The enzymes have been found to be contaminated with chloramphenicol, a potent antiobiotic. According to FDA, the contamination involved three lots of enzymes manufactured by Advanced Enzymes, a company based in Mumbai, India with a distribution subsidiary based in Chino, CA called Specialty Enzymes and Biochemicals Co.
Tangled web of contamination
FDA’s trace of the contamination trail is an illustration of the increasing complexity of global supply chains. According to the agency, Specialty Enzymes, which is both a distributor and a custom formulator, sold a portion of the affected lots to a distributor in Japan, which subsequently shipped and sold that affected product to the EU. The EU affected product that used the contaminated ingredient from Japanese distributor has found its way back to the US via further formulations made in Europe with the problem ingredient.
Specialty Enzymes also sold various custom formulations that it manufactured in California to a wide array of US food and feed manufacturers that subsequently used those formulations in the manufacture of conventional foods (beverages, baked goods, and others), animal feeds, and dietary supplements. Exactly how and why the contamination occurred is yet to be determined, according to the agency.
Wide-ranging recalls
Sources in the dietary supplement industry have said the resulting recalls could be the widest-ranging to date. Products contaminated with the ingredient have been recalled in the Canada and the US and the European Commission has issued notices on chloramphenicol in finished goods via its rapid alert network.
According to the Brussels-based Association of Manufacturers and Formulators of Enzyme Products (AMFEP), “there is no human health concern with regard to consumption of finished food prepared with these enzymes. Enzymes are used in very low doses in food processing and as the contaminated batches contain only minute amounts, only trace amounts would end up in the final food product.”
But, according to Health Canada, “This reaction is unpredictable and not related to a specific dose of chloramphenicol.”
In any case, AMFEP said it is a very serious issue and notes that “the use of chloramphenicol in the production of enzymes is not standard industry practice.”
Toxic side effects
Chloramphenical is an antibiotic that FDA ordered withdrawn from the market in oral forms for human consumption in July 2012. The drug can cause serious injuries including aplastic anemia, a type of bone marrow toxicity that in rare cases can lead to death. Because of its serious side effects, the drug is reserved for only the most serious cases in which less toxic drugs have been ineffective.
Chloramphenicol in various dosage forms is currently approved for use in non-food producing animals (dogs and cats.) The new animal drug applications (NADAs) for the oral solution form of chloramphenicol were revoked because of widespread illegal use in food animals, FDA said.
American Labs, based in Omaha, NE, has recalled nine products that may contain the contaminated enzymes. Products from at least two other US companies are reported to be affected with more sure to follow. To date FDA has issued no official statement on the scope of the contamination in the US. Health Canada has listed recalls of 26 finished products from 10 different manufacturers related to the contamination.
Supply chain security
The incident points to the vulnerability of global supply chains and the critical importance of vetting overseas suppliers. With ingredients potentially passing through so many hands, it’s vital that companies have a firm grasp on the issue both from a GMP compliance and liability risk management perspective.
“This is again going to raise questions about the sourcing of ingredients and the reliability of suppliers,” said Marc Ullman, an attorney based in Garden City, NY who represents dietary supplement and food companies. “How are manufacturers supposed to know to be testing for nonstandard antibiotics in their enzymes?”