Dietary Supplement Health and Education Act of 1994 (DSHEA) (an act of Congress signed into law by then-President Bill Clinton) took a controversial category of product traditionally regulated by FDA as either a food or a drug and created a new regulatory category called "dietary supplement" that was placed within the "food" definition. This act allowed, for the first time in decades, manufacturers of dietary supplements to make "structure/function" claims traditionally allowed only for drugs. Furthermore, unlike food ingredients, substances could be used in dietary supplements without being either approved food additives or generally recognized as safe ("GRAS") ingredients allowing products to enter the marketplace with broad-based claims without FDA premarket review or approval of the ingredients, formulation, or product claims. The
The effects of DSHEA were visible across the consumer landscape in the US; and almost overnight. Suddenly store shelves were full of "supplements" claiming (or at least implying) benefits for weight loss, sexual dysfunction, bodybuilding, baldness and a large number of other medical conditions. These sorts of products remain widely available today.
The problem with the DSHEA is that takes science "out of the loop". The act created a largely unregulated industry of quasi-drugs not unlike the patent medicine industry of the late 1800's. OTC supplement manufacturers and specifically NOT the FDA are given the "responsibility" for "determining" that their own products are safe and affective. Essentially the fox is left to guard the hen-house. Only when claims for a supplement exceed the scope of DSHEA or when a supplement is clearly dangerous does FDA have authority to regulate or ban it.
The real effect of DSHEA is to allow companies to make and sell products that contain materials (usually plant-based) that have never been carefully tested for safety or efficacy. DSHEA permits unsafe and ineffective products to enter and remain on the US market.
Does this mean that all OTC supplements are unsafe or ineffective?
It does however mean that to some extent, the consumer is on his or her own.
On the pages linked to the right you can find more information about OTC dietary supplements including some very frightening new findings about product adulteration.