Health Canada Offering NHP Exemptions

OTTAWA, OntarioHealth Canada released a regulatory proposal and impact statement in the Canada Gazette on May 8, which is designed to allow natural health products (NHPs) that have filed for licensing to continue to be sold while the agency deals with the backlog of 10,000 applications. Lorraine Heller, reporting for Nutraingredients, noted Health Canada will issue exemption numbers for NHPs that are already on store shelves or in queue for release that meet certain criteria. Such products include dietary supplements, traditional medicines, homeopathic products, and certain personal care and food/beverage products.

To qualify for the exemption, NHPs must meet certain safety criteria, including confirming the product does not contain an ingredient that is prohibited from being sold in a drug, does not contain an ingredient that would result in harm to consumers, is not recommended for use as a drug or by certain vulnerable populations. The products must also be produced and distributed in compliance with GMPs (good manufacturing practices).

Health Canada estimates implementing the proposal would increase the number of NHPs available for sale in the country to approximately 39,000, and preserve product sales of $245 million Canadian attributed to the pending backlogged products. In its proposal, the agency cited the primary benefits to consumers: Consumers should benefit from the status quo by continuing to have access to the marketed NHPs. In addition, consumers would be assured explicitly that the products meet certain safety criteria, that key on-market safeguards would be in place for those products affected by the regulatory proposal, and that they would have a mechanism to verify the regulatory status of the product.