Editor’s note (11/22/2022): We’re re-publishing the article below to emphasize the dire threat posed by Sen. Durbin’s “mandatory product listing” policy, which still has a real shot of getting passed. You can read about the current status of Sen. Durbin’s efforts in our legislative update article we recently published. If you haven’t already, please take action by scrolling to the bottom of this article and sending a message to your lawmakers opposing this policy!
How Sen. Durbin’s (D-IL) mandatory product listing will replace the supplements you rely on with standardized, low-quality, one-size-fits all products. Action Alert!
Imagine walking into your favorite store or doctor’s office to buy supplements. Instead of seeing a rich variety of products with various forms and dosages of vitamins and minerals, you see a few basic products, many of which do not fit your needs because the dosages are too low or the ingredients you need are not available. This is our future if we allow Senator Dick Durbin’s mandatory product registration bill to become law. This legislation will reduce consumer choice and destroy innovation in the supplement industry.
Sen. Durbin’s bill creates a database of all supplements, where each product is listed along with ingredients and dosages. As we’ve explained before, this sounds innocuous, but there are many problems with it. The main threat is how a list like this will be used by the FDA to find and eliminate supplements the agency believes are not in compliance with other overreaching regulations.
Take NAC (n-acetyl cysteine) and CBD (cannabidiol), two compounds with an array of health benefits that have been available as dietary supplements. The FDA has said that both are illegal. With Sen. Durbin’s list, the agency could have, right off the bat, easily identified and eliminated any supplements containing these ingredients. Companies would have stopped making them, and they would have disappeared, probably for good.
Instead, without the list, the public had time to push back, and now the FDA is considering a rulemaking to make NAC a legal ingredient. CBD supplements are in regulatory limbo right now, but there are bills to create a legal pathway for CBD supplements—bills that would have been superfluous if the agency had Sen. Durbin’s list, since the market would have already been swept of CBD supplements.
Consumers need these products. NAC is a precursor to glutathione, the body’s most important antioxidant that is helpful for a wide variety of health conditions. CBD has evidence to support its effectiveness for anxiety, insomnia, chronic pain, and addiction, to name a few.
There are other ways that Sen. Durbin’s list would restrict consumer choice. The list creates a streamlined way for the FDA to target supplements that compete with drugs. This has to do with the “new supplement” regulations we’ve written so much about over the years.
We explained this point in previous coverage, but let’s take curcumin as an example. This compound has an array of well-established health benefits (anti-inflammatory, anticancer, antiviral, antioxidant, and more), but is difficult for the body to absorb. Your doctor tells you about a great new liposomal curcumin product that has proven to have greater bioavailability, meaning you get more of this health-promoting nutrient than from other products.
Because it is liposomal it is likely considered “new” and thus subject to “new supplement” regulations. If the FDA gets Sen. Durbin’s list, the agency will easily be able to see all the products on the market that are considered “new” but have not yet complied—maybe including your liposomal curcumin. The FDA can simply remove these products in one go. And remember, compliance with a drug-like pre-approval system is expensive, and supplement companies can’t recoup those costs because supplements are natural and cannot be strongly patented. So once that liposomal curcumin product is pulled, it’s probably gone for good.
We also previously reported on the threat to high-dose supplements represented by Sen. Durbin’s bill. If that threat come to pass and US supplement restrictions are harmonized with Europe, the curcumin product your doctor recommends could be at a dosage level above the upper limit. With Senator Durbin’s bill, the FDA can quickly find and eliminate any product over that specified dosage.
We’re talking about tens of thousands of products getting removed from the market. If a company finds a better way to manufacture vitamin D to improve how well our body absorbs it, that makes the vitamin “new” and subject to the additional drug-like regulations—and if the company doesn’t comply with these outrageous requirements, Sen. Durbin’s list is there to help the FDA go into “search and destroy” mode to get it off the market.
The FDA has stated that it plans to release a new draft of the “new supplement” guidance by the end of this year. Is it a coincidence that Sen. Durbin is making his push now for mandatory product registration?
When the smoke clears, all that’s left will be the most basic, cookie-cutter supplements that do not help you regenerate health. Consumer choice in supplements is predicated on the existence of innovative companies to supply those products. But if just about any new product coming to the market will have to go through a pre-approval system (the “new supplement” procedures), and if you run afoul of this ridiculous system your products can easily be targeted by the FDA with Sen. Durbin’s list, why would supplement companies innovate how they manufacture supplements or create new and better formulations? Why create new and exciting products, if they simply increase your regulatory burden and the chance that you get targeted by the government?
Proponents say Sen. Durbin’s list is necessary to find and eliminate supplements with ingredients that are illegal, but do they really think that companies spiking their supplements with illegal ingredients will report themselves to the FDA? There are bad actors in every industry, including the supplement industry, but this legislation wouldn’t do anything about these criminals. Instead, the most innovative, beneficial supplements would disappear, leaving the consumer with only the most antiquated, low-dose supplements that pose no threat to drug industry profits.
The unfortunate truth is that there are some in the industry who welcome these regulations. These companies, many of which are owned by pharmaceutical companies, already sell their simple, low-dose products internationally due to the supplement restrictions already installed in European countries. They want to sell those same products here while eliminating the competition. Sen. Durbin’s bill helps these companies achieve that goal.
This has direct consequences for consumers. When Whole Foods was bought by Amazon, ANH staff members noticed a precipitous decline in the number of supplements that were available. All but the most basic products were removed from the shelves because they weren’t as profitable. Large corporations, including drug companies, benefit from a one-size-fits all, standardized model: one pill, or one vitamin D supplement, for everyone. ANH stands with consumers who need individual formulas and dosages; regenerating health requires customizing healthcare based on all our unique biology and needs—the very opposite to the one-size-fits all model.
Sen. Durbin’s bill accelerates a sharp reduction in consumer choice in supplements, undermining our ability to stay healthy, naturally. We must keep up the pressure so this policy does not become law and our supplement choices disappear.
Action Alert! Write to Congress and tell them to oppose mandatory product registration for dietary supplements. Please send your message immediately.