As trade barriers drop between European Union members, EU officials are attempting to harmonize country-by-country regulations so products can move freely between all member states. Food supplements are now subject to a comprehensive new set of regulations, put forth in the recently adopted EU Food Supplements Directive.
U.S. Industry watchers say the directive has both positive and negative repercussions and will undoubtedly affect the way U.S. supplements exporters do business. Although the directive applies to only minerals and vitamins, it also may foreshadow how herbal products could be regulated as well.
"There are two very different sides and views to this regulation," said Loren Israelsen, president of LDI Group, an industry consulting firm based in Salt Lake City. "One of the big problems is commerce between member states in the EU. Presently in Europe there are tremendous differences in approaches to the regulation of supplements."
While some countries have traditionally taken a liberal approach to supplements regulation—similar to U.S. Dietary Supplements Health and Education Act guidelines—other countries are more restrictive, limiting both the ingredients and doses available to consumers without a prescription.
"We're just starting to take a look at what the impact [of the directive] will be on high potency products," said David Seckman, executive director and CEO of the National Nutritional Foods Association based in Newport Beach, Calif. "I think the directive is both good and bad. Under their food laws, countries like the U.K. and The Netherlands allow the sale of supplements at any potency that's not unsafe. France and Germany only allow general retail sales for substances at low levels; high-potency products are treated as medicine." Under the directive, vitamins containing many times the recommended daily allowance—such as the megadoses of vitamin C that some consumers use at the onset of a cold—would no longer be available anywhere in Europe.
What does all this mean for U.S. manufacturers who export their products to Europe? "If you want to export to Europe, it will have an effect," Seckman said. "It does create an opportunity for some products to be sold in countries where they couldn't be sold before." And, by setting a continent-wide standard, the directive will do away with the hassles of creating different formulas and labels for each market.
On the other hand, some products previously legal in the United Kingdom will no longer be allowed in any European markets. The directive has created a "positive list," or list of substances allowed under the new regulations. But hundreds of substances currently widely used in dietary supplements are not on the list. "The huge question is, how complete is the list?" said Israelsen. Companies can continue selling products not listed, but have a three-year window in which to submit a dossier with detailed scientific support for the safety and efficacy of the ingredient in question.
This safe list was a point of contention for European trade associations, which fought its inclusion in the directive. Simon Pettman, director of the International Alliance of Dietary Supplements Associations, said, "It will now be up to the suppliers of ingredients to ensure that files for the ingredients not on the list are developed as fast as possible and submitted to the EU Scientific Committee for Foods."
Although this affects U.S. exporters, its greatest impact may be on raw materials suppliers; many European supplements manufacturers source their raw materials from American firms. "Since the majority of these [ingredients] are manufactured in the United States, it is vital that companies find out the criteria and what is required soon," Pettman said.
So far, reaction among U.S. supplements firms has been muted. "On the American side, very few seem to understand that this is a really big deal," Israelsen said. "They aren't familiar with the underlying issues, consequences and significance." The EU directive is the product of a consensus process, and, Israelsen said, consensus is particularly hard to reach on an emotionally charged issue such as dietary supplements.
He sees the possibility of two very different reactions to the regulations. "It depends on how you see the world," Israelsen said. Some countries have a strong tradition of government regulation to protect consumers, while others have traditionally placed the choice in consumers' hands, so long as a product isn't considered dangerous.
Those opposed to the regulation believe it places undue limits and restraints on the industry. "Any time you put a positive list together, it's bad news for industry," Israelsen said, "especially for small companies and those with interesting products. Hence, accusations [in Europe] that this is a big-industry initiative to drive out competition. New ingredients are important; [the directive] should recognize innovation."
A small minority in the industry see the new regulation as draconian and fear that it will eventually lead to stricter controls within the United States. "It will not," said Seckman. "It has no impact on the domestic market. We'll make loud and clear here at NNFA that there will be no backing away from DSHEA and the provisions that allow these products to be available." But, Seckman added, "There's no trend or sentiment that people want those requirements in the U.S."
The impact of the EU regulation will become more apparent as ingredients come up for review and as dosage limits are set. U.S. manufacturers who don't take a careful look at this regulation run the risk of ending up on the outside looking in at a European market to which they have no access.
Mitchell Clute is a poet, musician and freelance writer based in Louisville, Colo.
Natural Foods Merchandiser volume XXIII/number 5/p. 7