EFSA stand firm on decision to reject salt alternative’s blood pressure-reducing claims

By Will Chu

- Last updated on GMT

The European Food and Safety Authority (EFSA) has said its decision to reject a health claim for Han-Biotech’s Symbiosal was correct after the firm argued the ruling was not scientifically supported.

In a statement​ by the food agency, the opinion adopted in June 2018 concluded a cause and effect relationship had not been established​ between the Symbiosal consumption and lowering of blood pressure and reduced hypertension risk.

This was despite assertions by France-based Han-Biotech that the agency had rejected the claim ‘Symbiosal reduces blood pressure’​ rather than the applied claim ‘Symbiosal lowers the raising in blood pressure when used as a replacement of table salt.’

Han-Biotech followed up with claims that a reduction in systolic blood pressure (SBP) of 10mmHg was clinically significant and was a magnitude expected from a pharmaceutical product.

The firm also questioned whether the Panel expected a specific degree of blood pressure lowering (e.g. beyond 10mmHg) to reach a positive conclusion on the substantiation of the claim.

Section 3.1

In response EFSA said that for  easy  reference  and  convenience,  scientific  opinion  titles in relation  to  health  claim  applications specify  the  food/constituent  for  which  the  claim  is  made and the claimed effect.

They added that the conditions in which the claim was assessed were detailed in the body of the opinion.

“Section 3.1 clearly specifies that this is a replacement claim: “The Panel considers that the  food,  Symbiosal, which  is  the  subject  of the  health  claim,  and  the food,  table  salt  (i.e.  NaCl), which Symbiosal should replace, are sufficiently characterised,”​ the statement set out.

“In this context, the claimed effect is interpreted in the context of comparative claims, i.e. lowering of blood pressure as compared to table salt.  EFSA  would  like  to  reassure  the  applicant  that  this  is  the  scientific  question  that  the  Panel  has assessed in the opinion.”

‘Biological plausibility’

Regarding the SBP reduction of 10mmHg, EFSA agreed with the applicant that it was clinically significant and was a reduction expected from medications to treat hypertension. 

However, its comparison to pharmaceuticals remained a sticking point with EFSA as the agency highlighted a number of studies that were submitted in support of the product’s claimed health effects.

One of the studies​, which noted the reduction in SBP of 10mmHg using Symbiosal, was questioned by the panel as to its ‘biological plausibility.’

“There is no evidence for a mechanism by which Symbiosal could reduce SBP by10 mmHg as compared to table salt,”​ EFSA said.

“It is a magnitude of effect that could be expected from drugs rather than from a nutritional intervention.”

The  Panel  also  noted  that  the  results  of  the  study  have  not  been supported by other research groups.

They also added that the majority of nutritional interventions that reduced blood pressure mean changes in SBP ranged from 2 to 5 mmHg, which was half the reduction in SBP observed for Symbiosal as compared to table salt.

Such nutritional interventions  have  targeted  either  single  nutrients  with  a  recognised  effect  on  blood  pressure  (e.g. sodium, potassium) or the whole diet (e.g. Dietary Approaches to Stop Hypertension-DASH diet)

Mechanism of action

Further scrutiny of the product continued as the agency delved deeper into the possible mechanism of action by which Symbiosal could exert the claimed effect.

Symbiosal is produced by mixing sea salt (97%) with chitosan (3%), following a patented manufacturing process. Chitosan itself is a polysaccharide produced from chitin derived from crab shells.

In the rejected application, Han‐Biotech claimed that chitosan would bind chloride ions (Cl-) in the intestine and decrease their absorption, ‘neutralising’ the blood pressure-raising effect of Cl- through the Angiotensin-converting enzyme (ACE) system.

The  Panel  noted that  the  studies  provided  did  not  establish  that  Symbiosal binds Cl- in  the  gut or that,  upon  oral administration,  Symbiosal has  an  ACE  inhibitory  activity  through  this  or  other mechanisms.

Previous positive opinion

Han-Biotech responded by citing a previous positive claim that identified chitosan  as exerting  the  claimed  effect by binding  to  negatively  charged  lipids, reducing  their  gastro-intestinal uptake. 

The firm considered that such mechanism of action was the same as the one proposed in the present application for an effect of chitosan (Symbiosal) on blood pressure, and that the Panel has already ‘accepted’ an ion-binding effect of chitosan in the intestinal tract.

“EFSA  wishes  to  clarify  that  the  scientific  substantiation  of  the  claim  on chitosan  and  maintenance  of normal  blood  LDL-cholesterol  concentrations was  based  on  a  meta-analysis  of  human  intervention studies.

“The proposed mechanism of action was not taken into account in weighing the evidence. Although animal studies suggested decreased lipid absorption with chitosan, its effect on 24 hour faecal fat excretion in humans is not significant and it is unclear if this could play a role on the claimed effect.”

“The comments received did not provide evidence which would warrant a change in the conclusions of the NDA Panel.”

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