CODEX – Our Supplements Are Safe For Now!

As usual there is confusion surrounding the set of international standards brewing in Europe, the confusion can be referred to as the Codex. The following will provide you with some quick facts, and also reprints of press releases from Europe and the FDA to provide details about this stuff for the more curious reader.

First of all the Codex will not and does not regulate the way dietary supplements are sold within the United Sates. So when and if the European Union's Directive and Codex rules are passed and adopted, our dietary supplement regulations will rule over how supplements are made and sold in the USA.

However, when these regulations are finalized they will effect the supplements sold in the EU. This may have a negative effect on USA companies selling products to the EU countries, by eliminating thousands of products that contain ingredients and amounts not on the approved list.

Concerns

1.       One major concern for us is that if the more stringent standards are adopted in Europe, eventually regulators in the USA may turn to them as a model and try to change our supplement regulations to conform to these international standards.

2.       Second, as you will read below, the part of the EU regulations that is stirring things up, only involves vitamin and mineral containing products.

3.       Third, the European dietary supplement industry and concerned public are taking care of matters for themselves. Recently, The Alliance for Natural Health and Nutri-Link Ltd challenged the Food Supplements Directive of European Courts of Justice (ECJ).

On a preliminary basis the Advocate General Geelhoed, senior advisor to the ECJ gave his opinion in favor of the Alliance's case. It is now up to the courts to make a final ruling, expected in June 2005.

The following will provide you with overview information about the Codex from the FDA and a link to the Codex for readers who want to read about this for themselves. This FDA information is followed by recent press release information from The Alliance for Natural Health. I spoke to Paul Donkersley, who is based in the United Kingdom and is the media representative for ANH.

He told me to let you know that if you are interested in keeping updated on these issues, you can visit the ANH's website, and click on "Join The Alliance" (you can become a member for free, to receive e-mail updates on the Codex and related news and developments in the EU):

What The FDA Tells Us About The Codex

To help Americans better understand the issues surrounding the Codex, in March 2005 the FDA released the following statement, which includes questions and answers about the Codex.

Many U.S. consumers have expressed concerns about the development of the Codex Draft Guidelines for Vitamin and Mineral Food Supplements. Some are concerned that these Guidelines, if adopted by Codex, will restrict consumers' access to the wide range of vitamin and mineral supplements of varying potencies legally sold in the United States.

Others are concerned that the Guidelines will limit the amount and type of information on the labels of dietary supplements sold in the United States. Still others believe that the Guidelines will require dietary supplements to be sold as drugs in the United States.

We hope the responses below help you understand why the adoption of Draft Guidelines for Vitamin and Mineral Food Supplements by Codex will not restrict U.S. consumers' access to vitamin and mineral supplements or impose any restrictions that go beyond those established by U.S. law. We also hope the responses help explain why the U.S. participates in the Codex process and how you can keep abreast of Codex activities.

What Is The Codex?

The Codex Alimentarius Commission, or Codex, was created in 1963 by two U.N. organizations, the Food and Agriculture Organization and the World Health Organization.

It's main purpose is to protect the health of consumers and to ensure fair practices in international trade in food through the development of food standards, codes of practice, guidelines and other recommendations. Codex standards and guidelines are developed by committees, which are open to all member countries.

Member countries review and provide comments on Codex standards and related texts at several stages in the development process. In the United States, public meetings are held to receive comments on Codex drafts and comments are invited from all interested parties (See U.S. Codex Office web site). Codex standards and related texts are voluntary; member countries are not bound by or required to adopt them.

What Work Has The Codex Undertaken?

In the early 1990's, the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) began discussions on guidelines for vitamin and mineral supplements.

This Committee is responsible for studying nutritional issues referred by the Codex Alimentarius Commission; drafting provisions, as appropriate, on the nutritional aspects of all foods; and developing standards, guidelines, or related texts for foods for special dietary uses. Germany is the host government for the Committee, which has met either every year or every other year since 1966.

At its most recent session (Bonn, November 1-5, 2004), the Committee completed work on Draft Guidelines for Vitamin and Mineral Food Supplements and submitted them for adoption by the Codex Alimentarius Commission at the Commission's July 2005 meeting.

What Is The Scope & Content Of These Guidelines?

1.       The Guidelines apply only to supplements that contain vitamins and/or minerals, where these products are regulated as foods.

2.       The Guidelines address the composition of vitamin and mineral supplements, including the safety, purity, and bio-availability of the sources of vitamins and minerals.

3.       The Guidelines do not specify upper limits for vitamins and minerals in supplements. Instead, they provide criteria for establishing maximum amounts of vitamins and minerals per daily portion of supplement consumed, as recommended by the manufacturer.

The criteria specify that maximum amounts should be established by scientific risk assessment based on generally accepted scientific data and taking into consideration, as appropriate, the varying degrees of sensitivity of different consumer groups.

4.       The Guidelines also address the packaging and labeling of vitamin and mineral supplements.

We encourage you to read the complete text of the Guidelines, which is found in Appendix II of the report of the most recent session of the CCNFSDU. See ALINORM 05/28/26 on the page of Full Reports of Recent Sessions.

What Has Been The U.S. Position On The Guidelines?

The U.S. supports consumer choice and access to dietary supplements that are safe and labeled in a truthful and non-misleading manner. The Dietary Supplement Health and Education Act of 1994 (DSHEA) ensures that a broad array of dietary supplements are available to U.S. consumers.

The Codex Guidelines for Vitamin and Mineral Food Supplements will not, in any way, affect the availability of supplement products to U.S. consumers. On the contrary, the absence of science-based Codex guidelines could adversely affect the ability of U.S. manufacturers to compete in the international marketplace.

Why The Guidelines Don't Restrict U.S. Access

Some consumers mistakenly believe that if Codex should adopt guidelines on vitamin and mineral food supplements that are more restrictive than DSHEA, the U.S. would be required to automatically change its laws and regulations to comply with the international standard.

Some consumers have expressed concerns that the World Trade Organization (WTO) and its trade dispute settlement panels may place pressure on the U.S. to change its laws because of international trade agreements such as the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement), which references Codex as the international organization for food safety standards.

We see no basis for these concerns. First, the DSHEA covers a much broader range of dietary supplements than the vitamin and mineral supplements that are the subject of the Codex Guidelines. Moreover, for supplements covered by these Guidelines, we note the following:

"The SPS Agreement does not require a country to adopt any international standard. Rather, the SPS Agreement provides that members may base their Sanitary and Phytosanitary measures either on international standards, guidelines or recommendations, where they exist, or may establish measures that result in a higher level of protection if there is a scientific justification, or if a country determines it to be appropriate in accord with provisions of the SPS Agreement (SPS Agreement, Article 3(1) and (3)).

"WTO and WTO dispute panels do not have the power to change U.S. law. If a WTO decision in response to a dispute settlement panel is adverse to the U.S., only Congress and the Administration can decide whether to implement the panel recommendation, and, if so, how to implement it."

For dietary supplements, it is unlikely that another country will accuse the U.S. of imposing a trade barrier for the importation of supplement products into the U.S. marketplace because the U.S. laws and regulations are generally broader in scope and less restrictive than the international standard.

"However, other countries with more restrictive laws and regulations for dietary supplement products than the U.S. may create trade barriers to the importation of products manufactured by the U.S. dietary supplement industry. Thus, the U.S. government's involvement in the setting of international standards can help minimize the potential of trade barriers to U.S products in international trade.

Further, there is no basis for the concern that the Codex Guidelines on Vitamin and Mineral Food Supplements would require dietary supplements be sold as prescription drugs in the United States.

1.                   First, there is nothing in the Guidelines that suggests that supplements be sold as drugs requiring a prescription.

2.                   Second, U.S. regulatory agencies are bound by the laws established by Congress, not by Codex standards.

3.                   Third, because of our generally less restrictive standards, it is unlikely that the trade dispute would be brought against the U.S.

In summary, U.S. consumers' access to a broad array of dietary supplements under DSHEA would not be changed in any way by Codex's adoption of guidelines on vitamin and mineral food supplements.

The Guidelines also include packaging and labeling provisions for vitamin and mineral food supplement products. Would vitamin and mineral supplements sold in the U.S. be required to comply with these?

All Codex standards and related texts are voluntary, and vitamin and mineral food supplement products sold in the U.S. would not be required to comply with provisions that are more restrictive than U.S. law (i.e., DSHEA).

If the U.S. is not trying to harmonize its regulatory framework for dietary supplements with Codex, what are the benefits of our country participating in the process of developing these Codex Guidelines?

Our participation in the Codex process is important to encourage the development of guidelines on vitamin and mineral supplements that are based on sound science and not on arbitrary criteria.

For example, encouraging the use of science-based risk assessment for determining the maximum levels of vitamins and minerals in supplements reduces the chance that arbitrary standards will be used for determining maximum levels.

Alliance For Natural Health PR Info.

ANH PRESS RELEASE: Food Supplements Directive Deemed Invalid

Advocate General finds Food Supplements Directive invalid under EU law. This is a remarkable victory for ANH and consumers of leading-edge food supplements.

Advocate general finds food supplements directive invalid under EU law.

Alliance for natural health set to win its landmark challenge to the EU food supplements directive.

There was tremendous news today for the millions of people in Europe who choose to use food supplements. Following a landmark challenge in the European Courts of Justice (ECJ) brought by the Alliance for Natural Health and Nutri-Link Ltd to the contentious Food Supplements Directive, which effectively proposed to ban 75% of vitamin and mineral forms, Advocate General Geelhoed, the senior adviser to the ECJ, gave his opinion in favour of the Alliance's case.

What does this mean? That the chances of consumers being able to continue using the natural food supplements they believe are beneficial to their health are now greatly increased. There has been uproar about the proposed EU ban, and maybe, against the odds, the consumer is going to come out on top in what is a remarkable modern day case of David and Goliath.

In A Statement Released In Luxembourg, The Advocate General Concluded That:

"The Food Supplements Directive infringes the principle of proportionality because basic principles of community law, such as the requirements of legal protection, of legal certainty and of sound administration have not properly been taken into account.

"It is therefore invalid under EU law."

NOTE: It should be stressed that the Advocate General's pronouncement is not a ruling. That will come from the ECJ judges, later - probably around June. But typically, in the vast majority of cases, the Court Judgment follows the recommendations of the Advocate General.

If the Advocate General's recommendations are adopted, in effect, the ban on vitamin and mineral forms not included on the EU's 'Positive list,' due to come into effect on 1 August, 2005, will be declared illegal. In essence, the positive list of allowable nutrient forms will be deemed to be too narrow, too restrictive, and based on flawed science.

This would avoid the totally irrational situations that the Food Supplements Directive would otherwise create. For example, synthetically produced selenium would have been allowed on the positive list, while the natural source found in Brazil nuts would not; synthetic forms of Vitamin E would be allowed, but the natural, most beneficial food forms would not.

An Outstanding Moment For The ANH

The Alliance for Natural Health (ANH) is a Europe-wide professional organisation dedicated to ensuring that good science and good law are applied to regulation affecting the leading edge of natural health.

If the Advocate General's recommendations are endorsed by the ECJ judges, it will represent the culmination of three years dogged determination, dedication and hard work on the part of ANH and its many supporters around the world.

'It is commendable that the EU Advocate General has seen through the flawed science and law of the Food Supplements Directive and reached his recommendations today,' said Dr. Robert Verkerk, Executive Director of the ANH.

'All that ANH is campaigning and working cooperatively for is the right for consumers to have access to safe natural healthcare and for legislation to be based on good science and good law. This is a great day for the tens of millions of people who believe passionately in the benefits of natural, preventative healthcare.'

David C. Hinde, Solicitor and ANH Legal Director, added: 'This is a very significant Opinion in a landmark case. What we want to see in the EU is the Food Supplements Directive doing the job for which it was created which is to provide a "safe harbour" for food supplements so that they are not classified as drugs, and to promote their availability across the EU.

Advocate General Geelhoed is the most senior Advocate General at the ECJ and his considered reasoning vindicates ANH's legal analysis and position. We are very optimistic that the court will adopt his recommendations.'

Supporting Safe Supplements

ANH supports many aspects of the Directive, and firmly endorses the banning of ingredients that are patently not safe, stating that existing UK and EU food law already provides perfectly effective protection from unsafe products getting onto the market.

Furthermore, ANH says that it is not scientifically rational to classify an ingredient as being unsafe without taking dosage levels into account, something that was not a condition of being admitted onto the positive list.

ANH believes that a far more appropriate system for banning any substances that might pose a risk to health would be to produce a 'Negative list' for ingredients where there was proper evidence of lack of safety.

The system proposed by the EU was going to ban ingredients on the basis that companies did not have the financial capacity to meet the high data threshold required for the scientific dossiers demanded by EU authorities.

In this way, ingredients that have been part of the human diet for thousands of years, and which are increasingly difficult to derive from conventional foods, would be lost, and would not be able to be supplemented.

The Future Of Natural Health Secured

Drawing its support European-wide from consumers, manufacturers, retailers, practitioners and some of the leading experts in nutritional medicine, ANH has taken on the Goliath of the European Commission and those that support the unscientific and unlawful ban in the Food Supplements Directive, to protect the interests of everyone concerned with the leading-edge of food supplements and natural healthcare.

'None of the major EU countries felt the need to oppose our application for a declaration that the ban on vitamins and minerals in the Food Supplements Directive was unlawful,' added Anthony Haynes, Technical Director of Nutri-Link Ltd., a UK food supplements company that brought the legal challenge jointly with ANH. 'It's bizarre how this regulation got this far.'

A Wide Welcome If The Ban Is Overturned

Greg Watts, Chief Executive of Ultralife, a manufacturer of leading-edge food supplements, said: 'This is very encouraging news. If the ban came into force we would have to reformulate down to simpler, more basic products that consumers and practitioners find are less effective.'

Dr. Damien Downing, a medical doctor and one of the UK's leading practitioners in nutritional medicine, said: 'Practitioners of nutritional therapy, and there are thousands of them in the UK, largely use leading-edge food supplements.

If these nutrient forms remain, we can continue to treat our patients with meaningful solutions and provide the products that we know are so beneficial. A ban would in one fell swoop remove the vital tools of practitioners' trade.'

Sara Novakovic, owner of Oliver's Wholefood Store in Richmond, Surrey said, "At last it is now highly likely we can continue to offer the products that our customers ask for and want, rather than have to remove them all from the shelves for no good reason and supply them with inferior quality alternatives."

The End Of The Beginning

This is just the beginning for the Alliance for Natural Health. Regulatory and industry pressure through the EU Food Supplements Directive was always likely to translate globally, particularly to the US, through Codex and the World Health Organisation.

Without having to justify any health hazard, and without considering any benefits, safety has been used as a reason to restrict the availability of natural food products.

"Yet food supplements are the safest things that people put into their mouths - considerably safer even than conventional foods", said Dr Robert Verkerk. "With rapidly declining vitamin and mineral content in fruit vegetables and other foods, and continuing increases in degenerative diseases such as heart disease and cancer in the West, this has always been a very big issue worth fighting for.

"Fundamentally, an amended Directive would help to slow down the agenda of the Codex Alimentarius Commission to export worldwide an onerous, EU-style regime for food supplements."

David Hinde added. "The ANH is now going to be working on getting a proper procedure in place for the Food Supplements Directive and in addition, the next challenges will be on legislation proposing to reduce dosages to ineffective levels, and to restrict other nutrient forms such as amino acids, enzymes and plant nutrients.

Traditional herbal remedies are also under threat. In its work, the Alliance for Natural Health will continue its thorough, professional approach based, as always, on 'good science, good law."

Notes To The ANH Press Release

• The Alliance for Natural Health is a Europe-wide association of manufacturers, distributors, retailers, consumers and complementary practitioners who have an interest in food supplements. More information, including details of members, will be found at www.alliance-natural-health.org.

Good science and good law underpin all of the ANH's work, and the scientific reports produced by the ANH are endorsed by many of the world's leading doctors and scientists working in the field of nutrition.

• If the ban on vitamins and minerals is implemented there is much at stake:

• Over 5000 products will disappear from the shelves of UK health stores as a result of the ban removing access to over 300 vitamin and mineral ingredients (out of a total of about 420).These include, amongst others, the main natural forms of Vitamin E, several forms of vitamin C, the key natural form of folic acid, MSM and a range of minerals such as vanadium, silicon and boron, all being products which millions of consumers choose to take as part of their regular health regime and have done so without any ill effects for many years.

• An individual's freedom of choice to take safe natural health products will be removed - 40% of the UK's population take vitamins and minerals.

• Products are to be banned with absolutely no scientific justification. Many of the world's leading scientific and medical experts in nutrition support the absence of any proper basis for the proposed bans.

• Although the proposed bans related only to vitamins and minerals, unless overturned, the 'Positive list' system will most likely be transferred to other nutrients used in food supplements, such as plant extracts, amino acids and enzymes. The precedent set by an ANH victory will drastically reduce the chance of future bans on these other nutrient forms.

• Further legislative proposals by the EU are due to be considered by the European Parliament later this and next year. These include restrictions on maximum dosages of vitamins and minerals and restrictions on health claims of foods. Again, the ANH is working to help positively shape such legislation using its mantra of 'good science and good law'.

The EU Food Supplements Directive
 

1.       After some 10 years of negotiation, the EU Food Supplements Directive was narrowly passed into EU law in June 2002, amid considerable controversy.

2.       The FSD proposes a ban on 75% of forms vitamins and minerals contained in food supplements, these being in particular natural, food forms.

3.       The Alliance for Natural Health was initially formed in 2002 to campaign against this piece of legislation. After two years of mounting a landmark legal challenge, including a UK High Court victory, the oral submissions were heard in the European Court of Justice on 25 January 2005.

At this hearing the Advocate General's opinion referred to the scientific basis upon which ingredients are admitted on to the positive list as being "as transparent as a black box".

4.       The Advocate General issued his opinion on 5 April 2005. He concluded that The Food Supplements Directive infringes the principle of proportionality because basic principles of Community law, such as the requirements of legal protection, of legal certainty and of sound administration have not properly been taken into account. He concluded that the Directive is therefore invalid under EU law.

5.       The final decision of the judges in the ECJ will probably be made during June 2005.