The FDA regulates drugs by testing for safety and effectiveness before they are available to the public. However, supplement regulation by the FDA is more like how they regulate food. Meaning they only find adulterated supplements after they are already on the market and if they identify a spiked product, that product is logged in a public database. The most common approach the FDA takes is a voluntary recall to remove the adulterated supplements from public consumption. The company that made the supplement has to agreed to the voluntary recall and then the FDA publicizes it. From 2007 to 2016, the FDA has logged 776 dietary supplements that had pharmaceuticals in them. Fewer than half of those supplements logged were actually recalled. Pieter Cohen, an affiliate with Harvard Medical School and Cambridge Health Alliance put it, "the FDA fulfilled its responsibilities less than half of the time." If the company doesn't agree to the voluntary recall, the FDA has other ways to force that company to not be able to sell the supplement. This brings up a huge ethical dilemma of justice to the public. Having unlabeled and unauthorized medicines in supplements can have side effects for the people consuming them. What should be done? First of all, I think the FDA needs to have stricter regulation of supplements that mirrors drug regulation instead of food. That would be a long shot however, so a more realistic approach would be once a supplement is identified as spiked with pharmaceuticals they are immediately recalled from the shelves. The companies shouldn't be able to deny the recall in the first place to ensure the safety of the public and the company can still maintain some trust from the public. Does anyone have any other ideas of how to prevent spiked supplements being sold to the public?
Citation
Taylor, A. (2018). Hundreds of Supplements Spiked with Pharmaceuticals. Retrieved from https://www.the-scientist.com/news-opinion/hundreds-of-supplements-spiked-with-pharmaceuticals-64928
I actually just watched an episode of “Adam Ruins everything” on Netflix where he mentioned the unregulated nature of dietary supplements. It is so crazy to me that things that are advertised and sold as “healthy” can actually contain very harmful ingredients that aren’t even listed on the label, some of which consumers may be allergic to. A study done in 2013 found that 1/3 of herbal supplements contained no trace of the advertised ingredient on the bottle (O’Connor, 2018). With over 15,000 supplement manufacturers, the FDA still only conducts 400 inspections a year. Of these inspections, 60 percent of manufacturers fail (Kapoor & Sharfstein, 2016). What goes in your supplements is so unregulated that anybody without any prior medical knowledge can make their own custom supplements. If your curious in this, just click the link https://www.nutracapusa.com/?source=nutracapAW&utm_campaign=763680631&utm_term=supplement%20manufacturing&gclid=EAIaIQobChMIyealvZ6H3wIVj4dpCh1-5ge8EAAYAiAAEgLLj_D_BwE.
ReplyDeleteI definitely agree that for the beneficence of consumers that these products should be more strictly regulated.
Citations
Kapoor, A., & Sharfstein, J. M. (2016). Breaking the gridlock: Regulation of dietary supplements in the United States. Drug Testing and Analysis, 8(3–4), 424–430. https://doi.org/10.1002/dta.1892
O’Connor, A. (2018, October 19). Herbal Supplements Are Often Not What They Seem. The New York Times. Retrieved from https://www.nytimes.com/2013/11/05/science/herbal-supplements-are-often-not-what-they-seem.html