In its September 2010 edition, Consumer Reports (CR) identified 12 dietary supplement ingredients it says have been linked to serious adverse events. The report also criticized industry regulations and cited a lack of government oversight.

The “Dirty Dozen” supplements included aconite, bitter orange, chaparral, colloidal silver, coltsfoot, comfrey, country mallow, germanium, greater celandine, kava, lobelia and yohimbe.

Working with experts from the Natural Medicines Comprehensive Database, an independent research group, CR identified a group of ingredients (out of nearly 1100 in the database) linked to serious adverse events by clinical research or case reports. To come up with the final list, CR also considered factors such as whether the ingredients were effective for their purported uses and how readily available they were to consumers.

According to the report, FDA has warned about at least eight of these 12 ingredients, some as long ago as 1993; those eight supplements were chaparral, colloidal silver, comfrey, country mallow, germanium, kava, lobelia and yohimbe. The investigation also states that FDA has not made full use of authority granted by the Dietary Supplement Health and Education Act (DSHEA).

“Supplements are marketed with very seductive and sometimes overblown sales pitches for increasing your performance in the bedroom, slimming down or boosting your athletic prowess,” said Nancy Metcalf, senior program editor, CR. “And consumers are easily lulled into believing that supplements can do no harm because they’re ‘natural.’ However, some natural ingredients can be hazardous, and on top of that the FDA has repeatedly found hazardous ingredients, including synthetic prescription drugs, in supplements.”

The report also identified 11 supplements considered to be safe and effective: calcium, cranberry, fish oil, glucosamine sulfate, lactase, lactobacillus, psyllium, pygeum, SAMe, St. John’s Wort and vitamin D.

In a formal statement, the Natural Products Association (NPA), Washington, D.C., called the CR investigation “an attack on dietary supplements” that presents “a far from balanced and accurate representation of the industry or the laws that regulate it.”

The association noted that several of the mentioned products are actually illegal drugs. “The NPA questions the data Consumer Reports are using to suggest the dietary supplement industry suffers from inadequate quality controls. In actuality, evidence from the government suggests the contrary. Earlier this year, the U.S. Government Accountability Office (GAO) tested a number of products finding only trace amounts of contaminants, leading the FDA to testify before Congress that ‘we do not believe these levels represent a significant risk to health.’”

NPA went on to say the supplement industry has an “enviable safety record,” especially when compared with other FDA-regulated sectors.

In response to a USA Today editorial that addressed the CR article, Steve Mister, president and CEO, the Council for Responsible Nutrition (CRN), Washington, D.C., wrote a counterpoint piece, which stated in part: “The media circus surrounding the latest issue of Consumer Reports implicates the entire aisle of mainstream dietary supplements based on 12 ingredients that combined make up less than 1% of the marketplace. Yet given the attention, one would think these 12 herbs represent the mainstream dietary supplement aisle at your neighborhood pharmacy. They do not.”

According to the American Herbal Products Association (AHPA), Silver Spring, MD, much of the CR article is focused on individuals who suffered significant adverse events when taking products labeled as dietary supplements. These include one 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. The first of these products was an illegal drug, and not a dietary supplement, and the second failed to comply with good manufacturing practices, and so was adulterated, AHPA says.

“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.”