Re: House of Commons debate

[Guest guest]

Hi Sue,

Many thanks for this post. Whatever our views on the OTC market, we should

remain informed about current developments in the sector. Our patients

expect this (and my local paper wants some comments from me on both

directives). I have some questions and comments about aspects of the

briefing which your health food colleague, any nutritionist on this list or

McIntyre may be able to answer.

>The Food Supplements Directive:

>

>Unless changed from its present form, this directive will result in the

>loss of up to 300 currently available safe nutrients, and nutrient sources

>from the UK market

For example?

>, and the imposition of unnecessary and unacceptable limits on the dose

>level at which vitamins and minerals can be present in such supplements

So presumably consumers will end up paying more as they will have to

consume more.

>The Traditional Herbal Medicinal Products Directive:

>

>Unless changed from its present form, this directive will result in the

>loss from the UK market of a wide range of safe and popular herbal

>remedies, plus a large number of products that are a mixture of nutrients

>(vitamins and minerals) with herbs.

From the EHPA website table on amendments to the THMPD I see that an

amendment in principle has been adopted allowing for the combination of

herbs with other non-herbal ingredients. What's the difference between an

adopted amendment and one adopted " in principle " .

The first threat is that the Directive introduces a system of maximum

permitted levels for nutrient content. These levels are expected to be set

substantially lower than the scientifically assessed " upper safe level " .

The process will start with a cautious assessment of " safe level " (e.g.

vitamin B6 at 25mg/day, niacin at 10mg/day) by the EU Scientific Committee

on Food. That level will then be further reduced by the European Commission

to " take into account " risk management factors such as nutrient intake from

other dietary sources and population reference intakes (an outdated concept

of nutritional need which is the minimum required to avoid diseases like

scurvy and beriberi - nothing to do with the levels necessary to achieve

and maintain optimum health).

Any current issues we should be aware of? (and I don't mean the well know

risks of exceeding fat-soluble vitamins such as A and D).

> It will deny consumers access to safe and beneficial food supplements

> of their choice, and have major implications for the Government's own

> public health strategies (for example, promoting folic acid

> supplementation by pregnant women or women planning to become pregnant).

Is this correct or scaremongering?

>The draft Directive proposes a regulatory regime that allows some herbal

>remedies to be licensed as medicines without proving their " efficacy " (in

>the way that pharmaceutical drugs have to do). They would need to

>demonstrate that they were safe, were manufactured to high quality

>standards, and that the finished product, not just the ingredients, had

>been on the market for 30 years (15 years of which would need to be in

>Europe [amendment to 10 years passed by European Parliament]).

>

>But, the practical effect of the detailed proposals now contained within

>the Directive is that it would remove many safe and popular products from

>the market because:

>

>

> a.. some products have not been on the market for the necessary period

> of time; so the imposition of the arbitrary 30 year period would

> jeopardise the position of products introduced over a period of nearly 3

> decades

For example?

>and prevent all future product innovation.

Fair point.

> a.. the manufacturing and testing standards proposed are inappropriate

> for herbal remedies which should not be treated in the same way as

> pharmaceutical drugs.

>

Could someone on the manufacturing side comment on this?

> a.. the Directive would not allow for products which are combinations

> of otherwise legal ingredients (for example, existing mixtures of herbs

> with nutrients such as vitamins and minerals); this would leave some of

> these products (which represent an important section of the market) in a

> regulatory vacuum.

Amendments " in principle " (No 5 and part 2 of No 12) say they can.

> a.. the earlier drafts of the Directive related to " ingredients " but

> the text now deals with " products " , making it difficult in practice to

> provide evidence of market presence over the period of time required and

> requiring manufacturers of basically identical products to duplicate

> registrations at great expense.

Is this correct?

>These two Directives will reduce consumer safety. Consumers can at present

>buy specialist products at reputable high street retailers or responsible

>mail order companies. If the products of their choice are banned, there is

>a serious risk of them being purchased from overseas sources (internet

>sites and mail order) from companies which do not maintain the high

>standards which apply in the UK. There would be no quality control, no

>hygiene control, and no guarantee that the product contained what it said

>on the label. Some consumers would also decide to visit herbal

>practitioners some of whom are unqualified and not therefore regulated at

>all at present, and whose manufacturing processes are not covered by the

>above legislation, exposing them to substantial potential risks.

Is the last sentence an example of ambiguous punctuation or are the authors

seriously suggesting that visiting herbal practitioners is a riskier

enterprise than self-medication?

Separately, I've snipped in a piece from the EHPA's most recent text on the

Draft Directive on herbal products, in the context of the minimum period of

use of a traditional remedy:

" A further safeguard here is the undertaking by the UK MCA that because

one-to-one prescription of herbs does not come under the scope of the

Directive, professional herbal practitioner use of new remedy over the

required number of years would be sufficient to qualify a herbal remedy for

registration under the Directive. "

Do we have this undertaking in writing, and even if we do, what is there to

stop the MCA changing its mind.

All the best,

Krystyna

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Krystyna Krzyzak MNIMH, North Devon