In June, a number of people with similar symptoms became ill after attending an event in the Bordeaux region of France, according to a report by the European Food Safety Authority (EFSA). In both cases, the infection was linked to fenugreek sprouts harvested from a single farm in Germany. A “trace-back” report by EFSA found that the German producer had imported 75 kg of the tainted seeds from Egypt in 2009.⁷

Mathias Schmidt, PhD, a pharmacist with HERBResearch Germany, was puzzled by the outbreak. “What I do not understand is why the contamination was not discovered. Officially the manufacturers do microbiological testings, and E. coli is always part of the package,” he said (e-mail communication, September 7, 2011). “There are 2 possible reasons: Either the seeds were tested, and the problem was not detected as a random effect of sampling, or the material was not tested.”

Joe Veilleux, the general manager of Euromed U.S.A., is familiar with American regulations but does not deal with fenugreek or other fresh plant material. The mandatory screening procedures for Euromed’s products—standardized herbal extracts and natural active substances for the pharmaceutical, food, and cosmetic industries—eliminates the risk of E. coli contamination.

Veilleux explained that import regulations differ by product category. In the United States, he noted, herbal products are usually regulated as dietary supplements, a subset of foods. Both food and drugs are subject to guidelines known as current Good Manufacturing Practices (cGMPs), in which microbial testing is required. In order to be classified as a drug—which is seldom the case in the United States—each herbal ingredient in the product must go through a process that includes meeting stringent cGMP requirements for purity, plus human clinical trials to determine safety and efficacy. Dietary supplements, which have to meet high standards for identity and purity, do not have to go through the same rigorous testing for purity and safety as do drugs. “In Europe, because [our products] are more like medicine, many of the companies there require [the more stringent] drug GMPs,” said Veilleux (oral communication, July 24, 2011). 

Gencor’s Veeravalli said there is general confusion about the definition of organically produced products. “I think ‘organic’ by itself should not mean it’s safe or better,” he said. “The average consumer has got to be educated properly on what the product is and why we say organic is better.”

Although organic products are not immune from E. coli contamination, Veeravalli said this type of situation is rare in the herbal market. “I think every once in a while there is some [contaminated] product coming into the market, and one has to be a little cautious,” he said. “But it’s not the rule; it’s the exception.”

References