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Following a landmark win against the German government for the Rx-to-OTC switch of desloratadine last month, Novartis has again secured a victory in the German Higher Court system, this time to continue marketing its Biosan probiotics range in the country.



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Generics giant Novartis AG has once again through its Hexal subsidiary found itself in front of a German high court judge, this time successfully defending its right to market the Biosan range of probiotic food supplements in the country.  (Also see "Novartis Wins Landmark Case Against German Government Over Desloratadine Switch" - HBW Insight, 1 Oct, 2019.)

Last year, Germany’s Association for Social Competition (VSW) filed for a preliminary injunction against Hexal’s Biosan range of probiotics – which includes Biosan Basis, Biosan Immun, Biosan Stress and Biosan ASS – with the Munich Regional Court.

VSW questioned whether the brand name “Biosan” was misleading, whether health claims made for individual products were legitimate and whether Biosan ADD should be classified as a “food for special medicinal purposes” – in this case for antibiotic associated diarrhea. (Also see "German Wellness Market News: Dr Loges Ignores EU CBD Rules, Three ‘Noo’ Brain Health Supplements" - HBW Insight, 18 Oct, 2019.)

After the Regional Court ruled in favor of Hexal on “all points,” according to a spokesperson for Novartis, the case was referred to the Higher Regional Court in Munich, which also ruled largely in favor of the generics firm.

“A sales ban was not imposed,” Hexal told HBW Insight. The Regional Court ruled that the name Biosan was “not misleading,” the firm reported, because consumers would understand the "bio" prefix to mean “life,” and that this was legitimate “since living bacteria are in the product.”

Biosan ADD Plus should continue to be classified as a food for special medicinal purposes, the Court also decided, and the related health claim that the product was "for the dietary management of antibiotic associated diarrhoea" was also legitimate.

VSW has now withdrawn its application for an injunction, Hexal revealed, due to the “clear opinion of the Court” and a corresponding “lack of prospect of success” going forward.

Health Claims Still In Question
However, regarding certain advertising statements made for individual Biosan products, Hexal said that the Court had “followed the opinion of VSW.”

Asked for clarification as to what advertising statements this referred to and what opinion VSW had put forward in relation to them, the company said that it needed to “review thoroughly” the Court’s written decision – which has not yet been published – before commenting.

According to European Union regulations, there are no approved health claims for probiotics, and therefore any health claims made for probiotic food supplements within the EU would be considered unauthorized. Even the word “probiotic” is considered to be an unauthorized health claim.

As it stands, firms marketing probiotics within the EU are restricted to including the following information on packs by the Food Supplements Directive (FSD) Directive 2002/46/EC:

>   the names of the categories of the nutrients or substances that characterize the product or an indication of the nature of those nutrients or substances;

>   the portion of the product recommended for daily consumption and a warning of the risks to health if this is exceeded;

>   a declaration to the effect that the supplement is not a substitute for a varied diet;

>   a warning to the effect that the product should be stored out of the reach of young children.

The labeling of food supplements must not contain, according to this regulation:

>   any statement attributing to the product properties of preventing, treating or curing a human disease;

>   any mention stating or implying that a balanced and varied diet cannot provide appropriate quantities of nutrients in general.

Another avenue for firms looking to make health claims for probiotic supplements in the region would be to submit a successful application through the 2015 EU Novel Food Regulation.

However, as with all probiotic health claims submitted to the European Food Safety Authority for approval under FSD, so far no novel food health claims been approved for probiotics.

Industry And Consumers Undermined
“There is no universally agreed framework [in the EU],” explains retired professor of infectious diseases, Dr Claudio de Simone, in a recently published scientific review entitled “The Unregulated Probiotic Market.” “On the one hand there is rigorous scrutiny of product claims, but on the other hand there is little regulation of the manufacturing process and almost no post-marketing regulatory follow-up.”

In both the EU and the US – where probiotic supplement firms face few restrictions on claims they make on product labels, such as “boosts digestive health” or “supports the immune system,” with the US Food and Drug Administration requiring no information about potential adverse effects (Also see "Probiotic Safety Latest Target Of Supplement Regulation Critic Cohen" - HBW Insight, 5 Dec, 2018.) – the current situation had left a “regulatory void,” de Simone said, which did not take into account the “complex nature of probiotic products.”

Probiotics are “living organisms and therefore dynamic and not static,” he explains, with characteristics that “vary significantly among both species and strains,” adding also that “additional complexities” arise in multispecies or multi-strain products “where the individual components may interact with one another.”

“In the absence of specific and stringent regulations for probiotics, there is no appropriate protection for the interests of producers whose objectives are to identify, study and market new probiotic products benefiting human health,” he argues, “or for the interests of the end users, who may be misled by product labeling or trademarks and deprived of information on the true nature of the product they are using.”

“More strict regulations specifically addressing medically beneficial probiotics that are not classifiable as drugs would be welcome,” de Simone concludes.

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