Potential regulation on «other substances» in food supplements

The Norwegian authorities have over the years been restrictive with regards to food supplements and it is the outspoken intent that the strict policies are to be continued also in the future.

The aim is rather that the products serve an actual need in the population rather than what is safe. The strict policies on food supplements are evident in the current maximum and minimum levels of vitamins and minerals in food supplements, which are placing the maximum levels rather low compared to other European countries. However, no particular rules on “other substances” have been in place. “Other substances” means other substances than vitamins and minerals, which have a nutritional and/or physiological effect.

For a long time this non-regulation raised no concern. The authorities had drawn a strict line between food supplements and pharmaceuticals on the basis of the Regulation on Classification of Pharmaceutical Products of 1999. But after one producer successfully alleged in 2008/2009 that it was hindered in selling its product due to the Norwegian classification practice, and in conflict with the EEA agreement, the practice was changed. Now, whether a product is to be deemed a pharmaceutical depends on the function of the product and its presentation, and not just on the aforementioned Regulation. The Norwegian Medicine Agency decides upon the classification in cases of doubt, but in practice many suppliers launch their products in Norway without making the proper classification assessment.

For both the industry and the authorities the assessment of classification is complex, time-consuming, possibly costly and in the view of the Norwegian Food Safety Authority (“NFSA”) also challenging. NFSA has recently expressed its concern about the development in the Norwegian food supplements market. The concern is principally safety, and in particular NFSA is concerned that the products offered are not complying with the fundamental principle on safety as outlined in the Norwegian Act of Food of
2003 section 16. It further notes that the level of knowledge amongst the suppliers vary, and NFSA is in sum of the opinion that there is a “rather large risk of health damages occurring after intake” of food supplements available cf. letter from NFSA to the Ministry of Health and Care Services of 11 February 2014. In the same letter it recommends, taking into account the factors listed above, that the Ministry gives its formal approval so that NFSA can start establishing rules for “other substances” in food supplements. The letter is accompanied by an impact study elaborating on the need for regulation and which measures that ought to be taken.

NFSA has studied the Danish model and recommends introducing a regulation similar to the one the Danish government has introduced. The Danish regulation on “other substances” is based on a positive list, where the substances listed have been evaluated and deemed safe. Only the substances on the positive list may be used. Requirements on the use of these substances may be set – typically maximum limits – which the suppliers must abide by. Should a substance not be listed, then a supplier may apply for approval of the substance, followed by documentation on safety. If approval is granted, then the positive list is amended accordingly, which by implications means that any entity may start using the substance – not just the applicant. Should the application be rejected, then the substance will be added to a negative list, making it publicly known which substances that may not be used per se.

While this is written, it is not even a month since the NFSA approached the Ministry of Health and Care Services. It is however likely that the Ministry will give its formal approval, which in case will imply that NFSA will start detailing the rules for “other substances”. Whether this means that new rules may be brought into effect already this year, is not known, but probably less likely as time spent on drafting the regulation and the public hearing will take time. It also remains to be seen what transition period that will apply to products containing other substances and not potentially a part of the positive list, that are already on the market.