US Dietary Supplements Update

Given the exponential growth of the dietary supplement category in the United States to well over $30 billion in annual sales, it doesn’t come as much of a surprise that the US Food and Drug Administration has responded with the creation of the Office of Dietary Supplement Programs (ODSP).

The primary focus of the ODSP, which is to ensure the safe and informed use of dietary supplements by consumers, mirrors Health Canada’s introduction of the Natural Health Products Regulations which were unveiled in 2004 in order to regulate the rapidly expanding natural health product industry in Canada.

One key objective of the ODSP will be to enforce the standard of good manufacturing practices (GMP) by US dietary supplement manufacturers. This measure doesn’t directly impact manufacturers of natural health products in Canada. However, for those Canadian importers wishing to source dietary supplements from the US, the encouragement of GMP compliance for all dietary supplement manufacturers in the US will alleviate regulatory challenges involved in adding foreign manufacturing sites to Canadian importer site licenses for natural health products in Canada.

Although the direct benefits of the ODSP will be felt primarily by US consumers having more confidence in their choice of dietary supplements, Canadians north of the border will have some additional assurance that the products they purchase from the US are manufactured in GMP-accredited facilities. The creation of the ODSP is an important step in the right direction toward harmonizing requirements for regulated dietary supplements in both Canada and the US, leading to consistent approvals and enforcement in both jurisdictions.