To Health Canada: Put Canadians’ Health Before Corporate Interests
Bad Science Watch issued a press release on December 19, 2012, addressing a letter (below) sent to Health Canada criticizing the changes to the final natural health product (NHP) regulatory framework due to come into effect in February 2013:
FOR IMMEDIATE RELEASE
Bad Science Watch to Health Canada: Put Canadians’ Health Before Corporate Interests
Toronto, ON – Wednesday December 19th, 2012 – Bad Science Watch, an independent consumer protection watchdog, has issued critical feedback to Health Canada regarding its plans to compromise natural health product regulations for the benefit of manufacturers.
The new changes will make it easier for products to be licensed without safety and efficacy checks, allow for misleading advertising for products with sub-therapeutic doses of ingredients, and make manufacturing site inspections voluntary. The justification Health Canada offers for these changes include reducing “administrative burden” for manufacturers and shortening the product review process.
“What was at the beginning a strong regulatory framework now benefits only the corporations manufacturing these products.” said Bad Science Watch Board Chair, Michael Kruse.
These changes are based on recommendations from the Natural Health Product Program Advisory Committee, which is dominated by members from industry and lobby groups, such as Pfizer, Jamieson Laboratories, and the Canadian Homeopathic Pharmaceuticals Association.
“Over the past decade powerful industry lobby groups have eroded NHPD regulations to the point where Canadian families just can’t trust that the natural health products in their pharmacy are safe and effective,” said Jamie Williams, executive director at Bad Science Watch. “It’s sad that Health Canada has put industrial interests before the health and well-being of consumers.”
For media inquiries, or additional information, please contact:
Chair, Board of Directors
Bad Science Watch
Here is the letter we sent to the Natural Health Products Directorate on December 7, 2012, in response to the NHPD Roadshow that held meeting across Canada introducing the new Pathway to Licensing for natural health products:
Senior Executive Director
Bureau of Product Review and Assessment
Natural Health Products Directorate, Health Canada
2936 Baseline Road
Ottawa, ON, K1A 0K9
Thank you once again for your presentation on the new Pathway to Licensing for natural health products (NHPs) in November. We found it a very informative presentation and have been motivated to participate in the process through the submission of the attached concerns we have on behalf of our supporters and Canadian consumers.
While we understand that it is late in the process to receive these concerns, we worry that the Canadian public is being put at risk by a further weakening of the regulatory process while NHP manufacturers and distributers are given greater support to make unsubstantiated claims about their products.
We have distilled our concerns into the following most pressing issues and we hope that you will take them seriously.
Risk-Based Evidence Standards
We feel that the current risk-based evidence standards do not adequately serve the consumer. It allows manufacturers to tailor their health claims to provide the lowest evidence required to gain approval. This does a disservice to a public who are told that the Natural Product number was granted after checking for efficacy, when in actuality products making “low risk claims” can be approved without requirement of scientific evidence beyond the opinion of an “expert”, or the mere listing of the treatment in non-scientific compendiums.
Vague, general health claims mislead the consumer into believing the product has efficacy for an unspecified condition that they have to infer from the label: a condition that the evidence may not support at all. We would like to see evidence evaluated in a risk/benefit model, with evidentiary standards applied with equal rigor to all health products; products posing risks should only be approved if benefits can be shown to outweigh them, and products that have not shown any scientific evidence for benefit should be rejected if they pose even a small risk to the public.
This part of the labeling standard must be removed. It benefits only manufacturers and distributors, allowing them to subvert evidence requirements and exploit uninformed or unobservant customers. For example, if a manufacturer puts a sub-therapeutic dose of echinacea in a product and advertises it on the label then customers will assume that because echinacea is used to treat colds then the product will be an effective treatment for their cold. As a sub-therapeutic is, by definition, ineffective, this is completely misleading to consumers; they will not receive treatment for their condition and will have wasted their money due to misleading advertising.
This guideline also ignores a definition of “synergistic effects” and proposes no evidentiary standard for the support of such effects. While “synergy” is a recognized term in pharmacology, claiming synergistic effects requires evidence, and should not be used as a justification for listing medical ingredients at sub-therapeutic levels. It is misleading to the public and should not be allowed without appropriate scientific evidence.
Voluntary Site Inspections
Any health product manufacturer in Canada should be subject to mandatory site inspections in order to obtain a site license. As well, any health products that are manufactured outside Canada should come from inspected plants. It is obvious that only those manufacturers with GMPs and a QA system in place will have the incentive to conduct voluntary inspections, allowing those with sub-standard practices to continue to operate until they fail, which may be too late to protect the consumer.
We find it confusing that site inspections are voluntary unless a critical incident occurs that mandates an inspection, because the original standards released in July included mandatory inspections. Voluntary inspections benefit the manufacturers by saving them the cost of an inspection and allowing them the option to continue with sub-standard practices, while the public is left with the risk of consuming a substandard product until someone is hurt. Manufacturers who are unable to meet the inspection requirements should not be producing health products for Canadians. The NHPD’s priority should be to protect the public, not to facilitate unscrupulous manufacturers to mislead and take advantage of consumers with substandard, ineffective products.
Thank for you this opportunity to comment, and we hope to hear from you soon.
Jamie Williams Michael Kruse
Executive Director Chair, board of directors
For information from Heath Canada on the Pathway to Licensing of NHPs, please see here.