EU Health Products Directives To Have 'Serious International Impact'

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> 14 Sep 2004 07:46:17 -0000

 

> Health Supreme Update: EU Health Products

> Directives To Have 'Serious International Impact'

> sepp

>

> Health Supreme Update: EU Health Products

> Directives To Have 'Serious International Impact'

>

> September 14, 2004

>

>

>

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>

> The contentious issue of European health

> legislation has not been properly considered by the EU Commission

> before acting to support a series of directives - which will be

> applicable law in all member states - on preventive and

> curative foods and supplements as well as pharmaceutical medicines.

> During a conference at the international exhibition SANA

> in Bologna, Italy,

 

Dr. Robert Verkerk of the Alliance for

> Natural Health told a select gathering of Italian industry

> experts and consumer representatives on Saturday 11

> September, that his group is proceeding with a legal challenge

> against the EU Food Supplement directive's prohibition of a large

> number of leading edge nutritional supplements.

 

The directive, he said, was whipped through the EU legislative

process without proper consultation of affected health

sectors, such as leading edge manufacturers, health

stores, nutritional practitioners and consumers of the

products.

 

The hurried passing of the laws without due

consultation resulted in the Alliance's legal case now

pending before the European Court of Justice. Verkerk

invited Italian industry representatives to unite with

opposition from other EU countries in support of the

legal action, to prevent widespread prohibition of

natural health products, which according to Alexander

G. Schauss, PhD, could have a serious impact on

natural health options internationally.

 

According to Schauss, the new EU legislation already

passed for food supplements and herbal products could

affect availability of these products not only in

Europe but internationally, especially in view of

ongoing work by Codex Alimentarius, where European

member countries are heavily lobbying for an extension

of the new EU rules to the world wide regulations

being developed by Codex....

 

 

Article first published in Herbalgram

 

A Review of the European Food Supplements and

Traditional Herbal Medicines Directives

 

by Alexander G. Schauss, PhD, FACN

 

Summary: There is every indication that recent events

unfolding in Europe by Member States of the European

Union, relative to legislation affecting nutraceutical

products, including herbal medicines, will have a

long-term effect on countries world-wide that export

products into Europe. The author reviews the recently

passed Food Supplements Directive (FSD), recent

amendments to the Pharmaceutical Directive, and the

Traditional Herbal Medicinal Products Directive

(THMPD), with comments on their impact, including

proposed legal challenges to the FSD that may set the

stage for similar challenges to the restrictions

imposed by the THMPD.

 

There has been much activity - and much confusion -

about recent regulatory developments in Western Europe

that affect the manufacture and sale of herbs and

herbal products. Manufacturers, suppliers, retailers,

practitioners, and consumers in Europe have received a

wide range of sometimes conflicting messages about the

likely impact of the European Union (EU) legislation

on the availability of dietary supplements to

Europeans. EU legislation may have a profound impact

on the availability of a wide range of dietary

supplements in the future, particularly traditional

botanical medicines found outside of Europe and not

yet in the European marketplace.

 

Many stakeholders with an interest in the dietary

supplement marketplace in the United States (US)

assume that events in Europe will have minimal or

negligible impact on Americans or the US supplement

industry. The following discussion will make it clear

that this position is erroneous.

 

The Directives that have become law or are about to

become law among EU Member States (recently expanded

from 15 to 25 countries) are part of a comprehensive

plan for the regulation of dietary supplements,

including botanical medicines. If contemplated

challenges to the first Directive are not successful,

as will be discussed below, the chances of a

successful challenge to a second or subsequent

directive will inevitably be reduced. The second

directive, which was formally adopted by the European

Council of Ministers on March 11, 2004, involves the

sale of traditional botanical medicines and is known

by its acronyms, THMPD and DTHMP. To understand that

directive it is essential to review the first

directive that passed into law and will be enforced in

EU Member States beginning August 1, 2005.

 

Legislation making its way through the EU law-making

process covers the full spectrum of " nutraceutical "

products, including herbal products, so-called

" borderline products, " fortified foods, and sports

nutrition products. [Editor's note: Nutraceutical

refers to substances found in food or food

derivatives, other than nutrients with established

needs in human nutrition, that have beneficial effects

on the structure/function of the human body and are

non-toxic when consumed in amounts needed to produce

beneficial health effects. Nutraceuticals may be

distinguished from pharmaceuticals in that

pharmaceuticals generally have toxic side-effects at

doses needed to deliver a desired pharmacologic

effect.] New EU regulations on health claims are soon

to be enacted and for many observers here in the US,

the effects of recently enacted EU Directives are of

concern to the American marketplace and its consumers.

 

By July, 2004, two directives had passed into EU law,

affecting all member countries: (1) the Food

Supplements Directive (FSD) and (2) the Traditional

Herbal Medicinal Products Directive (the acronyms

THMPD and DTHMP are both used to refer to this

directive).1 Various European and international groups

have been engaged in legal campaigns to amend and

shape the FSD legislation.

 

To fully understand the European regulatory situation,

it is important to start with the FSD to see how

botanical products will be impacted through other

related directives.

 

Of concern to critics of the FSD is how this

legislation will restrict sales of some popular higher

dose nutrients presently in the marketplace, such as

vitamins C, B-6, and E, and certain essential

minerals, including selenium and zinc. These critics

contend that the FSD would limit consumers to

purchasing low doses of these supplements, as higher

doses would be considered " drugs, " thereby

dramatically increasing the unit cost for those

desiring to consume higher doses. A good illustration

of this was observed by the author when Norway, the

first country in Europe to effect such legislation on

a national level, in the early 1990s restricted the

allowable dose for most vitamins and minerals. Vitamin

C, for example, which could be obtained at a cost of

$9.80 (US) for sixty 250 mg tablets at any health food

store, became a " prescription " drug at that same dose,

and only obtainable at a pharmacy for a cost of $47.00

(US). One of the reasons the FSD managed to get

through the European Parliament (EP) is that major

international and European trade associations advised

their member companies and supporters that the

directive was going to be beneficial for the dietary

supplement industry. However, there was no consensus

supporting this position within the European natural

products industry.

 

For example, consumer, retailer, and practitioner

groups - in the United Kingdom (UK), some Scandinavian

countries, and Ireland - opposed restrictions that

would be imposed on supplements by the FSD. These

groups and their respective countries include the UK's

National Association of Health Stores (NAHS), the

Health Food Manufacturers Association (HFMA), the

Consumers for Health Choice (CHC), the Alliance for

Natural Health (ANH), and the Institute for Optimum

Nutrition (ION); Denmark's

MayDay; the Swedish Practitioner Association

(Näringsmedicinska Terapeutförbundet);

Norway's Health Freedom Association Fritt Helsevalg

(FHV); and

Italy's La Leva de Archimede. The above groups

consistently claimed that the legislation would be

" catastrophic " for sectors relying on dietary

supplements for their patients or customers.

 

Since the FSD's passage into EU law, many companies

and associations with an interest in innovative

product development within the European dietary

supplement industry have come together. For example,

Consumers for Health Choice (CHC)

[www.healthchoice.org.uk] expanded from being a

UK-based lobbying organization for consumers, to

lobbying on their behalf in the UK's Parliament in

London and the EP in Brussels. Similarly, another

UK-based organization, the Alliance for Natural Health

(ANH) [www.alliance-natural-health.org], developed

into a pan-European umbrella organization,

coordinating concerns on behalf of a diverse group of

consumer associations.

 

A detailed look at the FSD legislation suggests that

the primary reason for discrepancies in viewpoints

regarding the legislation's impact is the difference

in how the legislation will impact different sectors

of the nutraceutical industry. Innovative suppliers

(engaged in the development of new dietary supplements

not currently found in the EU market) and those who

depend on existing products, many with doses higher

than that permitted by FSD legislation, will

inevitably be hardest hit. By contrast, companies

manufacturing or selling relatively low-dose,

synthetic vitamins and certain forms of minerals, will

gain considerably from the legislation. They will

benefit from the single market conditions throughout

all EU member countries set by the directive, which is

its primary intent. One of the primary advantages to

these low-dose, synthetic vitamins is the quantity and

quality of research to date that supports their safety

and benefits.

 

Others, however, are concerned about the loss of many

food-derived vitamins (e.g., mixed tocopherols,

tocotrienols, natural carotenoids, and

methylcobalamin) and a range of minerals (e.g.,

sulphur, boron, vanadium, silicon, and many chelated

or plant-derived forms). Because the FSD is

incremental in its effects, with any bans on nutrient

forms not coming into full force until August 1, 2005,

many detractors argue that future effects could

cumulatively have a catastrophic impact on innovators,

independent retailers, practitioners, and consumers.

Some of the ingredients affected are so new that

relatively little is known about their bioavailability

or safety. Therefore, the concern is that excluding

them may chill further interest in doing research on

them.

 

Food Supplements Directive: Key Concerns

 

From the perspective of those involved in the

innovation sector of the dietary supplement and

botanical industries, there are four primary concerns

about the Food Supplements Directive:

 

(1) Limited range of nutrient forms allowed on the

" positive list, "

 

(2) Difficulties and costs in submission of

dossiers,

 

(3) Reductions in maximum permitted levels, and

 

(4) Future restrictions on supplements other than

vitamins and minerals as of 2007.

 

1. Limited range of nutrient forms allowed on the

" positive list " (Annex I & II of FSD). The UK Food

Standard Agency has determined that there are at least

270 ingredients (nutrient forms) presently used in the

UK that are not included on the positive list (e.g.,

such popular ingredients sold in the US as pro-vitamin

A carotenoids, chromium picolinate, and selenium

yeast). In contrast, the UK's National Association of

Health Stores (NAHS), an industry group representing

independent and chain retail health food stores, has

determined that this is an understatement and that the

real figure exceeds 300 ingredients. These " missing "

(i.e., unlisted) ingredients are included in some

5,000 commercial products currently sold in the UK

market. The Irish Association of Health Stores (IAHS),

for example, has determined that around 85% of

vitamin/mineral products in Irish health food stores

contain one or more of these missing nutrients or

nutrient forms and would require reformulation to

comply with the FSD. One of the greatest concerns of

the Alliance for Natural Health (ANH) is that many

missing ingredients are food-forms, which in many

cases are believed to be more bio-available and

generally safer. These food-forms lack the chemical

residues found at almost undetectable levels in

synthetic or inorganic forms that appear on the

positive list. However, the science to support these

concerns remains inadequate and controversial.

 

2. Difficulties and costs in submission of dossiers

(Article 4.6 of the FSD). The process of permitting

the use of unlisted nutrient forms is a highly

contentious issue, based on the fact that most

supplement companies are formulation companies that

buy raw ingredients from a limited number of

manufacturers or producers. If these manufacturers

choose not to submit dossiers to get their ingredients

on the positive list, then the formulation company

would not be able to use them. However, if one

manufacturer submits a particular dossier and has it

approved, any formulator can use that ingredient (at

least until December 31, 2009). Costs for dossiers

vary greatly according to the amount and nature of

existing data. Estimates vary from $25,000 (US) to

more than $300,000 (US), depending on the ingredient

and data needed for submission. In addition, because

the deadline to submit dossiers is July 12, 2005,

there may not be sufficient time to generate all of

the required data for the vast majority of the

300-plus affected ingredients. As of July 2004, less

than 20 dossiers have been filed, supporting critics'

concerns about the lack of motivation of raw

ingredients suppliers to submit dossiers and the

often-prohibitive additional costs needed to complete

whatever studies are needed for submission.

 

3. Reductions in maximum permitted levels (Article 5

of the FSD2). Reductions in maximum permitted levels,

via unnecessarily low " Upper Safe Levels " (USLs), are

being developed without procedures that would allow

for open consultation with outside scientists or

industry experts. An Expert Committee formed by the

ANH determined that much of the science justifying low

maximum levels of nutrients in food supplements is

flawed. Consequently, products containing higher

levels will be regarded as drugs and can therefore

only be prescribed by physicians, which is currently

the protocol in many of the countries with less

permissive legislation.

 

4. Future restrictions on supplements other than

vitamins and minerals as of 2007 (Recitals 6 & 8,

Article 4.8). Examples include amino acids, fatty

aids, phytonutrients, enzymes, fibers, probiotics, and

peptides. These restrictions could be brought in via a

positive list system as well, resulting in exclusion

of ingredients currently in the marketplace, on top of

exclusion of non-European traditional botanical

medicines. It should be noted that there is no

published or acknowledged EC schedule in place at this

writing to implement the FSD for ingredients other

than vitamins and minerals.

 

From reviewing the above four points, it seems evident

to critics of the FSD Directive that the intended

purpose of the FSD is to protect a limited number of

low-dose food supplements, the type typically sold in

European supermarkets and pharmacies. Supplements that

would be excluded from the marketplace unless their

dossiers are approved by August 2005, and those that

do not appear on the positive list, could become

history in Europe. (As of July 2004, it was not known

what maximums would be set.)

 

It has also been the contention of critics that for

many companies there is simply not enough time to

conduct the necessary safety studies. This is based on

the lack of incentives to invest in the high cost of

research for many of the botanicals and other

supplements that have a relatively long history of

traditional use that are affected by the FSD. For

others the task is simply too expensive. Take, for

example, selenomethionine, the most common form of

selenium found in foods and well known as an important

antioxidant mineral by experts who have reviewed the

data.3 This form of selenium was rejected in 1999 by a

committee of the FSD because long-term safety studies

had not been conducted. Ironically, the same committee

agreed to permit use of two inorganic forms of

selenium (sodium selenate and sodium selenite) that

have a higher potential for toxicity and less

effectiveness as an antioxidant. For consumers this is

confusing. On the one hand, they are told by the FSD

committee that they should increase their consumption

of Brazil nuts (Bertholletia excelsa Humb. & Bonpl.,

Lecythidaceae), which contains high doses of

selenomethionine (16 to 30 mcg/g).4-6 But on the other

hand, the EU Commission does not include

selenomethionine on its positive list as a safe form

of selenium simply because it claims the studies are

not available. Are food manufacturers being asked to

provide safety data on natural products that are used

as conventional foods? Who, for example, has been

required to prove via clinical trials that commonly

consumed fruits and vegetables are safe?

 

Whether the critics are correct or not will be

determined by which botanical products receive

registration or not under the next directive to be

discussed, the Traditional Herbal Medicinal Products

Directive (THMPD).

 

Definitions of Acronyms

 

AHPA - American Herbal Products Association

ANH - Alliance for Natural Health

CHC - Consumers for Health Choice

DSHEA - Dietary Supplement Health and Education Act of

1994

EFSA - European Food Safety Authority

EP - European Parliament

EU - European Union

FSD - Food Supplements Directive

HFMA - Health Food Manufacturers Association

IAHS - Irish Association of Health Stores

ION - Institute for Optimum Nutrition

NAHS - National Association of Health Stores

NNFA - National Nutritional Foods Association

PD - Pharmaceuticals Directive

THMPD - Traditional Herbal Medicinal Products

Directive

UK - United Kingdom

US - United States

USL - Upper Safe Levels

 

 

Legal challenge of the Food Supplements Directive

 

The ANH is working with its Expert Committee of

scientists, legal advisers, and public affairs and

media specialists to either annul or positively shape

key EU legislation that is expected to severely impact

the innovative supplement industry and its

beneficiaries. Although there is plenty that can still

be achieved through effective lobbying on amendments

to the Pharmaceuticals Directive (PD) and the

Traditional Herbal Medicinal Products Directive

(THMPD), ANH believes there are few lobbying options

for the FSD without a legal challenge.

 

There is still some possibility to influence the

maximum permitted levels and positive lists for

nutrient groups other than vitamins and minerals, but

the FSD has already passed into European law. It was

adopted by the EP and Council on June 10, 2002, became

effective on July 12, 2002, and implemented by the

Member States by July 31, 2003. Food supplements

containing vitamins and minerals that do not appear in

Annex I, or are taken from a source other than those

listed in Annex II, may not be entered into commerce

or manufactured in the EU after August 1, 2005. During

a transitional period, Member States may allow the use

of vitamins and minerals in their respective

territories if the ingredient has been marketed in the

EU before July, 2002. This temporary availability will

be allowed only on the following conditions:

 

(1) if a dossier supporting an ingredient's use is

submitted by July 12, 2005;

 

(2) if the ingredient has not been the subject of

an unfavorable opinion by the European Food Safety

Authority (EFSA); and

 

(3) the ingredient must not be on Annex I's and

Annex II's " positive list. " This exception is valid

only until December 31, 2009.

 

In some ways challenging the FSD in particular would

make no sense unless there were reasonable grounds and

probabilities of success. The ANH has retained the

only legal team to have ever had an EU directive

overturned by the courts. After ANH's law firm

completed an extensive examination of the FSD, ANH

made the decision to proceed against the EU by filing

a suit on August 8, 2003. The case is being built on a

number of grounds, but of particular importance are EU

constitutional grounds that suggest there is a

reasonable chance to annul the directive.7

 

In addition, it appears that the effects of the FSD

directive can be challenged on grounds of

proportionality, based on the fact that it will

disproportionately impact certain sectors of the

industry, notably those associated with innovative

products.

 

ANH's legal challenge resulted in a British High Court

ruling in February 2004 that gave opponents of the FSD

permission to argue their case before the European

Court of Justice. Interestingly, if the FSD directive

is annulled, all national laws that rely on the

directive are likely to be invalidated. Should the

Judicial Review result in the suit proceeding, this

could have a significant impact on the THMPD, should

aggrieved parties wish to pursue similar action based

on the same issues.

 

In an e-mail to the author on August 15, 2003, Robert

Verkerk, Ph.D., Executive Director of the ANH, said

that " The case will allow the real science of

nutrients to be showcased to the Commission, to the EP

and to the public generally. People will understand

that supplementation of a good diet with high quality

nutrients is a valid and effective way towards optimum

health. There is no scientific rationale for only

accepting synthetic vitamins and a limited range of

inorganic mineral forms while rejecting the plethora

of naturally occurring vitamins and minerals. Winning

the case will pave the way to a very bright future for

the industry. We are not suggesting that there should

be no directive at all, but the existing directive

needs to be replaced with a re-worked version that

allows for high quality, effective supplements across

the whole of Europe. It's about harmonizing to good

standards, not bad ones. "

 

The Traditional Herbal Medicinal Products Directive

 

The key EU directive that will regulate basic

supplements will be the FSD. For botanicals, however,

the amended Pharmaceutical Directive (PD) (Directive

2001/83/EC),8 of which the THMPD is a part, will be

critical.9 Essentially, if a product is not able to be

controlled under the FSD, it will default to the PD.

If it falls under the PD, it will either require a

full drug license (with very substantial data

requirements and costs required for drug approvals)

or, if appropriate, botanically-based products can be

classified as " medicinal herbs " and benefit from a

" fast-track " licensing process. This " fast-track "

THMPD procedure initially requires that the applicant

demonstrate many years of safe use or traditional use

in lieu of providing formal safety data (the major

component of data required for market authorization as

a drug).

 

The THMPD was debated during a Plenary Session of the

European Parliament on December 16, 2003, and became

law on March 11, 2004. One particularly contentious

issue has been the requirement in the EU Commission's

proposed legislation that calls for 30 years of safe

use and that 15 of those years occur within the EU.

CHC has tabled this amendment and campaigned to allow

30 years use to demonstrate safe use anywhere it has

occurred in the world. CHC argued that limiting non-EU

use will prevent interesting and beneficial herbs

found outside Europe with very strong herbal cultures

(e.g., China, India, South East Asia, South Africa,

South America) from being brought into Europe, and

therefore strongly impacting future innovation and

availability to Europeans. The legislation would

essentially have the effect of freeze-framing the

industry's products to what was available in the early

1990s. As reasonable as this may sound, the reality is

that once the law was passed on March 11, 2004, the

provision requiring a minimum 15 years safe use in the

EU out of the 30 years of traditional use will become

the critical criterion for acceptance in commerce.

 

However, this may not " freeze frame " the herbal market

as far as non-EU herbals are concerned for all,

because UK herbal practitioners, for example, are not

bound by the THMPD (i.e., if herbal products are

custom-made as individual medicines for their

patients). Such products are not industrially produced

and, therefore, not subject to the Directive

(2001/83/EC). Thus, the UK herbal practitioners' use

of herbs not previously used in Europe for 15 years

may subsequently be used as evidence of the 15-year

requirement within the EU. Hence, this may be the

route by which many botanical products will eventually

qualify for commercial manufacturing and subsequent

marketing. This refinement to the THMPD, which would

allow for entry of botanical medicines that have no

history of use in Europe, was championed by CHC and

ANH along with their supporters, following

considerable lobbying efforts in the EP in Brussels

and the UK Parliament in London.

 

It should also be emphasized that the THMPD gives a

legal basis for over-the-counter (OTC) herbal

medicines in the EU for the first time. The EU

Medicines Directive (2003/83/EC) requires that any

product that has a medicinal use or action and is

industrially produced must have a " market

authorization, " also known as a medicines license.

Until the advent of the THMPD, this meant that if EU

law were applied throughout the EU, nearly all herbal

products would disappear, as none could afford the

huge cost of licensing, including the proof of

efficacy that was required. The THMPD has substituted

traditional use for this proof of efficacy and,

hopefully, a much less expensive licensing procedure.

It also allows for the first time limited claims to be

made for the product, which until now has been

forbidden, while also requiring good manufacturing

practices to be applied to all products. Additionally,

the THMPD will allow for the first time a limited

range of vitamins and minerals to be included in

formulations with an herbal ingredient. Previously,

and continuing to this day, a number of Member States

prohibited combination products containing botanicals

and conventional nutrients.

 

In addition to the FSD and THMPD, other

directives/regulations being prepared by the EU

Commission are the Sports Nutrition and Fortified

Foods Directive and a draft of Health Claims

Regulations for conventional foods and dietary

supplements. Both are tabled in Brussels as of July

2004.

 

Conclusion

 

The US dietary supplement industry has flourished in

the face of what must be regarded by many around the

world as relatively liberal laws since passage of the

Dietary Supplement Health and Education Act of 1994

(DSHEA). A significant contingent of House and Senate

members in the US Congress, and others, are taking

steps to alter the existing regulatory environment,

but so far it seems that the industry (together with

its extensive consumer support base) has defended

itself against what it deems to be unnecessarily

restrictive legislation.

 

The current US industry campaign against the Dietary

Supplement Safety Act of 2003 (S.722) sponsored by

Sen. Richard Durbin (D-IL) is a good example of how a

diverse range of interested parties can work together.

 

However, recent significant media coverage over the

FDA's banning of ephedra (Ephedra sinica Stapf.,

Ephedraceae) as a dietary supplement ingredient, plus

alleged concerns over the safety of kava kava (Piper

methysticum Forst., Piperaceae), St. John's wort

(Hypericum perforatum L., Clusiaceae), and other

botanicals, have given those in Congress with a desire

to amend DSHEA considerable substance for their

efforts.It is important to realize that it is now

2004, not 1992 when initial efforts to pass DSHEA

began. Basically, the regulatory landscape, both in

the US and particularly in Europe, has changed and

will continue to change as events such as the problems

associated with ephedra unfold.

 

DSHEA was important and essential to the US natural

products industry when it passed in 1994. New

supplement legislation for the US is possible. In

fact, it may become inevitable in the face of consumer

demand for quality assurance and substantiation of

safety. Hence,whatever happens in Europe, especially

related to the lawsuit against the EU's FSD, may or

may not prove to be the bellwether for what happens in

the US in the future. Should the EU impose its various

supplement-related directives on its over two dozen

member countries, there is every reason to believe

that there is enough critical mass in the US Congress

for similar legislation to be passed to ensure that

supplements are more stringently regulated, especially

related

to safety. The impact this would have on the US

dietary supplement marketplace would be nothing short

of significant, impacting every stake-holder in the

nutraceutical industry, especially those in the

botanical medicines industry, which has been a

particular target of the media in recent years. To

disregard what the ANH, CHC, and others have tried to

do to bring attention to their plight in the EU with

the FSD and THMPD is equivalent to putting one's head

in the sand. In this author's opinion, what happens in

Europe in the next several years will impact the

future of the US dietary supplement marketplace in

profound ways.

 

The US industry is, without question, the

nutraceutical world leader. Its growth comes at a time

when there is mounting evidence that many nutrients

and botanical compounds found in dietary supplements

may be useful in the prevention, mitigation, and

treatment of a wide range of conditions and diseases,

as well as their possibly more obvious beneficial

effects on the structure and function of the human

body.

 

Owing to trends towards global harmonization, and in

particular increased pressure towards trans-Atlantic

harmonization, the EU directives will in time have a

direct influence on the shape of future US laws. In

addition to this, many US companies have substantial

and growing markets in Europe, which has a consumer

population of over 500 million people, nearly double

that of the US.

 

In July 2004, the joint international committee of the

National Nutritional Foods Association (NNFA) and

American Herbal Products Association (APHA)

unanimously supported the ANH's legal action against

the EU's FSD. Hence, some US trade associations are

beginning to give Europe's challenges the political

attention they deserve. However, there has been little

financial support of this effort, which has been a

frustration to organizations such as CHC and ANH that

have had to rely on funding support from primarily

European sources.

 

Time is of the essence. Every company or individual

with interests in the future of the dietary supplement

industry in Europe should study the regulations within

the FSD and THMPD and consider how these regulations

will affect their products' marketability in future

years in Europe. They may want to accept the FSD and

DTHMP, or they may want to be part of the potentially

ground-breaking challenges that would pave the way to

a more open future market within the EU supplement

industry marketplace.

 

As a final note, there is a real difference between

the FSD and the THMPD, which is worth considering. The

latter Directive may be viewed by many as draconian

and arbitrary; however, it may have allowed botanicals

to take their place among the panoply of medicines

readily available to health care consumers. Care

should be taken to differentiate the two Directives,

rather than lump them together, which may be a

mistake, considering the new protections given

botanicals under the THMPD.

 

Alexander G. Schauss, Ph.D., FACN, is President and

CEO of AIBMR Life Sciences, Inc., in Puyallup, WA

(www.aibmr.com), a nutraceutical consulting and R & D

company. AIBMR Life Sciences has worked on regulatory

requirements for dietary supplement products in 42

countries and has coordinated pharmacokinetic,

toxicological, and clinical trials to assess the

safety and efficacy of these products. Dr. Schauss is

also Adjunct Research Professor of Botanical Medicine

at the National College of Naturopathic Medicine in

Portland, Oregon, and he has held appointments at the

Southwest College of Naturopathic Medicine and Health

Sciences in Scottsdale, Arizona; Bastyr University in

Seattle, Washington; and City University, in Bellevue,

Washington.He is the author of over 125 scientific

papers on a wide range of subjects related to dietary

supplements and nutraceuticals.

 

Acknowledgements: For their assistance in providing

information and viewpoints for this article, the

author would like to thank Christopher J. Whitehouse,

Managing Director, The Whitehouse Consultancy Ltd.;

Ralph Pike, Director, National Association of Health

Stores; Robert Verkerk, MSc, Ph.D., Executive, Alliance for Natural Health; and Ingrid

Franzon, MN, with the Swedish Practitioner Association

(Näringsmedicinska Terapeutförbundet).

 

References:

 

1. Directive 2002/46/EC of the European Parliament and

of the Council of 10 June 2002, on the approximation

of the laws of the Member States relating to food

supplements. Official Journal of the European

Communities. July 12, 2002, pp. L183/51 - L183/57.

 

2. Alliance for Natural Health Legal Challenge of EU

Food Supplements Directive. David Hinde, LLb,

Solicitor, Legal Director, Mount Manor House, 16 The

Mount, Guildford, Surrey GU2 4HS, United Kingdom.

Available at: www.alliance-natural-health.org.

 

3. Combs GF. Impact of selenium and cancer-prevention

findings on the nutrition-health paradigm. Nutrition

and Cancer 2001; 40(1): 6-11.

 

4. Thorn J, et al. Trace nutrients. Selenium in

British food. British Journal of Nutrition,

1978;39:391-396.

 

5. Ampe C, Van Damme J, de Castro LA, Sampaio MJ, Van

Montagu M, Vandekerckhove J. The amino-acid sequence

of the 2S sulphur-rich proteins from seeds of Brazil

nut (Bertholletia excelsa H.B.K.). European Journal of

Biochemistry. 1986;159(3):597-604.

 

6. Ip C, Lisk DJ. Bioactivity of selenium from Brazil

nut for cancer prevention and selenoenzyme

maintenance. Nutrition and Cancer 1994; 21(3):

203-212.

 

7. Anderson D, Stratford J. Alliance for Health. Re:

Challenge to Supplements Directive. Joint Opinion.

July 18, 2003. Available at: www.brickcourt.co.uk.

 

8. Pharmaceutical Directive (PD) (Directive

2001/83/EC), by letter of January 17, 2002, the

Commission submitted to EU Parliament, pursuant to

Article 251(2) and Article 95 of the EC Treaty, the

proposal for a directive of the European Parliament

and of the Council amending the Directive 2001/83/EC

as regards traditional herbal medicinal products

[COM(2002) 1 - 2002/0008(COD)].

 

9. Final Report on the Proposal for a Directive of the

European Parliament and of the Council Amending the

Directive 2001/83/EC as Regards Traditional Herbal

Medicinal Products. Committee on the Environment,

Public Health and Consumer Policy, European Parliament

[COM(2002) 1-C5-0026/2002 - 2002/0008 (COD)], November

5, 2002, AS-0365/2002.

 

10. Draft Recommendation for Second Reading on the

Council common position adopting a Directive of the

European Parliament and of the Council amending, as

regards traditional herbal medicinal products,

Directive 2001/83/EC on the Community code relating to

medicinal products for human use. Committee on the

Environment, Public Health and Consumer Policy.

Provisional, 2002/0008 (COD), November 7, 2003.

 

 

Summary of Key European Union Directives on Food

Supplements and Herbs

 

There are three European Union directives of concern

to the nutraceutical industry and its consumers:

 

(1) amendments to the Pharmaceuticals Directive,

 

(2) the recently passed Food Supplements Directive,

and

 

(3) the Traditional Herbal Medicinal Products

Directive.

 

Amendments to the Pharmaceuticals Directive

 

This amends the existing Pharmaceuticals Directive

(which governs the supply of drugs in the EU) by

expanding the definition of a drug in a way that will

enable reclassification of any supplement as a drug if

it " restores, corrects, or modifies physiological

functions " in the body. The proposed wider definition

would cover practically all natural health products

and put them at grave risk of being reclassified as

drugs.

 

It also extends jurisdiction of the Pharmaceuticals

Directive so that it takes precedence over any product

defined as a drug under the wide definition, even if

that product was already regulated and permitted under

other EU legislation (e.g., Food Supplements

Directive, Traditional Herbal Medicinal Products

Directive, and Cosmetics Directive).

 

 

The Food Supplements Directive

 

The FSD, passed into law by EU Member States on July

21, 2003, creates a " safe harbor " for " food

supplements, " so that they are not classified as

drugs, but it limits the spectrum of nutrients,

initially only vitamins and minerals. In the near

future, however, FSD could substantially limit the

potency of nutrients in such products by reducing

maximum permitted levels. It provides a severe

restriction on freedom of speech by preventing

publicity over inadequacies of a normal diet. By 2007

it may be applied to other nutrient groups such as

fatty acids, amino acids, fiber, and plant extracts.

Because this directive has already passed into EU law

and is now being transposed into the law of Member

States, it will become fully implemented on August

1, 2005.

 

Traditional Herbal Medicinal Products Directive

 

This directive, currently working its way through the

EU legislature, creates a new class of " traditional

herbal medicinal products " by providing for a

" simplified pharmaceutical registration " (e.g.,

avoiding provision of safety and efficacy data) for

specific " traditionally used herbal medicinal

products. " However, this directive covers only those

products (including the same combination of herbal

ingredients) that comply with a range of conditions,

including having been in safe use for 30 years, 15 of

which must be in the EU. This will mean that herbs

with a history of traditional use outside the EU would

not be eligible and could only be used following

compliance with the full drugs regime required under

the EU's Pharmaceuticals Directive.

 

See also related:

 

 

Denmark To Eliminate Concept Of Supplements: 'They're

All Medicines'

 

New EU 'Medicine' Definition: Difficult Times for

Natural Cures and Prevention

 

European Directive on Medicinal Herbs Discriminates

Against China, India, Other Cultures

 

European Supplements Directive challenged in London

Court

 

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