Stress reducing supplement Relora gets Health Canada approval

02-Apr-2013 - Last updated on 03-May-2013 at 14:38 GMT

Relora has been studied for its stress relieving properties.

Relora, the stress-reducing supplement ingredient from Next Pharmaceuticals, has cleared a major regulatory hurdle by obtaining approval from Health Canada for sale in that country.

Unlike the United States, Canada has a premarket approval system for ingredients, involving the compilation and submission of a safety dossier. It’s no mean feat; according to Next’s Canadian distributor, EnZed Nutricorp, the process spanned six years. Health Canada requires reports on safety, efficacy and quality and required studies published in peer reviewed journals to support claims of stress reduction and weight loss.

Big market awaits

The work on the ingredient will be worth, though, according to Deanne Dolnick, vice president of Next Pharmaceuticals, which is based in Salinas, CA.

“The anti-stress market is continually growing in the US. We’ve seen this year after year,” Dolnick told NutraIngredients-USA. “The trend is growing and we believe will continue to do so well into the future. Stress is so pervasive in our society. I don’t see this category declining. It’s not unlike the weight loss category.”

And the situation appears even more promising in Canada. According to a statement from EnZed NutriCorp, “We believe the retail market potential in Canada is enormous. There are currently no other products that have been approved by Health Canada that combine stress reduction and weight loss. Now that NPN licenses have been issued for Relora we expect many manufactures to begin to produce their own branded product using the Relora ingredient.”

Relora, sold in the US since 2000, is a patented combination of extracts of the bark of Magnolia offcianalis and Phellodendron amurense and is based on their active ingredients, honokiol and berberine, respectively. Magnolia officianalis is commonly known as the Houpu Magnolia and is native to China; Phellodendron amurense, commonly known as the Amur Cork Tree, is native to northeastern Asia and Japan. The bark of both trees has a long history of use in traditional Chinese medicine.

In the West, they have been used mostly for treating stress, the primary application for which Next has developed its ingredient. In a double blind, placebo controlled study, Relora has shown a statistically significant effect in ameliorating stress in overweight, premenopausal women.

New applications

Relora has been used exclusively in supplements in both tablet and capsule form until recently, and is featured by some major manufacturers such as Now Foods, Source Naturals, HVL and Reliance Vitamins.

Another avenue that would seem a natural for the ingredient is in relaxation shots and beverages marketed as supplements. A launch last year by Celestial Seasonings of a Sleepytime shot including Relora was a first for the ingredient. But it won’t be the last, Dolnick said.

“Currently Celestial Seasonings is the only company that features Relora in a shot, but we are working with several companies to launch a Relora shot and hope that they will be on the market by Q4 2013,” Dolnick said.