Imperia Brand Stategies & Solutions

Natural Health Product Regulations

Natural health products (NHPs) are defined as:

Vitamins and minerals
Herbal remedies
Homeopathic medicines
Traditional medicines such as traditional Chinese medicines
Probiotics
Other products like amino acids and essential fatty acids

that are manufactured, sold or represented for use in:

the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans;
restoring or correcting organic functions in humans; or
modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health.

NHPs may be ingested or topically applied, must be safe to use as over-the-counter products and must not need a prescription to be sold.

Canadian Regulations

In 2004, Health Canada created the Natural Health Products Directorate (NHPD) and introduced the Natural Health Product Regulations to regulate and monitor Canada’s billion dollar natural health products industry. The Regulations set out requirements for the manufacture, packaging, labelling, storage, importation, distribution and sale of natural health products in Canada, as well as clinical trials involving human subjects. In particular, the Regulations state that NHPs must be licensed if sold in Canada, NHPs must not pose a hazard to consumers, and NHPs must be produced, imported and distributed via an NHPD-approved facility that operates using good manufacturing practices (GMP).

Thus, by law, each NHP sold in Canada must be licensed by Health Canada’s NHPD. For each NHP, manufacturers or distributors must submit a product license application demonstrating that the NHP is high quality in terms of content and purity and is efficacious and safe as per label claims. If approved by NHPD, the NHP is granted a natural product number (NPN) which must be displayed on the product label. This gives consumers confidence in the quality, efficacy and safety of the product.

Benefits for Compliant Companies

Companies with NHP product licenses (or exemption) acquire significant benefits. They:

acquire and/or maintain the freedom to sell their NHPs in Canada,
increase sales potential and competitive position, especially when unlicensed NHPs are removed from the market,
elevate the marketability of their NHPs around the world,
establish themselves as regulatory leaders in their domestic markets, and
position themselves favorably for changes to US NHP regulations to be implemented over the next five years.

What Imperia can do for your company

Many companies are unaware of the NHPD and the intricacies of its Regulations. Companies with unlicensed NHPs face risk that their products will be refused entry to Canada or will be pulled from store shelves. Distributors and retailers of unlicensed products face the risk of loss of sales. Potentially, millions of dollars are at risk.

Imperia is fully equipped and has unmatched ability to help your company obtain NHP licenses and achieve regulatory compliance for the Canadian market.

Imperia separates itself from other regulatory service providers in many important ways:

Imperia’s licensing services are overseen by a PhD medicinal chemist with in depth knowledge and experience of Health Canada regulations.
Imperia’s licensing function is located in Ottawa Canada, just 30 minutes from the door of Health Canada. The location is highly advantageous for the license submission process.
Imperia has access to specialized scientific databases which greatly speed the search and discovery of key scientific articles which may be necessary to support a license application.
Imperia does not charge its client when Health Canada sends information request notices (IRNs) in response to license applications. IRNs are forwarded to a license applicant when a license submission is incorrect or incomplete. Many licensing consultants charge applicants for responding to IRNs. In reality, the consultants are actually charging the applicant for the consultant’s mistakes. Imperia does not approve of this practice. Imperia stands by the quality of its license applications and thus does not charge clients for IRNs. This gives the client upfront cost certainty. Imperia will support the client to the end of the licensing process.

In summary, Imperia has the human resources, experience and expertise to provide the highest quality service for its clients. For more information on how Imperia can help you with regulatory compliance, please contact us.

USA Regulations

Regulations for dietary supplements in the USA are less strict than in Canada.

The U.S. Food and Drug Administration (FDA) regulates dietary supplements under the Dietary Supplement Health and Education Act of 1994 (DSHEA). Under DSHEA, the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed and that any representations or claims made about the product are substantiated by adequate evidence to show that they are not false or misleading. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Unlike the Canadian equivalent, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements in the USA. Except in the case of a new dietary ingredient, where pre-market review for safety data and other information is required by law, a firm does not have to provide FDA with the evidence it relies on to substantiate safety or effectiveness before or after it markets its products. Manufacturers must make sure that product label information is truthful and not misleading.

FDA's post-marketing responsibilities include monitoring safety, e.g. voluntary dietary supplement adverse event reporting, and product information, such as labeling, claims, package inserts, and accompanying literature. The Federal Trade Commission regulates dietary supplement advertising.

Manufacturers are required to register their facility with the FDA and must adhere to Current Good Manufacturing Practices (cGMP). The cGMPs apply to all domestic and foreign companies that manufacture, package, label or hold dietary supplements, including those involved with the activities of testing, quality control, packaging and labeling, and distributing them in the US. The rules are necessary to require that dietary supplements are manufactured consistently to ensure the identity, purity, quality, strength and composition of the dietary supplements.