Essential Nutrition Law Blog : Northwest Nutraceutical Lawyers & Attorneys : Stoel Rives Law Firm : Dietary Supplements, FDA Regulation

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The Canadian government recently proposed a temporary solution to allow continued sales of unlicensed Natural Health Products (NHPs). The proposed regulations, titled “Natural Health Products (Unprocessed Product License Applications) Regulations” (the “Proposed Regulations”) provide an exemption for some unlicensed NHPs that have pending applications for licensure. 

Under current Canadian regulations, NHPs must be licensed. There is currently a backlog of approximately 10,000 unlicensed NHPs on the market in Canada that have applications pending to receive regulatory approval. In January of this year, the National Association of Pharmacy Regulatory Authorities issued a statement urging pharmacies to halt sales of unlicensed NHPs because such products posed a risk to public safety. Some pharmacies adopted this position, cutting off market access for some manufacturers.

The Proposed Regulations would allow continued sales of unlicensed NHPs in some situations. To qualify, a manufacturer must have an application on file with Health Canada that has been pending for more than 180 days and the product must meet certain safety requirements. If implemented, the Minister of Health would notify an applicant that an exemption number has been assigned. Within thirty days of this notice, the applicant must consents to having its exemption information posted on the Health Canada website and must verify that the product meets certain safety and use criteria (for example that it is not intended for use by children or women who are pregnant or nursing and does not contain harmful or prohibited ingredients).

Once an applicant provides consent and verification, the NHP will be deemed to hold a license, allowing the product to be sold legally. Manufacturers will be required to display the exemption number (rather than an NHP number) on product labels. The Proposed Regulations give manufacturers 12 months or until the next label run to comply with the labeling requirements. Manufacturers must also comply with other safety requirements imposed by Canadian “Natural Health Products Regulations”, but will not share in all of the rights provided to licensees under such regulations. 

Note that deemed licenses provide only temporary relief. The Proposed Regulations will be in force for 30 months after becoming effective. Therefore, manufacturers will still need to complete the licensing process. For those whose Canadian applications are stuck in queue, however, the Proposed Regulations should provide some relief.