No new Escherichia coli infections have been reported in Europe since mid-July, marking the end of the deadliest E. coli outbreak in history.^1,2 The Robert Koch Institute (RKI), Germany’s disease control agency, identified fenugreek (Trigonella foenum-graecum, Fabaceae) seeds imported from Egypt as the source of the outbreak.³ More than 50 people died and approximately 4,400 people were left ill after eating raw fenugreek sprouts harvested from the contaminated seeds.⁴

“What I do not understand is why the contamination was not discovered. Officially the manufacturers do microbiological [testing], and E. coli is always part of the package,” said Mathias Schmidt, PhD, a pharmacist with HERBResearch Germany (e-mail, September 7, 2011). He added, “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.”

The E. coli outbreak began on May 21 when RKI reported a cluster of kidney failure cases in Germany associated with a particularly virulent strain of the bacteriaknown as Shiga toxin-producing E. coli (STEC), type O104:H4.³ Symptoms of STEC infection include severe stomach cramps, bloody diarrhea, and vomiting. In some serious cases, patients may develop hemolytic-uremic syndrome (HUS), which occurs approximately one week after exposure to the bacteria and can lead to kidney failure and, eventually, death.^5,6

As an herbal remedy, fenugreek seed is often used to treat symptoms associated with Type 2 diabetes by helping to normalize blood sugar levels. Fenugreek can also be used to treat loss of appetite, upset stomach, and can be applied topically to reduce inflammation.⁷ It also has traditionally been used as a galactagogue to increase breast milk production.⁸ Fenugreek sprouts are often eaten raw in soups and salads.

In June, a number of people with STEC infection-like 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 2009.⁹ According to the European Commission report, these organically-grown seeds contaminated with E-coli strain O104:H4 “[reflect] a production process which allowed contamination of fecal material of human and/or animal origin.”¹⁰

Imports to the European Union from foreign countries can include questionable sanitation credentials, Schmidt explained. “Of course you can [rely on] certificates of analysis delivered by the supplier, provided the lab is credible,” he said. “But with microbiology you never know who was in contact with the material between Egypt and the EU.”

Joe Veilleux, the general manager of EUROMED U.S.A.—a producer of standardized herbal extracts and natural active substances for the pharmaceutical, food, and cosmetic industries—is familiar with American regulations but does not deal with fenugreek or other fresh plant material.

“The only thing I would worry about is supply sources that aren’t doing all that testing,” said Veilleux. “Like everything else in our industry, you really need to stick with a quality source that you know does the testing. That’s the only way you’re going to eliminate the possibility of these kinds of things,” he said.

Import regulations differ by product category, Veilleux noted. In the United States, herbal products are usually regulated as dietary supplements, a subset of foods. Both food and drugs are subject to government-mandated manufacturing and processing guidelines known as current Good Manufacturing Practices (cGMPs); even though there are different sets of GMPs for dietary supplements and drugs, microbial testing is required for both.

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. Dietary supplements, which have to meet 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).

In July, the European Commission, an EU governing body, adopted emergency measures requiring member countries to remove and destroy specific lots of fenugreek seed imported from Egypt since 2009. Health officials from the German Federal Institute for Drugs and Medical Devices (BfArM) went a step further in requiring any medicinal products containing fenugreek seed to be removed from markets.¹¹ Further imports of the seed in all EU member countries were prohibited until October 31 of this year. In early September, however, Ukraine became the first country to resume importing Egyptian seeds and vegetables. More countries are expected to follow.¹²

“I think the BfArM overreacted by revoking the marketing authorizations of fenugreek-containing products, without even a re-test,” said Dr. Schmidt. “The new version of E. coli should have been detected even with the standard test battery.”

—Tyler Smith

References

1. Germany declares end to E. coli outbreak. Reuters. July 25, 2011. Available at: www.reuters.com/article/2011/07/26/us-germany-ecoli-idUSTRE76P42B20110726. Accessed July 25, 2011.

2. European Centre for Disease Prevention and Control. Rapid risk assessment: Outbreak of Shiga toxin-producing E. coli (STEC) in Germany. Available at: www.ecdc.europa.eu/en/publications/Publications/1105_TER_Risk_assessment_EColi.pdf. Published May 27, 2011. Accessed July 15, 2011.

3. EHEC/HUS Outbreak. Robert Koch Institute website. Available at: www.rki.de/EN/Home/homepage__node.html. Accessed July 25, 2011.

4. EU bans Egyptian seeds after link to deadly E. coli. Reuters. July 5, 2011. Available at: www.reuters.com/article/2011/07/05/uk-ecoli-europe-idUSLNE 76404S20110705. Accessed July 18, 2011.

5. Hemolytic-uremic syndrome. MedlinePlus website. Available at: www.nlm.nih.gov/medlineplus/ency/article/000510.htm. Accessed July 15, 2011.

6. Escherichia coli O157:H7 and other Shiga toxin-producing Escherichia coli (STEC). Centers for Disease Control and Prevention website. Available at: www.cdc.gov/nczved/divisions/dfbmd/diseases/ecoli_o157h7/. Accessed July 15, 2011.

7. Fenugreek seed. In: Blumenthal M, ed. Herbal Medicine: Expanded Commission E Monographs. Boston, MA: Integrative Medicine Communications; 2000. Available at: http://cms.herbalgram.org/expandedE/Fenugreekseed.html. Accessed August 8, 2011.

8. Herbs at a glance: Fenugreek. National Center for Complementary and Alternative Medicine website. Available at: http://nccam.nih.gov/health/fenugreek. Accessed July 14, 2011.

9. European Food Safety Authority. Tracing of seeds, in particular fenugreek (Trigonella foenum-graecum), in the context of an STEC outbreak in Germany and France. Available at: www.efsa.europa.eu/en/supporting/pub/176e.htm. Published July 5, 2011. Accessed July 17, 2011.

10. European Union. Commission implementing decision of 6 July 2011 on emergency measures applicable to fenugreek seeds and certain seeds and beans imported from Egypt. Available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:179: 0010:0012:EN:PDF. Published July 6, 2011. Accessed July 8, 2011.

11. Relevance of EHEC O104:H4 in fenugreek seeds which are processed into other foods than sprouts and germ buds. Bundesinstitut für Risikobewertung (Federal Institute for Risk Assessment). Available at: www.bfr.bund.de/cm/349/relevance_of_ehec_o104_h4 _in_fenugreek_seeds_wich_are_processed_into_other_foods_than_sprouds_and_germ_buds.pdf. Accessed August 11, 2011.

12. EU Likely to Lift Ban on Egyptian Seeds. Food Safety News website. Available at: http://www.foodsafetynews.com/2011/08/eu-likely-to-lift-ban-on-egyptian-seeds/