It is important to carefully consider the actual existence of information about historical use and the relevance of this information, taking into consideration whether the preparations are similarly processed, similar in route of exposure and duration of use, the potential for differences in concurrent use with substances, and whether or not the historical use would have revealed any possible adverse event. Appropriate historical use can then be weighed against the strength of other types of evidence suggesting possible harm (human, animal, and in vitro data or information about related substances).
This indication assumes greatest importance when the route of exposure is oral, the formulation tested is identical or highly similar to that consumed as an ingredient, and more than one species shows the same or similar toxicity.
Through the process of developing the Framework to evaluate the safety of dietary supplement ingredients, a number of legal and regulatory barriers were identified that hamper FDA’s ability to protect the public’s health. The following findings are designed to enhance the utility of the Framework and enhance the ability of FDA to protect consumers from unreasonable risk of illness or injury.