Changing Global Regs for Dietary Supplements

Consumer demand for dietary supplements is growing rapidly around the globe. Beyond just vitamins and minerals, combination products are increasingly popular, many of which incorporate botanical and other bioactive natural ingredients. And the growth in market availability has seen the emergence of more specific regulatory structures in every region of the world, as consumers seek to ensure availability of high-quality, safe dietary supplements.

More than 60 percent of the world is facing new regulation of dietary supplements, in large part due to international trade obligations, particularly in the World Trade Organization (WTO). Much of the focus of regulatory activity is on setting maximum levels of vitamins and minerals, the safety of botanicals and other bioactive ingredients, the use of nutrition and health claims in dietary supplements and GMPs (good manufacturing practices).

The key reference points for the change in dietary supplement regulations are the 1994 U.S. Dietary Supplement Health Education Act (DSHEA); the 2002 EU Directive on Food Supplements; the 2005 Codex Guidelines for Vitamin and Mineral Food Supplements; and the 2006 FAO/WHO Model for Establishing Upper Levels of Intake for Nutrients and Related Substances.

There are several key global regulatory drivers for new regulations. The two main harmonization initiatives are in the European Union (27 member countries) and in the Association of South East Asian Nations (10 member countries of ASEAN). As the largest single market in the world for dietary supplements, the United States has a major footprint in the global regulatory environment. But possibly the highest profile work is being done by Codex Alimentarius, the global food standards developing body.

The Codex Alimentarius is an international organization created in 1962 by the Food and Agriculture Organization (FAO) and the World and Health Organization (WHO) to protect the health of consumers and facilitate the international trade of food products through the development of international standards for food products.

The result is that Codex standards and guidelines are found in regulations worldwide. They promote the international harmonization of food legislation. They facilitate the trade of food products and the adoption of similar high standards to protect the health of consumers. Provisions of the Codex Guidelines for Vitamin and Mineral Food Supplements have been implemented at the national level in many countries. In addition, Codex measures are taken as a reference point within the WTO. The EU has used the Codex Guidelines for Vitamin and Mineral Food Supplements when commenting and correcting the definition of dietary supplements that were offered by other countries.

One of the key provisions within the Guidelines states maximum amounts of vitamins and minerals should be established on the basis of a scientific risk assessment. This was a major breakthrough in 2005; since then, the majority of the countries around the world applied safety levels of vitamins and minerals. However, a few countries still incorrectly apply recommended daily allowance-based levels.

While the Codex Guidelines provide the structure for establishing the maximum levels of permissible vitamins and minerals and other ingredients in a dietary supplement, the FAO/WHO Model for Establishing Upper Levels of Intake for Nutrients and Related Substances provides guidance to governments across the world on how to do this.

At the November 2008 meeting of the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU), which deals with standards and guidelines related to dietary supplements, the Committee finalized the development of Nutrient Risk Analysis Principles for application by the CCNFSDU. These principles incorporate the principles included in the FAO/WHO model and therefore will serve as an excellent basis for future discussion on the setting of maximum amounts of vitamins and minerals at the Codex level.

In addition, the CCNFSDU addressed a number of other key issues for the dietary supplement industry. In particular, CCNFSDU also finalized the Recommendations on the Scientific Substantiation of Health Claims. The agreed text is now sufficiently flexible to take into account the “totality of the evidence,” which means epidemiological and observational studies, in addition to the human intervention studies, may be taken into account to substantiate a dietary supplement health claim.

What does this mean for the future of the dietary supplement industry? Manufacturers can expect to access more international markets and consumers can expect and be able to buy high-quality, safe dietary supplement products worldwide.

Byron Johnson is an attorney and nutrition industry relations director for Access Business Group, and current chairman of the International Alliance of Dietary Supplement/Food Associations (IADSA). He has been involved in a range of IADSA activities across the world and played a role in the adoption of the Codex Vitamin and Mineral Food Supplement Guidelines.

David Pineda Ereno, director of regulatory affairs, IADSA, represents the organization in many Codex meetings and with governments worldwide and monitors WTO discussions in relation to regulations affecting food supplements.