French allergy warnings: ANSES accused of 'making examples' of beehive-derived supplement makers
In its latest opinion, ANSES cite three cases in which consumers suffered serious allergic reactions to food supplements containing royal jelly, propolis, honey and pollen.
However, for the manufacturers identified, there is a feeling the spotlight shines unnecessarily brightly on their products, especially considering that only three cases of this nature have been documented in six years.
France-based Apimab Laboratories—the makers of Propolia propolis gums mentioned in the report—state that the findings are not based on the latest information with no recourse given for a right to reply.
“We know and deal with these risks,” explained Morgane Jaffrelo, Apimab’s research and development manager.
“It’s why we claim on our packaging ‘not recommended for people with allergies to beehive products.’ We agree with the ANSES report and its recommendations and we follow them when we advise our customers.”
In its findings. ANSES said, “The imputability of these dietary supplements in the occurrence of the adverse effect is considered likely or very likely,”
“ANSES adopts the recommendations of the Nutrivigilance working group and the Human Nutrition expert committee. The Agency recalls that pollen allergy is a risk factor for allergy to bee products (royal jelly, propolis, honey). “
The cases form part of ANSES nutrivigilance scheme in which cases of severe allergies are better documented following the consumption of food supplements containing these products.
Its latest opinion, ANSES advised consumers to report any adverse effect occurring after consumption of a food supplement and comply with the conditions of use determined by the manufacturer.
The Agency also advised consumers to avoid taking food supplements on a multiple, prolonged or repeated basis throughout the year without having sought the advice of a healthcare professional.
Consumers are also advised to be vigilant with regard to products presenting unfounded claims, or products marketed outside regulated channels, particularly on the Internet.
“Given the severity of the reported adverse effects and the commonality of these three reports, ANSES, pursuant to the quality procedure for nutritional vigilance, felt it necessary to bring them to the knowledge of the general public and health professionals, for the purpose of improving the safety of the consumer,” the Authority stated.
Propolia propolis gum ingredients
Over the years Propolia propolis gums, which contain 935 milligrams (mg) of honey and 330 mg of propolis extract, have been blended with other ingredients including orange and liquorice, which Jaffrelo says changes the nature and the allergic risk.
As well as taking the necessary labelling precautions in communicating potential risks to the consumer, the product makers claim the report does not tell the whole story.
“The report’s findings were written on the basis of four product ingredients - propolis, honey, sugar and Arabic gum.
“Our products also includes essential oils and natural aromas. These two ingredients can be important when we analyse the allergic risk.
“We are surprised by the report’s findings because we asked ANSES for the full details of our case after the full report was released,” she added.
“We don’t even know the exact product name that ANSES is referring to and we have never been asked about the composition of the product and the full list of ingredients.
“The case study featured dates back to 2012. Since then our case has never been evaluated with the full list of ingredients. It has been six years. During that time, we know exactly which products we had on the market and we know of their composition. It is not possible that these products only contained these four ingredients.
“Apimab has been selling these products since 1980 and this product is the only one made by us identified by ANSES’ nutrivigilance program since the previous one back in 2009."
Be aware of potential allergies
Estelle Prevost, development project manager for Laboratoires Forte Pharma, makers of 1000mg Royal Jelly tablets and Vitality 4G Dynamisant energy-boosting supplements identified in the report, is similar in her sentiments.
“In order to inform and warn the consumer about the presence of bee ingredients in our products, we notify the ingredients in the front of the packaging,” she said.
“Therefore, people who are allergic to bee products can directly see the product composition and know not to take it in case of allergy.
“Moreover, we established on our packaging additional labelling measures,” she added.
“For example, ‘Not recommended for people allergic to bee products,’ is stated in order to alert consumers.
“Regarding the case of allergy reported by ANSES, the woman didn’t know that she was allergic to royal jelly. That is why the safety of our products was not called into question.”
Prevost was referring to a 2016 case highlighted by ANSES in which a 29 year-old woman with a pollen allergy consumed a Royal Jelly 1000mg tablet and Vitality 4G Dynamisant supplement.
An allergic reaction followed in which eyes appeared red, accompanied by sneezing, a runny nose, difficulty breathing, bronchospasms and cough.
ANSES declared this a severity level 3 on the scale of nutrivigilance scale of Level 1 (low severity) to Level 4 (death).
Sérélyspharma, the makers of Sérélys, a supplementary tablet containing 160 mg of pollen extract and 7.85 mg of vitamin E, was the final product identified by ANSES. The firm did not respond to our requests for comment.