4 December 2018

THE TRUTH ABOUT SUPPLEMENT REGULATION

by Aaron Hoey 0

SUPPLEMENTS AREN’T AS REGULATED AS YOU THINK. HERE’S HOW, AND WHAT TO DO ABOUT IT. Unlike pharmaceutical companies, supplement companies don’t have to demonstrate the safety and efficacy of their products prior to release. Instead, the FDA simply expects supplement companies to comply with FDA regulations of their own volition (and/or out of fear of…

SUPPLEMENTS AREN’T AS REGULATED AS YOU THINK. HERE’S HOW, AND WHAT TO DO ABOUT IT.

Unlike pharmaceutical companies, supplement companies don’t have to demonstrate the safety and efficacy of their products prior to release. Instead, the FDA simply expects supplement companies to comply with FDA regulations of their own volition (and/or out of fear of the penalties which can result from failing to achieve such compliance), and steps in primarily when they have reason to suspect a violation has already occurred. To their credit, the FDA does do some enforcement in the form of facility inspections and similar checks, but, based upon the number of publicly-documented violations which have occurred in the case of supplements already commercially available, the agency appears to lack the resources necessary to reliably catch violations preemptively. The overall result is that non-compliant supplements aren’t consistently caught on the front-end through the extremely extensive four-phase testing process required for pharmaceuticals (which, at least theoretically, ensures dangerous or otherwise non-compliant drugs are never used by the end consumer), or even through a less rigorous but fundamentally comparable and effective testing process designed specifically for the supplement industry. Instead, non-compliant supplements are usually identified, and the relevant companies penalized, after the products are released and used by consumers. This, unfortunately, leaves the door open for the uninformed consumer to be harmed by a supplement they trust to be safe (after all, it’s very intuitive that for something to be commercially available, someone has to have proven its safety), but which is actually patently non-compliant and dangerous.

Thus, while one should certainly do their due diligence prior to taking prescription drugs (indeed, practically all medications have adverse effects, some so significant the use of the relevant medication has to be discontinued by the patient – this is very common in the case of antidepressant medications, for example), it’s advisable to be doubly careful when taking a non-prescription supplement. After all, while you can at least reasonably assume that a Tylenol tablet is indeed a tablet of only acetaminophen and innocuous inactive ingredients, and thus you’re able to make an informed decision on the basis of the known risks associated with the use of that drug and that drug alone, the wide range of ingredient content violations which have occurred in the supplement industry call into question even the most basic of label claims. Therefore, while I don’t mean to suggest or encourage an attitude of fear toward dietary supplements, I do encourage you to seek out evidence of sufficient quality control on the part of your preferred supplement companies, with consistent third-party (independent) lab testing of each patch of the finished product being ideal.

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