Evaluating and Improving Product Safety

Are dietary supplements safe? Ask a consumer, manufacturer, distributor, researcher or physician, and most likely there will be five different answers.

In general, the use of dietary supplements in the United States has been regarded as safe, thanks to a number of factors. Supplements are used for minor medical conditions, which get better on their own over time, or for maintaining the health of a mostly healthy population. Special demographic groups, like children, the elderly and those with serious diseases, are not the primary consumers of these products; and those who regularly consume dietary supplements are less likely to have a serious medical condition.

Nonetheless, adverse reactions from dietary supplement use can occur for many reasons.

The product can be adulterated, contaminated or substituted. There is the possibility of ingredient toxicity; the product can have pharmacological effects; it can interact with other drugs or supplements; or may be abused.

Most safety data comes from historical use, case reports, clinical trials and pharmacovigilance (adverse event reporting systems). Dietary supplements, however, have much less data available than pharmaceutical products. Fewer published case reports and clinical trials are available, and, more importantly, pharmacovigilance has only recently become an option for supplement safety.

The need for such data has become necessary, and meaningful interpretation of this data is critical. One must be able to determine biological plausibility, incidence, prevalence, relative risk, cost, population, confounding factors and whether the suspected product was viewed and/or tested. The wrong determination can be enough “evidence” to tarnish an ingredient’s reputation, as occurred with kava kava and black cohosh.

Proactively collecting safety data, including all clinical trials designing and implementing safety trials; collecting adverse events (AEs) in concordance with the new AE reporting law; and using this information to look for safety signals (clusters of sentinel events) before they become a problem can help a manufacturer and the industry avoid mishaps. As an industry, manufacturers have the unique opportunity to collaborate and combine all safety data into a blinded database. When AEs are combined, it will be possible, for the first time, to provide a denominator to the number of adverse events. For example, if during a given year 10 million doses of a particular ingredient are sold, and five different companies report liver toxicity from this ingredient, a collective database could trigger a signal for further investigation, providing a ratio that the risk of such an event is only one out of 2 million. Such information is currently not available for the dietary supplement industry. Having such a system would offer a two-fold warning system: a potential safety issue would be quickly recognized and a defense system providing real, prevalent data, rather than speculation on the safety of these products, would be available.

Manufacturers must be proactive in safety data collection, run safety clinical trials, add safety data to all clinical trials, trace material back to its source and join together, as one industry, to provide the collective data, which will hopefully improve the position of safety in the dietary supplement industry. 

Jay Udani, M.D., ([email protected]) is CEO of Medicus Research LLC (www.MedicusResearch.com) and assistant clinical professor at the UCLA School of Medicine, as well as the medical director of the Northridge Hospital Integrative Medicine Program. He is formally trained in acupuncture, herbal therapies, functional medicine, nutritional supplements and homeopathy. He has published numerous book chapters and articles on integrative medicine in many prestigious medical journals, and has spoken on natural health topics to many audiences.