Posted on | October 21, 2009 | 2 Comments
Mike Magee MD
About 114 million Americans consume dietary supplements every day in America. That’s 1 out of every 3 citizens and 1 out of every 2 adults. What’s included in the general supplement waste basket? Vitamins, minerals, botanical products, amino acids and tissue extracts. Before 1994 herbal products were considered food additives and regulated by the FDA. That meant that manufacturers had to show proof of safety and conform to proper labeling of benefits and risks. Not anymore. The 1994 Dietary Supplement Health and Education Act presumed these things to be safe, and now they are marketed with minimal oversight.1
Consumers are largely unaware. They think the government is on the job, checking their safety and their labeling. That’s not true. And a lot of doctors are unaware as well. One study of primary care doctors showed that 1/3 thought dietary supplements required FDA approval.2 They don’t. They also didn’t know that problems with the supplements are supposed to be reported to the FDA.
This lack of knowledge is all the more alarming considering what’s in these products including toxic plant material, heavy metals and at times bacteria. But beyond that, they’re increasingly also contaminated with prescription medicines, experimental drugs, and drugs that have already been rejected for approval by the FDA. What kind of drugs? Stimulants, steroids, anti-depressants, anti-anxiety drugs, and diet suppressants – some at doses three times mormal. And not just one drug contaminant, but frequently combinations of illegal drugs.1
Many of the worst offenders sell over the Internet, but investigators frequently find them on traditional shelves in the US.1 And since patients and their doctors are largely unaware, these supplements are often overlooked when a patient comes to the doctor’s office sick. Many of the products come from overseas, especially China, but there have been convictions in the US, like California’s American Cellular Labs raided in 2009 for producing supplements that contained anabolic steroids.3
My best advice for patients and their doctors? Maintain a high index of suspicion when it comes to supplements. If a patient turns up sick, don’t forget to check if they’ve taken supplements; and if you have any suspicion, send the pill to a lab to be analyzed and inform the FDA. As for Congress, give the FDA authority to properly regulate supplements. It’s an action that’s long overdue.
1. Cohen, PA American Roulette – Contaminated Dietary Supplements. NEJM. 361;16, October 15, 2009; 1523-1525.
2. Ashar BH et al. Physicians’ understanding of the regulation of dietary supplements. Arch. Int. Med.2007;167:966-9.
3. Lai V, et al. Severe hepatic injury and adulterated Chinese medicines. BMJ, 2006; 332:304-305.