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!
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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 products 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 with 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; there is also 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.
So what lobby money does Dick Durbin take, how much and for how long? What engagements does he attend sponsored by Pharma?This information should be reported right along with his proposals so people can see a bigger picture.
What is it with Durbin? He appears to oppose Pharma, and then turns around and behaves like their employee. He, Tillis, and Coons are working on the Pharma friendly legislation that would allow Pharma’s riding roughshod over the patent system and actually INCREASE the drug-pricing crisis in this country. Recently, they’ve pushed forward the misleadingly named Patent Eligibility Restoration Act (PERA) and Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. Enacting these bills, alone or together, would richly reward pharmaceutical companies for their donations, and encourage them to give more to support Coons and Tillis’s re-election bids in 2026. (If Durbin is cashing in from Pharma it’s not obvious in disclosures, but payoffs could be held in trust.)
PREVAIL, also co-sponsored by Durbin, enables companies to keep patents that cover things that were already known or obvious to scientists in the relevant field. PREVAIL would protect wrongly granted patents by hamstringing the one mechanism the public has for challenging them outside of federal court: the Patent Trial and Appeal Board (PTAB), a government entity Pharma abhors. Congress created PTAB to make it more efficient to invalidate wrongly granted patents. And it has been a success: 46 percent of patents challenged at the PTAB have been found invalid in whole or part.
Supplements may be a parallel strategy to enrich Pharma by removing any “threat” to disease and standard of care approaches requiring expensive patent medicines, or they could be swept into the patent protection of PREVAIL where they would disappear under an improper patent.
I’ve been following Sen. Durbin’s relentless efforts to restrict supplements for decades. The FDA is Big Pharma’s government marketing arm that would implement Durbin’s supplement restricting agenda. 25 years ago, they used the National Academy of Science (NAS) to write an article that set very low “upper limits” for supplements. I wrote an extensive critique of the NAS article that Dr. Abram Hoffer published in his Journal of Orthomolecular Medicine in 2000. https://orthomolecular.org/library/jom/2000/pdf/2000-v15n02-p069.pdf
I think I covered the essential issues of limiting or even eliminating nutritional supplements from the market. What I said about the vital importance of nutritional supplements still applies today.
I’M A GROWN WOMAN WHO’S RESEARCHED & HELPED MYSELF FOR DECADES SUPPLEMENTS THAT HAVE HELPED ME BECAUSE THEY’RE WHAT WORKS BEST FOR MY BODY & HEALTH. I WAS ABLE TO FIND SOMETHING TO HELP WITH MY GALL BLADDER SO I DIDN’T HAVE TO HAVE SURGERY TO REMOVE IT. I ALSO FOUND HELP FOR A SECOND DEGREE BURN INFECTION, A BLADDER INFECTION DECADES AGO & ALSO SOMETHING THAT HELPED ULCERS THAT HAD DEVELOPED. I TAKE TIME TO DO RESEARCH TO FIND WHAT WILL HELP i DON’T JUST SWALLOW ANYTHING! THIS ANGERS ME BECAUSE I’M SENSITIVE TO CHEMICAL MEDS & HAVE SIDE EFFECTS. WHEN I USE WHAT HELPS ME I HAVE NO PROBLEMS. TO RESTRICT PEOPLE’S FREEDOM TO WHAT WILL HELP THEM IS NOT FAIR AT ALL! I DEAL WITH REPUTABLE COMPANIES WHO SELL QUALITY PRODUCTS & HAVEN’T EVER HAD A PROBLEM. WHAT WILL THEY WANT TO CONTROL NEXT BECAUSE I KNOW FULL WELL WHAT I’VE BEEN DOING FOR DECADES! THIS CAUSES ME MUCH ANXIETY! MR DURBIN THINK AGAIN, BECAUSE WE DON’T NEED OR WANT TO DO WHAT CANADA DOES. EXCEPT THAT IF THEY DON’T HAVE GLYPHOSATE & OTHER TOXINS IN THEIR FOOD & PESTICIDES ARE NO DOUBT MORE REGULATED THERE THAN HERE IN AMERICA SO PLEASE FOLLOW THAT B/C PLENTY OF CHILDREN & OTHERS ARE SICK BECAUSE OF THEM! CAN YOU DO SOMETHING ABOUT THAT??
When a supplement is even suspect from doing harm, it is taken off the market and targeted for destruction, but when a drug harms or kills people, oh well, its Big Pharma so keep selling them $$$$$$.
We need a bill passed that will take money out of politics and give a prison sentence to every ex government employee including Generals and lobbyists who take money from corporations etc. Vote for Trump and this country will have one of the most corrupt crooked country’s in the world. We have so many crooked people working for our country it is a disgrace.