behalf of CHFA “clearly demonstrate [that] the public supports a new act for NHPs.” In fact, said CHFA, the survey found that 7 in 10 Canadians supported developing a new law for NHPs in Canada.
Carl Carter, CHFA’s director of regulatory affairs and policy development, stated in an interview with Nutritional Outlook that “the industry feels very strongly that full regulation is needed, but in the form of a new act, a Natural Health Products Act.” Carter says that of the approximately 1,000 industry members of CHFA, “92 to 96% are behind this; we clearly have a very strong mandate from our membership.”
A separate law for natural health products would arguably be attractive for several reasons: 1) it would properly define and correctly regulate NHPs; 2) it would avoid many of the drug requirements being accidentally carried along in the regulation and enforcement of NHPs today; 3) it would establish an appropriate safety model for NHPs that recognizes the fact that supplements are intrinsically benign and that drugs are intrinsically dangerous, and that the relative safety of each is based on a completely different risk-benefit paradigm. Only time will tell if a new law would continue the existing preapproval process for NHPs and manufacturers, as new legislation has not yet been introduced.
Is it likely that a separate regulation could be created? Carter points out some obstacles. “One of the biggest obstacles we face is precisely the fact that since natural health products have such a great safety record,” it may be challenging to generate sufficient will on the part of Parliament to take NHPs out of the drug category in order to create a new law governing natural products. Carter’s comment recognizes the fact that if there were thousands of safety problems or a history of serious adverse events associated with NHPs, it would ironically be easier to make the case that the existing regulation is not working. However, that is not the case.
Also, note that not all stakeholder groups are behind the call for a new law for supplements. According to Gerry Harrington of the Canadian association Consumer Health Products Canada (Ottawa, ON, Canada), “It would defy common sense to abandon [the NHP regulations] now and start over, when they’ve never really been enforced.” By this, Harrington refers to those products that are temporarily allowed on store shelves under the NHP UPLAR provision.
When asked as to when we might expect a new supplements law to be put in place, Pasen of Natural Health Products Consulting said: “I’m 75; I don’t think I’m going to see it.”