Supplements under fire; EU legislation poses a threat to consumers' freedom of choice regarding the use of orthomolecular supplements for self-care

Despite the fact that 'Brussels'—that is, the European Parliament and the Commission—exerts enormous influence on what 'The Hague'—that is, the Dutch government and parliament—can and may do, most people are barely aware of plans being concocted in Brussels, and such policies become a fait accompli when it is already too late to fight against them.

Partly for this reason, I felt it was important to share this column by science journalist Pim Christiaans with you.

“European Commission waging silent war against supplements”

The European Commission is on the verge of reducing the dosage of vitamins and minerals in dietary supplements through regulations to such an extent that they become ineffective. This threatens to deprive the population of an important category of natural self-care remedies and make them even more dependent on medicines. This is stated by Nick van Ruiten, chairman of the Alliance for Natural Health Europe, an international non-profit organization that advocates for a natural approach to healthcare. “There is only one party that benefits from this, and that is Big Pharma.”

The plan to limit the amount of vitamins and minerals in food supplements dates back to 2002, when the European Parliament and the Council of the European Union adopted the European Food Supplements Directive (Directive 2002/46/EC). The aim is, among other things, to protect consumers against harmful side effects of vitamins and minerals and to harmonize the rules for supplements across all EU countries.

However, practical implementation proved so complex, and the intention met with so much resistance from consumer groups and the supplements industry, that it was shelved for over two decades.

That is, until the European Commission announced “fairly quietly” early this year, according to Van Ruiten, that there will be a consultation round for citizens and businesses this summer, after which the maximum permitted amounts of vitamins and minerals in supplements will be laid down in a final legislative proposal in early 2028. “So the clock is ticking,” says Van Ruiten. No list has yet been released of the proposed amounts of vitamins and minerals allowed in supplements, but leaked documents are circulating showing that if the EC has its way, only very low-dose vitamin supplements will be allowed to be sold in the EU within a few years. “If we don’t stop this, the consumer will lose their free choice to support their health, and an entire industry could be ruined,” warns Van Ruiten. “The European Commission is waging a silent war against supplements.”

According to a 2023 study, supplement use has skyrocketed worldwide since 2000, accelerating during the COVID-19 years. ‘Strengthening natural defenses’ and ‘preventive health’ are cited as major reasons. A food consumption survey by the RIVM (2019-2021) shows that more than half (57 percent) of the Dutch population now uses supplements; in other EU countries, this varies by an estimated 30 to 50 percent.

According to Van Ruiten, this development threatens the business model of pharmaceutical companies, and Big Pharma’s lobby in Brussels is running at full speed to thwart the supplement industry. He points to research from 2021 by Corporate Europe Observatory, an organization that monitors corporate influence on European politics. This reveals that over 290 pharmaceutical industry lobbyists are active in Brussels and that more than 36 million euros are spent annually to influence EU regulations.

According to Van Ruiten, the argument that consumers must be protected against health damage caused by dietary supplements through EU legislation is suspect, because supplements are actually very safe. In 2024, Lareb registered 226 reports of (suspected) side effects from dietary supplements, compared to 11,429 reports for medicines.

“So what are we talking about?” says Van Ruiten. “Vitamins and minerals are essential building blocks for health that many people actually consume too little of, while the EC acts as if they are potential toxins that must be minimized.”

According to Van Ruiten, the intention is to limit the amounts of vitamins and minerals in dietary supplements so severely that they no longer pose serious competition to medicines. However, it has been shown that various vitamins and minerals can actually have therapeutic effects in high doses. For example, according to various studies, vitamin C — for which the recommended daily allowance (RDA) for adults is 75 milligrams — can reduce the duration and severity of cold symptoms with a daily intake of 1,000 milligrams or more. Vitamin B3 (niacin) can have a beneficial effect on cholesterol in therapeutic doses of 1,000 to 3,000 milligrams per day. “There are many more examples, and the European Commission seems to want to remove them all from the shelves in effective dosages,” says Van Ruiten.

As an example, he mentions vitamin B6, for which the RDI is 1.5 milligrams. This vitamin is essential, among other things, for the production of red blood cells and the proper functioning of the nervous system. With prolonged high intake, a specific form of this vitamin (pyridoxine) can, in rare cases, cause nerve complaints. “Incidentally, those complaints disappear when you stop taking B6, but if the European Commission has its way, a supplement may soon be allowed to contain only 8 or even 4 milligrams of vitamin B6. Yet studies show that B6 can prevent anxiety disorders starting from 100 milligrams per day. That threatens the sale of expensive pharmaceutical products for these common complaints.”

Saskia Geurts, director of NPN (Natuur- en gezondheidsproducten Nederland= Natural and health products Netherlands), the trade association for producers, raw material suppliers, wholesalers, importers, and distributors of dietary supplements, confirms that few accidents occur involving dietary supplements. “You sometimes have a child who eats an entire bottle of vitamin D in one go. Furthermore, there are a number of reports annually of side effects associated with normal vitamin use, particularly of magnesium and B6.”

According to her, the European Commission’s main motivation for curbing the quantity of vitamin and mineral supplements is bureaucratic in nature: “There is a need to harmonize the rules. Currently, if the sale of a high-dose supplement is permitted in one of the EU countries, all other countries must also allow that product. Whereas different countries apply their own maximum limits for vitamins in supplements. That is a problem.”

According to Geurts, one problem is that the EC makes no distinction between different forms of vitamins and minerals when establishing maximum permitted amounts. “For example, there are six different forms of vitamin B6. One of them, pyridoxine, can sometimes cause tingling or neuropathic symptoms at high doses, whereas this is not the case with other forms. Yet the European Commission wants to impose a single maximum dose for all forms of B6 combined. The same applies to magnesium. If you ingest too much magnesium oxide, you may suffer from loose stools. However, this effect does not occur, or occurs to a much lesser extent, with more absorbable forms of magnesium., the maximum permitted amount for all forms is based on magnesium oxide.”

Another problem is that the European Commission “stacks worst-case scenario upon worst-case scenario” when calculating maximum permitted amounts of vitamins and minerals, according to Geurts. She explains that the maximum dose of a vitamin allowed in a supplement is aligned with the average daily intake of that vitamin through food. In doing so, the country with the highest dietary intake of the vitamin in question is taken as the starting point for all other EU countries. Next, the most vulnerable target group is examined for whom that vitamin can cause symptoms, and based on that, a safe margin is maintained for everyone. In some cases, this leads to dosages in supplements that have no effect at all.

According to Geurts, supplements will soon be allowed to contain hardly any iron, because a safe margin for 4-year-old children is used as the benchmark. “That amount is, of course, completely insufficient for a 15-year-old, even though supplementation is often beneficial for that target group. Girls lose a lot of iron during menstruation.” She points to recent Swedish research showing that 40 percent of all teenage girls have an iron deficiency, which can lead to severe fatigue, among other things.

If the European Commission's plans go ahead, the supplement industry in the Netherlands, which will account for a total annual turnover of 900 million in 2024, will face serious difficulties. “The companies that already produce low-dose supplements will not be affected much,” says Geurts. If you produce 100-milligram vitamin C pills, there isn't much of a problem. But specialized orthomolecular brands that recognize the importance of 1,000-milligram vitamin C supplements for immunity, or that target specific health benefits with other high-dose products, could run into trouble. Vitamin-related issues threaten to become very mainstream in Europe.

Summary

EU Legislation threatens high-dose vitamin supplements and consumer choice

The European Commission is moving to strictly limit maximum dosages of vitamins and minerals in supplements under the 2002 Food Supplements Directive. After decades of delay, a public consultation launches this summer, with final rules expected in early 2028.
Critics like Nick van Ruiten (Alliance for Natural Health Europe) argue the limits would make many high-dose products ineffective, restricting consumer access to orthomolecular self-care and boosting reliance on pharmaceuticals.
Supplements are shown to be far safer than medicines (226 vs. 11,429 Lareb reports in 2024), with proven benefits from higher doses of vitamin C, niacin, and B6.
The Commission’s worst-case approach and failure to distinguish vitamin forms risk rendering many products useless. This threatens the €900 million Dutch market and specialized orthomolecular brands.
With over half of Dutch adults using supplements, the changes could limit preventive health choices while allegedly benefiting Big Pharma’s interests.

Source: Supplementen onder vuur