Dietary Supplement v. Natural Health Product
One of the most notable ways in which the US and Canadian regulatory systems differ is in their treatment of products that are regulated as dietary supplements in the United States. Canada regulates these products as natural health products (NHPs). These classifications are similar with regard to product composition.
In the United States, dietary supplements contain one or more dietary ingredients such as vitamins, minerals, herbs or other botanicals, amino acids, and constituents, extracts and metabolites thereof. Similarly, NHPs in Canada also contain plant material, vitamins, amino acids, minerals and extracts thereof. However, this is where the similarities end.
The US and Canadian regulatory systems vary greatly in other respects related to intended use, claims and premarket approval.
Premarket Approval
Supplements sold in the United States are not required to undergo any premarket approval process unless they contain a new dietary ingredient that was not used in supplements sold prior to 1994 when the Dietary Supplement Health and Education Act went into effect.
New dietary ingredients must be the subject of a notification to the US Food and Drug Administration (FDA) 75 days prior to marketing of the supplement. If FDA does not raise any objections to the new dietary ingredient within the 75 day premarket notification period, the ingredients may be marketed in supplements.
By contrast, all NHPs must have a product license before they can be sold in Canada. The licensing process requires the submission of detailed information about the product's composition, potency, and recommended use.
Claims and Intended Use
The definition in Canada's Natural Health Product Regulations requires that NHPs must have a functional purpose such as the diagnosis, treatment, mitigation or prevention of a disease.
Conversely, in the United States, dietary supplements are products intended to supplement the diet. Supplements may bear claims describing the effect of the supplement on the 'structure or function' of the body - for example, a supplement might bear a claim such as "Helps to promote immune system functioning". However, claims related to the diagnosis, treatment, mitigation or prevention of a disease are not permitted and, if used, would cause the supplement to be regulated as a drug.
Because nutraceutical products such as dietary supplements can be brought to the US market with relative ease, manufacturers might believe the same is true in Canada. However, there are few similarities between Canada and United States in terms of the ways in which dietary supplements are regulated. The Canadian government's more stringent regulation of supplement-type products as NHPs must be considered when evaluating Canada as a potential market for expansion.Sarah A Key is an associate with Foley & Lardner LLP and a member of the firm's FDA and Government Affairs and Public Affairs Practice Groups, as well as the Life Sciences and Food Industry Teams. She can be reached at 202 295 4720 or by e-mail at skey@foley.com.