Plate VI.
In plain words
Four products. Three you swallow, one you do not.
These are supplements and one medical device, aimed at the gut and the urinary tract. We are not allowed to call any of them a probiotic, because the European Commission treats the word itself as a health claim, so the pages below name the organisms and count them instead.
Maxibalance
Capsule, 20
Named bacterial organisms with the count for each, in colony forming units at the end of shelf life.
BerryMan
Enteric-coated tablet, 14
D-mannose with cranberry fruit extract standardised to 20 per cent proanthocyanidins, and Echinacea purpurea.
Urotinex
Enteric-coated capsule, 30
A defined terpene composition rather than a plant extract, so every component is named and quantified.
Folial
Vaginal suppository, 10
Aloe vera polysaccharides, sage and tea tree oils, grapefruit seed extract and lactic acid in a triglyceride base. A reformulated version without tea tree oil has been approved and reaches supply in 2027.
How many, and when
Two tablets daily for BerryMan, which is the daily portion the figures on this page are calculated on. For the other three the daily amount is on the carton and not yet on this page.
What these will not do
None of these treats a urinary or vaginal infection. A urinary infection that comes with fever, back pain, or blood needs a doctor and usually needs an antibiotic, and delaying that is the one genuinely risky thing you could do with this page. These are for the ordinary business of keeping things in balance, not for treating something that has already gone wrong.
00 / The protective flora and urinary tract
Four products.
Two sets of rules.
Three of these are food supplements. One is a medical device. They sit in the same segment because they answer the same situation, and they are governed by entirely different law, assessed by different bodies, and permitted to say very different things. That distinction is invisible on a shelf and it is the most important thing on this page.
01 / The word
We may not call it a probiotic.
The European Commission treats the word probiotic as a health claim in itself, because it carries an implied benefit. No claim for any strain of any species has ever been authorised. Not for gut flora, not for immunity, not for anything. Several member states now tolerate the word on labels. The Commission has not moved, and Ukraine and Georgia have both transposed the Commission’s list rather than the tolerances.
So a product built on live cultures is, in European terms, a product that may state which organisms it contains and how many, and may say nothing whatever about what they do. That is a hard commercial position and we would rather hold it than argue our way around it.
Cranberry is in the same position, and for a longer time.
Proanthocyanidins and urinary tract health have been assessed and refused. D-mannose has never been authorised. Every botanical in this segment sits either on the on-hold list or outside the register altogether, and in April 2025 the Court of Justice closed the route that let companies use on-hold claims in the meantime.
02 / The three supplements
Named organisms, counted.
Each entry gives the strain or the extract, the standardisation and the amount in a daily portion. There are no claims below because none is available.
01
Maxibalance
Capsule · 20
Four named organisms per capsule, with the count for each: Lactobacillus sporogenes at 50 million colony forming units, Streptococcus faecalis T-110 at 30 million, Clostridium butyricum TO-A at 2 million and Bacillus mesentericus TO-A at 1 million.
No claim. Naming the strain and the count is the whole of what European law permits here, and it is the part a pharmacist can actually check.
02
BerryMan
Enteric-coated tablet · 14
A daily portion of two tablets provides 1,000 mg of D-mannose, 600 mg of cranberry fruit extract standardised to 20 per cent proanthocyanidins, which is 120 mg of proanthocyanidins, and 20 mg of Echinacea purpurea. Echinacea sits on the on-hold list, so it may be named and nothing may be said about it.
No claim. The proanthocyanidin figure is stated because it is the number that lets someone compare this against the published literature themselves.
03
Urotinex
Enteric-coated capsule · 30
A defined terpene composition rather than a plant extract: pinene 31 mg, camphene 15 mg, borneol 10 mg, fenchone 4 mg, anethole 4 mg and cineole 3 mg, in 33 mg of olive oil.
No claim. The pack carries the warnings it should: not for children under twelve, not in pregnancy or lactation, and not for anyone allergic to anethole or to the Apiaceae.
03 / The device
One of these is not a supplement.
Folial is a medical device, and that is not a marketing distinction. A device is assessed on whether it performs the physical action it claims, through a conformity assessment against the medical devices regulation, and it may describe that action. A food supplement is assessed on composition and may only use authorised claim wordings. Two products beside each other, two entirely different bodies of law.
04
Folial
Vaginal suppository · 10 × 2 g
Aloe vera polysaccharides, sage and tea tree essential oils, grapefruit seed extract and lactic acid, in a triglyceride base. This is the formulation in market now. A version without tea tree oil has been approved by the Ukrainian authority to meet European requirements, and it reaches supply in 2027 once current stock has sold through. We will change this entry on the day the new one ships and not before.
Classified and CE marked as a medical device, not a food supplement. Its permitted wording comes from its conformity assessment and its instructions for use, and we will publish that wording here rather than write our own once the current technical file is to hand.
04 / What is in it
Maxibalance, in full.
Counts below are guaranteed at the end of shelf life, not at the point of manufacture. That is the number almost nobody publishes, and it is the only one that describes what a patient actually swallows.
Maxibalance, one capsule
Nutrient and form
In ours
Of reference value
Legal minimum
Lactobacillus acidophilus
1.0 bn CFU
no NRV
no minimum
Lactobacillus plantarum
1.0 bn CFU
no NRV
no minimum
Both counts are stated as not less than one billion colony forming units at end of shelf life. The strain designations and deposit numbers are not yet published here, and that gap is recorded on the Corrections page.
The other three
Three products under three different laws.
Maxibalance above is a food supplement. So is BerryMan. Urotinex is a food supplement whose entire composition is a defined set of named terpenes rather than a plant extract, which is unusual and worth saying. Folial is not a supplement at all, it is a medical device, and it is regulated under a different act entirely. None of the three has an authorised claim available to it, so all three are described by what is in them.
BerryMan, a daily portion of two tablets
Nutrient and form
In ours
Of reference value
Legal minimum
D-mannose
1,000 mg
no NRV
no minimum
Cranberry fruit extract, 20% proanthocyanidins
600 mg
no NRV
no minimum
Echinacea purpurea
20 mg
no NRV
no minimum
Six hundred milligrams of cranberry extract at twenty per cent gives 120 milligrams of proanthocyanidins, which is the figure that matters and the one most cranberry products decline to print. Proanthocyanidins and urinary tract health have been assessed in Europe and refused. D-mannose has never been authorised. Echinacea sits on the on-hold list. So the whole of this product may be named and none of it may be claimed.
Urotinex, one capsule
Nutrient and form
In ours
Of reference value
Legal minimum
Olive oil
33 mg
no NRV
no minimum
Pinene, alpha and beta
31 mg
no NRV
no minimum
Camphene
15 mg
no NRV
no minimum
Borneol
10 mg
no NRV
no minimum
Fenchone
4 mg
no NRV
no minimum
Anethole
4 mg
no NRV
no minimum
Cineole
3 mg
no NRV
no minimum
Six named terpenes at stated weights rather than an extract of something described by its plant and its ratio. Every milligram in this capsule is accounted for by name, which is the standard we would like every botanical product to meet and which almost none of them do.
Folial, one vaginal suppository of 2 grams
Nutrient and form
In ours
Of reference value
Legal minimum
Triglyceride base
95.72% w/w
not applicable
not applicable
Grapefruit seed extract
3% w/w
not applicable
not applicable
Tea tree oil
0.55% w/w
not applicable
not applicable
Aloe vera
0.5% w/w
not applicable
not applicable
Lactic acid 90%
0.13% w/w
not applicable
not applicable
Sage essential oil
0.1% w/w
not applicable
not applicable
This is the formulation in market today. Reference values do not apply to a medical device, which is why the last two columns are empty rather than filled with something that looks like a percentage. A reformulated version without tea tree oil has been approved by the Ukrainian authority to meet European requirements and reaches supply in 2027 once current stock has sold through. We will change this table on the day the new one ships and not before, and the entry recording that will go on the corrections page.
04 / The line
What may none of these be said to do?
None of the three supplements may be described as treating or preventing an infection, restoring flora after antibiotics, or acting on the urinary tract. Cystitis, thrush and bacterial vaginosis are classified conditions. A supplement presented as addressing one of them stops being a supplement and becomes an unauthorised medicine, and in Georgia naming the condition at all in supplement advertising is prohibited outright.
This is the segment where the gap between what is known and what is sayable is widest, and where the temptation to close it with a suggestive photograph or a knowing subheading is strongest. If a symptom is present, the person to see is a doctor, and the answer may well be a prescription rather than anything on this page.