Guest article
The global regulatory environment for nutraceuticals
supplements and nutraceuticals is evolving in the United States, so
is the case in other key global markets. But for a number of years
both the EU and Japan have imposed restrictions on the marketing
and sale of nutraceuticals, which many manufacturers view as trade
barriers.
GMPs and suspicion of US products
One of the most important developments in opening these markets will be the long-awaited adoption by the US Food and Drug Administration of good manufacturing practice (GMP) guidelines for supplements. At last word, these were to be ready for release sometime this year. The establishment of GMPs will go a long way toward blunting criticism by other nations' regulatory bodies that US-manufactured products lack proper oversight, a contention the industry has steadfastly denied for years.
Uncertainty in the EU
In Europe, the implementation of the Food Supplement Directive, which was challenged last year and upheld by the European courts, remains a question mark largely because maximum nutrient levels have yet to be set. Individual countries can and do mandate maximum nutrient levels, which may be many times below the level accepted as safe by scientific bodies the world over and accepted in other countries.
Most recently, in April of this year, France took such a step by adopting a law that capped the maximum levels of various nutrients, in most cases below accepted safe levels throughout the world.
Health claims and communication
Similarly, the use of health claims in the EU remains severely restricted, pending the finalization and implementation of EU Health and Nutrition Claims Regulation. The ability of US companies to compete has been impaired for years by the inability of manufacturers to communicate with their consumers.
In Japan, ongoing efforts to loosen tight restrictions on health claims has been an issue between US manufacturers and Japanese authorities. At various junctures, Japanese regulators have attempted to categorize dietary supplements as drugs, an effort that continues.
In addition, there remain persistent disagreements over supplement potency levels in Japan, regulation of levels of naturally-occurring contaminants such as benzoic acid and sorbic acid, and widely-used processing aids.
As is the case in the EU, inconsistent regulations governing labeling and advertising remain, severely restricting the ability of manufacturers to communicate with their consumers. Industry has argued that regulation of claims on labels should be made compatible with those approved by the Codex Alimentarius Commission's Guidelines for the Use of Nutrition and Health Claims, ALINORM 04/27/22.
Tariff trade barriers
Tariff structure and equity is a major issue where Japan is concerned. Because trade associations in Japan are dominated by Japanese companies, there is no domestic outcry against tariff trade barriers for imports into Japan. The demand for tariff reform must be made by other countries that want to export products to Japan.
Many US companies have entered the Japanese market, including contract manufacturers for Japanese companies. US officials have communicated their concerns about these and other issues to Japanese officials, just as they have to their EU counterparts.
The expressed objective of all parties is the facilitation of international commerce. Until these significant anomalies are corrected, however, the nutraceutical/dietary supplement/food supplement sector will be merely a fraction of what it might be in a level playing field. The losers in such case will not only be manufacturers, but also billions of consumers around the world.
Mark Mansour is a partner with Foley & Lardner LLP and a member of the firm's Public Affairs and International Practices, as well as the Food and Nanotechnology Industry Teams. He can be reached at 202 672 5585 or by e-mail.
