Going Global

This summer, two events could have a big impact on the dietary supplement industry at home and abroad. The first is that the Codex Alimentarius Commission (Rome) is likely to approve new guidelines for vitamin and mineral food supplements. The second is that the European Court of Justice (Luxembourg) is expected to rule on the validity of the European Union’s (EU) Food Supplements Directive.

CODEX ALIMENTARIUS

Codex Alimentarius, an organization created in 1963 by the World Health Organization (WHO; Geneva) and the Food and Agriculture Organization (FAO) of the United Nations (New York City), literally means “food code.” FAO and WHO created the Codex to develop food standards intended to protect consumer health and ensure fair trade practices. Currently, more than 130 countries are members of the commission.

The spotlight will be on the Codex in July, when the commission meets in Rome to discuss its guidelines for vitamin and mineral supplements. The guidelines address issues such as nutrient selection, dosage, packaging, and labeling.

According to Codex rules, member countries must allow the importation of dietary supplements that conform to the guidelines. Thus, countries with restrictive food supplement laws, such as France and Germany, may be forced to accept products from abroad. Member countries that refuse to accept products that meet the guidelines could be subject to sanctions by the World Trade Organization (Geneva). However, member countries are not obliged to change their own internal laws to comply with the guidelines.

In the past, arguments over the dosage levels of vitamins and minerals that would be allowed in supplements under the guidelines have been a major source of contention. At issue were two competing models: recommended daily allowance (RDA) values and risk assessment.

The RDA model, which is favored by some nations with restrictive supplement laws, is based on estimates of the nutritional needs of consumers; risk assessment values are based on scientific data that determine the upper safe levels of vitamins and minerals. At a November 2003 meeting in Bonn, Germany, the Codex Committee on Nutrition and Foods for Special Dietary Uses, which was charged with developing the guidelines, decided on the risk assessment model. The following year, the committee sent the guidelines to the next step in the Codex’s deliberative process, which will take place in July.

The Codex remains a highly charged issue within the supplement industry. While some opponents of the Codex maintain that the commission would like to outlaw supplements or turn them into prescription drugs, Codex proponents claim that the commission’s purpose has been misrepresented. Industry trade organizations, such as the Council for Responsible Nutrition (CRN; Washington, DC), as well as the Food and Drug Administration (FDA; Rockville, MD), have called the idea that the Codex is trying to limit access to vitamins a myth and noted that the Codex does not set standards for any country.

“Some consumers mistakenly believe that if the Codex should adopt guidelines on vitamin and mineral food supplements that are more restrictive than DSHEA, the United States would be required to automatically change its laws and regulations to comply with the international standard,” FDA noted in a March 2005 press release. “We see no basis for these concerns.”

Claims that supplements would require prescriptions under Codex guidelines are also unfounded. “There is nothing in the guidelines that suggests that supplements be sold as drugs requiring a prescription,” FDA stated. “U.S. regulatory agencies are bound by the laws established by Congress, not Codex standards.”

The bottom line, according to FDA, is that the United States benefits from participating in the Codex. “Our participating 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 arbitrary criteria,” FDA explained. “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.”

FOOD SUPPLEMENTS DIRECTIVE

The Food Supplements Directive, scheduled to go into effect in August, creates a list of approved vitamins and minerals that may be sold in EU member countries. One major difference between the Codex guidelines and the directive is that each EU country must change its domestic supplement laws to reflect the provisions of the directive. Once the law goes into effect, any supplement product sold in any EU country must comply with the directive.

The legal status of the Food Supplements Directive is currently in question. In an advisory opinion issued on April 5, 2005, Leendert Geelhoed, advocate general for the European Court of Justice, declared the directive invalid under EU law. The full court is expected to rule on the issue in June.

Geelhoed’s opinion was the result of a lawsuit filed in October 2003 by several European companies and trade associations, including the Alliance for Natural Health (ANH; Guildford, UK). ANH, which supports some aspects of the law, asked for judicial review of the directive, claiming that it would ban more than 300 vitamin and mineral ingredients that formerly were considered safe, such as the natural forms of vitamin E and folic acid.

In his opinion, Geelhoed concluded that the directive was poorly written and failed to provide a clear procedure that explains how companies can petition to add ingredients onto the positive list of approved vitamins and minerals.

“This procedure, in so far as it may exist and in so far as it may deserve this title, has the transparency of a black box,” Geelhoed wrote. “No provision is made for parties to be heard and no time limits apply in respect of decision making. Nor is there any certainty that a final decision will be taken. The procedure therefore lacks essential guarantees for the protection of the interests of private applicants.” Geelhoed added, however, that the EU could make the directive valid if it addressed certain legal problems.

In a press release, Robert Verkerk, PhD, executive director of ANH, described Geelhoed’s recommendation as commendable. “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,” Verkerk said.

Here in the United States, Mark Mansour, legal counsel to CRN’s International Trade and Market Development Committee and an attorney with Morgan Lewis (Washington, DC), called the opinion “a striking and dramatic refutation of the contention often repeated in many quarters in Brussels that regulation lacking proportion, fairness, and appropriate empirical underpinnings not only can be fed on a silver platter to EU consumers, but exported to every other corner of the world.”

PREDICTIONS

Given the lengthy and exhaustive deliberative process that has occurred, it seems likely that the Codex Alimentarius Commission will approve the guidelines for vitamin and mineral supplements. In addition, the advocate general’s opinion may help cement approval of the guidelines, since his legal reasoning seems to uphold the idea that decisions about vitamin safety should have a rational and scientific basis.

According to Mark Le Doux, chairman of CRN’s International Trade and Market Development Committee, Geelhoed’s opinion means that the draft standard for vitamin and mineral supplements “is substantively vindicated.”

“Any effort to amend this draft standard at the upcoming Codex Alimentarius Commission meeting would not only violate Codex’s fundamental tenets, it would run counter to what the EU’s own jurists today opined,” Le Doux stated. More controversy surrounding the Food Supplements Directive can also be expected, since issues such as the fate of traditional herbal medicines are still unresolved.

According to David Hinde, legal director of ANH, industry must now work on getting a proper procedure in place for the Food Supplements Directive. “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,” Hinde said.

Although the Codex and European Court of Justice are based in Europe, their decisions could have a direct impact here in the United States, which exports many products overseas. Manufacturers on both sides of the Atlantic will be paying close attention to Europe in 2005.