SPECIAL ALERT: Health Canada’s Current Position on Oil of Oregano

September 2, 2011 By

Prepared by:
Christopher P.F. Marinangeli PhD, RD

Oil of oregano, derived from species of Origanum spp., is a popular natural health product that is acclaimed for its ability to reduce upper respiratory tract infections. Recently, Health Canada began issuing Section 16 notices for Oil of Oregano products currently for sale in Canada. Health Canada’s concern refers to levels of carvacrol, an alcohol that is naturally present in oil of oregano. Given that levels of carvacrol can vary substantially within and between species of Origanum and few human clinical trials have investigated the safety of carvacrol within humans, Health Canada has indicated that oil of oregano products that provide ≥ 0.22 micrograms carvacrol /kg body weight per day cannot be considered non-medicinal ingredients and will remain adulterated unless the appropriate safety data can be provided. Health Canada’s 0.22 microgram cut-off is derived from The Joint Food and Agriculture Organization/World Health Organization Expert Committee on Food Additives (JECFA) where the Maximum Survey-Derived Dietary Intake (MSDRI) of carvacrol for the European Union was determined to be 0.23 ug/kg bw/day for a 70 kg human.

It should be noted that Health Canada’s concerns over oil of oregano are directed at levels of carvacrol and not oil of oregano. Thus, oil of oregano products that provide minimum levels of carvacrol should be exempt from Section 16 notices distributed by Health Canada.

Currently, oil of oregano is a valuable product line within Canada’s Natural Health Product industry. As Dicentra Inc. continues to monitor Health Canada’s position on carvacrol, we invite manufacturers, suppliers and retailers to contact us to discuss solutions for navigating through Canada’s regulations for oil of oregano-derived carvacrol and provide solutions that minimize loss of market share.

We can be reached at 1-866-647-3279 or at dicentra.com