The comments, written by CRN’s vice president of scientific and international affairs James Griffiths, PhD, argue that a significant amount of development has gone into the existing Natural Health Products (NHPs) regulatory structure and companies have a lot invested in trying to understand and comply with the regime. CRN urges the agency not to throw the baby out with the bath water in an attempt to deal with perceived shortcomings in the existing system.
Turning back the clock
The new proposal “seemingly turns back the calendar, and starts from scratch in re-engaging with stakeholders, and it will substantively affect the ability of Canadians to make informed choices on the products they have relied on and that the industry has earned over the last decade under the current regulations,” Griffiths wrote.
Griffiths noted that the current system is already based on risk. If a product poses a higher risk, a greater amount of data proving safety is required in the premarket notification process. Products with lower risk need supply less evidence. The goal of the current system, according to Health Canada, is “to ensure that all Canadians have ready access to natural health products that are safe, effective, and of high quality, while respecting freedom of choice and philosophical and cultural diversity.”
“It is not clear where the real basis for concern lies, because the NHP system already comprehensively addresses quality, safety, and efficacy through existing risk-based evaluations,” Griffiths wrote.
Where does traditional healing fit?
Griffiths noted that the existing system recognizes that Canada is a multicultural society and leaves room for traditional modes of healing which might not have data behind them that conforms to Western notions of proof of efficacy. The new proposal seems to take a step back from this inclusive view.
“Philosophical and cultural distinctions and differences need to be embraced and not curtailed in the name of ‘pharmaceutical’ science,” Griffiths wrote.
Griffiths noted that the Health Canada’s overhaul proposal, titled “Consulting Canadians on the Regulation of Self-Care Products in Canada,” alludes to the need for scientific evidence, but lacks detail as to whether the existing standards of evidence will apply in the new process. In addition, Griffiths raises the question of what is to become of the existing 100,000 plus product registrations that are in place under the existing system.
He further takes the agency to task over its stance on health claims in the new proposal. Griffiths said the proposal is heavily weighted toward drug-type claims, which he said seems bases on an assumption that existing allowed claims on not based on scientific proof. This seems in his view to be mostly aimed at the currently allowed traditional use claims, which Griffiths said are based on data from earlier generations and on an older monographs. Griffiths also questions whether products arising from traditional medicine systems such as TCM and Ayurveda, which are allowed under the current regime, would be allowed under a new one.
“The document seems critical of the fact that NHPs may not meet the evidence requirements of OTC medications without seeming to wonder whether it is appropriate to expect or require NHPs to do so,” Griffiths wrote.
Are consumers really confused?
Griffiths was also critical of the perceived need for the regulatory change because of the fact that many exiting NHPs are sold from shelves in close proximity to OTC drugs, with the Health Canada proposal postulating that this could lead to confusion on the part of consumers about the relative veracity of claims on the products.
“Neither shelf proximity nor percentage considering themselves well-informed seems a reasonable basis for determining that NHPs need to be regulated in any different way,” Griffiths said.
Recommendation: Leave well enough alone
CRN offers three recommendations for Health Canada going forward:
- Conduct research to see if the proposed disclaimer (“Health Canada has not reviewed the product for effectiveness”) will confuse consumers who have come to trust this category of products.
- Better align the prosed health claims process with international standards.
- Better align the GMPs mentioned in the proposal with US GMPs.
But Griffiths’ real bottom line was contained in a sentence that appears early on in his comments: ”Changing the current NHP Regulations is an expensive attempt to fix a system that is not broken.”