Ruminations

Blog dedicated primarily to randomly selected news items; comments reflecting personal perceptions

Sunday, May 28, 2023

Labelled 'Health' Products, Are they Safe and Healthy?

Vanessa died in 2000 after complications from Prepulsid
"[The provisions had been discussed before, but] there was nothing that would have indicated to industry that it was imminent."
"The industry and the association were both caught off guard when we saw that included in the budget."
"We have seen no consultation efforts to persuade us that the regulatory powers conferred in Vanessa's law would be appropriate for the lowest-risk products, such as natural health products."
Aaron Skelton, president, Canadian Health Food Association
"I think post-market surveillance the monitoring for safety around natural health products is urgent."
Senator Judith Seidman, epidemiologist, health researcher

"We have no recourse."
"There's no reporting on side-effects, there's no follow up, there's no nothing for natural health products to this point -- not the same way that there is with the other prescriptive drugs or other therapeutic products that are much more regulated."
Katharine Kovacs Burns, co-chair, Patients for Patient Safety Canada
In The News for May 25 : New rules for reporting reactions to natural  health products - LakelandToday.ca
A new plan to force hospitals to report adverse effects of "natural health products" such as herbal remedies and supplements has come as a surprise to manufacturers, who say they were blindsided by the proposed change. THE CANADIAN PRESS/Darryl Dyck
 
Vanessa's Law, passed in 2014 -- was meant to improve adverse health reactions reportage -- named after Vanessa Young, the 15-year-old daughter of a Conservative Member of Canadian Parliament. She died in 2000 after her heart rate was morbidly affected by prescription medication her physician gave her a script for. 

Hospitals would be required to report any unintended consequences that might be associated with natural health products if they were to be placed under that framework. Such reports would enable Health Canada to recall products or to order that they be re-formulated should that be deemed to be necessary to ensure their safety to the consuming public.

The new plan would impose reporting of adverse effects of "natural health products" on hospitals with respect to herbal remedies and supplements. The plan was included by the federal government in the 2023 budget bill, now making its final passage through the House of Commons before it becomes law.  Once it does, natural health products would fall under the same category as pharmaceuticals respecting monitoring them once they are on the market.

The debate over whether natural health products should be included in Vanessa's Law generated "quite the discussion" when it was initially introduced  noted Senator Seidman.. Several high-profile tragedies since then where parents and patients chose to substitute conventional medicine in favour of natural remedies ensued, prompting a renewal of the conversation on regulation of natural health products in Canada. The Canadian Pharmacists Association has stated that natural health products should have been included when Vanessa's Law was originally passed back in 2014.

Module 1: Overview of Vanessa's Law and mandatory hospital ...
The federal auditor general in 2021 found Health Canada fell short of making certain that products were safe and effective on the market. Gaps in monitoring of such products left consumers exposed to potential health and safety risks. In that same report it was pointed out that 88 percent of natural health products reviewed were advertised with misleading product information. Some products had unproven and unauthorized health claims, incorrect dosages, incomplete lists of ingredients, or unreadable information on the product label.

The issue has heated debate to the extent that Aaron Skelton, in his position as president of the Canadian Health Food Association was left to argue that manufacturers are responsible themselves for reporting any ill effects associated with their products. Health Canada, he pointed out. has the power to stop sales and seize products at the present time.

Arguments in defence of his industry and his contentions that there is no need for government to impose additional restrictions on the health food production industry, nor to impose on hospitals the responsibility to keep records to report on all side effects or other incidents relatable to health food products, fails to impress the volunteer patient-advocacy organization Patients for Patient Safety Canada.

In the United States, the National Center for Complementary and Integrative Health, an American government agency regulating such products, notes that simply because an ingredient has 'natural' origins not synthetically manufactured, should not be construed as the product being completely safe. It cites as an example, that kava, a plant native to the South Pacific used as a dietary supplement may be implicated in severe liver damage.

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