The report by the DGCCRF – a French government department and sometime consumer watchdog – was instigated after “strong suspicion” was put on the lutein and zeaxanthin based eye health food supplement sector following the occurrence of adverse skin effects.
“50% of products [included in the report] were contaminated by meso-zeaxanthin, an unrated isomer of zeaxanthin. The ingredient present in this molecule is the result of a manufacturing process not authorised at European level that could cause adverse effects,” the report said.
Meso-zeaxanthin was found to be present in zeaxanthin ingredients extracted from Tagetes erecta (marigold) and labelled as zeaxanthin. Meso-zeaxanthin is absent in lutein ingredients extracted from Tagetes erecta.
The report concluded by saying warnings had been issued to the manufacturers in question who had all responded willingly, either modifying their formulas or halting distribution. However it said the “exact opposite” was true of the unnamed suppliers, some of which have gone on to face criminal procedures. The suppliers were not named in the report, but it was stated that they did not come from China, while a manufacturer told us that zeaxanthin is mainly sourced from India.
"It is anticipated that other EU member states will undertake similar investigations to ensure food supplement safety and truth in labelling."
Responding to the report, manufacturer and supplier Kemin Health said it “welcomed” the findings which cast light on a previously unknown issue.
“The report found that fraudulent practices, including unintentional acts from companies acting in good faith, are unfortunately still evident despite all of the EU’s efforts to regulate the nutritional ingredient industry,” Pedro Vieira, global vice president for Kemin’s eye and skin health division, told NutraIngredients.
“This situation undermines consumer confidence in this industry.The EU Novel Food regulation and other national nutritional vigilance legislation were intended to protect consumers from these types of unsafe and misleading practices. It is anticipated that other EU member states will undertake similar investigations to ensure food supplement safety and truth in labelling," he said.
Of the manufacturers and suppliers implicated, the report said: “The decision to issue a warning about the presence of potential adulteration with meso-zeaxanthin is justified in particular by the willingness of most of the dietary supplement manufacturers in question, who discovered this problem. Moreover, these manufacturers either modified their formulas or halted distribution, with 4 of them doing so after the warning was issued.”
However it added: “The exact opposite is true of the suppliers of the extracts, who are obligated to conduct their own quality control inspections for the manufacturing process and all of their production activities. In this regard, one supplier was subjected to criminal charges for falsification. The detection of meso-zeaxanthin also gave rise to administrative police measures involving one of the manufacturers.”
It added that various criminal procedures were also initiated against two of the companies that had placed certain therapeutic claims on their products, and, in the other instance, placed a product on the market that had negligible quantities of lutein and zeaxanthin.
“The first product resulted in a transaction for the amount of €7500 that was accepted by the operating company. Finally, a set of administrative police measures (injunction to enforce compliance with regulations) was initiated on account of a lack of proper indication of all ingredients on the label, which has resulted in a failure to report the presence of a major allergen,” the report said.
According to the review, of the 41 reports of adverse reactions potentially related to eye health dietary supplements since 2004 to the French National Agency for Food Safety (ANSES), ten were that of ‘toxiderma’ skin reactions to four lutein and zeaxanthin based products.
The report said this raised several questions on novel food approval as well as the motivations behind such a substitution. It said the meso-zeaxanthin is not permitted for use as a novel food ingredient according to European regulation, and that legitimate doubts had been raised over the safety of this unapproved molecule due to links made between it and the skin reactions.
Furthermore, the French authority said: “The origins and motivations of a possible substitution also deserve to be considered, some operators highlighting economic considerations due to a lower cost of the synthetic version.”
Viera told us: “The DGCCRF reports that half of the eye health supplements present on the French market were fraudulent insofar as they contained instead of dietary zeaxanthin (as claimed on their label) the less expensive and different isomer, meso-zeaxanthin. Meso-zeaxanthin is not only illegal when marketed without EU novel food approval prior to commercialisation, but is also suspected to have caused adverse health effects.”
The report said: “There is a real opacity of the nature of plant preparations implemented and their concentration of lutein and zeaxanthin.”
While Vieira said: “While lutein and zeaxanthin were found to be safe, the investigation also reviewed the formulation and labelling practices in this category.”
The report referenced the analysis carried out by Zeaxanthin Trade Association (ZTA) – of which DSM and others are members – in 2009 which looked into the possibly fraudulent substitution of zeaxanthin with its synthetic isomer meso-zeaxanthin.
DSM manufactures products with both lutein and zeaxanthin but said to its knowledge its ingredients had not been inspected. It said the issue was in part the motivation behind this work with ZTA.
“There was an obligation on our side to make clear what the difference between the two was,” Jens Birrer, global marketing manager for the company told us.
"Meso-zeaxanthin is from a commercial point of view cheaper than zeaxanthin. Hence, there is a commercial incentive in using meso-zeaxanthin."
"Meso-zeaxanthin is not the same ingredient as zeaxanthin. While zeaxanthin is part of the food chain, meso-zeaxanthin is not," he said.
He added that from a regulatory point of view it could be that there were companies including meso-zeaxanthin that unbeknown to them is not approved for safe use in the EU.
"Meso-zeaxanthin is manufaturered out of lutein - the starting material - which itself is mainly extracted out of tagetes. The main plantation of tagetes is found in India. Meso-zeaxanthin is from a commercial point of view cheaper than zeaxanthin. Hence, there is a commercial incentive in using meso-zeaxanthin. I'm not saying that supplement manufacturers are intentionally deciding to go for meso-zeaxanthin, but maybe not aware of the difference or not being informed of the real ingredient," he said.