Researchers from the University of Novi Sad, Serbia, analyzed 87 commercially available herbal food supplements and found that only 10.7% of labeled health claims were fully compliant with EU regulations.
They also reported that nearly one in 10 (9.3%) were labeled with claims that attribute properties of prevention, treatment or cure of diseases, which is strictly prohibited.
“Such findings confirm that not only do producers circumvent/overstep regulatory requirements, but also that, to be effective, the system of mandatory pre-market registration has to be quality assured,” the researchers wrote in Nutrients.
Study details
The study evaluated food supplements containing herbal extracts or propolis (‘bee glue’) purchased in pharmacies, drugstores and health food stores located primarily in the city of Novi Sad.
The final collection of supplements included 87 commercially available domestic and imported brands marketed between 2021 and 2023. Each supplement was then evaluated for its regulatory compliance using four EU laws: the EU Register of Health Claims, Directive 2002/46/EC and Regulations 1169/2011 and 1924/2006.
In total, 12 supplements had no health claims on their labels. The remaining were then classified into three groups: fully compliant, partially non-compliant and non-compliant.
Eight products (10.7%) were found to be fully compliant. However, the compliant health claims were associated with vitamins and minerals rather than the accompanying botanicals.
Twenty-nine products (38.7%) carried ‘on-hold’ claims pending a final regulatory decision, while the remaining 38 products (50.6%) did not comply with the regulations.
More than half of the products carried health claims related to effects on the respiratory and/or immune system, while a smaller number carried claims about effects on the gastrointestinal tract and the urogenital, cardiovascular and nervous systems.
In addition, 14 products did not carry the mandatory warning that the recommended daily doses cannot be exceeded. Of these, six products also failed to state that supplements cannot be used as a substitute for a varied diet and a healthy lifestyle.
The researchers concluded that there is a “worrying lack of adherence” to food supplement labeling regulations regarding both voluntary and mandatory information.
Are food business operators to blame?
In the EU, supplements are regulated as food products. This means that products citing nutritional claims do not have to be authorized by a regulatory body before going to market.
However, when it comes to health claims, the regime is “stricter and more fragmented,” according to Katia Merten-Lentz, a leading practitioner in European food, feed and agricultural law.
“[Health claims] must be specifically authorized by the European Commission and EFSA,” she told NutraIngredients. “The list of already authorized health claims was established in Commission Regulation (EU) No 432/2012 of 16 May 2012.
“However, the Commission also drew up a list of more than 2,000 claims EFSA had not been able to evaluate. Most of these claims refer to the benefits of plant or herbal substances.”
There are 2,078 health claims related to plant substances which are pending a final decision. These claims may still be used under the responsibility of the business operators, provided that they comply with EU regulations.
However, Merten-Lentz says that this is creating legal uncertainties for food business operators, not only in Serbia but across the European Union.
“Within such an unclear legal context, it is likely that similar findings could be found in the EU,” she said. “In other words, Serbia is not the only Member State where food business operators do not properly use botanical claims, so I am not sure that they are the ones to blame.”
Addressing public health concerns
The University of Novi Sad researchers said there is an “imperative need” to address public health concerns regarding food supplement labeling and advertising, with input from both regulatory bodies and consumers.
“Addressing these concerns requires engagement and collaboration of all links in the food supplements’ chain, including regulatory authorities and industry and public health professionals on one side and consumers on the other, and all these parties should be held accountable,” they wrote.
In addition, Merten-Lentz says the European Commission must take action to ensure food business operators are clear on the legal requirements when bringing botanical supplements to market.
“So far, no action has been taken by the European Commission to put an end to a ‘temporary’ situation of 15 years,” she said. “Has the European Commission forgotten that it high time to assess the pending botanical claims and more generally to clarify their status?”
Source: Nutrients. doi: 10.3390/nu17091571. “Landscape of Herbal Food Supplements: Where Do We Stand with Health Claims?” Authors: S. Vojvodić, et al.