EU legislation interfering in the supplements market

#1

I became aware of this today on receipt of an email from the company British Supplements which I have simply copied and pasted below.

Hey healthier people

One of you guys emailed me this week about something happening in Europe. I went digging for a day. It’s worse than what you think.

Here’s the short version.

Since 2002 the EU has had the legal power to cap the dose of every vitamin and mineral sold in a supplement. For twenty years they never got round to it.

Last December, Germany and sixteen other countries dragged it back onto the table and told the Commission to get on with it.

The Commission has now confirmed the timetable. Public consultation this summer. Law on the books by early 2028.

So basically that means:

Big Gov and Big Pharma are looking to control the dose in a food supplement in the EU.

So weak supplements (snake oil) will mean you will have no other choice other than a Big Pharma pill.

They’re not picking a dose and asking whether it’s safe. They’re doing sums.

They take the highest amount they reckon is safe. Then they subtract what the biggest eaters in the country already get from their food. Whatever’s left over is what you’re allowed to buy in a supplement.

Think about that for a second. The more of a nutrient there is in the average diet, the less you’re allowed to top up with. That isn’t a safety limit. That’s a sum set up to land on a small number.

And they’ve already started.

EFSA cut the safe limit for vitamin B6 to 12.5mg a day. America and the World Health Organisation both say 100mg. That’s eight times the gap, and part of the case for cutting it rests on a study from 1987.

France has proposed a vitamin C cap of 208mg,

**Germany has pushed for a vitamin D limit of 20mcg, thats 800iu.**Their own European food authority says 100mcg is fine.

And your skin makes about 10,000iu in one afternoon in the sun. Enough to go slightly pink. Twelve times what Germany reckons is safe.

Herbs are a separate fight and it’s going worse.
A working group of food safety agencies flagged 117 substances, with thirteen at the top of the queue for binding restriction. Curcumin. St John’s wort. Ashwagandha. Melatonin. Maca. Black cohosh. Holy basil. Tribulus. Piperine, which is just black pepper.

Basically, most of our products they are trying to ban.

Denmark has already banned ashwagandha outright. France followed. Belgium classes it as a medicine so you can’t sell it as a supplement at all. EFSA has decided there’s no safe level of berberine, one of the most studied plant compounds we have. Red yeast rice is awaiting a ban decision this year.

Before anyone says none of this matters because the UK has left Europe.

We make everything in Gilford, Northern Ireland.

Under the Windsor Framework, EU nutrition law still applies directly in Northern Ireland.

And it’s not only Europe. Australia is moving every B6 product over 50mg behind the pharmacy counter from June 2027. Over here, Which? has been demanding tighter rules since October, and Holland & Barrett quietly reformulated their entire B6 range down to the European number before anyone even made them.

Now notice what isn’t in any of this.

Not one line about fillers. Not one line about bulking agents. Nothing about products that carry so little active ingredient that you’d never feel them. They love to promote snack oil with nasites so why not change the law so a company like mine can never come about.

A capsule with 5mg of something and a load of magnesium stearate sails straight through.

It’s the strong stuff that’s the problem. The stuff that actually does something.

If you want to do something about it, here’s where.

Sign the Save Our Supplements petition. It’s Irish-led, past 20,000 signatures and heading for 50,000, and it’s already landed on desks in government:

https://my.uplift.ie/petitions/save-our-supplements-3

Read what they’ve put together first if you want the full picture: https://saveoursupplements.ie

The Alliance for Natural Health have been fighting this exact directive since 2002. They took it to the European Court and won part of it. Here is their site:

https://anhinternational.org

Forward this to anyone who takes a supplement. Most people have no idea any of this is happening, which is exactly how it’s meant to go through, and if Europe is doing something, you know the UK will just copy it more than likely. It’s already happening with Ashwagandha as we speak.

Lastly, here’s a link to the report if you want to see all the products they are looking to ban so far. This is just the start.

"This report was elaborated under the Heads of European Food Safety Agencies (HoA) by a working group of 26 Members, chaired and coordinated by the Federal

Office of Consumer Protection and Food Safety (BVL) GERMANY and Netherlands Food and Consumer Product Safety Authority (NVWA) THE NETHERLANDS.

Responsibility for the information and views set out in this document lies entirely with the authors."

6 Likes
#2

As a European I haven’t purchased supplements from the EU for years, I only use iHerb. Multivitamins in the EU are ridiculous, you can’t get Allulose and so many other things. So it may be getting worse but it was already untenable for anybody health conscious.

1 Like
#3

Everyone should sign this. It’s so ridiculous to restrict people’s freedom like that in the name of “protecting” them against harms. All such banning has unintentional harms.

#4

This is scary and not just in the UK or even the EU. The US FDA has been trying to assert this power since the 1970’s. In a typical year, there are no deaths from the use of supplements, including herbs. When there is an occasional death, the FDA seizes upon it as an opportunity to reclassify and regulate the substance. In contrast, annual US deaths from the legitimate use of prescription drugs ranges from 106,000 to more than 800,000. The range is due to classification criteria and even with those numbers, many more deaths caused by prescribed drugs are believed to be misclassified as natural causes. These facts don’t stop the FDA’s war on supplements. It is rare year in which they make no attempts to restrict the sale of at least one supplement. Part of the US push is paternalism as we see in the UK but part of it is driven by pharma. Public outcry has driven the protective legislation we enjoy but we are only one bad runs of congressional leaders away from joining the UK.

1 Like
#5

For a contrary view… well, not entirely - I do agree that these limits are ridiculous, although I don’t believe the motives are “evil pharma” driven, just good old paternalism.

But let us think a bit about the “why” - I actually do hope for a bit of regulation, but along the line of truth in labelling. The supplement situation in the US is an absolute scandal. You simply have no idea what you are getting, there is widespread fraud and unsafe ingredients, rife with fly by night operators. With such a completely untrustworthy market, something should be done - we don’t accept that in the food industry, why should we do so in supplements which are supposed to augment our health.

I would be 100% in favor of strict enforcement of truth in labeling requirements, obligatory testing and certification.

You should be able to take what you want with minimal hassle. For that matter, I’m in favor of allowing most meds to be OTC. But at the same time, I think you should have the right to get what you paid for without the constant russian roulette fear of being swindled. And again, for that matter I think even meds are poorly controlled for quality by the FDA. Both need to up their game. YMMV.

1 Like
#7

I agree that the US is too libertarian, as it were, on supplements. We have seen that a company can sell capsules labeled “500 mg UA” which turn out to contain less than 1 mg and yet suffer no legal consequence. Ingredient purity and amount and batch-level testing should be a market entry requirement and entrants to the market should need to possess more than articles of incorporation. Less egregious but still irritating is the common supplement phrase, “Assists in regulating X already within normal levels.” Requirements for claims need to be reworked. I won’t make a suggestion here because it is a thorny issue and a challenge to get right.

I disagree that paternalism is the sole driver in the US. Medical paternalism/arrogance is definitely a factor but, through the eyes of a good friend on the inside, I have seen the refined skills of pharma in capturing FDA regulators through strategic and carefully orchestrated methods. They wine and dine to ensure favorable positions cf. the supplement industry and they have installed revolving administrative doors between pharma and the FDA. While tracing the exact count of inbound FDA decision-makers is hampered by disclosure limitations, available information indicates that direct lateral moves from pharmaceutical corporate roles into top FDA drug approval positions account for 10% to 15% of upper-tier administrators. If the definition is broadened beyond direct corporate employment to include indirect industry ties (industry-funded clinical research at academic medical centers, biotech venture capital, or paid consulting) the overlap rises to 30% to 50% among top decision-makers and advisory panel members.

In contrast, pharmaceuticals are required to label potentially adverse effects of approved drugs. Their approach has been to obfuscate by providing overwhelming detail on side effects with no requirement to clearly state the probability that they drug will benefit the person; for many, it will not.

#8

For anyone interested here is a deeper look on what is behind this initiative (from the same source as before):-

Hey healthier people

On Saturday I wrote to you about the EU plan to put legal caps on how much of a vitamin or mineral you’re allowed to buy. So I thought Id do follow up piece on who is behind it ?

Who is actually behind this?

It’s one country doing all the heavy lifting.

Germany.

The letter

On 10 December 2025, Germany tabled a paper at the EU Agriculture and Fisheries Council.

Sixteen other countries signed it. It’s titled “Maximum levels for vitamins and minerals in food supplements and fortified foods are indispensable” and it asks the Commission to get the caps set in 2026.

You can read the letter here- https://data.consilium.europa.eu/doc/document/ST-15839-2025-INIT/en/pdf

That letter is why the consultation is happening this year instead of never.

This isn’t new. The Germans have been at it for 25 years.

Back in the 1990s Germany had a rule. If a vitamin product contained three times the recommended daily amount, it wasn’t a food any more. It was legally a drug. Vitamin C, B1, B2, B6, B12, folic acid. Three times the RDA and you needed a pharmaceutical licence.

The European Commission took Germany to court over it. Germany defended the rule and argued it was justified.

Germany lost. On 29 April 2004 the Court ruled that applying the strictest criterion to every vitamin regardless of the actual risk went further than protecting health required, and wasn’t proportionate.

Case C-387/99, if you want to look it up:

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:61999CJ0387&from=EN

Same year they lost that case, their Federal Institute for Risk Assessment published its first set of proposed maximum levels for supplements. Court route closed, rulebook route opened.

Then in 2007 they tried it again. This time with garlic.

German authorities blocked garlic extract powder capsules from being imported, on the grounds that garlic in a capsule was a medicinal product. The Commission sued again.

The Court found the capsules contained nothing but garlic and an excipient, had no effect beyond eating garlic normally, and that to be a medicine a product has to actually prevent or treat disease.

Germany lost again. Case C-319/05, 15 November 2007:

https://www.newhope.com/regulatory/ecj-garlic-extract-powder-capsules-are-not-medicinal-products

Garlic. They took garlic to the European Court of Justice.

The Institute behind all of this ?

The BfR, Germany’s Federal Institute for Risk Assessment.

They’ve been working on vitamin and mineral limits since 2004 and updated them again in 2024, before Brussels had decided anything.

Their proposed ceiling for vitamin D in a supplement is 20 micrograms a day. That’s 800 IU. Their reasoning is that 20 micrograms covers 97.5% of the population even with no sun at all, so anything more isn’t necessary.

10,000 IU is roughly how much you get when you get a little pink while out in the sun, for context.

Crazy to think how these people think. The all-knowers of everything that will keep us stupid little people safe, so let’s take away all their freedoms bit by bit. Insane.

I’ll be fair to them on one point. They’re not saying high doses are dangerous.

The man who has run that institute since 2003 is Professor Andreas Hensel. He’s also been Germany’s representative on EFSA’s scientific Advisory Forum for the same 23 years.

Same person on both sides of the table.

In 2015 the BfR was given the job of assessing glyphosate, the weedkiller, for the EU.

A plagiarism expert later analysed their report against the submission from the Glyphosate Task Force, the industry group that includes Monsanto. In the chapters assessing health risks, half the content was found to be copied.

Their own assessment method had been lifted from the industry text and presented as the authority’s own work.

Even the Guardian wrote about it.

https://www.theguardian.com/environment/2019/jan/15/eu-glyphosate-approval-was-based-on-plagiarised-monsanto-text-report-finds

The BfR rejected the findings. Their defence was that integrating passages from applicant documents was customary practice, and that the word plagiarism wasn’t relevant.

So. Weedkiller gets the benefit of the doubt using the manufacturer’s own research.

Vitamin D gets a ceiling of 800 IU because they say so.

Maybe its because -

Glyphosate came with a funded dossier. Eleven thousand pages of it, paid for by the companies who sell it.

Vitamins and herbs don’t have that, because nobody owns them and nobody can patent them, so nobody funds the paperwork.

Whoever pays for the paperwork writes the science. No dossier means “insufficient data”. Insufficient data means restrict.

1 Like
#9

I can see the logic behind making regulations stricter for supplements that have case reports for toxicity like ashwagandha or banning vitamin D supplements in doses exceeding 10k IE.

#10

But can’t you just stack pills? Like, if you want 20K IU, just take more pills. A hassle and more expensive, but doable. If there’s a will, there’s a way. Silly regulations only stop the less determined. A dedicated biohacker will find ways around it.

1 Like
#11

In many cases taking more pills wouldn’t just be inconvenient but far more expensive, not to mention you would be eating a lot more fillers. In addition, in some cases lower doses would outright prevent you from being able to take it. Take NAC as an example. The maximum dose allowed in supplements in Iceland was only 100 mg many years ago (and likely still is). That makes taking the grams daily used in human studies on GlyNAC not only impractical, but basically impossible even with a lot of money because nobody even sells 100 mg NAC pills. Usually it’s sold in 600 mg doses. So keeping the maximum allowed amount at 100 mg is basically a subtle way to ban it.