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Durbin Bill Signals End of High-Dose Supplements

Durbin Bill Signals End of High-Dose Supplements
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Powerful forces, including Senator Dick Durbin (D-IL), Bill Gates, and the National Academies, are working to bring about supplement bans. We must stop them. Action Alert!

Relative to the rest of the world, the US consumer has access to a wide range of supplements at a variety of dosage levels. This includes higher doses which are often used by integrative doctors to regenerate our health. That could all change if Sen. Durbin’s newly-introduced mandatory product listing bill for supplements gets enacted by Congress. History has shown that Sen. Durbin’s end game is to target high-dose supplements because he tried to do this in previous versions of this bill. This is in line with supplement bans being devised in the European Union, which is setting draconian restrictions on the maximum level of nutrients supplements can deliver. We must act now to avert this disaster.

An analysis of a previous iteration of Sen. Durbin’s bill in 2013 is telling. It had two sections. The first was similar to his current bill, mandating that supplement companies register all of their products with the FDA, submitting a description of each product, a list of ingredients, and a copy of the label. But the second section called 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.”

NASEM, known previously as the Institute of Medicine, has already developed levels above which they believe nutrients can cause adverse events (referred to as tolerable upper levels, or “ULs”). This was done decades ago. It seems obvious, then, that Sen. Durbin intends for his bill to be used to eliminate high-dose supplements; this second section was omitted in the current bill, but we believe his intent and long-term plan is the same. In fact, the new version of the bill specifically requires companies to submit the amount per serving of ingredients and the percent of the daily value of each ingredient, if such information is required by other regulations.

It’s a one-two punch: companies are required to register all their products with the FDA, giving the agency a list that can be referenced when maximum levels of nutrients are set for supplements under the guise of preventing “potentially serious adverse events.” The FDA can then eliminate these products at the drop of a hat.

The situation in Europe provides the blueprint. Europe’s march toward banning high-dose supplements has been going on for decades. The intention of EU law is to implement EU-wide, harmonized limits on maximum levels of vitamins and minerals in supplements. While EU authorities pursue that goal, individual member countries have issued their own restrictions on high-dose supplements. For example, Germany has decreed that magnesium supplements cannot contain more than 250mg of magnesium. Similar maximum limits have been created for a number of other nutrients in several countries, including Italy, France, Ireland, Belgium, and the Netherlands.

If you think that this can’t happen in the US, think again. The maximum permitted levels in nutrients created by European authorities are derived from ULs. The framework is already in place for US regulators to do exactly what some European countries have done in restricting dosages based on ULs. “Harmonization” of nutrient levels permitted in supplements is coming. All of the pieces are falling into place to eliminate the supplements that compete with drug companies.

This isn’t just speculation. In 2018, at the request of the Bill & Melinda Gates Foundation, NASEM convened a workshop to “assess methodological approaches that could be applied uniformly across countries in setting nutrient intake recommendations.” The big players, like the pharmaceutical giants and the supplement companies they own, want global harmonization because it makes it easier to do business. These discussions are being had, hidden behind layer upon layer of bureaucracy. This is a very real threat.

Why should we care about maximum permitted levels, like magnesium being capped at 250mg in supplements? Magnesium supplements in the US are very commonly sold at dosages above 250mg; 400 and 500mg capsules are routinely available. Without these higher dosages, it would be difficult to take advantage of the many therapeutic effects of high dose magnesium. Take hypertension, for example. A meta-analysis found supplementation with magnesium at an average of 410mg a day for 11 months significantly reduced blood pressure, with an even greater effect at higher doses.

Additionally, Germany’s limit on magnesium was devised without consideration of the different forms of magnesium, the different effects they produce, and with a flawed risk assessment model that ignores benefits—subjects we will return to in the future.

All of this signals the main purpose behind these ridiculous supplement restrictions: governments, beholden to pharmaceutical interests, do not want consumers using affordable, safe natural products for disease prevention and treatment; they want you buying expensive and dangerous drugs that make you sick but lots of other people very rich.

We cannot emphasize this point enough. If European-style standards come to the US, thousands of products would immediately be banned, a project made even easier by Sen. Durbin’s bill. This would be a disaster for public health. As we will elaborate in future articles, high-dose supplements are required to derive therapeutic benefits from nutrients. Government regulators seem unable, or unwilling, to grasp this fact.

The threat of Durbin’s mandatory FDA registration is urgent. Members of Congress do not understand the problems stemming from this mandate. They are currently considering attaching this proposal to the must-pass prescription drug user fee legislation. This could become law in a matter of a couple months if we don’t ensure that Congress understands why this is such a bad idea. We need to act now to preserve our freedom to stay healthy, naturally.

Action Alert! Write to Congress and tell them to oppose Sen. Durbin’s bill and mandatory product listing for dietary supplements. Please send your message immediately.

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