Description:
<jats:title>Abstract</jats:title><jats:sec id="S1368980018004081_abs1" sec-type="general"><jats:title>Objective</jats:title><jats:p>The Food Standards Code regulates health claims on Australian food labels. General-level health claims highlight food–health relationships, e.g. ‘contains calcium for strong bones’. Food companies making claims must notify Food Standards Australia New Zealand (FSANZ) and certify that a systematic literature review (SLR) substantiating the food–health relationship has been conducted. There is no pre- or post-notification assessment of the SLR, potentially enabling the food industry to make claims based on poor-quality research. The present study assessed the rigour of self-substantiation.</jats:p></jats:sec><jats:sec id="S1368980018004081_abs2" sec-type="general"><jats:title>Design</jats:title><jats:p>Food–health relationships notified to FSANZ were monitored monthly between 2013 and 2017. These relationships were assessed by scoping published literature. Where evidence was equivocal/insufficient, the relevant government food regulatory agency was asked to investigate. If not investigated, or the response was unsatisfactory, the project team conducted an independent SLR which was provided to the government agency.</jats:p></jats:sec><jats:sec id="S1368980018004081_abs3" sec-type="general"><jats:title>Setting</jats:title><jats:p>Australia.</jats:p></jats:sec><jats:sec id="S1368980018004081_abs4" sec-type="general"><jats:title>Participants</jats:title><jats:p>Self-substantiated food–health relationships.</jats:p></jats:sec><jats:sec id="S1368980018004081_abs5" sec-type="results"><jats:title>Results</jats:title><jats:p>There were sixty-seven relationships notified by thirty-eight food companies. Of these, thirty-three relationships (52 %) from twenty companies were deemed to have sufficient published evidence. Four were excluded as they originated in New Zealand. Three relationships were removed before investigations were initiated. The project initiated twenty-seven food–health relationship investigations. Another six relationships were withdrawn, and three relationships were awaiting government assessment.</jats:p></jats:sec><jats:sec id="S1368980018004081_abs6" sec-type="conclusions"><jats:title>Conclusions</jats:title><jats:p>To ensure that SLR underpinning food–health relationships are rigorous and reduce regulatory enforcement burden, pre-market approval of food–health relationships should be introduced. This will increase consumer and public health confidence in the regulatory process and prevent potentially misleading general-level health claims on food labels.</jats:p></jats:sec>