When Consumer Reports (CR) first identified its “Dirty Dozen” dietary supplement ingredients in 2004, the media became very excited and reported broadly on this “news” and its catchy moniker. But there were a lot of problems with the list, and AHPA’s Steven Dentali, Ph.D. submitted a letter to the editor to provide some clarity:
- FDA had already forbidden the sale of herbs that contain aristolochic acid in the U.S. This was included on that 2004 list, as the only “definitely hazardous” material.
- It was wrong to say that skullcap (Scutellaria lateriflora) damages the liver, when it had been well established that case reports suggesting such effects should be attributed to adulteration with germander (Teucrium chamaedrys), which was not meaningfully present in the marketplace. Both skullcap and germander were on the 2004 list.
- The issue with pennyroyal (Hedeoma pulegioides) is related to internal use of the essential oil, not the herb itself. And while it was the oil that CR included in its “dozen,” only products made from the herb were identified.
- Federal regulators had acted as early as 2001 to remove comfrey (Symphytum officinale) from the market when offered for sale for internal use.
But apparently the tagline was too good to give up, so this year’s “Dirty Dozen,” just reissued in its September edition, has been repopulated with six other ingredients that again betray a lack of expertise. The four new herbs on the list are aconite, country mallow (Sida cordifolia), greater celandine (Chelidonium majus) and coltsfoot (Tussilago farfara).
As Matt Lauer said on the Today Show while interviewing Nancy Metcalf, CR’s Senior Program Editor on August 3rd: “I haven’t heard of most of these things.”
But even though these herbs might not be on the tip of everyone’s tongue or be key marketplace ingredients (Mark Brush at Nutrition Business Journal issued “A Response to Consumer Reports’ Scary Supplements” yesterday and provided figures that estimate the cumulative sales of these 12 ingredients as ~0.2 percent of the annual supplement market), Dr. Dentali offers the following thoughts:
- Aconite: In the U.S. aconite is primarily available as a homeopathic medicine, which has not been associated with any of the potentially toxic constituents in the plant itself. AHPA recommends that aconite root be excluded as an ingredient from dietary supplements available for retail sale.
- Coltsfoot: AHPA has recommended since 1996 against the oral use of any herb that contains toxic pyrrolizidine alkaloids – including coltsfoot and also comfrey, which was retained by CR from its 2004 list. The Food and Drug Administration declared in 2001 that it considers any product for oral use that contains toxic pyrrolizidine alkaloids to be adulterated, and the Federal Trade Commission has also acted against the sale of such products.
- Sida cordifolia: CR has identified a concern about “country mallow” based on “possible dangers linked with its ephedrine alkaloids.” If there is any ephedrine in Sida cordifolia, however (recent research suggests that there is not), it is present only at a very low level, less that 0.1 percent. And if this herb was, in fact, providing ephedrine it would not be legal to use in a dietary supplement.
- Several of the other herbs that were identified in both 2004 and CR’s current list are labeled to inform consumers of safety issues material to their use. For example, AHPA maintains a labeling policy for kava (Piper methysticum) that provides information that is consistent with FDA’s 2002 Consumer Advisory on this herb. And chaparral (Larrea tridentata), lobelia (Lobelia inflata), and yohimbe (Pausinystalia johimbe) are all classified by AHPA’s Botanical Safety Handbook in categories that identify specific cautions.
Much of this article is focused on individuals who suffered significant adverse events when taking products labeled as dietary supplements. These include one unfortunate man who took a product found to be laced with a synthetic steroid, and another who suffered from a product found to contain 200 times as much selenium as was stated on its label. But the first of these products was an illegal drug, and not a dietary supplement, and the second failed to comply with good manufacturing practice, and so was adulterated.
“Consumer Reports is attempting to draw broad conclusions about the regulation of dietary supplements based on anecdotes related to products that do not represent the mainstream,” noted Michael McGuffin, AHPA President. “This tone is unfortunate and misses an opportunity to express support for the efforts of responsible industry players to improve enforcement of the good laws already in place.”