Have you ever read a news report discussing Adverse Event Reports (AERs) and dietary supplements? If so, then you may have seen a statistic cited by FDA (and other government agencies) suggesting the agency receives “less than 1% of all adverse events associated with dietary supplements.” This groan-inducing line has appeared in multiple government reports and has been cited in the media and attributed to FDA, yet its origins are questionable and its math somewhat murky. Perhaps it’s time to actually take a look at the math.
 
First, it must be noted that the statistic in question came from a study published in 2000, years before the 2006 AER law was passed that required dietary supplement manufacturers to report serious adverse events. It then appeared in a Government Accountability Office (GAO) report and has subsequently shown up in other government documents. Further, the author of that original paper based his “less than 1%” finding on data that was based on statistics for drugs and biologics (e.g., vaccines), not dietary supplements. This data showed that adverse events related to drugs and vaccines were underreported. The author then arrived at a “best estimate,” suggesting that if adverse events for drugs and vaccines/biologics were underreported, then surely the same must be true of dietary supplements. There was no real math used to arrive at this statistic; just a best guess effort tied to numbers for an entirely different product category. Despite this inaccuracy, critics of the dietary supplement industry have used the stat to make a case for the need for FDA’s overreaching draft guidance for new dietary ingredients (NDI).
 
The meaning behind (or surrounding) the AER reports received for dietary supplements is not nearly as bad as some might suggest, and in fact, the number of reports demonstrate the supplement category’s strong safety profile. A quick glance at the number of serious adverse events (SAERs) received by FDA between 2007 and 2010 shows that the agency received a total of 4194 SAERs from dietary supplement companies. Compare this number to the 471,000 SAERs reports related to drugs or biological products that FDA received in 2010 alone. It might seem odd that the numbers for dietary supplements are so low, but I would argue that they are actually on point and much more a measure of the safety of dietary supplements then an indication that the industry is underreporting.
 
Recent comments by senior officials at FDA when discussing Good Manufacturing Practices (GMPs) and the NDI draft guidance underscored the agency’s position that more must be done to ensure supplement safety. As a result of FDA’s comments, others have begun to suggest that supplements should be subject to pharmaceutical-like regulation, which would be inappropriate. These suggestions, which often find their way into the press, could easily erode consumer confidence in dietary supplements. If this were to happen it would be responsible companies that are following the law that suffer the consequences. For this reason, among others, industry deserves a more accurate portrayal of AER reporting statistics and what they mean. No more best guesses. 
 
Rend Al-Mondhiry is regulatory counsel for the Council for Responsible Nutrition, the dietary supplement industry’s leading trade association.