French supplements industry to act over adverse reporting scheme

Synadiet said that the promotion of the project initiated by the French food agency, AFSSA (Agence Francaise de securite sanitaire des aliments) calling for health professionals to report any observed side effects in terms of dietary and food supplement was mismanaged and resulted in a myriad of stories in the mainstream press last month that highlighted potential dangers of supplement intake.

Hervé Morisset, secretary general of Synadiet, told NutraIngredients.com today that the association will hold a press conference early in the New Year with the aim of reassuring their clients and the general public that food supplements are safe and that the AFSSA adverse reporting scheme was not, in fact, prompted by any serious cases of adverse effects from supplement intake but was simply set up to mirror an existing mechanism for prescription drug intake.

“We are not against the reporting system in itself. The association supports any initiative to ensure dietary intake of supplements by consumers is done so safely. ​

However, we are frustrated with the fact that AFSSA did not seek the input of industry until the day prior to the scheme’s launch and also the fact that the agency’s communication around the reporting mechanism was misleading resulting in so many negative stories in the press,”​ he added.

AFSSA's website states that consumption of food supplements "has no proven advantages especially given that we lack studies showing they are safe when taken regularly and for an extended amount of time, and also that severe acute accidents have been reported."​

And Morisset maintains that no supporting evidence of acute side effects was given by AFSSA to substantiate this statement during the promotion of the reporting mechanism.

Growing popularity​

Marie Favrot, director of nutrition risk assessment at the government agency, told this publication at the time of the monitoring programme's launch that it was aimed at a better understanding of any potential side effects and was triggered by the growing popularity of dietary supplements in the country.

She said that the reporting phase of the programme will last a minimum of six months and requires health professionals to submit data to AFSSA relating to any adverse effects observed in patients who have taken food supplements, with the programme being extended to all types of functional foods after the initial six months.

"We want health professionals to ask patients whether they have recently taken dietary supplements to ascertain whether this might be the cause of the symptoms they are presenting with,"​ added Favrot.

AFSSA said that all data received will be analysed by a technical committee, which may collaborate subsequently with its own scientific panels or with its European counterparts.

Transparency sought​

But Morisset claims that the French supplements industry has not received any guarantees from AFSSA that there will be absolute transparency in reporting, that the health professionals involved will request follow up appointments with patients in question or that the supplement manufacturers will have access to the medical data submitted to the agency.

Moreover, he said that the online reporting document that the health professionals are required to use to report adverse effects of supplement intake does not include a section on dietary intake and he maintains that this omission prevents the inclusion of a patient's food habits in the report.

Dr Robert Verkerk, executive and scientific director at the pan-European group, Alliance for Natural Health (ANH), told this publication previously that although government-led efforts to accumulate adverse event reports through practitioners, health stores and other suppliers of supplements is in principle sound, there is great potential for such data to be misused:

“We have seen both in Europe and the USA, numerous cases where food supplements have been flagged as causative agents of particular adverse effects when further scrutiny demonstrates they were simply among large lists of products, often including medications and even alcohol and recreational drugs, consumed. It is utterly misleading to misrepresent the role of food supplements in such instances.”​

Morisset said that Synadiet will be meeting AFSSA in early January to discuss their concerns with the reporting scheme.

A comment from AFSSA was sought but was not forthcoming in time for publication.