It should be easier to report problems with food to FDA

Pear in Mind: A Blog in the Public Interest

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What do you think of when you hear “MedWatch”? A special wristwatch that tells you when to take your meds? A TV drama with doctors patrolling beaches? A government program that collects information on safety issues concerning foods? Probably not the last one—but that’s actually, in part, what MedWatch is.

MedWatch is a program that the U.S. Food and Drug Administration uses to collect reports of adverse events related to a wide range of products, including prescription and over-the-counter drugs, medical devices, cosmetics, foods, and more. Although the name “MedWatch” might suggest the system is only for issues with medicines, if a consumer or health professional wants to report a problem with food, FDA asks that they fill out the same MedWatch form originally designed for drugs.

FDA uses this program to learn about unusual allergic reactions to foods, inaccurate food labels, and foods that appear to be contaminated (especially with dangerous substances, like poppy seeds contaminated with opiates). When it receives this information, FDA will conduct an investigation of the issue and may even require the company to issue a recall.

Unfortunately, MedWatch is vastly underutilized for reporting these food-related issues. (It doesn’t fare too well for drugs either.) It certainly doesn’t help that the MedWatch form asks questions that make little sense with respect to foods, inquiring into the product’s “Strength” and asking, “Why was the person using the product?” These questions could prompt anyone reporting an issue with a food to wonder if they’re in the right place.

Researchers from CSPI have been involved with multiple studies whose results point to the need for an improved system for reporting adverse events related to foods to FDA. The latest of these studies, published this month, identified 379 adverse events related to sesame reported through an online survey between October and December 2018, including 360 allergic reactions that resulted in anaphylaxis. By contrast, a search for “sesame” in the FDA’s Adverse Event Reporting System (CAERS), a public database where the food-related MedWatch reports are compiled, revealed only one report of anaphylaxis from 2018.

Another study by CSPI researchers published earlier this year found that 604 adverse events involving poppy seeds were reported to Poison Control Centers between 2000-2018, but only 18 adverse events involving poppy seeds were reported in CAERS in a similar period. That’s 34 times fewer reports to FDA than to poison control!

A third study conducted by a team of scientists at FDA, along with CSPI president Dr. Peter Lurie, found that between 2008 and 2015, 13,753 adverse events related to caffeinated energy drinks were reported to Poison Control Centers compared to 510 such events reported in CAERS. That’s 27 times fewer reports to FDA than to poison control.

The FDA needs a better system for reporting adverse events related to foods so that the agency can monitor potentially serious risks, from food allergies to inadequate labeling to microbial contamination. FDA is working on a new and improved, food-specific adverse event reporting system, and CSPI is advocating that the agency makes this a priority. But until then, spread the word—MedWatch is for more than just meds.

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