New research sheds light onto U.S. and European supplement regulation

Three decades after the landmark Dietary Supplement Health and Education Act of 1994 (DSHEA) was passed, "some of the states within the U.S. have rules that are different than federal guidelines, and this creates market confusion and legal risks for FBOs (Food Business Operators)," the researchers wrote.      

When it comes to the EU, legislative overlap between state and central legislators creates harmony (in legislation applying to all member states) regarding substances that can legally be permitted in foods.

“However, where no harmonization exists (e.g., almost all botanicals) then each state has a role in defining what substance can be placed on the market," the researchers added.

EU member states versus U.S. states​

In contrast to the U.S., there was no sector specific legislation governing the labeling and sale of food supplements across Europe prior to 2002. Instead, there were laws that could be applied to such products for the purposes of labeling and composition. As a result, member states took different approaches to regulating these products, the researchers explained.

When the Food Supplement Directive (FSD) was adopted, it created a minimum level of regulatory oversight across the EU for this category. It left many areas of interpretation including national rules on maximum and minimum levels of vitamins and minerals and permitted use of other substances.

"It was the competency of member states to decide on their legality," the researchers noted.

The result is difference in food law specific to each country across the EU that can create barriers, said Mark Tallon, managing partner at Legal Products Group and an author on the paper.

In the EU, the primary aim is the development of a single market where the free movement of goods can operate unhindered by country legislation. However, despite efforts to develop a single market over the past 40 years, fragmentation remains as not all aspects of food law have been harmonized (a single law applying to all members of the EU).

“In practice, this means different rules for botanicals, permitted maximum and minimum levels of vitamins and minerals, different languages, and for supplements possible pre-market notification,” Tallon said. “These differences all impact the goal of free trade.”

Although the U.S. supplement market is regulated by the U.S. Food and Drug Administration at the federal level, individual states pass their own regulations and rules which impact the dietary supplement industry and the consumer.

"These activities are framed as a fight over state authorities regarding citizens of the state versus federal law for all citizens," said Douglas Kalman, PhD, clinical associate professor of sports nutrition at Nova Southeastern University and co-author on the paper. "One does think that the state versus federal clashes that are going on may result in the higher courts looking to resolve who has final say."

Court action​

All members of the EU single market have a vote within the European parliament when it comes to adopting new laws. However, sitting above parliament is the EU court of justice (CJEU) which can rule on the interpretation of a specific law. This means that although the legal arm of the EU (the Commission) and its risk assessors (The European Food Safety Authority) can take a view on the science to create a relevant law, its interpretation can be viewed differently by the courts, in effect creating new laws, Tallon said.

These judgements from the CJEU are binding on member states even if a country has adopted its own laws. If in conflict with the CJEU opinion, the court’s judgement rules.

However, it’s not always practical for a business to seek recourse from the European court. Cases referred to the CJEU may take more than five years to be concluded.

A significant difference to the U.S. may lie in the lack of cases before the EU courts as brought by trade associations.

"We almost never see a case brought by a trade association to the CJEU," Tallon said. "In the U.S., we see a greater engagement in this area by the likes of NPA (Natural Products Association) citizen petitions against the FDA or at the state level, such as the recent constitutional case against New York."

International cooperation​

Relationships exist in regulation beyond the state and national levels. There is increasing interest in cooperation between agencies and risk assessors internationally to reach common alignment on ingredient safety assessments. However, these agreements have not been solidified.

"At this time, I am not sure we can say that there are many cooperative agreements between international agencies," Dr. Kalman said. "Pointedly, while the U.S. FDA participates in the International Council on Harmonization (ICH), the FDA has also stated that it does not consider, go by, or have to accept what other regulatory agencies do or rule around the globe. It comes off as an Agency that is not really looking to cooperate and work with industry or one that helps drive harmonization across the globe."

Source: Journal of Dietary Supplements​
doi:  10.1080/19390211.2024.2308261​
"The Regulatory Challenges of Placing Dietary Ingredients on the European and US Market"
Authors: M. J. Tallon and D.S. Kalman