Like many primary care sports medicine practitioners, I field many questions from parents and athletes about supplements. Parents often ask if the supplement their son or daughter is taking is safe. They make it more difficult because they often don't know many details about what their child is taking. Prior to 2004, I used to emphasize the importance of reading labels. As an attendee of the 2004 American College of Sports Medicine (ACSM) meeting in Indianapolis, I was fortunate to attend two related presentations on supplements given by Professor Ronald J. Maughhan of Loughborough University, UK. After hearing those presentations, I began to realize that no one knows what is in any supplement and whether any given supplement is safe. Now when asked if a supplement is safe, I have begun to utter those most difficult three words in medicine, “I don't know.” As I contemplated this issue, I began to reflect on what has happened in recent history and want to share some of the information presented at ACSM.
The 1994 Supplement Act
Most of the problems with supplements began with the passage of the 1994 Dietary Supplement and Health Education Act (DSHEA), which limits the ability of the US Food and Drug Administration (FDA) to regulate any product that is labeled as a supplement. Under this law, companies may promote supplements claiming to improve function and health as long as they make no claims to affect disease. After this law was passed, the marketing and sales of supplements skyrocketed without any studies of their safety. Worse yet, before the FDA can do anything about a supplement, DSHEA makes the FDA prove that supplements on the market are unsafe. This can take years.
The Tryptophan Disaster
It is startling that the 1994 DSHEA was still passed after deaths associated with the tryptophan disaster. In 1989, an outbreak of eosinophilia-myalgia syndrome (EMS) was occurring in L-tryptophan users. A rare disorder, EMS is a debilitating disease characterized by severe muscle and joint pain, weakness, swelling of the arms and legs, fever, skin rash, and an increase in eosinophils. In the 12 months after the first report, 1500 cases were reported with 28 deaths. When the link between EMS and L-tryptophan became apparent, the FDA quickly banned its sale. Further study of L-tryptophan revealed that the EMS outbreak was traced to impurities in the L-tryptophan produced by a Japanese wholesaler who was the major supplier of the supplement in the United States. Was the tryptophan saga not an issue when the DSHEA was passed by Congress?
The Ephedrine Saga
In August 2003, I wrote a commentary about the risk of taking ephedrine, noting that there was accumulating evidence that the risk of adverse effects from taking ephedrine was significant. When three prominent athletes died in a 12-month period and ephedrine was implicated in their deaths, the regulation of ephedrine finally grabbed the attention of the FDA and lawmakers. And with the help of a few scientific papers showing an association between ephedrine use and severe side effects such as stroke, seizures, and death, the FDA banned its sale in December of 2003.
The Disappearance of Androstenedione
Popularized by the discovery that Major League baseball player Mark McGwire had used androstenedione (andro) the year he set a new record for home runs in a season, sales skyrocketed. After studies showed the same side effects as with other anabolic androgenic steroids, the Department of Health and Human Services (HHS) announced that it was urging Congress to enact legislation to classify andro-containing products as controlled substances. In March 2004, HHS published a statement that no one in the United States should be selling andro unless he could prove that it is safe. It warned 23 companies to stop marketing andro, causing supplement stores to quickly remove it from their shelves. I wonder how may athletes still have a bottle of andro on their shelves unaware of the risks of using it.
What Supplement Is Next?
Does anyone see a pattern here? What will be the next supplement taken off the market? When will lawmakers figure out that the 1994 DSHEA was a mistake? This law makes it difficult for the FDA to discover a problem until many people are hurt or die. When will Congress rescind the 1994 DSHEA?
Because the purity of supplements is entirely up to the producer with no regulations, how do consumers know what they are getting? A few studies have made it painfully clear that supplements may not contain much of what the label states and may have other substances not listed on the label. This is most disturbing news. The FDA has recalled products containing excessive levels of Vitamins A, D, B6, and selenium because of potentially toxic levels of these compounds. Some products were shown to have traces of lead, broken glass, and animal feces because of poor manufacturing practices. Both the International Olympic Committee and a laboratory in Cologne, Germany have shown a high percentage of supplements are contaminated. In the Cologne laboratory, 634 different product samples from 214 suppliers were purchased from 13 countries around the world and analyzed for steroid hormones or their precursors. Eleven different steroids were found in 94 (14.8%) of the samples. In 66 (10%) samples, the results were equivocal. For more details in German, consult the laboratory's web site at http://www.dopinginfo.de. These results demonstrated that ingesting a supplement is risky for the athlete who is in jeopardy of drug testing for steroids.
Finding accurate information about supplements is difficult. Some of the most current information is on the Internet and I am now encouraging athletes and their families to read more about them. The National Center for Drug Free Sport at http://www.drugfreesport.com is a good resource, as well as the World Anti-doping Agency at http://www.wada-ama.org. For recent reports of recalled products and some information on products that have been tested, the FDA and Consumer Labs web sites are helpful at http://www.fda.gov and http://www.consumerlabs.com.
The passage of DSHEA in 1994 has made the ingestion of supplements like a game of roulette. A consumer never knows when a supplement might contain a contaminant or when a particular supplement is might be dangerous, until many people have been harmed. Taking a supplement, to paraphrase Forrest Gump, is like eating a box of chocolates, “you never know what you are going to get.”