I enjoy working out. And as many 20-something year old males who frequent the gym, I use creatine, a dietary supplement powder of a natural metabolite produced by the body, to help me maintain a high intensity during my workouts. However, the brand of creatine I use is almost certainly not identical to the brand of creatine used by a classmate, friend, or fellow random gym-bro. This brand variance exists because creatine is classified by the Federal Drug Administration (FDA) as a supplement rather than a drug. In doing so, it is not scrutinized under the same microscope the FDA would use for assessment of a hypothetical new heart drug. But what exactly is a supplement, and why aren’t they held to the same standard of pre-market testing the FDA uses for medical drugs? And what can we as healthcare professionals do to ensure the safety of our patients taking supplements?
According to the 1938 Federal Food, Drug, and Cosmetic Act a dietary supplement is a product taken orally that contains a dietary ingredient intended to supplement the diet. If that sounds incredibly broad and undescriptive, it’s because of the nature of the supplement industry. Dietary supplements range from but are not excluded to tablets, powders, energy bars, and liquids that can be purchased without the need for a prescription. This makes sense, as their purpose is to supplement aspects of a normal diet. They are not meant to be viewed or used as therapeutic medications for the treatment of diseases. As such, a supplement company can make the generic claim that their product “improves memory”, but it cannot claim that it “slows the progression of Alzheimer’s disease”.
The FDA treats supplements differently than therapeutic drugs. Before taking it to market, all drug manufacturers must prove to the FDA that their product is safe by rigorous testing and approval. Conversely, supplement manufacturers can take their product to market without the same rigorous testing imposed on drugs. By federal law, a supplement is assumed by the FDA to be safe until it is proven unsafe through public consumption, if at all. This lower burden of proof allows some supplement companies to enact shady schemes.
In the hope of cutting costs and boosting sales, some supplement brands may choose to “adulterate” their product by including less expensive ingredients in the place of the more expensive “real thing”. According to the AMA, others may even add active pharmaceutical agents which are deliberately not listed on the label. This pharmaceutical adulteration is most prevalent in supplements marketed under weight loss, sexual enhancement, or sports categories. These practices continue until the manufacturer is ultimately caught by a 3rd party, after which the FDA becomes aware and puts a stop to the practice. But as with any government action, this process is slow. In the meantime, an estimated 23,000 emergency department visits each year are linked to the consumption of pharmaceutically adulterated supplements.
This isn’t to say that all supplement companies are bad. Many aspects of patient care, particularly those regarding vitamin and mineral deficiencies, depend on dietary supplements for management. There are steps physicians, medical students, and other healthcare professionals can take to ensure patient safety with supplements. The most efficacious action a physician can take is to ask the patient for their specific brand of supplement. The physician can then scrutinize the supplement with their medical and professional knowledge, or they can cross reference the product with the assessment of various 3rd party companies that independently verify supplement ingredients. These companies arose due to the varying ingredient quality of brands and offer verification/certification services to companies seeking to advertise the genuine purity of their products. Physicians should be on the lookout for and advise patients to take supplements that hold certifications by reputable verification companies.
Due to the relative laxity of federal law, the supplement industry has become a vast and difficult market to navigate. However, given enough time and education about its landscape, both patients and physicians alike may be able to discern the mark of a good supplement, and the mark of a scam.
References:
AMA J Ethics. 2022;24(5):E410-418. doi: 10.1001/amajethics.2022.410. https://journalofethics.ama-assn.org/article/which-features-dietary-supplement-industry-product-trends-and-regulation-deserve-physicians/2022-05.Lam C, Patel P. Food, Drug, and Cosmetic Act. [Updated 2023 Jul 31]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024. https://www.ncbi.nlm.nih.gov/books/NBK585046/.
Alec Simoni is a medical student of the Class of 2026 at The University of Arizona College of Medicine – Phoenix. He graduated from UCLA majoring in Psychobiology and minoring in Classical Civilization. When he's not spending his time skating around the streets of Downtown Phoenix in search of a new lunch spot, Alec enjoys reading classical Roman and Greek literature and working out at the gym. Feel free to contact him at @alecsimoni on Instagram or alecsimoni@arizona.edu