SimplyThick Infant Formula Experiment

John L. Holahan—SimplyThick®—Xanthan Gum

John L. Holahan, SimplyThick® president/patent holder, showcased his xanthan gum adult dysphagia-treatment product at the American Dietetic Association trade show in October 2001. This presentation and followup sales promotions contractually linked the SimplyThick® product to nursing home centers, home health agencies, state Medicaid formularies and neonatal intensive care units.

The FDA has been investigating whether the SimplyThick product was the causative factor in infant deaths and illnesses.

FDA Restricted to Post-Injury Product Recall Power

The public is likely not aware that SimplyThick® entered the elder/infant health care market without FDA knowledge or assent. Food additive safety concerns become governmental matters only after injurious incidents. The FDA was relegated an after-the-fact agency in 1958.

Burdock Group SimplyThick Safety Assurance

Xanthan gum SimplyThick infant formula safety assurance was provided by the Burdock Group in 2001. The Burdock Group generally recognized as safe (GRAS) rationale was based on one dated (1987) industry-sponsored clinical trial study titled "The dietary effects of xanthan gum in Man."

SimplyThick®—Necrotizing Enterocolitis

The SimplyThick®/necrotizing enterocolitis incidence link was raised in 2005 by a neonatal intensive care nurse who wrote:

Does anyone else use Simply Thick in NICU? We have been using it for about a year and a half and coincidentally it seemd to be the year of NEC now.

This information indicates that the SimplyThick infant formula product was being prescribed for neonatal intensive care patients in 2003. For further information please see SimplyThick Neonatal Intensive Care Practices.

SimplyThick®—product safety—became a publicly-known issue in May 2011 when in response to medical centers' SimplyThick death/illness notifications the FDA released warnings stating that the xanthan gum formula additive posed health risks to premature infants.

As a result of continuing adverse event reports, the FDA expanded the SimplyThick® necrotizing enterocolitis risk factor to encompass all infants in September 2012.

Health Canada posted a SimplyThick® necrotizing enterocolitis advisory in October 2012. Canadian health authorities have verified two cases of SimplyThick necrotizing enterocolitis incidents.

FDA Multi-Country SimplyThick® Recall

The FDA determined in June 2011 that SimplyThick products manufactured at the Thermo Pac facility (June 1, 2009-June 3, 2011) did not include "an adequate pathogen kill step."  For additional information please see Thermo Pac, LLC—SimplyThick—Processing Deficiencies.

In addition to the U.S. and Canada, the countries in receipt of the recalled SimplyThick product include: Puerto Rico, Guatemala, Ecuador, Panama, Barbados, Cayman Islands, and Italy.

SimplyThick® Necrotizing Enterocolitis Case Histories

SimplyThick® NEC case studies investigated by the FDA involved twenty-two infants greater than 37 weeks post-menstrual age. Nineteen infants developed NEC, fourteen required surgery and seven of those died. Jay Hochman, an Atlanta pediatric gastroenterologist, reviewing the J Pediatr 2012; 161: 354-6 data noted that the time of SimplyThick feeding and necrotizing enterocolitis onset varied:

• 9 patients –1-10 days
• 7 patients –11-20 days
• 6 patients –>20 days
• Median –13 days

Dr. Hochman is of the opinion that "since most cases of NEC occur in the hospital and are associated with extreme prematurity, these cases are unusual & likely causally related to the use of SimplyThick."

The "Late onset necrotizing enterocolitis in infants following use of a xanthan gum-containing thickening agent" authors, according to Dr. Hockman, "postulated that an increased production of short-chain fatty acids by breakdown of xanthan gum component was the mechanism for SimplyThick to increase the risk of NEC."

Xanthomonas Campestris—Gram-Negative Bacteria—Xanthan Gum Endotoxins

Xanthomonas campestris, a plant-causing-disease bacterium, is the food thickener/pharmaceutical lubricating source of xanthan gum. The viscous properties of xanthan gum are also applicable for oil and gas drilling endeavors. To obtain the xanthan gum biopolymer powder, Xanthomonas campestris microorganisms are fermented in nutrient-rich (generally corn derivative) broths and extracted by alcohol precipitation.

Because xanthomonas campestris is a gram-negative bacteria, the conversion to xanthan-gum process releases lipopolysaccarides (endotoxins). As explained by Monsanto researcher, John L. Holahan et al. (1999) 14 grams of Keltrol T xanthan gum dissolved in 2 liters of water will produce in excess of one million eu (endotoxin units) per gram of dry unpurified xanthan gum.

Pharmaceutical grade xanthan gum should be free of endotoxins but this goal is generally not achievable. The level of endotoxins present in food-grade xanthan gum
i. e. SimplyThick® is not known.

Xanthan gum as described by the U. S. Foreign Trade Commission, "is a naturally-derived stabilizer of water-based solutions that is used primarily for its thickening, stabilizing, and suspension properties in a wide variety of products and industries.

The Centers for Disease Control and Prevention report that:

Gram-negative bacteria cause infections including pneumonia, bloodstream infections, wound or surgical site infections, and meningitis in healthcare settings. Gram-negative bacteria are resistant to multiple drugs and are increasingly resistant to most available antibiotics. These bacteria have built-in abilities to find new ways to be resistant and can pass along genetic materials that allow other bacteria to become drug-resistant as well.

Xanthan Gum is Profitable End Product for Dairy & Agro Industry Waste

Sbang-Tian Yang noted in his 1989 Pollution Prevention/Waste Minimization presentation that Whey Permeate, a dairy industry waste by-product, "can be used as a substrate for xanthan fermentation, thus lowering the BOD on sewer systems, reducing disposal costs, and generating a high-value marketable product."

U. S. and international researchers continue to probe industry waste residue as possible cost-effective xanthan gum fermentation mediums. A 2012 research proposal outlined utilization of agro-industrial fruit/vegetable peels as viable substrates for xanthan gum synthesis.

Xanthan Gum Safety Considerations

Since xanthan gum health-effect studies are dated and the trials primarily industry-sponsored projects, the referenced generally recognized as safe conclusions are plausibly irrelevant.

Xanthan gum, a 1950s US Department of Agriculture invention, entered the marketplace in 1964. Early 1960s rat and dog xanthan gum feeding regimens indicated that xanthan gum should pose no acute human health risk.

As a food additive xanthan gum was approved quantum satis, in other words, any amount is deemed safe for consumption. Four counties are producing xanthan gum: U.S., China, France, and Austria.

Because xanthan gum is ubiquitous in food and present in pharmaceutical supplies, tracing product usage to harmful medical events is problematic.

Two xanthan gum facts are known:

—Gram negative bacteria are antibiotic resistant and can manipulate DNA. For additional information on this topic please visit the Xanthomonas Genomics Conference Web site.

—SimplyThick (xanthan gum) has been substantively linked to infant necrotizing enterocolitis disease.