On July 6, the European Commission directed all European Union (EU) Member States to immediately withdraw from the market and destroy certain lots of fenugreek seed (Trigonella foenum-graecum L.) imported from Egypt.
In addition to fenugreek food and feed recalls, Germany became the first EU member to also recall fenugreek active-drug substances and finished herbal-medicinal products (HMPs) containing fenugreek seed as well as fenugreek active pharmaceutical ingredients in inventories waiting to be used in HMP manufacture.
In the EU, fenugreek herbal tea or extract is regulated as a traditional HMP for temporary loss of appetite.
The recall comes on the heels of new evidence that Egyptian-grown fenugreek seed is the likely source of the deadly outbreak of Shiga-toxin Escherichia coli or STEC that has killed 48 people in Germany and one in Sweden and has sickened more than 4,000 across Europe since May of this year. Fenugreek seeds are used as sprouts as well as an ingredient in many food products. Among its more common medicinal uses is the treatment of digestive problems (including ulcers), loss of appetite, and inflammation.
In a press release issued July 8 by the German Federal Institute for Drugs and Medical Devices (BfArM), based in Bonn, German authorities were ordered to remove active substances and finished medicinal products that contain fenugreek seed imported from Egypt from 2009 - 2011. The order is in compliance with a broader EU ruling that obligates all EU member states to remove specific lots of fenugreek seed from the EU market that were imported during the corresponding time frame. The further import of all Egyptian seeds and beans for sprouting has been halted until at least the end of October.
A report issued by the European Food Safety Authority (EFSA), based in Parma, Italy, says a "trace-back" investigation--which identifies the distribution and production of products--points to a specific lot (#48088) of 15,000 kg. of organic fenugreek seeds grown in Egypt as the likely common link between the STEC outbreak in Germany last May and a more recent one in France in late June. The seeds were exported from Egypt in November of 2009 and imported first into Germany, the United Kingdom, Austria, and Spain, but other countries could be affected, as well. The EFSA report makes clear that it is difficult to trace the exact whereabouts of the contaminated seed lot because of the relabeling, repackaging, or mixing of products during distribution in different countries.
According to the report, the seeds likely became contaminated with human or animal fecal material at the farm level, well before leaving the EU importers for other points of distribution. It's likely, too, that even though the number of cases of STEC appears to be dwindling, some of the seeds still remain in the supply chain, says EFSA.
"There have been no reports of any contaminated fenugreek food- or supplement-safety issues that have occurred in the United States or cases that have originated in the Unites States that we are aware of," said Steven Dentali, Ph.D., AHPA's chief science officer. "U.S. producers may nonetheless want to review their inventories to see if they have any Egyptian-source fenugreek seed and take appropriate action to ensure public safety."
Josef Brinckmann, vice president of research and development for Sebastopol, Calif.-based Traditional Medicinals, who provided AHPA with an English translation of the BfArM press release, also noted that German authorities are considering accepting the release into commerce of batches of fenugreek seed that have undergone certain steam-treatment processes validated for lethal kill of pathogenic bacteria.
AHPA will keep its members informed about any new developments in this matter. For more information, contact Steven Dentali via email or phone at 301.588.1171 x103.