“FDA Approval”

Prairie Doc Perspective Week of December 22nd, 2024
“FDA Approval”
By Debra Johnston, MD


Most of my family dreads the thought of going to a museum with me. It really doesn’t matter what the museum is, or how interested they might be in the subject, they’d prefer to do something, perhaps anything, else. 


I recognize that I am the problem. I love museums. One of my early memories is of exploring the King Tut exhibition at the Chicago Field Museum, and being drug out by my exasperated parents long before I was ready to leave. I wasn’t done reading all that fascinating information. 


Perhaps this explains why my Apple News Feed often presents me with historical trivia. Recently, I encountered a description of a patent medication marketed well into the 20th century that almost stopped my doctor heart. This particular product was targeted to parents, promising a myriad of benefits from soothing their fussy infant to freshening his breath. I have no doubt those fussy babies stopped crying. The combination of alcohol and opioids is generally pretty sedating. It is also pretty dangerous, and some of those babies never woke up. 


It wasn’t until the Pure Food and Drug Act of 1906 that companies were required to specifically identify the presence and amount of certain ingredients, at least in products sold across state lines. Importantly, this law did not prohibit the sale of ingredients like cocaine, chloroform, or formaldehyde in over the counter medications. It simply said that if those ingredients were present, and the product wasn’t being sold in the same state where it was manufactured, the label had to say so. At least now those parents knew they were giving morphine to their children! 


This same act prohibited “filthy, decomposed, or putrid animal or vegetable” material in food products. Admittedly, this applied only to items transported from out of state. If your groceries came from your own state, you were on your own. 


Over time, amendments to that original law, court decisions, and new laws brought us to the expectations we as consumers have today: 
-That manufacturer claims about food and medication are true 
-That medications and medical devices are safe and effective
 -That we can find information about the potential risks and side effects of a treatment
 -That product labels are accurate 
-That common allergens are identified 
-That imported foods and medicines are held to the same standards as domestically produced products 
-That ongoing monitoring of products occurs 


Still, the system is imperfect. There aren’t enough inspectors, and there isn’t enough post-market testing. Changes in drug manufacturing processes have introduced risky chemicals that go undetected for years. Contaminated foods sicken and kill before they are identified and pulled out of the food chain. 


Concerningly, people are often unaware that many products aren’t regulated even to these imperfect standards. Herbal and nutritional supplements aren’t reviewed even for safety prior to sale. Most skin and hair care products are classified as cosmetics and can also be marketed without any FDA approval (sunscreen is an exception). 


History has important lessons to teach us. Maybe I should be dragging my family along to those museums after all.


Debra Johnston, MD. is part of The Prairie Doc® team of physicians and currently practices as a Family Medicine Doctor at Avera Medical Group in Brookings, South Dakota. Follow The Prairie Doc® at www.prairiedoc.org, Facebook, Instagram, Youtube and Threads. Prairie Doc Programming includes On Call with the Prairie Doc®, a medical Q&A show (most Thursdays at 7pm streaming on Facebook), 2 podcasts, and a Radio program (on SDPB), providing health information based on science, built on trust.