Supplements Gone Wild!

In 1994, something called the Dietary Supplement Health and Education Act (DSHEA) became U.S. law. The act was intended to meet the concerns of consumers and manufacturers to help ensure that safe and appropriately labeled dietary supplements remained on the market. My personal impression is that the passage of this act was largely driven by lobbying from supplement manufacturers along with a fear campaign that led the public to believe their access to supplements was in jeopardy. Prior to this act, 4,000 supplements were available to consumers. Flash forward to today, and consumers now have access to over 90,000 supplements!

With consumers having access to so many supplements, I think it is important for folks to know about the inadequacies of supplement oversight: 

• The Food and Drug Administration (FDA) oversees enforcement of the supplements, but supplements are classified as a food, not a drug, Therefore, the law does not require that dietary supplements (unlike drugs) undergo rigorous FDA testing and approval for safety and effectiveness. 
• The law forbids supplement manufacturers and distributors from producing and selling mislabeled or adulterated products.  The FDA can take action against any dietary supplement that is mislabeled or adulterated only after it hits the market. Manufacturers must alert the FDA of any serious issues that occur (it seems like the fox guarding the henhouse, in my opinion). 
• Supplements sold before 1994 can be sold without evidence of safety or effectiveness. Dietary supplements made after 1994 with a new ingredient must disclose this to the FDA. The FDA then reviews the ingredient; it does not approve it.
• The law does not require pre-market approval of any health claims made by supplement manufacturers. Products sold as dietary supplements are not permitted to claim that they can treat, prevent or cure a specific disease or condition (but they can and do claim pretty much everything else!) This why all supplements with health claims must contain the following disclaimer: "The Food and Drug Administration has not evaluated this statement". 

I do not explain any of this to scare people away from supplements. I share it to help people understand the limits of supplement oversight and the responsibility they need to take for making an informed decision. 

PS: If you want a great real-world example of how supplements have gone wild, revisit the story of Ephedra.  It took the FDA seven years to officially ban ephedra after growing concerns about its safety.