Solidarity!

Global Efforts to Standardize Supplement Regulations

Solidarity!
Global Efforts to Standardize Supplement Regulations

by Steve Myers

Gaining knowledge about the regulations that manufacturers, retailers and consumers encounter abroad helps U.S. retailers compare their experience with their foreign counterparts. This can result in a better understanding of where the current U.S. dietary supplements regulations stand globally.

What one country does legally with respect to supplements can influence to what extent other countries regulate dietary supplements. Thus, the sharing of information and science becomes an increasingly appealing solution to the problem of how to regulate this special category of products. To some, the answer is worldwide harmonization of supplement regulations.

The biggest movement to create harmonized or uniform health food standards is the Rome-based Codex Alimentarius ('food code') Commission (CODEX), which was created in 1962 by two United Nations (UN) organizations, the Food and Agriculture Organization (FAO) and the World Health Organization (WHO). The goal was to design CODEX as an "international mechanism for promoting the health and economic interests of consumers while encouraging fair international trade in food," according to the U.S. Codex Office. CODEX is composed of more than 150 member countries and international organizations that meet and exchange information and ideas related to food safety and trade issues. Its members are also members of FAO and WHO, and represent 98 percent of the world's population, according to the FAO. Country delegations may include industry representatives, consumer organizations and academic institutions in addition to government representatives. The commission is comprised of 18 committees, each of which is led or "hosted" by a member country.

The highest international body on food regulations, CODEX prepares food standards, codes of practice, guidelines and recommendations for its member countries. It adopts these regulations after consideration by all CODEX member countries. Currently, Codex Alimentarius contains more than 200 standards, covering such issues as labeling, additives, methods of analysis and sampling, food import and export inspection and certification, pesticides in foods and contaminants. The code also deals with nutrition and foods for special dietary uses, which includes dietary supplements.

The Commission for Nutrition and Foods for Special Dietary Uses (CNFSDU), hosted by Germany, is charged with developing standards for essential nutrients--several dozen vitamins and minerals that are found in foods. It does not address the broad category of dietary supplements, which includes amino acids, concentrates, metabolites and many other non-essential nutrients. According to Citizens for Health (CFH), a grassroots advocacy organization based in Boulder, Colo., action to incorporate herbs was rejected. CFH participates as a non-governmental organization (NGO) and can attend Codex meetings as an observer.

As yet, Codex has not adopted any guidelines specifically for dietary supplements. According to Karl Riedel, chief executive officer of Nature's Life and a Codex participant representing two NGOs--the National Nutritional Foods Association (NNFA) and the International Association of Dietary Supplement Association (IADSA), the commission has dietary supplements on its year 2000 agenda. He reported that CODEX plans to define dietary supplements and the role they play in the commission's responsibilities. It will compile a backgrounder of information on dietary supplements to determine the basis for developing guidelines.

At its next meeting, slated for this June in Berlin, the CNFSDU will consider a table of conditions for claims for nutrient content and will discuss vitamins and minerals in foods for special medicinal purposes. Its new work will include a consideration to revise the advisory list on mineral salts and vitamin compounds for use in foods for infants or children, as well as production of two discussion papers. One will focus on fortifying foods with iodine, iron and vitamin A, and the other on the definition of criteria for scientific evidence in order to establish the scientific basis of health claims.

The Committee on Food Additives and Contaminants, hosted by the Netherlands, also has dietary supplement issues on its year 2000 schedule. It will discuss which, if any, excipients specific to the manufacture of dietary supplements will be added to its positive list of food additives.

The Committee on Food Labeling (CFL), hosted by Canada, is also of importance to the dietary supplement industry, as this group deals with standards on allowable benefits and claims. When one major country permits a certain claim, its acceptance there could be used by people lobbying for similar approvals in other countries. For example, proponents of a soy health claim in Canada have used the approval of a soy health claim by the U.S. Food and Drug Administration (FDA) to boost their lobbying efforts aimed at the Health Canada department of the Canadian government.

The remaining Codex group whose decisions can directly impact dietary supplements is the Committee on General Principles (CGP), hosted by France. The CGP deals with rules and procedures referred to it by the Codex Alimentarius Commission including the establishment of principles that define the purpose and scope of the Codex Alimentarius and the nature of Codex standards. At its next meeting to be held this year in April in Paris, the CGP will consider the use of legitimate factors other than science in Codex decision making. It will also discuss working principles for risk analysis, which will be applied to safety standards for foods and dietary supplements.

Fortunately for the U.S. supplement market, the Dietary Supplement Health and Education Act of 1994 (DSHEA) cannot be influenced or changed by Codex or any other international law, according to CFH. Under DSHEA, U.S. law regulates dietary supplements as a special class of products. "Although FDA is required to review U.S. regulations against any newly developed Codex guidelines, dietary supplements were specifically exempted from regulatory change from this process by inclusion of a special proviso in the Food and Drug Administration Modernization Act (FDAMA) in 1998," Riedel said.

Other countries, however, can be heavily influenced by CODEX standards.

"Even though World Trade Organization (WTO) signatory countries are pledged to attempt harmonization of their domestic regulations to international standards, protection of national citizens takes precedence," explained Riedel. "Countries may apply a different standard, if such standard can by validated by science and law. Variant national regulations will still be the norm."

The overall goal, either way, is to protect consumer health and safety while also ensuring fair practices in food trade. "Global harmonization of standards reduces artificial (e.g. technical) barriers to trade and increases the flow of both products and information to consumers and lowers prices by removing government created monopolies and unilateral systems," stated Riedel.

Harmonization is an issue being debated in several regions of the world, including the European Union and the Trans-Tasman pact.

The European Union (EU), formerly known as the European Community (EC), is an institutional framework for the construction of a united Europe. Its members include Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, The Netherlands, Portugal, Spain, Sweden and the United Kingdom (UK). The EU is scheduled to release this year a Supplement Directive that will reportedly be based on safety rather than on multiples of Recommended Daily Allowances (RDA) for nutrients. This reliance on safety was chief among concerns repeatedly issued by some of the European natural health industries including that of the United Kingdom. Still other countries, such as Greece, are in favor of RDAs as a border between foods and drugs.

Many natural health organizations and executives, such as Maurice Hanssen, president of the Surrey, U.K.-based Health Food Manufacturers Association (HFMA), said the proposed draft directive is as good as the industry could have expected. However, the industry does not like the inclusion of a positive list of ingredients that can be used in the manufacture of vitamin and mineral supplements (VMS). According to Natural Products News, a trade publication in the U.K., this list will probably be based on a list already in discussion for Particular Nutritional Purposes (PARNUTS).

PARNUTS has five categories: baby foods, baby formula, low calorie diet foods, foods for special medicinal purposes and sports nutrition. Ingredients excluded from upcoming list will affect VMS as well as makers of products in the five categories of PARNUTS. The list was to be finalized by late 1999. Initial proposals left out a number of ingredients such as selenium yeast and chromium picolinate.

Another concern is that there is no clear method of getting overlooked or new substances on the list. According to Hanssen, the EU can amend the rules later, but that makes it difficult for businesses to plan. The limitations of the positive list could represent a barrier to trade, as many substances not on the list will come from the United States.

With the EU final Draft still outstanding, its members are going head-to-head over the issue of supplement regulations. "We are lobbying for a liberal directive, and Brussels, the European Commission, also wants a liberal market," said Theo van Rooij of Natural Health Products Netherlands (NPN), a 75-member health food trade association based in Holland. Van Rooij noted that German-speaking countries, as well as certain Southern European countries, present problems for the food supplement industry. "We must try to defend ourselves against restrictive countries in the EU. This will be the battle for the coming two years," he said.

Opposite the globe, the Trans-Tasman countries are immersed in a battle of Trans-Tasman harmonization. At the center of the debate is Australia, which has some of the world's most restrictive regulations governing dietary supplements. Dietary supplements are regulated by the Therapeutic Goods Act of 1989 (TGA), which mandates that all therapeutic goods be "registered" or "listed" via a lengthy and costly process.

"Australian regulation of dietary supplements is the toughest in the world--being indistinguishable from the way in which pharmaceuticals are regulated," reported Bren Milsom of the Complementary Healthcare Council of Australia (CHC). "Over-regulation and over-government is part of the Australian psyche, and it is very difficult to make substantial progress in liberalization." He noted that through Trans-Tasman harmonization, New Zealand is slowly being drawn into this restrictive web. He added that the CHC is pressing the Australian government to examine the Canadian model closely as this looks to hold out the most promise for industry here.

New Zealand and South Africa (which is far from being a Tasman country) are both in the process of adopting the Australian TGA model. Dietary supplements are currently covered under the less restrictive Food Law in New Zealand, according to Ron Law of the Nutritional Foods Association of New Zealand. He noted that the New Zealand industry needs to ensure that its products are regulated based on science and long history of safe use, as well as evidence based risk analysis. As much as Law praises New Zealand regulations over those from Australia, Law reported that his country's laws are restrictive in that they deny manufacturers the right to make fair and accurate claims about their product.

The situation is much the same in South Africa, where only medicines need be registered and supplements are considered foods. According to Armstrong Wilson of Formule Naturelle, which markets natural products in South Africa, the Department of Health, which is in charge of regulating dietary supplements, is trying to formulate registration procedures for natural supplements by emulating the Australian TGA.

Amid international and local harmonization, the question of whether dietary supplements should be considered foods or drugs/medicines is key. Along with that question are debates on the basis of supplement regulations (safety, science or other) and what health claims can be made. There are many arguments for and against various harmonization efforts, but one thing is certain. The future availability and options for the sale of dietary supplements is in the process of being decided around the world.

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