Differences in natural product regulation between Canada and the U.S.

Last week I attended the Natural Health Products Research Society of Canada (NHPRS) http://www.nhprs.ca/ annual meeting in Windsor, Ontario as an invited speaker, thanks to my colleague Dr. Sidhartha Ray of the Manchester University. I was invited to talk about our work on thymoquinone, a compound present in Black Cumin Seed. I picked up a few important ideas from the conference.

In the U.S., food extracts are treated as foods, so if you make an extract of Ginkbo biloba or some other herb, it's considered to be a food, not a drug. As long as you don't make any drug claims (such as "cures diabetes"), anyone can sell the product. The FDA doesn't approve the products, but it will get involved if toxic effects are subsequently shown. In Canada, regulations are more strict. You still can't make a drug claim for a product, but you can say things like, "Lowers glucose levels in the blood", which would be one way to treat diabetes, for example. Canada, it seems, regulates natural products more like drugs than like foods. For the consumer, this is a good thing, because the consumer can be assured that any health claims made are backed by scientific evidence ventolin inhaler price. In the U.S., this is not the case. In Canada, they're trying to reduce the requirements for approvals, because having a drug-level requirement for something that is already a food might be a little over the top and costly for the manufacturers. Still, efficacy testing is critical.

The way that manufacturers market their products in Canada is to prove that their own products are efficacious. They might find that Nigella sativa extract is beneficial, for example, using their methods of extraction. This does not guarantee that the product produced by a different company is going to have the same effect. In fact, my own studies with our extracts show that they rapidly degrade with time, even in the freezer, losing their potency. This certainly wouldn't be true for every natural product, but it's something that NEEDS TO BE TESTED.

I appreciate NHP's mission statement: "The NHP Research Society's mission is to facilitate and support meaningful, scientifically rigorous research and education in the field of natural health products (NHPs)."

At this point, I would say that looking at a label saying that the natural product is approved in Canada is probably the best we in the U.S. can do regarding natural products.

(note: I realize this is grossly oversimplified, but I wanted to give the take-home message.)