Banning Vitimin C and Herbal drugs A reply from my MP

[Guest guest]

Following a report here concerning Vit C and other such innocuous OTC drugs

I wrote to my MP Karen Buck. In the last para she offers to take up any

further concerns with the appropriate Minister. I have not replied. Perhaps

some of the correspondents can suggest a reply unless they think the answer

satisfactory and that there is nothing to worry about.

 

Best wishes,

 

 

Robin

 

 

Here is her reply:

 

Thank you for writing to me about the recently enacted EU directive on

traditional herbal medicinal products.

 

The first thing to say is that the Directive was not introduced in order to

limit the availability or range of herbal products that are currently

available. Rather the reason for its introduction was as a result of the

widely recognised shortcomings in the current regime for unlicensed herbal

medicines. The overriding objective was that the public should have access

to a wide range of safe herbal medicines of acceptable quality with

appropriate information to consumers about the safe use of the product.

 

Key problems that needed to be dealt with were contamination (e.g. heavy

metals), the accidental inclusion of the wrong herb and failure to give

adequate safety information. This was and still is an international problem

in the unregulated sector and there are many examples of these poor quality

and dangerous products using our current regime to reach the consumer.

 

The Directive will put in place a simplified registration scheme with

systematic requirements in relation to safety, quality, and provision of

information about safe use of the product. Companies will be able to make

claims for the product on the basis of its traditional use. Safety will be

based mainly on long use. Quality requirements will be similar to those

already used for licensed herbal remedies. These require, for example,

correct identification of ingredients, assurance that there is no

unacceptable contamination, systematic record keeping.

 

The cross party House of Lords Science and Technology Committee report on

Complementary and Alternative Medicines (Nov 2000) after taking evidence

from a wide range of sources was very clear on the public health case for

regulation of herbal remedies: " We are concerned about the safety

implications of an unregulated herbal sector and we urge that all

legislative avenues be explored to ensure better control of this

unregulated sector in the interests of the public health. "

You may also find the following background information helpful.

 

Support for the Directive

The Directive is wholly or broadly supported by a range of manufacturers of

traditional herbal remedies, by herbal practitioner organisations,

pharmacists, doctors, the Consumers Association, experts on safety,

academics. The Herbal Forum which represents all ten UK manufacturers trade

associations operating in the sector has said that it sees the need for the

Directive and wishes to work with Ministers and the Medicines Control

Agency (MCA) to address various points of specific concern.

 

In meetings with Ministers and with the MCA over last year the clear

majority of interest groups from the herbal sector have on repeated

occasions urged the Government to support the Directive while arguing for

additional flexibility on scope and close working between the sector and

MCA to ensure the regulatory impact is contained through sensible

implementation.

 

Many interest groups and individuals have told Ministers that they believe

the Directive will protect public health and boost consumer confidence in

herbal medicines. They believe it is likely to lead to an expansion in the

sector rather than the adverse effects which opponents of the Directive

fear.

Were UK concerns about the scope of the Directive addressed?

The UK worked hard in the negotiations to make the Directive as flexible as

possible.

 

The Directive will specifically permit herbal/nutrient combination

products. This would permit the addition of non herbal ingredients, such as

vitamins and minerals, to traditional herbal remedies. This will meet the

concerns raised by many in the UK herbal sector and would allow a

substantial extension in consumer choice. Currently such products would

require a full marketing authorisation.

 

Regulatory impact

The MCA is committed to working closely with the Herbal Forum, representing

all manufacturing trade associations to ensure the maximum possible

streamlining of regulatory requirements, such as preparation of dossiers.

Fee levels will be kept to a minimum, reflecting the fact that it will not

be necessary to demonstrate efficacy and, where a herbal remedy is on the

positive, list safety and traditional use will be take as read.

 

In response to fears expressed that the Directive would lead to the loss of

large numbers of existing legal products Ministers extended the

consultation period on the Directive last year and asked for examples of

such products to be sent in. The response did not justify these

fears. Very large numbers of the products sent in would have little

difficulty in demonstrating traditional use.

 

Implementation of the Directive

Now that the Directive has been agreed the proposed transitional period is

likely to last until 2009. It would not be until the end of this

transitional period that existing products would need to comply with the

terms of the Directive. This would give companies a number of years to

adjust. An additional advantage of the transitional period is that this

time can be used to help complete the minimum period of traditional use.

 

Regulations resulting from the Directive are intended to come into force in

August 2005.

The Directive sets out a framework for regulation of food supplements to

overcome problems in intra-Community trade. The Directive establishes:

 

Principles for setting maximum limits for vitamins and minerals in food

supplements, although no specific figures are proposed.

 

_ `Positive lists' defining the range and form of vitamins and minerals

which may be used in these products;

_ Mandatory labelling provisions in addition to those required by the

general labelling rules in 2000/13/EU.

 

Under UK law, there are currently no specific limits on the levels of

vitamins or minerals that may be contained in food supplements, nor are

there limits on the range of vitamins, minerals or other nutrients they may

contain. In some quarters there is concern about the implications of the

Directive for products already on the UK market, both in terms of

availability of nutrient sources and maximum limits for vitamins and

minerals.

 

Lists of permitted vitamin and mineral sources (which omit around 300

sources used in products currently on the UK market) remain open pending

safety assessments for additional substances. The Government intends, when

implementing the Directive, to take advantage of provisions the UK secured

which enable Member States to allow (subject to certain criteria being met)

the continued sale of products containing vitamin and mineral sources not

yet on the permitted lists up until 31 December 2009.

Even though the directive has now been passed consultation is continuing.

Within the last few days the Health Minister Lord Hunt repeated his request

to the herbal sector to provide evidence in order to help the Government

analyse the total impact of the proposed EU Directive on Traditional Herbal

Medicinal Products. Speaking at a discussion meeting with representatives

from the herbal sector and the Medicines Control Agency on Wednesday 24

July, he stressed how important it was that the MCA is provided with

further specific information to inform the Government's response to the

Directive. Lord Hunt said:

 

" Our starting point is that patient safety must be paramount. We wish the

herbal sector to thrive and so it is important to ensure that regulation is

proportionate to the nature of the products involved. I am aware that

concerns have been expressed by some, particularly within the health food

sector, about the possible impact of the proposed Directive on the

availability of herbal remedies. Given the mixture of positive and negative

views being expressed, it is imperative that we see the evidence which

suggests that the Directive will lead to the loss of products.

 

However, the MCA's consultation has shown that so far there is considerable

support from within the herbal sector for the proposed Directive. A range

of operators in the sector, including representatives of UK manufacturers,

herbal practitioners and experts on safety of herbal remedies have told me

that they are supportive of this approach and welcome the systematic safety

and quality standards which would be introduced.

 

I would again urge interested parties to provide the MCA with specific

examples of any products, currently legal, which they believe would become

illegal as a result of the Directive and specific examples of proposed

quality and manufacturing standards which they believe to be over-

regulatory or unnecessary. "

I apologise for the length of this letter but I Thought it was important

that the concerns expressed by you and other constituents are responded to

as fully as possible.

 

I hope this explanation of the position and what the Directive aims to

achieve will help to reassure you, but if you do have any further specific

concerns, do let me know and I will be happy to take them up with the

Minister on your behalf.

 

Karen Buck MP

[Guest guest]

What leaves me incredulous, is the notion that we can allow people that are

basically opposed to what they describe as " alternative " medicine, to make

" laws " concerning the use, manufacture, doses, availability, etc., of these

substances.

 

There needs to be 5 years set aside for an examination of the staggering

complexities of this situation. 5 years is a bare minimum. But it would

allow us to lay a groundwork for an appreciation of what we're dealing with.

 

JP

 

 

( Moderator's Note: There you go JP, thiking rationally again.

I believe that this is nothing more than the latest step by Big Pharma in their

plan to " do away with " anything that will make the customers more healthy, do it

cheaply, take away customers, etc. They are now going to try and legislate,

hinder,and eventually make the process of approval prohibitively expensive by

demanding expensive testing, fees, etc.Frank )

 

 

-

" Robin Stewart " <benfordlaw

 

Saturday, July 03, 2004 10:24 AM

Banning Vitimin C and Herbal drugs A

reply from my MP

 

 

> Following a report here concerning Vit C and other such innocuous OTC

drugs

> I wrote to my MP Karen Buck. In the last para she offers to take up any

> further concerns with the appropriate Minister. I have not replied.

Perhaps

> some of the correspondents can suggest a reply unless they think the

answer

> satisfactory and that there is nothing to worry about.

>

> Best wishes,

>

>

> Robin

>

>

> Here is her reply:

>

> Thank you for writing to me about the recently enacted EU directive on

> traditional herbal medicinal products.

>

> The first thing to say is that the Directive was not introduced in order

to

> limit the availability or range of herbal products that are currently

> available. Rather the reason for its introduction was as a result of the

> widely recognised shortcomings in the current regime for unlicensed herbal

> medicines. The overriding objective was that the public should have access

> to a wide range of safe herbal medicines of acceptable quality with

> appropriate information to consumers about the safe use of the product.

>

> Key problems that needed to be dealt with were contamination (e.g. heavy

> metals), the accidental inclusion of the wrong herb and failure to give

> adequate safety information. This was and still is an international

problem

> in the unregulated sector and there are many examples of these poor

quality

> and dangerous products using our current regime to reach the consumer.

>

> The Directive will put in place a simplified registration scheme with

> systematic requirements in relation to safety, quality, and provision of

> information about safe use of the product. Companies will be able to make

> claims for the product on the basis of its traditional use. Safety will be

> based mainly on long use. Quality requirements will be similar to those

> already used for licensed herbal remedies. These require, for example,

> correct identification of ingredients, assurance that there is no

> unacceptable contamination, systematic record keeping.

>

> The cross party House of Lords Science and Technology Committee report on

> Complementary and Alternative Medicines (Nov 2000) after taking evidence

> from a wide range of sources was very clear on the public health case for

> regulation of herbal remedies: " We are concerned about the safety

> implications of an unregulated herbal sector and we urge that all

> legislative avenues be explored to ensure better control of this

> unregulated sector in the interests of the public health. "

> You may also find the following background information helpful.

>

> Support for the Directive

> The Directive is wholly or broadly supported by a range of manufacturers

of

> traditional herbal remedies, by herbal practitioner organisations,

> pharmacists, doctors, the Consumers Association, experts on safety,

> academics. The Herbal Forum which represents all ten UK manufacturers

trade

> associations operating in the sector has said that it sees the need for

the

> Directive and wishes to work with Ministers and the Medicines Control

> Agency (MCA) to address various points of specific concern.

>

> In meetings with Ministers and with the MCA over last year the clear

> majority of interest groups from the herbal sector have on repeated

> occasions urged the Government to support the Directive while arguing for

> additional flexibility on scope and close working between the sector and

> MCA to ensure the regulatory impact is contained through sensible

> implementation.

>

> Many interest groups and individuals have told Ministers that they believe

> the Directive will protect public health and boost consumer confidence in

> herbal medicines. They believe it is likely to lead to an expansion in the

> sector rather than the adverse effects which opponents of the Directive

> fear.

> Were UK concerns about the scope of the Directive addressed?

> The UK worked hard in the negotiations to make the Directive as flexible

as

> possible.

>

> The Directive will specifically permit herbal/nutrient combination

> products. This would permit the addition of non herbal ingredients, such

as

> vitamins and minerals, to traditional herbal remedies. This will meet the

> concerns raised by many in the UK herbal sector and would allow a

> substantial extension in consumer choice. Currently such products would

> require a full marketing authorisation.

>

> Regulatory impact

> The MCA is committed to working closely with the Herbal Forum,

representing

> all manufacturing trade associations to ensure the maximum possible

> streamlining of regulatory requirements, such as preparation of dossiers.

> Fee levels will be kept to a minimum, reflecting the fact that it will not

> be necessary to demonstrate efficacy and, where a herbal remedy is on the

> positive, list safety and traditional use will be take as read.

>

> In response to fears expressed that the Directive would lead to the loss

of

> large numbers of existing legal products Ministers extended the

> consultation period on the Directive last year and asked for examples of

> such products to be sent in. The response did not justify these

> fears. Very large numbers of the products sent in would have little

> difficulty in demonstrating traditional use.

>

> Implementation of the Directive

> Now that the Directive has been agreed the proposed transitional period is

> likely to last until 2009. It would not be until the end of this

> transitional period that existing products would need to comply with the

> terms of the Directive. This would give companies a number of years to

> adjust. An additional advantage of the transitional period is that this

> time can be used to help complete the minimum period of traditional use.

>

> Regulations resulting from the Directive are intended to come into force

in

> August 2005.

> The Directive sets out a framework for regulation of food supplements to

> overcome problems in intra-Community trade. The Directive establishes:

>

> Principles for setting maximum limits for vitamins and minerals in food

> supplements, although no specific figures are proposed.

>

> _ `Positive lists' defining the range and form of vitamins and minerals

> which may be used in these products;

> _ Mandatory labelling provisions in addition to those required by the

> general labelling rules in 2000/13/EU.

>

> Under UK law, there are currently no specific limits on the levels of

> vitamins or minerals that may be contained in food supplements, nor are

> there limits on the range of vitamins, minerals or other nutrients they

may

> contain. In some quarters there is concern about the implications of the

> Directive for products already on the UK market, both in terms of

> availability of nutrient sources and maximum limits for vitamins and

> minerals.

>

> Lists of permitted vitamin and mineral sources (which omit around 300

> sources used in products currently on the UK market) remain open pending

> safety assessments for additional substances. The Government intends, when

> implementing the Directive, to take advantage of provisions the UK secured

> which enable Member States to allow (subject to certain criteria being

met)

> the continued sale of products containing vitamin and mineral sources not

> yet on the permitted lists up until 31 December 2009.

> Even though the directive has now been passed consultation is continuing.

> Within the last few days the Health Minister Lord Hunt repeated his

request

> to the herbal sector to provide evidence in order to help the Government

> analyse the total impact of the proposed EU Directive on Traditional

Herbal

> Medicinal Products. Speaking at a discussion meeting with representatives

> from the herbal sector and the Medicines Control Agency on Wednesday 24

> July, he stressed how important it was that the MCA is provided with

> further specific information to inform the Government's response to the

> Directive. Lord Hunt said:

>

> " Our starting point is that patient safety must be paramount. We wish the

> herbal sector to thrive and so it is important to ensure that regulation

is

> proportionate to the nature of the products involved. I am aware that

> concerns have been expressed by some, particularly within the health food

> sector, about the possible impact of the proposed Directive on the

> availability of herbal remedies. Given the mixture of positive and

negative

> views being expressed, it is imperative that we see the evidence which

> suggests that the Directive will lead to the loss of products.

>

> However, the MCA's consultation has shown that so far there is

considerable

> support from within the herbal sector for the proposed Directive. A range

> of operators in the sector, including representatives of UK manufacturers,

> herbal practitioners and experts on safety of herbal remedies have told me

> that they are supportive of this approach and welcome the systematic

safety

> and quality standards which would be introduced.

>

> I would again urge interested parties to provide the MCA with specific

> examples of any products, currently legal, which they believe would become

> illegal as a result of the Directive and specific examples of proposed

> quality and manufacturing standards which they believe to be over-

> regulatory or unnecessary. "

> I apologise for the length of this letter but I Thought it was important

> that the concerns expressed by you and other constituents are responded to

> as fully as possible.

>

> I hope this explanation of the position and what the Directive aims to

> achieve will help to reassure you, but if you do have any further specific

> concerns, do let me know and I will be happy to take them up with the

> Minister on your behalf.

>

> Karen Buck MP

>

[Guest guest]

HI, I'd write this sentence back to her and ask why she isn't concerned about

the Mercury that is in a lot of vaccines and given to little children? Isn't

she concerned about that? This sort of thing is why I prefer to go

herbal/wholistic. Stress that to her and see what her reply is. I mean that's

only one thing to stress anyway. There's countless others that kill us. Big

Pharma ought to clean up it's poisonous act first.

Jenny

Your MP wrote>

> " Key problems that needed to be dealt with were contamination (e.g. heavy

> metals), the accidental inclusion of the wrong herb and failure to give

> adequate safety information. This was and still is an international

problem "