The Food and Drug Administration recently announced efforts to strengthen its regulation of dietary supplements.
The FDA’s actions are a much-needed move to shed light on what can sometimes be a shady business. They are a signal to lawmakers that the FDA needs the resources to provide this kind of oversight.
The business behind dietary supplements is larger than many would think. The industry as a whole is worth $40 billion, with more than 50,000 products available. Three out of four Americans take a dietary supplement on a regular basis according to the FDA.
Many college students fall into that category. A 2015 article in the health journal Clinical Nutrition found that 66 percent of college students studied used a dietary supplement at least once a week, and college students appeared more likely to use dietary supplements than the general population.
Despite the industry’s size, dietary supplements are also a kind of a gray area for the FDA. It’s difficult to track products, especially when they’re sold on the internet. Moreover, producers of dietary supplements don’t have to tell the FDA what’s in them.
Dietary supplements sometimes dangerously market themselves as if they’re a drug, even though they’re not. Strengthening the FDA’s oversight of dietary supplements prevents companies from spreading misinformation and marketing unsafe products.
Part of the FDA’s renewed efforts involved sending 12 warning letters and 5 advisory letters to companies who illegally claimed their dietary supplements could prevent, treat or cure diseases such as Alzheimer’s disease, diabetes and cancer.
The FDA also plans to update its new dietary ingredient notifications, or NDIs, which flag new ingredients for inspection. These compliance policies require manufacturers to alert the agency of any ingredients not sold in the US prior to 1994.
There are many cautionary tales of "dietary supplements gone rogue" that evidence the need for these regulatory reforms and expansions in oversight.
For example, the FDA has seized kratom imports and issued several warnings after 44 deaths were directly linked to kratom in 2017. Kratom is a botanical chemical that has been marketed as an “opioid alternative” to fight opioid addiction, but these claims are built on little knowledge about the effects of its use. From these deaths, it’s clear that kratom is not safe, but it is marketed as if it were.
A similar story took place when the FDA declared supplements with highly-concentrated caffeine to be unlawful, or when the agency warned that Rhino male enhancement products were adulterated with unlabeled prescription drugs.
Although these actions are much needed, I wonder if the FDA can also regulate dietary supplements before they hit the market. As a consumer, I don’t want the warning after I’ve eaten something dangerous — I want the warning before.
Some feel that the FDA’s statements are not enough and want the agency to take more action.
Dr. Peter Lurie, a former associate commissioner at the FDA, was reportedly frustrated that the agency had spent years debating policies that improve oversight of new dietary ingredients but had not released it.
At worst, the FDA’s announcements are an ineffective stunt that bring attention to concerns surrounding the dietary supplement industry. At best, the FDA’s announcements are a sincere attempt to clear up a gray area and make change. We need the agency to inform and guide the public in dietary decisions.
