LUXEMBOURG --The European Union (E.U.) Food Supplement Directive is ill-designed and grossly insufficient, according to an April 5 statement from Leendert Geelhoed, advocate general for the European Court of Justice, which is the last legal stop for the legislation before its ban on unapproved vitamins and minerals is scheduled to go into effect Aug. 1, 2005. The high court received the controversial case in January 2004 as a result of lawsuits filed by various European supplement industry groups including the British Health Food Manufacturers Association, National Association of Health Stores and the Alliance for Natural Health (ANH).

Subject to the pending ban would be 75 percent of vitamin and mineral forms, including MSM (methylsulfonylmethane), natural forms of vitamin E, the key form of folic acid and several forms of vitamin C, as well as a range of minerals such as vanadium, silicon and boron. Health food advocates, including several European celebrities, contend the ban has no scientific justification nor does it have the support of leading scientific and medical experts. The additional fear is that implementation of the ban would lead to future bans covering plants, amino acids and enzymes.

Geelhoed, whose job it is to advise the high court’s judges, agreed, noting the directive infringes the principle of proportionality, because basic principle of E.U. law--such as the requirements of legal protection, of legal certainty and of sound administration--have not been taken into account. “I must conclude the E.U. has seriously failed in its duty to design such a far-reaching measure with care,” he wrote. He further recommended the court, which is expected to rule in July, find the law invalid. Geelhoed noted he is not opposed to the idea of a supplement directive, opening the door for E.U. officials to correct the law’s flaws.

Industry reaction was robust and upbeat. “This is a very significant opinion in a landmark case,” exclaimed David Hinde, solicitor and legal director of ANH, in a press release. “What we want to see in the E.U. is the Food Supplements Directive doing the job for which it was created, which is to provide ‘safe harbor’ for food supplements so that they are not classified as drugs, and to promote their availability across the E.U.”

“None of the E.U. countries felt the need to oppose our application for a declaration that the ban on vitamins and minerals in the Foods Supplement Directive was unlawful,” noted Anthony Haynes, technical director of Nutri-Link Ltd., a supplement manufacturer. “It is bizarre how the legislation got this far.”

Damien Downing, M.D., a leading European medical practitioner, voiced praise from the nutritional medical community. “If these nutrient forms remain [legal], we can continue to treat our patients with meaningful solutions and provide the products that we know are beneficial,” he said. “A ban would, in one fell swoop, remove the vital tools of practitioners’ trade.”

The outcome of the E.U. supplement law could affect supplement regulation worldwide, as Codex is scheduled to meet in Rome in July, at which time the draft standard for vitamin and mineral supplements composed by the 2003 Codex nutrition committee is up for consideration. The current draft standard is more aligned with the supplement industry than the E.U. law challenged by Geelhoed.

“Any attempt to amend this draft standard at the upcoming Codex Alimentarius Commission meeting in July would not only violate Codex’s tenets, it would run counter to what the E.U.’s own jurists today opined,” reported Mark LeDoux, chairman of the International Trade and Market Committee of the Council for Responsible Nutrition (CRN). CRN urged its members to support the scientifically sound Codex draft standard.

“[Geelhoed's] decision is a striking and dramatic refutation of the contention often repeated in many quarters in [E.U. headquarters] Brussels that regulation lacking proportion, fairness and appropriate empirical underpinnings not only can be fed on a silver platter to E.U. consumers, but exported to every other corner of the world,” proclaimed Mark Mansour, international counsel to CRN. “As it turns out, precautionary principle-based regulation has, yet again, given European courts indigestion at first bite.”

January 2004 as a result of lawsuits filed by various European supplement industry groups including the British Health Food Manufacturers Association, National Association of Health Stores and the Alliance for Natural Health (ANH).

Subject to the pending ban would be 75 percent of vitamin and mineral forms, including MSM (methylsulfonylmethane), natural forms of vitamin E, the key form of folic acid and several forms of vitamin C, as well as a range of minerals such as vanadium, silicon and boron. Health food advocates, including several European celebrities, contend the ban has no scientific justification nor does it have the support of leading scientific and medical experts. The additional fear is that implementation of the ban would lead to future bans covering plants, amino acids and enzymes.

Geelhoed, whose job it is to advise the high court’s judges, agreed, noting the directive infringes the principle of proportionality, because basic principle of E.U. law--such as the requirements of legal protection, of legal certainty and of sound administration--have not been taken into account. “I must conclude the E.U. has seriously failed in its duty to design such a far-reaching measure with care,” he wrote. He further recommended the court, which is expected to rule in July, find the law invalid. Geelhoed noted he is not opposed to the idea of a supplement directive, opening the door for E.U. officials to correct the law’s flaws.

Industry reaction was robust and upbeat. “This is a very significant opinion in a landmark case,” exclaimed David Hinde, solicitor and legal director of ANH, in a press release. “What we want to see in the E.U. is the Food Supplements Directive doing the job for which it was created, which is to provide ‘safe harbor’ for food supplements so that they are not classified as drugs, and to promote their availability across the E.U.”

“None of the E.U. countries felt the need to oppose our application for a declaration that the ban on vitamins and minerals in the Foods Supplement Directive was unlawful,” noted Anthony Haynes, technical director of Nutri-Link Ltd., a supplement manufacturer. “It is bizarre how the legislation got this far.”

Damien Downing, M.D., a leading European medical practitioner, voiced praise from the nutritional medical community. “If these nutrient forms remain [legal], we can continue to treat our patients with meaningful solutions and provide the products that we know are beneficial,” he said. “A ban would, in one fell swoop, remove the vital tools of practitioners’ trade.”

The outcome of the E.U. supplement law could affect supplement regulation worldwide, as Codex is scheduled to meet in Rome in July, at which time the draft standard for vitamin and mineral supplements composed by the 2003 Codex nutrition committee is up for consideration. The current draft standard is more aligned with the supplement industry than the E.U. law challenged by Geelhoed.

“Any attempt to amend this draft standard at the upcoming Codex Alimentarius Commission meeting in July would not only violate Codex’s tenets, it would run counter to what the E.U.’s own jurists today opined,” reported Mark LeDoux, chairman of the International Trade and Market Committee of the Council for Responsible Nutrition (CRN). CRN urged its members to support the scientifically sound Codex draft standard.

“[Geelhoed's] decision is a striking and dramatic refutation of the contention often repeated in many quarters in [E.U. headquarters] Brussels that regulation lacking proportion, fairness and appropriate empirical underpinnings not only can be fed on a silver platter to E.U. consumers, but exported to every other corner of the world,” proclaimed Mark Mansour, international counsel to CRN. “As it turns out, precautionary principle-based regulation has, yet again, given European courts indigestion at first bite.”