How the Canadian system for regulating dietary supplements shows why we need to stop Senator Dick Durbin (D-IL) and his anti-supplement policy. Action Alert!
THE TOPLINE
- Sen. Durbin is trying to march the US in the direction of Canada when it comes to restricting supplements. Canada treats supplements similarly to drugs, requiring pre-market approval and registration numbers.
- Sen. Durbin’s anti-supplement policy is a slippery slope leading to fewer choices and higher prices for the consumer.
- We need to defeat Sen. Durbin’s efforts like we did two years ago and protect our supplements!
Recently, we reported that Sen. Durbin is planning on introducing his anti-supplement bill sometime in 2024. This bill would institute “mandatory product listing” (MPL) for supplements. Creating a registry of the supplement industry may sound harmless, but for the reasons we’ve outlined in the past, this policy is a real threat to your supplement access. To help show why, we need only look to our neighbors in the north: Canada. The evolution of the Canadian system shows how additional supplement regulations sought by Sen. Durbin and the FDA lead us down a path where consumers have ever fewer choices because so many products—especially the most efficacious—will be eliminated.
In the US, supplements are regulated as food; in Canada, they are regulated under the Natural Health Products Regulations as a distinct ‘third’ category, between foods and drugs, requiring pre-market approval. To sell a supplement in Canada, companies must first apply for and obtain a Natural Product Number (NPN) from Health Canada (the equivalent of the FDA). To get an NPN, a company must provide extensive information regarding the safety and efficacy of the natural health product.
Since Canada’s law came into effect in 2004, leading natural health advocates like Shawn Buckley at the Natural Health Product Protection Association have argued that innovation has taken a nose-dive and many small- and medium-sized supplement manufacturers and importers have been driven out of business. It’s not hard to see why—only large manufacturers selling cookie-cutter products are able to comply with the extensive costs of gaining pre-approval, muscling out smaller, more innovative companies offering the most effective natural products.
Does any of this sound familiar? Supplements requiring a registration number to be sold is exactly what Sen. Durbin is proposing. Requiring extensive, pre-market data to authorize “new” supplements is what the FDA is trying to do in its New Dietary Ingredient regulations. It isn’t a big leap to think that, after Durbin gets his legislation passed requiring supplement registration with the FDA, the next step is to require additional pre-market requirements for supplements to get that registration number.
This is the whole point: MPL for supplements isn’t just about a registry. This was made clear in a previous iteration of Sen. Durbin’s bill, which included another section calling on the Department of Health and the National Academies of Sciences, Engineering, and Medicine (NASEM) to create a list of supplement ingredients that could cause “potentially serious adverse events.”
That section may not be included in the forthcoming bill, but it demonstrates the potential of a slippery slope: registering supplements is the first step that could lead to much more mischief down the line.
And this is exactly what we’re seeing now unfold in Canada. In 2017, Health Canada introduced the Self-Care Framework that seeks to amend and make, in stages, the Natural Health Products Regulations even more onerous. Natural health advocates in Canada maintain that additional regulations being attempted under this Framework will have devastating impacts on the natural products industry in Canada. The strategy is taken from the same regulatory playbook as usual: boil the frog slowly and hope the industry doesn’t kick up. In a poll of Canadian supplement companies, 76% of brands said there is a high/very high chance they will need to pull product from the market as a result of these regulations, with 1 in 5 companies saying they are seriously considering leaving the Canadian market.
Yet this could just be the tip of the iceberg. Other initiatives contained in the Self-Care Framework, but that have not yet been implemented, include major limitations on the ability of natural health products to make health claims. Currently, traditional medicines in Canada can be licensed using evidence of their traditional use to show safety and efficacy. But Canadian health authorities are looking to do away with that, which could severely restrict access to traditional medicines in Canada like Traditional Chinese Medicine, Ayurvedic medicine, and others.
There’s a theme here. Both Canadian and US health authorities are trying to regulate supplements like drugs, which is a backhanded way of banning the best natural products that offer a genuine alternative to drugs. Supplements, being natural, cannot be strongly patented, so the costs of complying the costly drug regulations cannot be recouped. Yet recall that the FTC is now saying it will require randomized controlled trials to back up supplement advertising claims; evidence that the FDA is trying to use the NDI guidance to create a de facto supplement pre-approval system.
We cannot afford to even tiptoe down the road to the kinds of supplement restrictions we see overseas or on our northern border. We must protect our supplements and oppose Sen. Dick Durbin’s terrible policy.
Action Alert! Write to Congress opposing MPL for supplements. Please send your message immediately.
The post Stop Canadian Supplement Restrictions Coming to the US first appeared on Alliance for Natural Health USA – Protecting Natural Health.
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Author: ANH-USA
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