Meso-zeaxanthin’s road to EU novel approval – blindsided by commercial interests?

OmniActive: We have the novel food application work done, but we'll have to plan our strategy in light of French upset.

The discourse around eye health carotenoid meso-zeaxanthin (MZ) has been marred by commercial interests, according to supplement firm OmniActive Health Technologies.

OmniActive vice president Hiren Doshi told NutraIngredients at Vitafoods that the MZ sector was characterised by commercial in-fighting driven by patent access.

He said a recent report on MZ from a French watchdog (the French Directorate General of Competition, Consumer Affairs and Fraud Prevention (DGCCRF)) that found widespread contamination in French supplements was a prime example of commercial territorialism and sabotage.  

He said the report would be taken into consideration as the Indian-HQ'd firm moves forward with its plans to apply for novel approval for its version of MZ in the EU. 

Responding to report

The two-year report found that half of eye health products on the French market labelled as containing the carotenoids zeaxanthin and lutein – pigments found in the eye responsible for filtering blue light and linked to Age-Related Macular Degeneration (AMD) – contained undeclared MZ, also found in the eye but far rarer in the diet.

He claimed that his company, which lawfully markets products containing MZ in the US and lutein and RR-zeaxanthin in Europe, preferred to, “stand for all nutritionally relevant ingredients”, as opposed to picking sides. 

“Essentially we don’t take a side based on just commercial interests,” he said.

Doshi suggested that the investigation had been launched as a result of lobbying by a trade body only representing companies that produce RR zeaxanthin, one of the two isomers of zeaxanthin along with MZ. The report makes reference to the Zeaxanthin Trade Association, which indicated that "there were a number of false dietary supplements on the market containing meso-zeaxanthin, a synthetic isomer of zeaxanthin. This assertion was made on the basis of a series of tests making use of a specific method of detection (chiral HPLC)". 

Doshi said the mislabelling revealed by the report was a separate issue, calling this a, “no-no in general”.

Novel food application in the pipeline?

These cases were illegal in the failure to label all ingredients, but the legality of declared MZ under novel food regulation in Europe remains somewhat disputed. In the US MZ received Generally Recognised As Safe (GRAS) status required for the marketing of novel food ingredients after OmniActive filed a dosier in 2013 that received no objections from the US Food and Drug Administration (FDA).

However in the EU this is yet to be confirmed, with researcher and MZ proponent professor John Nolan even speculating that this may not be necessary under EU law since it existed in the food chain before 1997.

Critics have said that MZ does not exist in the food chain, calling the isomer synthetic. OmniActive says it is found in low levels in 21 different fish species and eggs, albeit at low levels. 

The report also shed doubt on the safety of MZ, which it suggested had been linked to toxidermia, but Doshi countered, “The products which were referred to contained many other ingredients in addition to MZ, in addition to other carotenoids. How did the DGCCRF pin down and conclude that it was MZ that was forming the toxidermia?”

It was still to decide on the EU situation.

“In Europe now we will have to plan our strategy in light of what happened [with the report], because what happened was really unfortunate,” he said.

“It kind of sets the stage. We are a little disappointed that an ingredient that has potential got bracketed as ingredient that is an impurity. So our concern is that it is not an impurity, it is a nutritionally relevant ingredient. We do respect that if regulation requires a certain thing then that needs to get done. Luckily all the work at our end is done, so it’s only a matter of doing necessary submissions to get it blessed which we will do,” he said.   

He added that it remained to be seen whether a novel food submission was the best or necessary way to go.  

Badmouthing is bad 

Asked if it was possible to take commercial interests out of the equation, Doshi said it was possible to abstain from 'badmouthing'. 

You don’t have to talk negatively about something. That’s the starting point. You can talk positively about what you know and let where research has to come out, give it a chance to evolve. Because that’s where the innovation is happening."

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