The proposal would lump “low-risk” natural health products, over-the-counter (OTC) drugs, and cosmetics together. These products would be prevented from making any disease treatment or prevention claims on their labels. Currently, for example, a company selling curcumin can list the health benefits of curcumin for inflammation. Under the new rules, the label couldn’t have any information other than that the product is called curcumin.
In the US, at least, the bottle of curcumin might be able to mention some health benefits, so long as it does not refer to any specific disease. “Heart healthy” or “brain healthy,” for example, would be OK, while “prevents heart disease” or “reverses dementia” would not. Canada would not even allow “heart or brain healthy.”
Natural health products considered “high” or “moderate” risk—such as OTC painkillers or new medicinal ingredients—would be reviewed by Health Canada and could only make claims if enough scientific evidence is provided. We know how that works—enough is never enough for regulators in bed with Big Pharma!
Currently, Canadian regulations allow these products to make certain health claims based on different kinds of evidence. This includes clinical studies, but also histories of use in traditional medicine. Under the new proposal, pharmaceutical-style evidence would be required. As we have explained before, supplements are not suitable for drug studies for many reasons, including the fact that supplement use depends on the patient’s nutritional status, and that dietary co-factors are usually involved.
Health Canada is no doubt doing this in concert with the US Food and Drug Administration. We’ve been telling you about the FDA’s massive attack on supplements through its new supplement guidance. If the FDA is allowed to continue tightening its control over supplements by forcing pre-approval as with drugs, we will eventually have few supplements, and the ones that remain will have little therapeutic value.
The Federal Trade Commission (FTC) has also apparently been enlisted by the FDA to limit the information consumers can have about natural health products. In the POM Wonderful case, the FTC attempted to force natural product companies to pay for two random-controlled trials (RCTs)—a drug standard—before they can make certain health claims. This was ruled unconstitutional, but the court said that requiring one RCT might be OK. The cost of such a study is not usually feasible for natural (and therefore not patentable) substances.
Action Alert! If you haven’t done so already, write to the FDA and tell them to abandon their New Dietary Ingredient (NDI) guidance. (The NDI guidance is the pre-approval process we mentioned). Please send your message immediately.
Other articles in this week’s Pulse of Natural Health: