To: IAHF List
Subject: Health claims: USA and EU collaboration, or coincidence?
From: IAHF.COM
Date: 18 Jul 2003 19:41:07 -0000

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.

David 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
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