By Joerg Gruenwald, analyze & realize GmbH01.15.24
In the European Union, health claims (i.e., claims made on the product label relating to the maintenance and support of body functions) must be authorized by the EU Commission. All authorized health claims are stated in the Annex to the Nutrition and Health Claims Regulation (NHCR, EC No 1924/2006), which is a positive list. No other health claims can be used.
However, it is not quite so simple. There are a number of health claims related to botanicals that are not listed there, as they have not been approved. Still, they can, theoretically, be used. These are the so-called “on-hold claims” that were not finally evaluated after application as the European Food Safety Authority (EFSA), tasked with giving opinions on these claims, ran into fundamental issues regarding the measures that should be applied to the evaluation.
Rather than forbidding the use of these claims altogether while EFSA tried to solve the issue, the EU Commission decided to allow the use of on-hold claims pending their final evaluation, provided that their respective conditions of use are met.
This has worked for almost a decade. However, one of the issues that EFSA encountered now affects the use of the claims.
Further Reading: Botanicals in the EU: National Plant Lists Fill Void Without Harmonization
Many botanicals, of course, are widely known to have pharmacological effects at certain intake amounts. They used to be added to food supplements just for these effects before the NHCR came into effect. The on-hold claims relating to them, submitted just after the NHCR came into effect, still refer to the intake amounts necessary to exert these effects as their conditions of use.
Thus, use of the on-hold claims on the product labels today present a catch-22 situation for food business operators: either 1) use the stipulated condition of use for the on-hold claim that results in pharmacological effects, and is thus not permitted to be marketed in a food supplement, or 2) reduce the intake amount below the pharmacological dose in order to market as a food supplement—resulting in not meeting the condition of use, and thus not being allowed to use the on-hold claim.
This situation was so far quietly ignored in the industry. FBOs used the on-hold claims, as they are still legally allowed to do, and dutifully reduced the intake amount to avoid the food-drug-demarcation issue.
However, industry insiders in the EU have observed that watchdog authorities are issuing complaints regarding the on-hold claims, requesting manufacturers to produce dossiers proving the claimed effect for the botanical in their products. This dossier must be compiled using published data.
Not surprisingly, the effect that is claimed on the respective product can only be observed at intake amounts within the pharmacological dosage. Thus, the dossier will prove that the on-hold claim cannot be used, as the amount within the products either carefully avoids the pharmacological dose and does not meet the respective condition of use, or it is within the pharmacological dose and thus renders the product a functional drug.
Consultancies such as analyze & realize GmbH have come to advise clients to steer clear of the on-hold claims. The legal consequences are unclear but will at least involve a request to remove the claims from the product label. Therefore, they should not be used to begin with.
However, this situation is a fundamental problem for many manufacturers in the botanical food supplement space that are now effectively unable to use the on-hold claims and can only make health claims if other substances that can legally carry health claims are added to the product.
The concern in the industry is now that if and when EFSA concludes its evaluation of the on-hold claims, they may be finally rejected, as food not being pharmacologically effective is one of the basic tenets of European food law. No one knows when this final evaluation may happen, so the use of the on-hold claims may end as early as next year. Or, just as likely, this limbo situation may continue for another 5 years.
About the Author: Dr. Joerg Gruenwald is co-founder of analyze & realize GmbH, a specialized business consulting company and CRO in the fields of nutraceuticals, dietary supplements, herbals and functional food, and author of the PDR for Herbal Medicines. He can be reached at analyze & realize GmbH, Waldseeweg 6, 13467 Berlin, Germany; +49-30-40008100, Fax: +49-30-40008500; e-mail: jgruenwald@a-r.com, www.analyze-realize.com
However, it is not quite so simple. There are a number of health claims related to botanicals that are not listed there, as they have not been approved. Still, they can, theoretically, be used. These are the so-called “on-hold claims” that were not finally evaluated after application as the European Food Safety Authority (EFSA), tasked with giving opinions on these claims, ran into fundamental issues regarding the measures that should be applied to the evaluation.
Rather than forbidding the use of these claims altogether while EFSA tried to solve the issue, the EU Commission decided to allow the use of on-hold claims pending their final evaluation, provided that their respective conditions of use are met.
This has worked for almost a decade. However, one of the issues that EFSA encountered now affects the use of the claims.
Further Reading: Botanicals in the EU: National Plant Lists Fill Void Without Harmonization
A Catch-22
In the EU legislation, a strict demarcation exists between products and ingredients that are food and those that are medicinal products. A food product—and food supplements are legislated as food in the EU—cannot have a pharmacological effect (i.e., they cannot cure or prevent diseases, or claim to do so).Many botanicals, of course, are widely known to have pharmacological effects at certain intake amounts. They used to be added to food supplements just for these effects before the NHCR came into effect. The on-hold claims relating to them, submitted just after the NHCR came into effect, still refer to the intake amounts necessary to exert these effects as their conditions of use.
Thus, use of the on-hold claims on the product labels today present a catch-22 situation for food business operators: either 1) use the stipulated condition of use for the on-hold claim that results in pharmacological effects, and is thus not permitted to be marketed in a food supplement, or 2) reduce the intake amount below the pharmacological dose in order to market as a food supplement—resulting in not meeting the condition of use, and thus not being allowed to use the on-hold claim.
This situation was so far quietly ignored in the industry. FBOs used the on-hold claims, as they are still legally allowed to do, and dutifully reduced the intake amount to avoid the food-drug-demarcation issue.
However, industry insiders in the EU have observed that watchdog authorities are issuing complaints regarding the on-hold claims, requesting manufacturers to produce dossiers proving the claimed effect for the botanical in their products. This dossier must be compiled using published data.
“This situation is a fundamental problem for many manufacturers in the botanical food supplement space that are now effectively unable to use the on-hold claims and can only make health claims if other substances that can legally carry health claims are added to the product.”
Not surprisingly, the effect that is claimed on the respective product can only be observed at intake amounts within the pharmacological dosage. Thus, the dossier will prove that the on-hold claim cannot be used, as the amount within the products either carefully avoids the pharmacological dose and does not meet the respective condition of use, or it is within the pharmacological dose and thus renders the product a functional drug.
Consultancies such as analyze & realize GmbH have come to advise clients to steer clear of the on-hold claims. The legal consequences are unclear but will at least involve a request to remove the claims from the product label. Therefore, they should not be used to begin with.
However, this situation is a fundamental problem for many manufacturers in the botanical food supplement space that are now effectively unable to use the on-hold claims and can only make health claims if other substances that can legally carry health claims are added to the product.
The concern in the industry is now that if and when EFSA concludes its evaluation of the on-hold claims, they may be finally rejected, as food not being pharmacologically effective is one of the basic tenets of European food law. No one knows when this final evaluation may happen, so the use of the on-hold claims may end as early as next year. Or, just as likely, this limbo situation may continue for another 5 years.
About the Author: Dr. Joerg Gruenwald is co-founder of analyze & realize GmbH, a specialized business consulting company and CRO in the fields of nutraceuticals, dietary supplements, herbals and functional food, and author of the PDR for Herbal Medicines. He can be reached at analyze & realize GmbH, Waldseeweg 6, 13467 Berlin, Germany; +49-30-40008100, Fax: +49-30-40008500; e-mail: jgruenwald@a-r.com, www.analyze-realize.com
