Fw: Health claims: USA and EU collaboration, or coincidence?

[Guest guest]

Passed on by group member anne from UK, please just delete if you are not

interested, this is a very important issue for all of our future health

freedoms.

SentSubject: Health claims: USA and EU collaboration, or coincidence?

> IAHF Webmaster: Breaking News, Whats New, All Countries

>

> IAHF List: ANH's interpretation of matters below is worthy of close

scrutiny. They see dovetailing regulatory efforts on both sides of the

Atlantic which they feel are indicative of a global Pharma Cartel plan to

harmonize the laws pertaining to dietary supplements globally in order to

block them from competing in the marketplace with toxic pharmaceutical

drugs.

>

> Still more evidence of the dire need to back ANH's lawsuit to overturn the

EU Food Supplement Directive. Please forward this to more people, and urge

them to read http://www.iahf.com/anh_lawsuit.html

>

> ANH's article follows:

>

>

> Is the simultaneous release of the perceived need by the US government and

EU Commission to enforce very restrictive health claims regulations in the

USA and European Union a mere coincidence - or is it part of bigger plan?

>

> In late April and early May there was a global media assault on

nutritional supplements centred on Europe, USA and Australia which has

already had a negative impact on businesses.

>

> Now we see both the US Food and Drug Administration (FDA) and the European

Commission put forward proposals more or less simultaneouslywhich will have

further negative impacts on the natural foods industry. In the EU, the

proposal includes a 'positive list' of allowed health claims. Is release of

these statements of intent on both sides of the Atlantic simply a

coincidence, or is it part of a planned global effort?

>

> We are told that the new proposed EU regulations are again based on a need

to harmonize trade - or is this yet another attempt to limit the health

freedom of European citizens? The last time Commissioner Byrne assured the

natural products industry that a Directive was there only to harmonise

trade - and would have no negligible impact on trade - was when the Food

Supplements Directive passed through the EU parliament in March 2002.

>

> The natural products industry is beginning to wake up now to the

realization that the Food Supplements Directive is potentially catastrophic

to particular sectors of the industry, particularly those involved with

innovation.

>

> Will the industry be more circumspect about the health claims proposals

this time round?

>

> See below for detail on the EU (16 July 2003) and USA (17 July 2003)

health claims proposals.

> --------------------------------------------------------------------------

-----

>

> IP/03/1022

>

> Brussels, 16 July 2003

>

> Commission proposal on nutrition and health claims to better inform

consumers and harmonise the market

>

> The European Commission today adopted a proposed Regulation on nutrition

and health claims made on foods, including food supplements. As consumers

have become increasingly concerned about what they eat and how this affects

their health, the food industry has responded by providing more detailed

nutrition labelling and often making claims about the beneficial effects of

certain foods. The existing EU rules on labeling [1] and nutrition

labeling[2], which do not define conditions for the use of nutrition claims

and do not allow health claims to be made, are often not properly enforced.

>

> Consumers can therefore be misled by claims that have not been properly

substantiated. The proposed Regulation will give legal security and address

these issues by specifying the conditions for the use of nutrition and

health claims, prohibiting certain claims and scientifically evaluating the

use of claims in relation to the nutritional profile of foods. No food

product will as a consequence be prohibited but claims on food products will

have a true meaning for the consumer.

>

> Byrne, Commissioner for Health and Consumer Protection, underlined

the importance of the proposed Regulation. " The implementation of this

proposal will allow both industry and consumers to benefit from the correct

use of claims.

>

> Consumers will receive accurate and meaningful information while food

producers will be able to use serious and scientifically substantiated

claims as a marketing tool without being drowned out by the many

unsubstantiated and inaccurate claims that currently exist on the market.

Furthermore, the creation of a Regulation at EU-level will enable operators

to compete on a fair and equal basis in all EU Member States " .

>

> Nutrition claims: what am I eating?

>

> Nutrition claims, such as low fat or high fibre, refer to what is or is

not contained in the product. There are currently no legally binding

conditions regulating the use of these claims. The proposed Regulation aims

to harmonise the use of such claims so that products claiming to be for

example high fibre have a defined minimum amount of fibre per a defined unit

(eg 6 g per 100 g). Furthermore, some claims may be misleading. For example

a product claiming to be 90% fat free may be stating correct facts but it is

still misleading since it implies that it has a low fat content while in

reality 10% fat represents a fairly high fat content. The annexed list of

nutrition claims gives an overview of the definitions.

>

> Health claims - what does this food do to me?

>

> Health claims refer to what a food or a food component does to the

consumer. It is currently prohibited to make any claims that are misleading

to consumers. Many health claims regarding the role of a nutrient in the

body are uncontroversial and well established, such as the claim that

calcium plays an important role in strengthening the teeth and bones.

>

> Within three years of the Regulation entering into force, the Commission

will make a positive list of such well established claims that will be

permitted. A distinction is made between these well established claims and

more novel claims, such as whole grain may keep your heart healthy/may

reduce the risk of heart disease. For the latter type, individual scientific

evaluation and pre-marketing approval will be required.

>

> Only claims that can be substantiated will be permitted on the EU level

after being evaluated by the European Food Safety Authority. Food operators

will thus benefit from the possibility to make a meaningful claim, including

promoting a products possible impact to reduce the risk of diseases.

Consumers will be able to rely on clear and verifiable claims.

>

> Some claims will not be allowed

>

> It clearly follows from this new approach to health claims, that any

information about foods and their nutritional value used in labelling,

marketing and advertising which is not clear, accurate and meaningful and

cannot be substantiated will not be permitted. This concerns vague claims

referring to general wellbeing (eg " helps your body to resist stress " ,

" preserves youth " ) or claims making reference to psychological and

behavioural functions (eg .improves your memory. or .reducesstress and adds

optimism.). Slimming or weight control claims will not be allowed(e.g.

" halves/reduces your calories intake " )3. Reference to and endorsement by

doctors or health professionals will not be permitted as they might e.g.

suggest that not eating the specified food might lead to health problems.

Health claims on alcoholic beverages above 1.2 % will also not be allowed

since alcohol is known to entail other health and social problems. Only

claims referring to a reduction in alcohol or energy content, will be

allowed.

>

> Nutritional profiles: " good diets " and " bad diets "

>

> The basic principle in nutrition is that there are no .good foods. and

..bad foods. but rather good diets and bad diets. In a long-term varied diet

all foods can be included.

>

> However, foods bearing a claim will automatically be perceived as " good "

foods by consumers. Furthermore, claims about the benefit of consuming a

certain product may lead consumers to eat too much of something that should

only make up a small part of a good diet. It is therefore necessary to

restrict the use of claimson some foods based on their nutritional profile.

The amount of total fat, saturates, sugar or salt are criteria for the

nutritional profile of products, since scientific evidence shows a link

between over-consumption of such nutrients and some chronic diseases (in

particular WHO report of March 2003).

>

> Within 18 months of adoption of the Regulation, the Commission will

evaluate nutritional profiles in close consultation with stakeholders and

based on the opinion of the European Food Safety Authority (EFSA) and in

conjunction with the Member States in the Standing Committee for the

Foodchain and Animal Health.

>

> Exemptions may be necessary for certain claims on foods depending on their

role and importance in the diet of the population.

>

> Further steps

>

> The draft Regulation will need the approval of the European Parliament and

the Council of Ministers. It is foreseen to come gradually into force by

2005.

>

> [1]Directive 2000/13/EC on the labelling, presentation and advertising of

foods

>

> [2] Directive 90/496/EEC on nutrition labelling on foodstuffs

>

> [3] Directive 96/8/EC on foods intended for use in energy-restricted diets

for weight reduction

>

> --------------------------------------------------------------------------

----------------------

> Federal Register: Docket No. 2003N-0069: July 11, 2003 (Volume 68, Number

133)

>

> DEPARTMENT OF HEALTH AND HUMAN SERVICES

> Food and Drug Administration

> Release of Task Force Report; Guidance for Industry and FDA: Interim

Evidence-Based Ranking System for Scientific Data; Interim Procedures for

Health Claims on the Labeling of Conventional Human Food and Human Dietary

Supplements; Availability

>

> SUMMARY: The Food and Drug Administration (FDA) is announcing the

availability of the report of its Task Force on Consumer Health Information

for Better Nutrition (the Task force) and two final guidance documents

entitled ``Guidance for Industry and FDA: Interim Evidence-Based Ranking

System for Scientific Data'' and ``Guidance for Industry and FDA: Interim

Procedures for Health Claims in the Labeling of Conventional Human Food and

Human Dietary Supplements.'' These documents further update the agency's

approach on how it intends to implement the Court of Appeals decision in

Pearson v. Shalala. FDA is taking this action to inform interested persons

of the release of the Task Force report and to make available the guidances

announced in the Task Force report in accordance with FDA's good guidance

practices.

>

> DATES: The guidances are final on July 11, 2003. However, you may submit

written or electronic comments on the guidances at any time. The Task Force

report entitled ``Consumer Health Information for Better Nutrition

Initiative--Task Force Report--July 2003'' is available on FDA's Web sites

at<http://www.fda.gov/oc/mcclellan/chbn.html>

>

> The final guidances are available at

http://www.cfsan.fda.gov/guidance.html

http://www.cfsan.fda.gov/guidance.html

>

> Date: 17-Jul-03

> International Advocates for Health Freedom

> POB 10632 Blacksburg VA 24062 USA

> http://www.iahf.com; http://iadsa-exposed.tripod.com

> 800-333-2553 N.America

> 540-961-0476 World

>

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