Supplements under investigation

King of Kings

rbd wrote: »

especiallt tobacco

wtf is going on

anyone can see that tobacco is bad for you

just put an age limit on the vits and supps and go away

surley the fitness industry is worth a lobby group

alcohol and tobacco sedate the populous. this keeps the status quo.
you are unlikely to ever see restrictions on these.
to quote saddam hussein "full bellies make bad revolutionaries" and the same applies to alcohol and fags.
also alcohol and tobacco companies own a lot of politicians.
supps are new on the market and don't have the clout of other big corporations. If the powers that be were serious about health, the drug companies would make whey / explod etc..... (to rip off dragans quote)

it easier to control us if we're sedate and hooked on prescriptions rather than walking around fit healthy and with the mental strength to change things.

Note - for a right winger my above statement sounds very socialist worker .hmmmmmm

anyway powerthirst will never be banned
http://www.youtube.com/watch?v=ok0JH7KSDAs

hardtrainer

There seems to be some confusion between the EU directive on food supplements (Directive 2002/46/EC) and the IMB banning a number of products from sale in Ireland because they contain regulated substances. The two are not related in any way, shape or form.

The IMB banning a number of products has nothing to do with the EU directive. The products they banned contain substances which are regulated as medicines and as such cannot be sold except under the supervision of a pharmacist. Before everyone here gets up in arms about this conspiracy theory and that and why cigarettes are sold and they can't buy their vitamins, I'd like to just offer some insight into the IMB decision. I should state that I am affiliated with neither the IMB or any pharmaceutical company (for those conspiracy theorists).

In the case of NO Explode, the methylxanthine complex, which includes caffeine, also contains another related compound (also a methylxanthine) called theophylline. This compound was used as a drug to treat respiratory problems. It is regulated as a medicine and thus it's inclusion in NO explode means that it cannot be sold in a supplement shop. It's been openly on sale in a number of supplement shops in dublin, so those claiming this has something to do with a 'raid' on the shop on capel street are barking up the wrong tree. I'm pretty sure the owners of that shop (who I don't know, am not affiliated with in any way) were not aware that NO explode contained theophylline.

Now, those who've claimed that they do their research and that they always know what they put into their body, think again. Some of the compounds are not explicitly stated on the labels. Calling it a methylxanthine complex doesn't tell you the full story.

So whats wrong with theophylline?
Theophylline isn't used much anymore as a drug, because it has too many side effects, including nausea, diarrhea, increase in heart rate, arrhythmias and CNS excitation. Also, you need to monitor patients closely to ensure they do not show signs of toxicity (which is very serious). The reason why medicines are dispensed by pharmacies is because the pharmacist is trained to know what way different classes of drugs interact within the body. Theophylline is significantly more toxic if you're taking certain antibiotics, for example.

Vitamin B12 (very high dose) as found in some thermogenics can also have some pretty horrible adverse reactions in the body.

The EU directive, which seems to harmonise and regulate food supplementation across Europe, is not going to just ban everything above 100% RDA of vits and minerals. The aim is to harmonise. The RDA levels that they will take and the upper and lower limits will be decided by a scientific committee. The problem I have is that the committee is an EU committee and therefore not really answerable to anyone. I'd rather an independant, pan European committee, made up of nutritional scientists from each and every country. I think that would be a fairer way to take into account not just cultural practices, but also the fact that it would mean a more conservative approach being taken in general.

The ban will relate to things being sold as foodstuffs/supplements. It doesn't necessarily mean that you won't be able to get high dose vitamins, you might just have to buy them from a pharmacy. That doesn't mean they will be available only on prescription. They may be sold as OTC medication, but under pharmacist supervision.
As for herbal supplements. That's a completely different kettle of fish. The problem with herbal supplements is that they are not subject to the kinds of regulations (at present) that medicines etc are. So the concentration of the active ingredient can vary greatly from pill to pill, batch to batch and so on. This presents a significant risk where overdosing is concerned. The misconception that herbal remedies are natural and therefore cannot be harmful is a very dangerous one. Herbal supplements can contain compounds which are physiologically active and/or neurologically active. Aside from dosing concerns, there is the possibility for other compounds, also present in a natural plant extract, to interact not necessarily with the compound of interest, but with some other compound in the body (including traditional medications that are being taken...contraceptives, antibiotics, painkillers etc).

There is more to the whole debacle than meets the eye, so simplifying it to 'bad EU men', 'pharma conspiracies' or 'simplistic banning' adds nothing of value.

eroo

its not even funny what people think about whey.'its not safe','its a drug' etc,you know the bull****.its not made from ecstacy or heroin.the people who say 'supplements' are bad are going out destroying their bodies with fags and booze,yet they ridicule supplement users for actually trying to improve their body

g'em

some fairly heavy claims there hardtrainer, sources?

nesf

g'em wrote: »

some fairly heavy claims there hardtrainer, sources?

Theophylline is a listed ingredient in Animal M Stack and it would be considered a medicine and is toxic etc. Which would justify removing the products from the general market tbh.

crotalus667

nesf wrote: »

Theophylline is a listed ingredient in Animal M Stack and it would be considered a medicine and is toxic etc. Which would justify removing the products from the general market tbh.

I have a very simple way of looking at this
“it’s my body ,it’s my choice”

nesf

crotalus667 wrote: »

I have a very simple way of looking at this
“it’s my body ,it’s my choice”

That's a whole different issue. As is, with our present laws, the product should be taken off the shelves in supplement shops.

g'em

nesf wrote: »

Theophylline is a listed ingredient in Animal M Stack and it would be considered a medicine and is toxic etc. Which would justify removing the products from the general market tbh.

Well Animal M stack is like a pick n' mix of slightly dubious ingredients :rolleyes: I didn't know that about theophylline, I must have a read up about it. It was more the 'horrible adverse reactions' to Vit B12 levels that I was getting at. I'm stuck for time now but I'll get back to this.

hardtrainer

g'em wrote: »

some fairly heavy claims there hardtrainer, sources?

Pubmed.

I'm sick of people quoting the propaganda that appears on commercial sites, especially US sites, where a lot of money is spent to write pseudo scientific statements about the products they sell. Just because it is preceeded/followed by 'Dr Wolfowitz says...' or something similar doesn't make it true. If a product makes some wild claim about how it adds 10lbs of muscle in a week or helps to 'melt the fat from your body, right in front of your eyes' or something similar, you know what, save your money, or at the very least so some proper research into the effects of all the ingredients and see where they are basing their claim.

I find it funny that so many people started shouting conspiracy on the part of the pharma companies, claiming they're lobbying the EU to ban >100% RDA vits so they can make more money, yet they are perfectly willing to accept the claims of supplement manufacturers that everything is natural, harmless are 100% guaranteed to help you build/lose muscle/fat.

If this board were the simpsons, you'd all have pitchforks and flaming torches now, an angry mob running amok looking for the evil pharma companies while Mr Burns rubs his hands together and laughs aloud at your gullibility [cue radioactive ooze being added to giant whey vat...or something similar]*


*Slight dramatisation to illustrate point

Dragan

hardtrainer wrote: »

If this board were the simpsons, you'd all have pitchforks and flaming torches now, an angry mob running amok looking for the evil pharma companies while Mr Burns rubs his hands together and laughs aloud at your gullibility [cue radioactive ooze being added to giant whey vat...or something similar]*


*Slight dramatisation to illustrate point

Dude,

While you input into this thread has been invaluable ( as is normally the case in any thread you care to post in ) I find that ending a post by basically questioning the intelligence of the rest of that threads participants is rarely a good thing.

I imagine not insult is intended here, simply pointing out the way this could be taken up.

Tigger

Dragan wrote: »

Dude,

While you input into this thread has been invaluable ( as is normally the case in any thread you care to post in ) I find that ending a post by basically questioning the intelligence of the rest of that threads participants is rarely a good thing.

I imagine not insult is intended here, simply pointing out the way this could be taken up.

i wish it was the simpsons in fairness

g'em

hardtrainer wrote: »

Pubmed.

Really? Have you any specific examples because I'm pretty sure I can't find any. Vit B12 (cobalbamin/ cyanocobalbamin) is a water soluble vitamin which isn't stored in great amounts in the body, athough it is stored in the liver at higher levels than other members of the Vit B family. It's RDA (varying from country to country) is around 2-6ug/day. Anything over 7 x that amount generally will not get absorbed by the body and is excreted without harm. The Institute of Medicine of the National Academies (a US agency) states that "no adverse effects have been associated with excess vitamin B12 intake from food and supplements in healthy individuals". In fact, the IOM recommends that adults older than 50 years get most of their vitamin B12 from vitamin supplements or fortified food because of the high incidence of impaired absorption in this age group of vitamin B12 from foods that come from animals.

Source: Institute of Medicine. Food and Nutrition Board. Dietary Reference Intakes: Thiamin, riboflavin, niacin, vitamin B6, folate, vitamin B12, pantothenic acid, biotin, and choline. National Academy Press. Washington, DC, 1998.

So hold your horses there nelly, and be a touch more careful with these sweeping statements of yours. I know I certainly make a careful background search on all the compounds I use - if anything looks a little dodgy, or if I can't get the information I require, I don't take it. I definitely don't unquestionably believe everything that the big supp companies tell me (although in a slightly twisted way I would trust them slightly more than I trust pharma companies - at least they're upfront about their $ making intentions). Is it really any wonder that people are suspicious of the IMB and our government's stance on these potentially medical (or so they say) supplements when, since it became available, creatine has been heralded as the street version of crack cocaine.

Now, I'd love to believe that the crack-downs from the IMB (which I was under the impression were being made in conjunction with the EU directive, or at least that's the message I picked up from the IMB website) are their way of protecting us good citizens from the horrific dangers of accidently ingesting too many vitamins, but frankly that's just not hte case.

My issue is not that they want to ban potentially harmful substances, my issue is a blanket ban telling us that everything they believe will harm us, will. No evidence, no research, nothing. And yet in the same way that you're criticising the public for believing marketing spiels, it's ok for us to belive nameless, faceless beaurocrats who tell us that too much Vit B12 will damage us irreperably?

As you say, this is a very complex issue, so I hardly think it's fair to brandish anyone opposing the ban as being a pitchfork wielding villager (although lovely imagery!!!). My point here isn't to nit-pick at your post, which I by and large agree with, more to point out that from my perspective a blanket ban is unfair and unnecessary.

hardtrainer

Dragan wrote: »

Dude,

While you input into this thread has been invaluable ( as is normally the case in any thread you care to post in ) I find that ending a post by basically questioning the intelligence of the rest of that threads participants is rarely a good thing.

I imagine not insult is intended here, simply pointing out the way this could be taken up.

Point taken. That wasn't the intention. I wasn't using the analogy to say folks were stupid, but to illustrate that people can get a little caught up in the fight and lose sight of who their opponent is. Sometimes you have to take a step back to get some perspective.

I was trying to get at the fact that the thread has been going all over the place with all manner of claims about what the IMB are doing, what the point of the EU directive is, people's right to take what the want etc. There has been a lot of misinformation and it has confused the whole thing. Obviously people are angry (hence the angry mob analogy) at what they see as unjust banning of their supplements, but what I wanted to point out to people is that the IMB are justified in what they have done. It is not the fault of any one supplement shop selling things they shouldn't have been (as was alluded to above). It is also nothing to do with the EU directive, which I think everyone agrees is both annoying and worrying, but the exact way in which that is implemented remains to be seen.

At the end of the day, the IMB is there for our safety, to ensure that medicines, and lets be upfront about this, the products they have banned do contain medicines, are not sold without prescription and/or supervision of a pharmacist. In Spain you can buy antibiotics over the counter. In Ireland they are prescription only. I strongly support that and I have every confidence in the IMB and their decisions. I don't think they did wrong by banning potentially dangerous products, which lets face it are used for essentially cosmetic or competitive reasons.

hardtrainer

g'em wrote: »

... It's RDA (varying from country to country) is around 2-6ug/day. Anything over 7 x that amount generally will not get absorbed by the body and is excreted without harm. .....In fact, the IOM recommends that adults older than 50 years get most of their vitamin B12 from vitamin supplements or fortified food because of the high incidence of impaired absorption in this age group of vitamin B12 from foods that come from animals.

The problem with very high doses of vit B12 is not that it is absorbed into your body, but that high concentrations in your gut can interact with other medications there, producing unwanted/toxic compounds. It is the same problem with taking high concentrations of anything. The idea that RDA is minimum is something that supplement companies have been proporting. That is not the case. RDA is sufficient, not minimum. In most cases it is far above the minimum.

You're right, elderly should take B12 supplements because they may have impaired absorption. But nowhere is it prescribed that they should take high dose supplementation of B12. Therein lies the distinction.

g'em wrote: »

So hold your horses there nelly, and be a touch more careful with these sweeping statements of yours.

Indeed, sweeping statements are not good for anyone. Have a look through this thread and count to sweeping statements. Indeed, look across this board. Have you ever made them g'em?

g'em wrote: »

Is it really any wonder that people are suspicious of the IMB and our government's stance on these potentially medical (or so they say) supplements when, since it became available, creatine has been heralded as the street version of crack cocaine.

And yet the IMB hasn't banned the sale of creatine. Does this not instill some confidence in you? They know what they are doing. They are not blindly banning things without reason.

g'em wrote: »

Now, I'd love to believe that the crack-downs from the IMB (which I was under the impression were being made in conjunction with the EU directive, or at least that's the message I picked up from the IMB website) are their way of protecting us good citizens from the horrific dangers of accidently ingesting too many vitamins, but frankly that's just not the case.

Are you privy to some inside information? Or is this just a sweeping statement made to fan the flames a little. You seem so sure of yourself there.."frankly that's just not the case". I'd love to know why.

g'em wrote: »

As you say, this is a very complex issue, so I hardly think it's fair to brandish anyone opposing the ban as being a pitchfork wielding villager (although lovely imagery!!!). My point here isn't to nit-pick at your post, which I by and large agree with, more to point out that from my perspective a blanket ban is unfair and unnecessary.

Indeed it is and as I have said already, I wasn't brandishing people as pitchfork wielding villagers to imply they were stupid, though I can see how that may seem. I've explained it already. I should also point out that I said that kinda tongue in cheek, to lighten the mood on this thread a little, it's all very glum and depressing.

As I have said numerous times already, I'm not in favour of blanket bans of anything. I don't think it's the best way forward. The EU directive is yet to be fully implemented and we don't yet know how that will progress. We all have representatives in Europe though. Might it not be better to write to them and express our concerns rather than get caught up in the confused and multi issue debate that has developed here?

Go to http://www.europarl.ie/irish.html and find out who is representing you and find out what they can do for you in this matter.

g'em

hardtrainer wrote: »

Indeed, sweeping statements are not good for anyone. Have a look through this thread and count to sweeping statements. Indeed, look across this board. Have you ever made them g'em?

Touche . I was making sweeping statements about the IMB though, not the posters, so that's *totally* allowed

nesf

g'em wrote: »

It was more the 'horrible adverse reactions' to Vit B12 levels that I was getting at. I'm stuck for time now but I'll get back to this.

I figured as much but the point about theophylline in the products made things very black and white with regard to those specific products (if not the whole other debate about supplements in general). I thought it was important to underline/support what he was saying since it might have been "lost" in the brewing argument over vitamin dosage levels, which again, is something he has a point on. The issues with high dose supplements are something that I've heard about from two other people (one doctor, one geneticist), but I don't know enough about to comment on myself in any depth.

The vitamin discussion might be more suited to Biology/Medicine though than here.

#Smokey#

Hey I just sa thaat no-xplode and load of other supp's got pulled off shelves even fitnessireland and nutritionconnection dont stock em anymore. Did the IMB even give a reason that no-xplode was great for focus and stamina

Any other places besides BB.com that i can get it? or even a boardsie to boardsie deal?

Hanley

You probably won't find any body selling it openly online in Ireland. And it would be unwise to attempt to import it from the US as it will probably be confiscated and you'll get a nice little letter from the IMB.


You best bet is going into one of the stores in person and asking them if they know where you might be able to obtain some.

WHIP IT!

F*ck sake... is that it then, never gonna be available over-the-counter again? I'm only just nearly finished my first tub of it and I've found it a great pre-workout boost...

g'em

The ingredients of NO Xplode have been deemed to be of medicinal quantities by the IMB, so sale of this product (along with others of similar content) will not now be available for purchase. This was published on 19/10/07 on hte IMB website:

Notice Information: Human Medicines - Advisory - 19/10/2007
Title:
IMB Statement on Body Building Products

Product:
Body Building Products

Issue:

The IMB can confirm that it is carrying out a number of investigations in relation to the illegal sale of products that are suspected to breach the medicinal products legislation. Products either containing a medicinal substance or making a medicinal claim are considered to be medicinal products that fall within the remit of the IMB and therefore must be authorised prior to being placed in the Irish market. The IMB actively enforces against known breaches of the medicines legislation in this regard and can confirm that its enforcement unit has been successful in a number of prosecutions in this area and is actively investigating some 500 potential breaches of medicinal products legislation.

In addition, the Classification Committee of the IMB has reviewed and continues to review many borderline products that can be considered to fall into the category of ‘body-building products’ to determine whether they are medicinal products and takes appropriate action where necessary.

The IMB would reiterate its warning to consumers against purchasing medicinal products on-line as there is no guarantee that these products are of appropriate quality, are effective or that they contain what they purport to contain. The Irish Medicines Board cannot guarantee the quality, safety or effectiveness of any product that is supplied by an unauthorised source and strongly advises against anyone purchasing medicines in this manner.

The issue of internet sales is a global one and commands extensive resources from regulatory agencies worldwide. The IMB would like to reassure consumers that it will continue to monitor the marketplace for such illegal activity, in close collaboration with Gardaí and Customs, and will continue to take the appropriate legal action to prevent illegitimate supply of medicinal products in Ireland. The IMB was involved in the closure of 12 internet sites last year selling prescription-only medicines and it is continually monitoring new Irish registered sites as they come online.

There's already a thread discussing this so .... let there be merging...

g'em

Oh and there was a raid on a supplement provider based in Carlow yesterday. The IMB are on the hunt...

And ftr, there are still NO/ CEE products available to buy legally, they just don't have the same high Vit B12 content.

justsomebloke

WHIP IT! wrote: »

F*ck sake... is that it then, never gonna be available over-the-counter again? I'm only just nearly finished my first tub of it and I've found it a great pre-workout boost...

well you could probably get it up north.

I could also suggest that if you can find an UK based company selling it that will ship to Ireland then due to the free movement of goods and services within the EU it shouldn't be checked so you could get it that way. However due to the legal implications of this I won't suggest it

davyjose

ali.c wrote: »

Oh the irony, you defended your right to self-prescribe lipotrim and now your defending the right of the IMB to restrict the self prescription of vitamins and other supplements?

Sorry but that is nothing if not ironic. Anyhow the RDA is the minimum amount of vitamins one needs not the maximum also the requirement for dietary supplements varys with different stages in life and activity levels.

I think personally it means more money for pharmacutical companies and the medical profession and less for us.

Some might even say hypocritical!

rubadub

hardtrainer wrote: »

And yet the IMB hasn't banned the sale of creatine.

Would they be technically be able to ban creatine here? I have heard it is banned in France but I am not sure if laws would allow it here, i.e. they might have to ban red meat if they did.

http://www.nucare.com/noname2.html in that link they are calling creatine "food", and a "muscle vitamin".

tribulus

jsb wrote: »

well you could probably get it up north.

I could also suggest that if you can find an UK based company selling it that will ship to Ireland then due to the free movement of goods and services within the EU it shouldn't be checked so you could get it that way. However due to the legal implications of this I won't suggest it

Lol, good lad.

Dragan

Hey guys, i'm happy enough to let people not suggest things, just be careful not to post any links etc.

yomchi

Apparently the IMB conducted more searches in Dublin yesterday in the City Centre, Dun Laoighre and Kildare.

t-ha

NutritionX Xplode is still sold though isn't it, given it's manufactured within the EU and already subject to various EU controls?

Why do people need such high doses of stimulants just to hit the gym?

WHIP IT!

What's the nearest legal thing to No Xplode now so?

g'em

t-ha wrote: »

NutritionX Xplode is still sold though isn't it, given it's manufactured within the EU and already subject to various EU controls?

Just because it's fine according to the EU, doesn't necessarily make it OK according to the IMB. From the IMB website:
Under European and Irish legislation, all medicinal products must be authorised before being marketed. Medicinal products marketed in Ireland must be authorised by the Irish Medicines Board (IMB).

I'm pulling something together about what they do/ don't allow now.. afaik Nut X XPlode is fine though. Alri WTF Pump is fine too I think.

g'em

Okaaaaaaay... I’ve been looking through all the stuff I can get my hands on relating to the IMB’s policy on medicinal products.

First off, who are the IMB?
The manufacture, importation, distribution and supply of medicinal products
for human use in Ireland is regulated by the Irish Medicines Board.

The Irish Medicines Board (IMB) is the licensing authority for medicinal
products for human use in Ireland pursuant to the provisions of the Irish
Medicines Board Act 1995.

IMB regulates the licensing and sale of medicinal products for human use in
Ireland by means of the Medicinal Products (Licensing and Sale) Regulations
(S.I. 142 of 1998) (Regulations) and relevant EC Directives.

These Regulations require that a medicinal product shall not be marketed without a Product Authorisation. The granting of such authorisation ensures
that a product complies with required standards of quality, safety and efficacy.

It is the responsibility of those marketing medicinal products to comply with
the relevant legislation and to ensure that such products are only marketed in
accordance with this legislation.

So the IMB are the last and final word on what can and can't be sold in the Republic of Ireland in the context of medicinal products. What they say ultimately goes.

In their “GUIDE TO THE DEFINITION OF A MEDICINAL
PRODUCT” they define a medicine as:

Article 1 (2) of European Council Directive 65/65/EEC defines a medicinal
product as follows:
‘Any substance or combination of substances presented for treating or
preventing disease in human beings or animals.

Any substance or combination of substances which may be administered to
human beings or animals with a view to making a medical diagnosis or to
restoring, correcting or modifying physiological functions in human beings or
in animals is likewise considered a medicinal product’.

There are products, however, which could be said to occupy a "borderline"
position between for example medicines and nutritional products, between
medicines and cosmetic substances between medicines and medical devices
and between medicines and so-called "lifestyle" products.

Some of those ‘Borderline’ Products include (but aren’t limited to):

Foods
In general most foods are clearly not medicinal products. There are
however certain manufactured preparations presented in a form, such
as capsules, tablets or certain liquids, usually associated with
medicines to which have been added various substances such as
vitamins, minerals, amino acids and herbal ingredients. Such
preparations may be classed as medicinal products even in
circumstances where they may be described by the manufacturers
concerned as “foods” or “food supplements”. In these cases the use
assigned by the purchasers and users of the products will be taken into
account by IMB in establishing the classification of a product.
The following therefore is an outline of the position in regard to those
products which are presented in a form usually associated with
medicinal products :

Products containing vitamins and/or mineral ingredients
These preparations are considered to be medicinal products
when -
(a) their labelling or accompanying or associated literature
makes any preventative, curative or remedial claim; or
(b) the recommended daily intake calculated with respect to
any of the added vitamin or mineral constituents
exceeds the maximum recommended daily dietary
allowance for such constituents as published from time
to time by the Minister for Health, or if their content is
otherwise sufficient to exert pharmacological or
toxicological effects.

The current Table of Maximum Recommended Daily
Dietary allowances is set out in Appendix 2 to this
guideline. In the case of preparations intended for a
particular population category, e.g. children, the
maximum recommended allowance for that category is
applied.

It should also be noted that where there are no written
particulars or directions as to dosage the vitamin or
mineral preparation concerned is automatically classed
as a medicinal product, thereby requiring a product
authorisation under the Regulations, because of the risk
of overdosing in the absence of such dosage
instructions.

Amino Acids
Products containing selected amino acids
These preparations are considered to be medicinal products
when -
(a) the labelling or accompanying or associated literature
makes any preventative, curative or remedial claim or
(b) any of the amino acid constituents are presented at an
enhanced level greater than that ordinarily encountered
in the course of a normal daily diet.

It must be noted that amino acids are the constituent
units of dietary protein and break down during
digestion. For the most efficient use to be made of
amino acids to the body a complete range must be
supplied in the diet at the same time.
The taking of individual amino acids at levels greater
than ordinarily encountered in the course of a normal
diet cannot therefore be considered as being of dietary
or nutritive value alone.

The use of amino acids in these circumstances is
considered medicinal and accordingly such preparations
are considered to be medicinal products for which
product authorisations must be held under the
Regulations.

It should also be noted that certain amino acids if used
in non-dietary proportions may be hazardous to health.
This has been recognised in the case of oral preparations
of L-Tryptophan which under the Medicinal Products
(Prescription and Control of Supply) Regulations, 1996,
may only be sold on presentation of a medical
prescription.

Products containing other ingredients (e.g. Fish Oils, Omega 3
Fatty Acids, Evening Primrose Oil and Caprilic Acid etc.)
In the case of fish oils such as cod liver oil to which no
additives have been added the classification for product
authorisation purposes will be considered on the basis of the
recommended daily intake of the vitamin constituents as
described in paragraph (5.2.1) above.

The position in regard to products containing other ingredients
will be considered on their individual merits. In the case of
Omega 3-fatty acids, evening primrose oil and caprilic acid
(and its salts) it is clear from the promotional literature
associated with those products available on the market that their
use is medicinal and accordingly product authorisations are
required.

Herbals (Products containing medicinal herbal ingredients)
Herbal medicines (herbal remedies) are medicinal products containing
active substances derived from plant material and/or vegetable
substance preparations.

All such preparations are considered to be medicinal products, since by
definition these plant substances have known pharmacological
properties.

However, it should be noted that preparations consisting of dried,
crushed or comminuted herb(s) labelled in a manner which specifies
the herb(s) and the process of production only are excluded from the
scope of the regulations provided no other name is given to the
preparation and no recommendation as to use as a medicinal product is
made (Article 10b of SI 142) 1998.

Examples of such exempted products would include senna leaves,
cinnamon bark, ginger root and carrageen moss appropriately labelled.
Examples of herbal substances can be found in Appendix 3A to this
guideline.

Certain herbal substances are known to have potent pharmacological
action and many of these have therefore been restricted to tightly
controlled sale or supply conditions. For example, the substances
listed in Appendix 3B may be only supplied in Ireland on foot of a
prescription from a registered medical practitioner. This list also
includes certain potent plant substances where the active principle is
well characterised and more usually presented as a purified substance.

Slimming Products
Preparations presented in a form, such as capsules, transdermal
patches, tablets or other dose forms usually associated with medicines
and which are intended for use with a view to weight loss or weight
control are considered as medicinal products for which product
authorisations are required under the Regulations.
Examples of products which fall into this category include appetite
suppressants, bulk forming agents (e.g. methycellulose, sterculia)
starch blockers, amino acids and “anti cellulite” preparations.

Homoeopathic and anthroposophic medicines represent special types of
medicinal product for which particular rules may be applied by Member States
recognising their tradition of homoeopathic practice, in accordance with the
requirements of Directive 92/73/EEC8. This Directive is given effect in Irish
legislation by the Regulations (S.I. 142 of 1998) made under the Irish
Medicines Board Act, 1995. Under this legislation it is recognised that the
principles of Directive 65/65/EEC apply to any homoeopathic medicinal
product being placed on the market with therapeutic indications or in a form which may present risks which must be balanced against the desired
therapeutic benefit. However, a simplified registration procedure in
accordance with Article 7 of Directive 92/73/EEC may also be applicable be those homoeopathic products marketed without medicinal claims as specified in Article 8 of the Regulations. In order to obtain the certificate of registration referred to above, an application should be made to the IMB setting out the documents specified in the Third Schedule to the Regulations.


A summary of their policies:

9.1The definition of a medicinal product used in Ireland and throughout the
European Community is that contained in Article 1 of European
Council Directive 65/65/EEC.

9.2. This definition is in two parts. The first refers to the presentation of the
product and the second refers to its actions on the body.

9.3. A summary of the IMB's policy is as follows:
9.3.1. Products which claim to cure, alleviate or prevent disease are
considered medicines. The IMB takes into account in its
decision the words used, the presentation and the relationship to
similar products.
9.3.2. Products which contain substances of a type and in amounts
such as to exert a significant pharmacological effect, will also
be considered as medicines.
9.3.3. Products presented as nutritional or cosmetic substances may be
considered as medicinal products if medicinal claims are made
or if they contain ingredients which have significant
pharmacological effects.

9.4. Unless a specific exemption has been granted medicinal products may
not be marketed without a current product authorisation, in accordance
the 1998 regulations (S.I. 142 of 1998).

9.5. It is the responsibility of the person or organisation marketing such a
product to ensure that the relevant legislation is complied with. Failure
to comply with this legislation may result in prosecution with liability
for fines or prison terms as specified in the Irish Medicines Board Act
1995.

9.6. This document is for guidance only and should not be considered to be
a complete or definitive statement of the law. It may be subject to
change in the light of new developments over time or as appropriate.

Products Subject to Prescription Control
The following medicinal substances for human use of herbal origin are subject
to prescription-only control in Ireland.
Aconite
Belladonna (herb and root)
Broom (Cytisus scoparius species)
Confrey (Symphytum species)
Conium leaf (Coniine)
Croton oil
Croton seed
Curare
Digitalis leaf (whether prepared or not)
Ephedra (including Ma-Huang)
Ergot (prepared)
Ginkgo biloba
Jaborandi
Mistletoe (Viscum album L)
Nux vomica seed
Papaveretum
Podophyllum (including resin)
Pokeroot (Phytolacca species)
Poppy capsule
Ragwort (Senecio jacobaea L)
Rauwolfia serpentina
Rauwolfia vomitoria
Sabadilla
Sassafras (bark and root)
Sassafras oil
Yohimbine hydrochloride

All taken from:
http://www.imb.ie/images/uploaded/documents/6342926_guidelines.pdf

yomchi

Products Subject to Prescription Control

Mistletoe

Prescription or not...I'll take my chances this xmas

*i'm lookin at you G'em

rubadub

g'em wrote: »

It should also be noted that where there are no written
particulars or directions as to dosage the vitamin or
mineral preparation concerned is automatically classed
as a medicinal product, thereby requiring a product
authorisation under the Regulations, because of the risk
of overdosing in the absence of such dosage
instructions.

So if you have a fortified breakfast cereal without a portion size on it it is a medicinal product!

g'em wrote: »

Aconite
Belladonna (herb and root)
Broom (Cytisus scoparius species)
Confrey (Symphytum species)
Conium leaf (Coniine)
Croton oil
Croton seed
Curare
Digitalis leaf (whether prepared or not)
Ephedra (including Ma-Huang)
Ergot (prepared)
Ginkgo biloba
Jaborandi
Mistletoe (Viscum album L)
Nux vomica seed
Papaveretum
Podophyllum (including resin)
Pokeroot (Phytolacca species)
Poppy capsule
Ragwort (Senecio jacobaea L)
Rauwolfia serpentina
Rauwolfia vomitoria
Sabadilla
Sassafras (bark and root)
Sassafras oil
Yohimbine hydrochloride

There are other plants with similar substances to these, e.g. belladonna has compounds found in mandrake, henbane and other plants.

Seems I will need a prescription for my mistletoe if I want a kiss at christmas...

Dragan

Guys,

just to let you know Longjack is now banned as well, or at least considered a medicine.

This mean Norateen Heavyweight 2 by LA Muscle, Promax Extreme by Maximuscle and Cyclone by Maximuscle are all gone.

This was legal on Wednesday , illegal on Thursday.

So thats pretty much sums up the IMB's intentions for me.

Dragan

Thermobol by Maximuscle gone due to B vit content.

fatal

Dragan wrote: »

Guys,

just to let you know Longjack is now banned as well, or at least considered a medicine.

This mean Norateen Heavyweight 2 by LA Muscle, Promax Extreme by Maximuscle and Cyclone by Maximuscle are all gone.

This was legal on Wednesday , illegal on Thursday.

So thats pretty much sums up the IMB's intentions for me.

Although its still early days, do you know how strictly these bans are being enforced?
This sounds like something out of a cartoon.As far as I know IMB have not even given specific reasons for banning each of the supplements that are now on the banned list.

g'em

fatal wrote: »

Although its still early days, do you know how strictly these bans are being enforced?

Extremely strictly. There are ongoing raids in supplement stores and warehouses and one supplement store owner has reportedly been indicted. The importation of banned substances from the UK/ Europe is being targeted too.

Dragan

Hey guys,

just off the phone with the IMB, i have asked to speak to someone who can clearly detail the way the IMB will be acting over the coming weeks and also the reasoning behind some of the decisions they have made.

The person i was talking to wasn't a massive help, but they have guaranteed me a phone call from someone with all the answers next Tuesday.

I'll keep you all updated.

fatal

Dragan wrote: »

Hey guys,

just off the phone with the IMB, i have asked to speak to someone who can clearly detail the way the IMB will be acting over the coming weeks and also the reasoning behind some of the decisions they have made.

The person i was talking to wasn't a massive help, but they have guaranteed me a phone call from someone with all the answers next Tuesday.

I'll keep you all updated.

good work dragon.Im looking forward to hearing their reasoning for all of this madness

SpAcEd OuT

This is absolute bull****.

Are the PHs gone as well or do the IMB even know they exist...

g'em

SpAcEd OuT wrote: »

Are the PHs gone as well or do the IMB even know they exist...

So far gone they're probably on Pluto by now.

rubadub

Dragan wrote: »

Thermobol by Maximuscle gone due to B vit content.

Is this simply because a listed dosage is more the the RDA of B vitamins?

Is a loophole simply overlabelling a product with a lower recommended dosage, so it then falls short of the RDA? and then people just make up their own mind what to do.

This overnight ban is crazy and unfair, it would be sad to see the likes of Jon stuck with product which is essentially OK. FFS they gave a years notice before the smoking ban was introduced to allow people to "prepare", and there was a hell of a lot more peoples health being adversely affected during that year than a few vitamins would have done.

Even a months notice would allow a quick sale of surplus stock in a legal manner.

#Smokey#

say if i ordered some stuff from the states would they check it in post because i ordered no xplode from bb.com and im still waiting for it to arrive. Would it be confiscated? or is it chance?

Hanley

#Smokey# wrote: »

say if i ordered some stuff from the states would they check it in post because i ordered no xplode from bb.com and im still waiting for it to arrive. Would it be confiscated? or is it chance?

It'll probably never get to you.

#Smokey#

theres always hope and its by fedex too. also theres animal pak in it also will i get that if it is intercepted

Dragan

#Smokey# wrote: »

theres always hope and its by fedex too. also theres animal pak in it also will i get that if it is intercepted

If it's fedex then it's gone....they all get checked.

And Animal Pak will get wiped on you as well.

#Smokey#

but my animal pak is safe and legal. thats a load of bull. And they wonder why crime is increasing when they force us to try to get safe supplements from shady characters.They are adding more ways for criminals to get money.These supplements were approved by EU and US . Only in Ireland i swear

Dragan

#Smokey# wrote: »

but my animal pak is safe and legal. thats a load of bull. And they wonder why crime is increasing when they force us to try to get safe supplements from shady characters.They are adding more ways for criminals to get money.These supplements were approved by EU and US . Only in Ireland i swear

I could be off the mark but i reckon the Animal Pak is WELL Over RDA's on lots of vits?

#Smokey#

Thats your opinion and i respect that but its great for me overall. no side effects and ive been on them since july.
Also can you suggest something along the lines of animal stak to get if there are any other similar products that arent banned

yomchi

Dragan wrote: »

I could be off the mark but i reckon the Animal Pak is WELL Over RDA's on lots of vits?

Animal Pak is waaaaaaaaaaaaaaaaaaaaaaaaayyyyyyyyyyyyyyyyyyyyyyyy over the RDA's - scarily so !!