Following the recall of two herbal medicines for containing high levels of lead and arsenic, The Globe and Mail is questioning why a new drug safety law excludes natural health products from its provisions.
The Protecting Canadians from Unsafe Drugs Act—commonly known as Vanessa's Law—came into effect on 6 November 2014, after years of campaigning for stricter drug monitoring mechanisms by Conservative Member of Parliament Terence Young. The law was named for Young's daughter, who died of a heart attack at age 15 while taking the drug Prepulsid, which was later pulled from the market in both the US and Canada after hundreds of patients died of serious cardiac events.
Vanessa's Law amends Canada's Food and Drugs Act to require mandatory adverse drug reaction (ADR) reporting by healthcare providers. The law also encourages companies to more clearly label their products with health risk information.
In addition, the law substantially increased the penalties makers of unsafe products are subject to—from $5,000 to $5 million (CAD). Courts also have the option to increase penalties if violations are caused intentionally.
Natural Health Products in Canada
In Canada, natural health products are regulated separately from pharmaceutical drugs, and include vitamins, minerals, herbal remedies and homeopathic medicines, and "must be safe for use as over-the-counter products."
While Vanessa's Law applies to a host of products including drugs, vaccines, gene therapies and medical devices, natural health products are excluded from the law, and remain regulated under the Natural Health Product Regulations (NHPR). Under the regulations, natural health product manufacturers must take steps to ensure their manufacturing facilities are in compliance with good manufacturing practice (GMP) standards and are required to report serious adverse reactions to Health Canada on an annual basis.
However, according to The Globe and Mail, Health Canada issued some 70 warnings for natural health products in 2013 alone. The grounds for the warnings were often serious; some products were found to contain unlisted pharmaceutical ingredients, while others were contaminated with bacteria.
Because natural health products are excluded from Vanessa's Law, they will not be subject to the increased monitoring and enforcement measures that other health products are subject to under the law.
Michael Kruse of Bad Science Watch told The Globe and Mail that, “The government has so far shown no interest in increasing the scrutiny of the natural health sector."
Enforcing Vanessa's Law
While many provisions of Vanessa's Law have already come into effect, others require new regulations to be entered into force. These include the minister of health's "authority to require and disclose information … order a label change/package modification and … order a recall."
A public consultation is being held through 8 June 2015 on Health Canada's draft implementation guide for these new authorities under Vanessa's Law.
The Globe and Mail