As a physician who has worked in the area of drug safety for many years, I was pleasantly surprised that Consumer Reports, published by Consumers Union (CU), has recently provided a well-reasoned overview of some of the problems with dietary supplements that have irritated me for years. (The article, titled "Dangerous Supplements" is in the September 2010 issue, starting at page 16, and the first few paragraphs are on-line for free at their website. The report is the cover story for the September issue, with the headline "The 12 Most Dangerous Supplements.")
The report points out that $26.7 billion was spent in 2009 on these products (unclear if that's worldwide sales, or only USA), and that the FDA has a terribly difficult job with surveillance of the market. The list of the problems that the FDA faces in regulating this industry includes:
- The FDA has limited ability to pull dangerous supplement products: as of now, they have banned only one product (ephedrine alkaloids)
- The FDA has identified ingredients that should never be sold, some as long ago as 1993, that are still on the market.
- FDA rules covering quality don't apply to companies that supply the ingredients, so products contaminated with heavy metals, pesticides, and even prescription drugs have been sold. Two examples: a product called "Herbal Viagra" was found to indeed contain prescription Viagra. And a Chinese "all-natural" product sold in the US, which was promoted as helping diabetes, was found to contain a prescription diabetes drug, glyburide.
- The FDA hasn't regularly inspected manufacturing facilities (according to CU, FDA hasn't inspected any factories in one big supplier nation, China, that has "repeatedly been caught exporting contaminated products")
- Supplements do not have to demonstrate that they work, nor that they are safe, before they are marketed. This is entirely different from the situation for a new prescription drug, which have to undergo rigorous (and lengthy and expensive) clinical trials to show that the drug has efficacy, and to identify what side effects show up in those trials.
- Until recently, supplement manufacturers weren't required to report serious side effects to the FDA.
- Although supplement manufacturers are not allowed to claim that their products can prevent, treat, or cure disease, they sometimes do: the FTC has filed or settled 30 cases in the past two years.
- Requirements for safety information on labels needs strengthening, including listing of potential drug interactions.
- Products have been sold that claim to contain one amount of the ingredient, yet on analysis are found to have vastly different. One product had 200 times the labeled amount of selenium
The dirty dozen supplements are in a table at the CU report. The purported indications,
possible dangers, and some comments, including FDA advice are provided for each. The 12 are aconite, bitter orange, chaparral, colloidal silver, coltsfoot, comfrey, country mallow, germanium, greater celandine, kava, lobelia, and yohimbe. If you are any of these, please let your physician know, and get off them ASAP.
CU also lists eleven supplements that people should consider using. As always, talk to your physician before starting any of these (or other supplements). The supplements to consider: calcium, cranberry, fish oil, glucosamine, lactase, psyllium, pygeum, SAMe, St. John's Wort, and vitamin D. Again, CU has a table describing the good and the bad for each, and also some drug interactions that could occur.
If you are taking a dietary supplement, or considering starting one, please read the CU report!