Addendum to Weiner, M.L. (2016) Parameters and Pitfalls to Consider in the Conduct of Food Additive Research, Carrageenan as a Case Study.

Does Carrageenan Have Side Effects

Does Carrageenan Have Side Effects?

 

Carrageenan Safety

New study proves no adverse effects of carrageenan in human cells

Effects of carrageenan on cell permeability, cytotoxicity, and cytokine gene expression in human intestinal and hepatic cell lines

TH HAND OUT WAITING FINAL APPROVAL

RESOURCE LINKS & NEWS

Social and economic dimensions of carrageenan seaweed farming

Exhibiting at the Long Horn IFT September 22, 2016 Booth 254

The common food additive carrageenan is not a ligand for Toll-Like-

Previous Research on Food Additives Deemed “Faulty”

Polysaccharide Gums May Promote Probiotic Growth in Milk – See more at: http://www.nutritionaloutlook.com/science/polysaccharide-gums-may-promote-probiotic-growth-milk#sthash.WaTCIqzu.dpuf

WHY IS CARRAGEENAN IMPORTANT

Ingredients Like Carrageenan Make Healthy Choices More Convenient

POLYSACCHARIDE GUMS KEEP PROBIOTICS ALIVE IN YOGURT, NEW STUDY FINDS

https://transforming-science.com/new-research-finds-natural-method-to-keep-probiotics-alive-in-products/

 

Carrageenan Safety / An Exposé

  1. Is Carrageenan Natural

Here is a quote from the FDA website. “The FDA has not developed a definition for use of the term natural. However, the agency has not objected to the use of the term if the food does not contain added color, artificial flavor or synthetic substances”. Synthetic substances, as defined by the USDA, are those substances created by the reaction of two or more chemicals. Carrageenan is extracted from seaweed as a fully formed substance and does not require the reaction of two or more chemicals. Therefore carrageenan is a non-synthetic food additive and can be used in food labeled as natural.

2 . Customer Complaints

The reason customers develop the attitude toward carrageenan that they do is the result of an internet campaign based on false or incomplete research. The campaign has been perpetuated by professional bloggers and so-called “Comsumer Advocate” groups who have an interest in keeping the campaign alive. Most research being referred to is the work coming from the laboratory of Dr. Joanne Tobacman of the University of Chicago. Before exploring Dr. Tobacman’s research; a little background.

3.The History of Carrageenan Toxicology

Carrageenan first became a commercial food additive in the early 1930s when Krimko, a dairy company, began using carrageenan to suspend the coca in chocolate milk. It was not until the 1960s that the toxicology of carrageenan began to be studied seriously. There is available, a very thorough review paper published in 2014 with over 150 references on animal (in vivo) feeding studies. (This paper can be provided if desired.) All of the studies performed with Good Laboratory Practice (GLP) using food grade carrageenan showed no abnormal effects save for softened stool when excess doses were fed to the animals.

Many of the studies were carried out with a non-food grade derivative of carrageenan known as degraded carrageenan or poligeenan. Poligeenan is a known toxic substance that is an animal carcinogen. The only relation between carrageenan and poligeenan is that carrageenan is the raw material from which poligeenan is produced by treating it with strong acid at high temperature. The molecular weight of poligeenan is so low as to be totally non­functional as a food additive. Thus there is no reason for it being food grade carrageenan. Suspicions have been raised over the years that carrageenan is hydrolyzed to poligeenan in the stomach; but careful recent studies have dispelled that concern. These studies have shown that carrageenan is indigestible in the GI tract and virtually 100% is excreted with the feces. If carrageenan is not hydrolyzed in the stomach then there is no poligeenan like material present to cross the intestinal epithelium and cause the problems known to be caused by poligeenan.

Backing up these toxicology studies is the fact that after 80 years of carrageenan being consumed by humans (and pets in pet food, there have been no documented instances of health problems other than occasional soft stool or diarrhea from excessive consumption of product containing carrageenan.

4.The in vitro Studies of Dr. Tobacman

The concern of today’s customer leads back to the work of Dr. Tobacman and her team. They have introduced in vitro (bench top) studies based on molecular biology. They have studied the interaction of carrageenan with particular genes related to specific functions of intestine, liver or kidney cells. We and many others question the applicability of this technology to what happens when a primate consumes carrageenan in food. For instance, food containing carrageenan will usually contain protein and carrageenan binds to protein, so it is unavailable to interact with genes in the walls of the GI tract.

Dr Tobacman also argues that carrageenan penetrates the intestinal epithelium. If this was true and the carrageenan entered the general (blood) circulation would definitely cause a variety of disease syndromes. To dispel this hypothetical argument, ISI is participating through Marinalg, the industry association, in studies being carried out By Dr. James McKim. Jim is a world class toxicologist with universally recognized expertise in in vitro toxicology. He has already completed work which is about to be published showing the interaction of carrageenan with genes is a physical adsorption mechanism and not a biological interaction, thus no disease implication. Jim is about to complete a study proving that carrageenan even of very low molecular weight does not penetrate the intestinal epithelium and does not enter the general circulation.

He has also addressed the comment about diabetes raised by some. The Tobacman work on diabetes was particularly badly performed and certainly not under GLP. Therefore it is impossible to ascribe the effects noted to carrageenan by itself. Purity, including freedom from endotoxins in the carrageenan and the animal drinking water, were not determined. There is no dose response data reported, a requirement in any toxicology study.

  1. Concluding Remark: Carrageenan is a Thoroughly Studied and Safe Food Additive

There is nothing in the work cited in this report to suspect that carrageenan is an unsafe food additive. Under the purity criteria of government regulators, carrageenan is a perfectly safe food additive. The terrible publicity on the Internet getting to consumers is the real problem. So far the carrageenan industry has been unable to get ahead of the anti-carrageenan internet crowd, but new approaches are under consideration.

ISI’s staff, of course stands ready to answer more specific questions.

 

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Access the article “k-Carrageenan from marine red algae, Kappaphycus alvarezii – A functional food to prevent colon carcinogenesis” by clicking on the CGN link below;

CGN

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The common food additive carrageenan is not a ligand for Toll-LikeReceptor 4 (TLR4) in an HEK293-TLR4 reporter cell-line model James M. McKim Jr., Paul C. Wilga, Jeffrey F. Pregenzer, William R. Blakemore

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Why You Should Care About Carrageenan

Marinalg: Joint FAO/WHO Expert Committee on Food Additives (JECFA) Affirms Carrageenan Safety for Use in Infant Formula

Carrageenan now approvedby the Joint FAO/WHO Expert Committee on Food Additives (JECFA) for use in liquidinfant formula.  See link below;

JECFA 79 Summary Version Final

Carrageenan has been used safely in a wide variety of foods for over a century. While most consumers are not even aware of it, the Today Show just did a segment on “Strange-Sounding Food Ingredients”, which included a segment on Carrageenan. Watch the segment from The Today Show here;

 

Carrageenan, a Versatile and Safe Food Ingredient

Let Science and Facts Guide You

 Carrageenan has become an essential ingredient in a wide variety of foods we consume every day such as flavored milks, stabilized milk substitutes such as soy, processed deli and fresh meats, and as a vegetable-based gelatin replacer.

Carrageenan has a number of positive attributes in today’s food environment.  Carrageenan can be used in foods labeled Organic and is considered Natural. Ingredients Solutions Inc. has carved out a niche in the US market by being the leading marketer of Natural Grade (Semi-Refined) carrageenan, a minimally-processed type of carrageenan.  Natural Grade carrageenan is lower in cost than the highly refined types but equally effective in the applications noted above.

The fact that carrageenan is a seaweed extract gives it a certain cache among those consumers seeking “green” and “sustainable” products.  Seaweeds grow in seawater without the need for fertilizers, pesticides or herbicides.  The predominant seaweed types producing carrageenan (Kappaphycus and Eucheuma spinosum) grow naturally on tropical reefs.  To augment the natural harvest these two seaweeds have been farmed by coastal fisherman predominantly in Philippines and Indonesia for the last forty years.  As fishing in these areas has declined, seaweed farming has become the principal income for this population.  So, there is a social-economic empowerment associated with the carrageenan industry.

Let’s return to carrageenan’s attributes as a food ingredient.  Carrageenan from the two tropical seaweeds noted in the previous paragraph give a wide range of textures or “mouth feel”.  These textures range from rigid to elastic gels and in suitable blends with other gums can have the texture of salves or pastes.  If carrageenan from cold water seaweeds are added to the mix free flowing viscous solutions can be formulated.

Another attribute of carrageenan is its ability to bind water.  Syneresis control is important in processed meats.  Without carrageenan in the mix of gums used in processed meats, controlling package purge would be an even bigger problem than it already is.  Syneresis control also plays a role in fragrance release in air fresher gels an important application for carrageenan.  While not a food application it is worth mentioning.  Carrageenan is also a synergistic gum.  That is, it can be formulated into blends of gums to make stronger gels than with a single gum. Blends can also be formulated with lower syneresis than can be achieved with a single gum.

Probably the most unique property of carrageenan is its ability to interact with proteins, a special type of synergistic behavior.  Milk protein forms a particularly strong bond with carrageenan.  Suspending the cocoa in chocolate milk requires only a few hundred parts per million while also imparting a whole milk-like mouthfeel in a low fat milk.  Protein synergy in meat is less than in milk, but it still plays a role in enhancing the sliceability of deli meats. Carrageenan is also gaining use in fresh meats to improve juiciness and reduce cook loss.

Turning to the safety of carrageenan, there has been an amazing amount of unsubstantiated blogging about carrageenan being unsafe as a food ingredient.  In spite of this misinformation, carrageenan continues as the safe food ingredient it has always been.  If it were not, the principal regulatory agencies of the world (US FDA, FAO/WHO JECFA, EU EFSA, and Japan Ministry of Health) would not continue to approve its use, and all of them give the necessary approvals for use in all the applications noted above.  The only application restricted as a precautionary measure is stabilizing liquid infant formula.  Definitive toxicology is about to be published that is expected to remove this restriction.  One fact very much in carrageenan’s favor on the safety front stems from very low use levels. Furthermore, being a relatively expensive ingredient it is only used in applications where its unique functionalities justify its use.

Why all the concern about the safety of using carrageenan in foods?   Starting in the 1960s there have been research studies showing that if excessive doses of carrageenan are consumed in animal trials inflammation can be induced in the small intestine.  Likewise, inappropriate methods of introducing the carrageenan into the animals can create a similar inflammatory response, i.e. feeding carrageenan to the animals in their only source of drinking water.  However, there has never been a validated inflammatory response in humans over the seventy plus years carrageenan has been used in foods.  The anecdotal “upset tummies” reported in blogs as coming from consuming a food containing carrageenan are hardly reliable sources of toxicological information on the safety of carrageenan.

Inflammatory responses in animals only occur when carrageenan can cross the blood membrane barrier of the small intestine. This only occurs when the extreme feeding conditions mentioned above are employed.  Normal feeding regimes induce no such response.

Over the last decade a group of molecular biologists at the University of Illinois at Chicago lead by Dr Joanne Tobacman have explored the in vitro interaction of carrageenan with various genes involved in inflammatory diseases. They concluded that carrageenan can cause inflammation in the gut via a binding mechanism involving TLR-4 receptors.  This group also concluded that carrageenan degrades in the gut and the degraded carrageenan can permeate the membrane barrier.  Recent studies sponsored by the carrageenan industry (in press) provide scientific evidence refuting both of these claims.  The industry-sponsored studies also raise the caution that in vitro studies may not be a good model for in vivo events in the GI tract after a carrageenan-containing food has been consumed.

There is no scientific evidence known to Ingredients Solutions Inc. that would require your company to abandon using carrageenan in your product because of safety concerns.  Likewise, there is no reason for you or your company to stop developing new products with carrageenan as an ingredient based on safety issues.  Of course consumer concerns, no matter how ill-founded, must be considered, and the carrageenan industry is trying to get ahead of the bloggers with a positive PR program.

Marinalg International for Food Safety and Regulatory Issues:

www.marinalg.org

National Organic Standards Board for Organic Status of Carrageenan:
http://www.ams.usda.gov/

FDA_CFSAN_to_Joanne_K_Tobacman_MD_Petition_Denial

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