An FDA Enforcement Report for the week of November 13, 2013, requested a voluntary recall of Xylanase after the discovery September 30th, citing that products may be contaminated with Chloramphenicol.
Enzymes manufactured by Advanced Enzymes in Mumbai, India may result in one of the most widespread recalls of products in history. The incomplete list that follows represents primarily digestive enzymes. More products are being added daily. To date, the FDA has issued no official statement on the scope of the US contamination, though there has been a recall alert in Canada. Not only are dietary supplements affected, but also various baked goods, beverages and animal feed are now contaminated with Chloramphenicol residues that have infiltrated the United States (U.S.), Canada, Japan and the European Union (EU).
Sales from India to Japan began the chain of contamination, which traveled through the EU and onward. A manufacturing plant in Chino, CA, (Specialty Enzyme and Biochemicals Company) was the point of entry into the U.S. where the tainted products were released to food and feed manufacturers.
This is a wake-up call to manufacturers who adhere to Good Manufacturing Practices (GMPs) in the U.S. to hold their suppliers to the same high standards they subscribe to; not trusting in promises, but visiting raw material suppliers on site in unscheduled inspections. This is an added expense; however, liability issues come into play so to neglect vetting suppliers is a false economy.
In an era of increased focus on food sourcing, integrity and transparency in labeling, this is a violation of the highest order adding one of the most dangerous, banned antibiotics to an increasing burden of antibiotic resistance in a general population fully awake to the multiple assaults against them.
Sadly, there has been a lack of media attention in response to one of the largest recalls in recent history and you may still be consuming contaminated product if your supplier lacked the integrity to participate in the voluntary recall.
Chloramphenicol is quite familiar to the National Health Federation (NHF), as we recently attended the Codex Committee on Residues of Veterinary Drugs in Food (CCRVDF) in August 2013 to fight to ban this potentially fatal drug in our food supply. Chloramphenicol is a veterinary antibiotic and an unexpected “solution” to sanitizing manufacturing equipment as in the case of this recent contamination in India.
NHF was the only health-freedom organization in attendance at Codex and also the only one with the right to fight against vet residues of drugs in our food, beverage and nutritional supplement supply and we won! The news release summarizing the results of CCRVDF is at this link on the NHF website: http://www.thenhf.com/article.php?id=3664. At the time of this Codex meeting, it was not common knowledge that India was washing equipment with a soon-to-be contraband, dangerous antibiotic. Had NHF known this, we would have argued against this on your behalf as well.
At CCRVDF, NHF successfully argued to get nine out of 10 antibiotics banned in the global food supply entering the U.S. as imports. One of those antibiotics was deadly Chloramphenicol, which is used in imported meat producing animals and aquaculture, primarily shrimp and clams. It is banned in the EU, Canada and United States, yet illegal use of inexpensive Chloramphenicol to treat seafood products remains a possibility due to its broad-spectrum antibiotic activity. This is a concern as dangerous Chloramphenicol has among listed side effects aplastic anemia leading to leukemia.
Even pro-drug-industry Wikipedia has this to say about this toxic antibiotic, which NHF demanded banned at CCRVDF, “Chloramphenicol…is both cheap and easy to manufacture and it is frequently an antibiotic of choice in the Developing World…The most serious adverse effect associated with Chloramphenicol treatment is bone marrow toxicity, which may occur in two distinct forms: bone marrow suppression, which is a direct toxic effect of the drug and is usually reversible, and aplastic anemia, which is idiosyncratic (rare, unpredictable, and unrelated to dose) and generally fatal.”
Potent Chloramphenicol has excellent blood-brain barrier penetration as well as passing through breast milk. A 20-g cumulative dose seems to be the tipping point into serious disease, even increasing chances for childhood leukemia. While these potentially fatal levels seem unlikely to be obtained by the amount of Xylanase present in digestive enzymes, consider the unnecessary introduction of antibiotics into our system in nutritional supplements and the potential for accumulation by consuming it regularly with the addition of other Chloramphenicol tainted foods and beverages.
In nutritional supplements, Xylanase was the ingredient contaminated by Chloramphenicol. It is used to break down cornstarch, which leads to a whole other issue: get verified non-GMO nutritional supplements from a reputable source like Mountain Health Products, which only stocks pharmaceutical-quality supplements in over 30 professional lines. Sharon Lynn, owner of Mountain Health Products, shared how this problem was resolving from her standpoint as a raw materials purchaser, “A clean form of Xylanase is now available but to be on the safe side I requested reformulations of our product lines without Xylanase in them.” She added, “Make sure you ask your retail supplier, if you buy from them instead of a professional quality line, if their product contains Xylanase as the recall was voluntary. Vendors lacking integrity will simply choose not to say anything.” And they must not have as this has not been prominent in the media.
The contamination initiated in India blindsided supplement manufacturers. How are manufacturers supposed to know to test for non-standard items like antibiotics in their enzymes? Sharon Lynn added, “If this is happening with Xylanase where they are washing their equipment down with Chloramphenicol, we can assume it may be happening with other supplement ingredients as well.” This kind of deception, so recently evident in the Chinese food supply as well, raises doubt and trust issues between consumers and suppliers. This is one of the main reasons NHF has a strong, protective presence as food and supplement regulators at Codex where these guidelines and standards are set for the World.
What you can do to cut your chances of contamination:
- Demand to know the source of your raw ingredients, whether supplements, beverages or food.
- Buy from only reputable sources that adhere to Good Manufacturing Practices.
- Good manufacturing practices (GMPs) are guidelines that provide a system of processes, procedures and documentation to assure a product has the identity, strength, composition, quality and purity that appear on its label. NSF International’s GMP Registration Program enables manufacturers to become independently registered by NSF to meet GMP requirements. The program is open not just to manufacturers of dietary supplements but also to manufacturers of ingredients and raw materials, as well as distribution, warehousing and packaging companies, who want to demonstrate their commitment to public safety.
- Insist on non-GMO nutritional supplements and foods.
- Support the ongoing work of NHF ensuring these dangerous contaminants are kept out of the food, beverage, and nutritional supplement supply by joining and donating at www.thenhf.com. NHF has no government funding and relies on the public solely for financial support to continue representing consumers on the Global level as food regulators with a highly successful track record.
Katherine Carroll writes for several blogs and magazines, and is the associate editor of NHF’s Health Freedom News. Carroll is a nutritional therapy practitioner and clinic administrator at her and her husband Donn Carroll’s optometry offices.
Published on WholeFoods Magazine Online, January 7, 2014
The following statement from Specialty Enzymes was posted on its Web site on November 5, 2013
Specialty Enzymes & Biotechnologies announced last month a voluntary recall of specific lots of enzyme product because they have the potential to be contaminated with trace amounts of the antibiotic chloramphenicol. These lots represent a very small fraction of annual production. All customers affected by this recall have already been notified.
Specialty Enzymes consulted a leading scientific firm to evaluate health risk, no matter how remote. Based on a comprehensive scientific analysis, the firm determined that in this case, the probability of a serious adverse health consequence is remote. Though unlikely, any other potential consequences would be temporary or medically reversible. As a precautionary measure, Specialty Enzymes conducted a voluntary recall of the specific lot numbers affected by this issue.
For nearly 30 years, Specialty Enzymes has distributed high-quality enzyme solutions to customers throughout the nation and the world. This is the first time the company has ever issued a product recall. We do not use chloramphenicol in the manufacture of our products. Rather, the issue is believed to originate with certain raw materials used by Specialty Enzymes in the manufacture of its product. We deeply apologize for any inconvenience caused to our customers, and have taken comprehensive measures to quickly and effectively address the issue.
Moving forward, Specialty Enzymes is conducting rigorous multi-level testing of all products. This includes independent third-party laboratory testing before raw materials are sent to Specialty Enzymes and re-testing of the same materials prior to acceptance in our facilities. As an added precautionary measure, we are also testing our finished products before they are shipped to our customers. Finally, we have engaged a reputable independent consultant to conduct a root cause and corrective action analysis at the supplier’s facility. Specialty Enzymes remains committed to consumer safety, quality products and customer satisfaction.
Specialty Enzymes is working closely with the FDA and other regulatory bodies to bring a swift and thorough resolution to this matter. Please do not hesitate to contact us with any questions.