New Health Canada Regulations Came Into Effect Today

Doing business in Canada just got a step harder for Natural Health Products: are you prepared?

Today, December 1st, 2013, Health Canada imposed a new set of regulations on Natural Health Products that are sold in the Canadian Marketplace. Those new rules make it especially onerous for any companies who are in violation of the regulations to continue doing business in Canada. Penalties for non-compliance are severe and include fines, bans, FDA notifications, and even criminal charges.

Are you in compliance? If you’re not sure or if your current fulfillment company didn’t inform you of the coming changes, contact us using the form to the right. We’ll be happy to help you review where you stand with the new regulations.

The new Health Canada Regulatory Requirements, which govern the manufacturing, importing, and distributing of all Natural Health Products, state:

Every organization in the supply chain must have valid Site Licenses, including:
manufacturers
packagers
labelers
importers
Importation into Canada must be done by a fully compliant facility licensed by Health Canada, or goods will be refused entry
All goods must have Natural Part Numbers (NPNs) in place
All guidelines around formulation and labeling must be followed

Additionally, Health Canada is on the lookout for dosage errors, incorrect ingredients, companies using unproven claims on their labels, lack of warnings on bottles, lack of warning about side effects or drug interactions.

How does a company get a site license?

In order to obtain a site license, companies must have clearly documented distribution records, clear procedures for recalling products in an emergency, and strict internal controls around the storing, handling, and delivering of their products.

Additionally, companies must be able to prove that they are meeting good manufacturing practice principals (GMP). This covers such topics as sanitation programs, quality assurance standards, product stability specifications, batch samples, and more. It is imperative that your nutraceutical fulfillment company has a clear and current knowledge of these principals.

What products fall under these regulations?

In Canada, the following products are classified as Natural Health Products:

herbal tinctures, ointments, capsules, drops, or tablets
vitamin and mineral supplements
any traditional Ayurveda or Chinese medicine
homeopathic remedies
probiotics
amino acids
EFAs (essential fatty acids, like omega 3 fish oils)

Natural Product Numbers

Natural Product Numbers (NPNs) and Homeopathic Medicine Numbers (DIN-HM) have been added to all approved Canadian products. This 8-digit code on labels mean that Health Canada has evaluated every claim, ingredient, etc, and has deemed the product safe for consumers in Canada.

All products must be labeled in both official languages, and must display the 8-digit Natural Product Number (NPN)

Health Canada keeps databases for consumers to access to check the status of any products they may be looking at.

In addition to the regulations above, Health Canada also does spot-testing to check for contamination or ingredients that are incorrectly labeled (or missing from products entirely). They also do post-market monitoring of products to ensure that all the new Natural Health Product regulations are being followed.

In short, it’s a different world north of the 49th parallel: you need a fulfillment partner you can trust to be on top of the regulations so that you don’t inadvertently put a foot wrong and jeopardize your Canadian operations. Stalco can help. Contact us at 647-367-2459 or using the contact form on the right for your free evaluation and assessment.