By Mark O’Brian
The U.S. Department of Justice and its federal partners last week announced criminal and civil charges against several manufacturers and marketers of dietary supplements as part of a nationwide sweep involving more than 100 companies over the last year. The most recent indictments by the DOJ allege that companies sold products adulterated with substances known to have adverse health effects, lied about the contents of the products or made outrageous health benefit claims.
Several studies over the last few years indicate that these shady practices are neither new nor rare. The actions announced by the DOJ are part of an attempt to clean up a mess made by bad legislation that allows snake oil salesmen to peddle their wares with little regulatory oversight. In the absence of stricter regulation, the cleanup will likely be an ongoing venture.
The Dietary Supplement Health and Education Act of 1994 (DSHEA) redefined what a dietary supplement is and how agencies could regulate them. Traditionally, a dietary supplement was an essential compound that may be lacking in the diet such as a vitamin or mineral. After DSHEA, a dietary supplement can be just about anything that is not strictly defined as a drug. The ability to skirt around this definition is clear when one considers that some human hormones can be sold without prescription as a dietary supplement. The law sparked the explosion of a $40 billion industry that hawks herbs, salves and pills claiming to increase sex drive, lose weight, improve cognition and prevent or treat disease. There is very little science behind most of these claims and, thanks to DSHEA, there does not need to be. The FDA website states that a dietary supplement manufacturer “is not required to provide the FDA with the evidence it relies on to substantiate safety or effectiveness before or after it markets its product.” Yes, you read that correctly.
The FDA and other federal agencies can intervene only after evidence of harm by the supplement has been established. This is where the recent DOJ indictments come into the picture, after the mess has been made. The criminal case alleges that USPlabs sold the weight-loss supplements Jack3d and OxyElite Pro despite their knowledge that they were associated with liver damage. They also charge that USPlabs falsified certificates of analysis and lied about the source and nature of the ingredients.
A sane, rational and obvious solution to the problem is to place the burden of proof of efficacy and safety of dietary supplements on the manufacturers of these products before they enter the marketplace. Surely, most consumers are under the mistaken assumption that this is already being done. DSHEA is no friend of the consumer, and new, strict legislation is needed.
Mark R. O’Brian is professor of biochemistry at the University at Buffalo.