Caffeine Case Study

Scientific knowledge evolves. ILSI’s work on caffeine demonstrates the organization’s commitment to stay involved over the course of time.

In its earliest years, the basic safety of ingredients and chemicals – particularly in foods and beverages – were ILSI’s primary concern. At the time (and still today) regulations in the United States and elsewhere in the world placed main responsibility for product safety on manufacturers. Industry was therefore eager to have the best data available both to guarantee and document the safety of the foods and beverages they offered the public.

Operating Principles for a New Kind of Scientific Organization

Proprietary data and information on ingredient safety generated by individual companies and trade and commodity groups certainly existed before ILSI was established. But the industry and academic leaders who envisioned ILSI’s unique model for conducting work wanted to completely separate its scientific activities from lobbying and marketing efforts. The results of research funded by ILSI were to belong to the individual scientists who generated the information, not the organization or its paying members. Findings were to be made public regardless of outcome through publication in peer-reviewed journals, in books, and as white papers and other technical reports.

...industry and academic leaders who envisioned ILSI’s unique model for conducting work wanted to completely separate its scientific activities from lobbying and marketing efforts.

The safety of caffeine was the first health concern to which ILSI applied its principles.

Is Caffeine GRAS?

At the time of ILSI’s incorporation in 1978, the US Food and Drug Administration (FDA) had been asking a series of questions on the potential toxicology of caffeine when used as an additive, especially to soft drinks. The status of caffeine’s classification as generally recognized as safe (GRAS) was being explored. The Federation of American Societies for Experimental Biology (FASEB), commissioned by FDA, produced a report that confirmed caffeine’s general safety as a food additive.

However, the FASEB report also noted a significant lack of data on potential health effects of caffeine consumption on neurological, carcinogenetic, cardiovascular, and behavioral outcomes. This lack of information prompted FDA to postpone an official decision on caffeine’s GRAS status.

ILSI stepped in to help fill this gap in scientific knowledge.

By 1981, ILSI’s caffeine effort had a research budget of $1.2 million and projects were being funded at universities in Germany, Italy, the United Kingdom, and the United States. The body of new research ILSI generated was part of the evidence FDA used to address many of the questions raised by FASEB. The work on caffeine validated ILSI’s vision to provide science for decision-making. In 1987, FDA reaffirmed caffeine’s GRAS status.

ILSI’s other early scientific programs established the organization’s reputation for expertise in toxicology and risk assessment. Activities on food colorings, emulsion stabilizers, saccharine, and other ingredients were organized in similar fashion to those on caffeine: industry combined resources to fund work conducted by internationally recognized experts at some of the most prestigious universities in the world.

Caffeine Research Today

The scientific community remains interested in caffeine’s potential health effects today, especially since caffeine is an ingredient used in many more and more diverse food and beverage products than at ILSI's founding. Since 2003 alone, approximately 5,000 peer-reviewed articles have been published on either effects or exposure in humans. ILSI North America has commissioned a systematic review of caffeine research following the Institute of Medicine (IOM) Framework “Finding What Works in Health Care—Standards for Systematic Reviews.” An independent scientific advisory board has been formed to undertake this work. The review will specifically look at adverse health outcomes related to caffeine, general toxicity, physiological effects, cardiovascular, bone and calcium, behavior, and reproductive and developmental endpoints and pharmacokinetics.

ILSI North America Committee on Caffeine | IOM Framework on Systematic Reviews

Publications

All Publications

Beverage Caffeine Intakes in the U.S.

Food and Chemical Toxicology, 2014

This study estimated the caffeine intakes of the U.S. population using a comprehensive beverage survey, the Kantar Worldpanel Beverage Consumption Panel.