On December 6, 2013, the Government of Canada introduced new patient safety legislation, named the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law).  The Law would protect Canadian families and children from unsafe medicine by enabling the Government to:

• Require strong surveillance including mandatory adverse drug reaction reporting;
• Recall unsafe products;
• Impose tough new penalties for unsafe products, including jail time and new fines of up to $5 million per day instead of the current $5,000;
• Provide the courts with discretion to impose even stronger fines if violations were caused intentionally;
• Compel drug companies to revise labels to clearly reflect health risk information, including updates for health warnings for children; and
• Compel drug companies to do further testing on a product, including when issues are identified with certain at-risk populations such as children.

It should be noted that Natural Health Products have been specifically excluded from this legislation. This is a significant development because for the first time NHPs have been recognized in the Food and Drugs Act as being distinct from drugs. This development serves as further recognition of the low risk nature of NHPs compared to pharmaceutical drugs.

The official press release can be found at http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2013/2013-174-eng.php.

NHP Consultant and FDA Consultant dicentra provides sought-after regulatory and scientific guidance on product and marketing compliance, quality assurance, research and development, new ingredient assessments and overall regulatory strategies for health-related products sold in North American marketplaces. Contact us at info@dicentra.com or at 1-866-647-3279.