Nutravigilance program marks ‘the beginning of a new era of adverse event reporting’

Nutravigilance, which is derived from well-defined principles of pharmacovigilance in the drug and biologics industries, is defined as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects related to the use of a food, dietary supplement, or medical food”​.

The program's principles is outlined in an article in the International Journal of Food Sciences and Nutrition​​, authored by Dr Steve Schmitz from Supplement Safety Solutions, Dr Hector Lopez from Supplement Safety Solutions and The Center for Applied Health Sciences, and Dr Duffy MacKay from the Council for Responsible Nutrition (CRN).

“The nutravigilance approach, critical to assuring the safety of supplements already on the market, is an important part of a robust supplement safety continuum and quality assurance platform, which includes controlled clinical studies in healthy subjects,”​ Dr Lopez told NutraIngredients-USA.

“This comprehensive approach to substantiate the efficacy and safety of finished dietary supplement products while addressing post-market surveillance further bolsters a commitment to consumer safety and quality.”​

Different​

Dr Schmitz told us: “What makes Nutravigilance different from traditional ‘pharmacovigilance’ is that many dietary supplements are unique, often containing multiple bioactive ingredients; and to better understand the source of a potential safety issue requires engagement of the dietary supplement companies that know the detailed and sometime unique composition of their products. When safety signals arise detailed product and company data info can assist FDA and other regulatory bodies to establish the root of the concern.  ​

“Without data, the FDA and the supplement manufacturers cannot adequately assess the safety of their products,”​ he said, and “high quality adverse event reports and detailed product composition data are essential.”​

AERs​

The reporting of adverse events (AER) by manufacturers, packers, and distributors of dietary supplements in the US was signed into law on December 22, 2006, with compliance effective one year later. This law details the definitions of what constitutes serious vs. non-serious adverse events, reporting and submission requirements and record-keeping related to such.

Despite initiatives such as the FDA’s MedWatchPlus web portal, there have been questions raised about how the industry is performing.

A report by the US Government Accountability Office (GAO), which can be accessed here​, showed that the Food and Drug Administration (FDA) received 6,307 AERs from 2008 through 2011, with 71% of these coming from industry for serious health problems. The majority of these reports were for multi-component supplements.

The GAO report added that the actual number of AERs is thought to be higher since poison control centers received over 1,000 more reports of adverse events for dietary supplements during the period 2008-10 than FDA.

In addition, the AERs correspond to only 257 companies, a number which is said to be much lower than the estimated 4,000 dietary supplement firms in existence.

Seal​

Supplement Safety Solutions has launched a Nutravigilance Verified seal that it licenses to companies that meet minimum requirements as defined by the Nutravigilance system. The consultancy explained that companies in the dietary supplement, natural products and medical foods industry may license the trademarked Nutravigilance Verfied logo as a seal that is displayed on product labels, online, TV, radio and print marketing materials to demonstrate that they have in place a robust, comprehensive approach to product safety, product quality and adverse event surveillance and analysis that exceeds the current regulatory standards. 

“The supplement, natural product and functional food industries would benefit increased efforts to demonstrate to their consumers and to regulatory agencies like FDA, that they take their safety responsibilities very seriously,”​ said Dr Schmitz. “Instead of waiting for and reacting to product safety issues, the industry must embrace pro-active best practices from other industries and adapt them.”​

Dr Lopez said that this paper marks the beginning of a new era of adverse event reporting – one in which supplement manufacturers are taking the lead in demonstrating their safety. 

“The Nutravigilance ​approach provides a rational, well-vetted framework for mitigating risk for the entire industry,”​ he said. “If you are not taking proactive steps to protect product safety, then you’re not doing enough, and you are vulnerable to regulatory liability, safety issues, and it decreases the essential dialogue between the consumer and the dietary supplement manufacturer or brand.  ​

“Moreover, it provides a bridge for unifying, as opposed to creating a larger rift between the ‘islands’ of industry on the one hand and regulatory bodies, such as the FDA on the other.  So, the point of a well-run Nutravigilance program is also to focus on an area where there is common ground to enhance the communication and relationship between industry and regulators.”​

Source: International Journal of Food Sciences and Nutrition​​
Published online ahead of print, doi: 10.3109/09637486.2013.836743
“Nutravigilance: principles and practices to enhance adverse event reporting in the dietary supplement and natural products industry”​
Authors: S.M. Schmitz, H.L. Lopez, D. MacKay