Should the FDA Increase Dietary Supplement Review
(Thursday, August 24, 2023)
Unlike pharmaceuticals, supplement ingredients don't undergo FDA preapproval for effectiveness or safety prior to market introduction. This regulatory gap has paved the way for manufacturers to overlook basic manufacturing standards, resulting in compromised product quality. The identity, purity, and composition of dietary supplements are often neglected, which becomes a critical issue given the complex physiological effects these products can induce.
In an effort to shed light on these concerns, a recent study evaluated the accuracy of dietary supplement labels claiming to contain R. vomitoria, methylliberine, halostachine, octopamine, or turkesterone. Products including one or more of these ingredients on their label were tested for the actual content of these components. All products were procured online. The researchers used well-established test methods, such as liquid chromatography and mass spectrometry, for comprehensive ingredient detection and quantification.
Among the 57 products selected for this analysis, 40% did not contain detectable amounts of the specified ingredient listed on their label. For those that did contain traceable quantities, the actual content ranged from a mere 0.02% to a staggering 334% of the labeled amount. Only 11% of products were found to contain within 10% of the labeled quantity of a given ingredient. Additionally, about 12% of the products contained at least one FDA-prohibited ingredient such as synthetic stimulants like 1,4-dimethylamylamine, deterenol, octodrine, oxilofrine, and omberacetam. One product even contained a concoction of four prohibited ingredients.
The study found that a staggering 89% of dietary supplement labels failed to accurately declare the ingredients present and 12% contained ingredients prohibited by the FDA. The most disconcerting fact is that this is not the first time such findings have been reported. Numerous studies have reported mismatches in the labeled amounts and actual contents, presence of prohibited components, and other defects in the dietary supplements sold in the US market. So, do we need new regulations or better enforcement of the existing ones?
There are few things that can be done without onerous efforts. Independent quality certification of the manufacturing sites to assure that Good Manufacturing Practices (GMP) is being followed are a good start. Second, enforcement of incoming materials and release testing would assure that the ingredients used for manufacture and the final product do not contain prohibited content. Although dietary supplements do not require a prescription, it would help for clinicians to educate consumers about the potential risks associated with dietary supplements as well when discussing the benefits. There is a need for more rigorous oversight and regulation in the dietary supplement industry to ensure consumers' health and safety are upheld.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC