How Safe Are Supplements?
By Joe Zimo, Mechanical Engineering, 2015
From gym-goers gulping down protein shakes to daily vitamin devotees, supplement users have become ubiquitous in modern society. But how safe are these supposedly miraculous compounds?
In 1994, the Dietary Supplement Health and Education Act (DSHEA) became law. This act removed the requirement for products “taken by mouth that contain a ‘dietary ingredient’ intended to supplement a diet” to be regulated under the same requirements as food. Since the passing of the DSHEA, dietary supplement manufacturers are no longer required to even contact the FDA about distributing their product unless it contains a “new dietary ingredient.”
In that case, documentation is required proving that the ingredient is safe and explaining why it is included in the supplement. This step can be skipped, however, if the manufacturer can prove that the ingredient was included in a marketed product before 1994.
The DSHEA led to a flourishing of the dietary supplement market as companies no longer had to go through the FDA to market and sell their product.
Apart from products containing “new dietary ingredients,” the manufacturer alone is directly responsible for ensuring the product’s safety and that effectiveness claims are substantiated by reasonable evidence. In other words, there are no regulations that prohibit the manufacturer of a dietary supplement from selling an untested and potentially unsafe product to a consumer.
By law, the company must report all adverse event claims to the FDA, and only after the FDA substantiates these claims can the supplement be recalled.
Acknowledging these facts, it is important for a consumer to research and consult with a doctor before purchasing any dietary supplement. Claims of miracle diet pills and one-pill cure-alls are unequivocally unsubstantiated and taking any product that does not have scientific evidence backing its intended usage is potentially very dangerous. Because a recall can only be initiated with adverse event reports, companies are essentially using their consumers as experiments.
By taking a best guess with their product’s effectiveness, mass-marketing their product with bright colors and big buzzwords on the container, and subjecting consumers to potentially harmful concoctions, dietary supplement manufacturers may be putting uninformed customers in danger. Customers should thoroughly research any dietary supplements before consuming, or they face putting their health at risk.