Literature monitoring and hazard characterisation for food supplements

Client

A large global producer of food supplements and consumer products.

Background

The client was interested in the potential adverse and beneficial effects of a number of ingredients found in food supplements and other ingested consumer products. In addition to the assessment of some defined chemical substances, the ingredients under investigation included several plant and mushroom extracts along with their key constituents.

Project goals

The client asked bibra to review the relevant toxicological, epidemiological, and pharmacological literature on the substances of interest, and to summarise the studies giving insights into their potential adverse and beneficial effects in humans exposed orally. Compositional information for the naturals, and the regulatory status of each substance in food and food supplements in Europe and North America, were also considered.

Approach and outcome

As a first step, key constituents (i.e. those found at a high level in the natural mixtures, or those suspected of being responsible for key effects) were identified by preliminary searches, and were confirmed with the client. Comprehensive literature searches for toxicological and beneficial effects data were then conducted using the bibra in-house database (TRACE) and external databases including PubMed. 

In many cases, the supplements and/or their key constituents were well-studied, with a long history of use, and a pragmatic approach based on comprehensive literature reviews was utilised. Hazard profiles, focused on the oral route of exposure, covered the key human, laboratory animal, and in vitro data on critical endpoints including acute and repeated-dose systemic toxicity, genotoxicity and carcinogenicity, and reproductive and developmental toxicity.

Epidemiology was key for the evaluation of beneficial and/or pharmacological effects; study data, including the exposed population, identity of the substance administered (especially important for naturals), dosing regimen, and results were extracted and tabulated. Key laboratory animal studies were also flagged. 

In many cases, the toxicity data allowed for tolerable exposures, at which no adverse effects were expected following long-term oral dosing with supplements, to be calculated. bibra also used the human data to establish which adverse effects, such as headache or gastrointestinal issues, might be seen under the likely conditions of use.

The result

In many cases, the toxicity data allowed for tolerable exposures, at which no adverse effects were expected following long-term oral dosing with supplements, to be calculated. bibra also used the human data to establish which adverse effects, such as headache or gastrointestinal issues, might be seen under the likely conditions of use.

Why bibra?

• An extensive in-house database TRACE enables comprehensive literature searching 
• All of our senior team are UK and European Toxicologists 
• Bibra has been providing expert, industry-leading toxicology consulting for the food and food contact industries for decades, and we have established ourselves as authorities in this area 

Learn more about our literature searching services

Our literature monitoring and searching services utilise our in-house database TRACE to retrieve and analyse information that is often not reliably identified via searches of the usual range of data sources.