By: Tasneem Mewa
Brands like Neptune’s fix have enlivened the discussion on the consequences of readily available dietary supplements that are unapproved by the Food and Drug Administration (“FDA”).
Around six years ago, the Journal of the American Medical Association (“JAMA”) analyzed FDA warnings released from 2007 to 2016 regarding adulterated dietary supplements. The study found that FDA warnings were not effective enough to get unapproved drug ingredients off the shelves. For one, dietary supplements still contained 1-3 unapproved drugs after receiving FDA warnings. Also, of the over 750 tainted supplements at the time, less than half of the products were recalled. Where dietary supplements were not voluntarily recalled, the FDA failed to issue warning letters to all the noncompliant companies and did not issue any mandatory recalls.
Notably, the majority of these supplements were marketed to improve sexual activity, for weight loss, or for muscle building.
The most recent dietary supplement in the headlines is Neptune’s Fix which contains tianeptine. Other countries use tianeptine to treat depression and anxiety, but in large quantities, it can be addictive and has serious side effects including seizures and death.
Beyond tightening regulation and enhancing the FDA’s enforcement powers, Congress may consider other paths to unpack this problem holistically.
- As the studies suggest, there are clear target markets associated with these dietary supplements. While this kind of targeting stems partly from cultural and social issues, perhaps Congress can revisit how and to what extent these dietary supplements can be marketed to address medical concerns. More specifically, Congress may be able to rein in targeted ads that use consumer’s search engine data and website visits to market dietary supplements to them.
- Another potential topic of debate could be to find ways to create domestic safety regulations that override companies’ ability to lawfully import unapproved drugs.
- A less systematic solution could include raising awareness about the dangers of these dietary supplements. This may involve encouraging doctors to mention these issues with their patients, for the bottles themselves to have detailed warnings, and for them to be less accessible within grocery stores and gas stations.
These are simply ideas to spur the conversation. Of course, each idea has its drawbacks. That said, spikes in emergency room visits lead medical professionals to urge lawmakers to enact more safety measures to protect consumers.
Citations
Ali Rogin and Courtney Norris, FDA warns addictive ‘gas station heroin’ supplement widely available in the U.S., PBS Newshour, February 13, 2024, https://www.pbs.org/newshour/show/fda-warns-addictive-gas-station-heroin-supplement-widely-available-in-u-s
Rachel Rettner, Hundreds of Dietary Supplements are Tainted with Prescription Drugs, Scientific American, October 12, 2018, https://www.scientificamerican.com/article/hundreds-of-dietary-supplements-are-tainted-with-prescription-drugs/
J. Tucker and Madhur Kumar, Unapproved Pharmaceutical Ingredients Included in Dietary Supplements Associated with US Food and Drug Administration Warnings, JAMA Network Open, November 30, 2018, https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2706496?#211236404
About the Author:
Tasneem Mewa earned her undergraduate degree in Critical International Development Studies from the University of Toronto, Scarborough. During her studies, she worked for a research and policy organization in Bengaluru focusing on privacy, tech, and data issues in India and across Asia. As a student at the Chicago-Kent College of Law, Tasneem has had the opportunity to work in a litigation clinic, as a judicial extern, and within a law firm setting. She hopes her career will involve exploring new areas of law and contributing to policy.