The Peanut Allergy Panacea

Anyone who enjoys eating peanuts holds the hope that one day peanut allergies will be a thing of the past. For decades, researchers, food scientists, inventors and others have tried to find a solution to the peanut allergy problem.

And when peanut growers formed the National Peanut Board fifteen years ago, one of their first priorities was to help fund viable peanut allergy research and treatment options. While less than one percent of the population has a peanut allergy, the founding Board decided that one person harmed by the food that they grow was one person too many. To date, the Board has contributed more than $11 million to peanut allergy research, outreach and education.

As the news media has given increasing attention to peanut allergy issues in the last few years, so too has there been more public attention focused recently on hypoallergenic peanuts—or on ways to reduce the allergenic components in peanuts.

National Peanut Board wanted to explore the reports by researchers, entrepreneurs, the media and others about the possibility of bringing a hypoallergenic peanut product to market. What is the science behind hypoallergenic peanuts? What clinical trials are being done and how do the processes for taking the allergens out of a peanut affect the flavor, nutrition, and appearance of the legume? What are the potential uses for a hypoallergenic peanut product and would it be accepted by the peanut industry and the allergy community?

At the outset, it’s important to understand the term “hypoallergenic.” Hypoallergenic does not mean allergy-free or non-allergenic and was first used in the 1950s in skin care products. According to Merriam-Webster’s Medical Dictionary, hypoallergenic meanshaving little likelihood of causing an allergic response.”

Hypoallergenic cosmetics are products that manufacturers claim produce fewer allergic reactions than other cosmetic products. There are no Federal standards or definitions that govern the use of the term “hypoallergenic.” The term means whatever a particular company wants it to mean. In the past, FDA tried to regulate the term hypoallergenic, but any regulation proposals were ultimately ruled invalid by the courts.[1]

In the past few months, three hypoallergenic peanut methods have emerged from the lab, gained media attention and have entrepreneurs seeking to commercialize them. All processes are non-GMO, work on post-harvest peanuts only, and have the claim made that allergens are reduced, not eliminated completely.

Attention-grabbing headlines such as, “Hypoallergenic peanuts offer hope for peanut allergy sufferers” and “Hypoallergenic peanuts move closer to commercial reality,” give the impression products will be on the market soon. The reality is hypoallergenic peanut proponents have a long way to go in the clinical testing process from the clinician’s point of view and a long road ahead from a manufacturer’s point of view.

Three Ways to Take Allergies Out of Peanuts

Announced last year, Dr. Jianme Yu, a food and nutrition researcher at North Carolina A&T’s School of Agriculture and Environmental Science, along with a team and support from USDA-ARS, found a way to treat peanuts and reduce its allergens by, as they claim, about 98 percent.

The treatment consists of pretreating shelled and skinless peanuts with a food-grade enzyme. Whole roasted peanuts go through a one-minute soaking to make it possible for the peanut to absorb the food-grade enzymes. These are the same types of enzymes used for decades in breads, wines and cheeses; to name a few. Then, the peanuts go through an incubation period (at first for around 1.5 hours, but now down to 30 minutes or less.) After drying, the peanuts are ready for consumption. Whole roasted peanuts are used in the process (instead of raw) because it is believed to produce a more consistent product with a longer shelf life.

A similar process has been developed by The Honeycutt Company, based in Norcross, Ga. Travis Honeycutt, entrepreneurial chemist, created a hypoallergenic peanut process based on his success in innovating a non-allergenic natural rubber latex that is now used in over 40,000 latex products. Honeycutt holds 40 U.S. patents for a range of products and has a provisional patent for a process that reduces allergenic protein in creamy peanut butter to below detection levels.

The Honeycutt process involves roasting the peanuts, removing shells and skins, and then treating the nuts with a chemical ingredient used in foods which is on the FDA Generally Recognized as Safe (GRAS) list and is edible. The chemical ingredient can be added before, during or after grinding when making peanut butter.

“Initially we tested this process on off-the-shelf creamy peanut butter,” said Glen Smotherman, Financial Director at Honeycutt. “We verified our process with an independent allergy testing lab (Donald Guthrie Foundation/LEAP Testing Service). We found the treated peanut butter showed a 15 to 18 percent reduction in the allergen and were reduced to non-detectable levels.”

A third process is known as pulsed light technology or PLT. A team led by Wade Yang, an assistant professor in food science and human nutrition at the University of Florida told Newsweek[2] that PLT “may remove up to 80 percent of peanut allergens in whole nuts.”

Yang explained to Newsweek, “PLT is the light emitted from a lamp containing an inert gas like xenon… It can be tens of thousands times more potent than conventional light…The heating effect of UV light breaks down the structure of the peanut proteins that elicit allergic reactions in a way that normal light cannot—effectively cutting allergens …to below 1.5 milligrams, or, as Yang says, enough of a reduction so that 95 percent of those with peanut allergies would be safe.”

Yang and a team of scientists had the results of Pulsed Light Technology research published in the Journal of Food Science in July, 2008.[3]

Putting Hypoallergenic Peanuts to the Test

“It’s nothing new for researchers to study the allergens, or protein, in peanuts. We’ve been doing that for decades,” said Howard Valentine, retired executive director of The Peanut Foundation. Valentine and other researchers interviewed by NPB outlined the familiar process for gaining credibility for a new discovery in the lab.

First, the researcher attempts to prove a hypothesis and finds something unique. Next comes a proof of concept study, which is usually small and used to verify that a concept has the potential of being used. If the proof of concept holds, the researcher files for a series of tests, with groups that increase in numbers of people, in controlled settings. Sometime within this process, scientists may file for a patent. Findings must be published in a reputable scientific or medical journal. The findings must be peer-reviewed to gain credibility.

“For hypoallergenic peanut products,” said Valentine, “a series of tests needs to done with peanut allergic and non-peanut allergic people. It is important to have a placebo control component because some people, who may be anxious, may have a response that mimics an allergic reaction.  A series of feeding studies need to happen starting with giving subjects a small amount of crushed peanuts and pushing it until a predetermined amount can be tolerated. All studies would need strong FDA oversight.”

The North Carolina A&T enzyme process, in conjunction with the University of North Carolina at Chapel Hill has had their clinical trial results published also. A proof of concept study, in the form of skin prick tests, has been conducted to “determine the safety and allergenicity of hypoallergenic peanut product extract as compared to standard peanut extract in an adult population with known peanut allergy,” according to Clinicaltrials.gov.[4] The test was performed on 22 adults ages 18 to 65. The study ended in December 2014 and has been accepted into Food Research International, a journal of the Canadian Institute of Food Science and Technology (CIFST).

Michelle Hernandez, MD., Investigator, University of North Carolina at Chapel Hill was the study’s lead, and said, “We have to be guarded about the results because this is a proof of concept study. “The bottom line is we don’t know how this will perform in people who are allergic to peanuts. If researchers are able to confirm the safety and efficacy of a hypoallergenic peanut product, then studies on larger populations can be conducted,” said Hernandez. “The results thus far have to be taken with a lot of caution.”

“I’m glad researchers are working on improving the lives of people with peanut allergies,” said Soheila Maleki, Ph.D., Lead Research Scientist, Food Allergy Research at the U.S. Department of Agriculture. “But many more questions need to be asked and the proper testing on humans needs to be done before we can have full confidence that this is a solution that prevents or helps reduce allergic reactions to peanuts.”

Discrepancies

For those of us outside the medical and allergy communities, discrepancies lie between claims made in the news media and press releases and actual clinical test results to date.

“I got calls from major national news outlets who were excited about the hypoallergenic peanut news and I had to say to each of them, ‘slow down, we still have a long way to go,’” said Hernandez.

For instance, the media reports say the treatment reduces two key allergens, Ara h 1 to undetectable levels and ara h 2 by up to 98%.[5] While it is true scientists have identified up to twelve allergens in peanuts (Ara h 1 up to Ara h 12) and Ara h 1 and 2 are the most likely to cause dangerous systemic reactions or anaphylaxis in the U.S population.[6]

“The allergic population in different countries can be more allergic to different allergens in peanuts and tree nuts,” said Maleki.  Also, Maleki questions a focus that emphasizes just two allergens.

“The researchers put an enzyme in the presence of a peanut,” said Maleki. “The enzymes used here are like molecular scissors. They chop up all of the proteins they come in contact with. It’s impossible to chop up only a few. All the allergens, and proteins in the peanut, are affected by the enzyme.”

Others are skeptical about claims about the reduction of only two of the seven allergens. What about the remaining allergens? One research and development scientist with a major manufacturer, who asked to have his name withheld, said hypoallergenic peanut products are irrelevant from a manufacturer’s point-of-view. He indicated it takes a minute amount—sometimes a nanogram—in a highly allergic person to cause a severe reaction. He worries that putting a hypoallergenic peanut on the market would give consumers a false sense of security, while not eliminating the problem of peanut allergies.

In a statement attributed to Yu, North Carolina A&T’s website[7] states, “Treated peanuts can be used as whole peanuts, in pieces or as flour to make foods containing peanuts safer for people who are allergic.”

Maleki points out that the only test that has been conducted uses a peanut product extract. She explains, “When the peanuts are put in the solution, and even if it is crushed, some particulates become soluble—or liquid–while some particles remain insoluble. The majority of tests only measure the proteins or allergens in the soluble matter—the extract. The immunological parts of the study are only conducted on a peanut liquid extract, not on the part that does not dissolve. So we only have results for 2 reduced allergens in the extract—not for the whole peanut. It is impossible from this clinical trial, which only involves skin testing with extracts, to say the treatment is effective on whole peanuts, peanut pieces or peanut flour.”

Other claims include the enzyme process “maintains the nutrition and functionality needed,[8]” “has same taste” and “does not change physical characteristics.[9]

“How does the NC A&T process affects flavor, texture or nutrition? No one can possibly know without more testing,” said Maleki. “Scientists can measure the nutritional content of the treated product in this study, but, again, most of the measures are with the extract.  There is a long road to making or marketing the hypoallergenic peanut.  Approved clinical trials, in which peanut allergic volunteers ingest the product, are necessary.  A successful food challenge would result in minimal or no symptoms.  This is called a ’food challenge’ and is considered the gold standard for testing allergenicity.  Until this is done, all claims to a hypoallergenic peanut are premature.”

Maleki continued, “The same information is true for the pulsed UV treated peanuts.  They only study the soluble extracts and not the whole peanut.  Insoluble material cannot be used in the currently-existing scientific methods used to measure simple immunological responses.  Pulsed UV will cross-link all proteins as well, it is not an allergen-selective treatment.”

Valentine agrees, “We cannot possibly test the nutrition of any food without doing a feeding study, in animals or humans. We won’t know how the treated peanuts break down and are digested in the body until we test that.”

Allergy Community

Eleanor Garrow-Holding is founder and CEO of the Food Allergy & Anaphylaxis Connection Team (FAACT) and a member of NPB’s Food Allergy Education Advisory Council. Also, she is the parent of a son with life-threatening food allergies, including a peanut allergy. “As a parent, I think hypoallergenic peanuts are confusing and dangerous. Hypoallergenic peanuts are not allergen-free, so how could someone be sure they wouldn’t react if they ate one? I can’t imagine someone with a peanut allergy wanting to take that risk.”

Garrow-Holding continued, “Hypoallergenic peanuts allow the non-allergic person to say peanut allergies are no big deal. It trivializes allergies along with the life-threatening reactions some people get when they eat certain foods. I’m afraid proponents of hypoallergenic peanuts are offering a simple solution to a vexing problem.”

From Lab to Market

Currently, two groups are working to bring the hypoallergenic peanut to market: North Carolina A&T and The Honeycutt Company.

North Carolina A & T has given exclusive license of their patented hypoallergenic process to Alrgn Bio, a spin-off of N.C. A & T and Xemerge, that set up operations at Gateway University Research Park in Greensboro, N.C. around the same time.

In a demonstration to industry officials as he announced the formation of Alrgn Bio, Johnny Rodrigues, founder, said he could see hypoallergenic peanuts becoming the new standard in the industry. He believes the process will be attractive to businesses that make and sell peanut products and will be easy to incorporate into the food preparation process.

Rodrigues said, “We are seeking out industry partners—food processors and manufacturers—to establish this process as the industry standard for peanuts and peanut-derived ingredients. We want to make sure everyone will benefit from this technology, so we are careful to pick the right partners to make that happen. We’ll work together to deliver safer peanut products to consumers as quickly as possible.”

When asked how he would ensure the hypoallergenic peanut is safe when only an extract had been tested, Rodriguez said, “We’re making a safer peanut, that’s the target. We will always have testing going on. We’re working with others to do more testing and we will never stop that.”

The Honeycutt Company has a similar model to help bring a hypoallergenic peanut to market.

“Our emphasis is not on becoming peanut butter manufacturers ourselves, but to find industry partners that can produce prototypes of this product and do further testing themselves,” said Smotherman. “We know there is a lot of testing and developing that goes into something like this. Our goal is to show that it can be done and to help others further develop hypoallergenic peanut products and let the industry decide if they’re valid of not.”

Honeycutt continues, “We believe we have the chemistry that will work. It doesn’t change the nature of the peanut butter, does not discolor it and uses chemicals already on the market. Also, as we experimented with the viscosity, we found the peanut butter works well in a squeeze bottle, which adds another dimension to a potential product. We feel we’re on to something.”

Critics point out that latex is not ingested while, of course, peanuts are.

“True,” said Smotherman. “We’ve got to make sure the protein allergens in peanuts are blocked before we take this to market. We’re at the beginning stages with this and clearly we have more testing to do. We do know there was a strong concern about the allergens in latex at the time we developed that process and we reduced the allergens to below detected levels. To our knowledge there have been no allergenic problems brought to the attention of the company manufacturing those products.”

Right now, “moving the needle” by reducing the allergens is what Smotherman and Honeycutt wanted to see to continue moving forward.

Researchers and others see a small potential market for hypoallergenic peanuts in immunotherapy. “With medical supervision,” said Maleki, “hypoallergenic peanuts could be administered in small doses over the course of treatment to build up a patient’s resistance to peanut allergies.”

A Manufacturer’s Perspective

“Before any new product would come into the fold, we need to ensure there is sound science behind it,” said Michael Guanella, Skippy Brand Manager, Hormel Foods. “The idea must be thoroughly vetted and looked at from all angles and there must be a high degree of confidence in the science behind the product.”

“There also needs to be enough interest in the marketplace to justify bringing a new product to market,” he said.

To determine if consumers are interested in a hypoallergenic peanut product, Guanella pointed to the need for focus groups among people with a peanut allergy. “Potential consumers need to be asked questions like, ‘what is their sensitivity level to peanuts? Are they willing to expose themselves, or their children, to a hypoallergenic peanut?”

So the question remains, is there a market to manufacturers? Proponents of the hypoallergenic peanut say manufacturers would have a market with schools and institutions as a way for these groups to offer a potentially allergenic food (peanuts and peanut butter) with a reduced risk of a severe reaction.

“I think it is still too early to tell, said Guanella. “The science has to be solid and proven and the consumer demand has to be there as well.” ”


[1] U. S. Food and Drug Administration, “Hypoallergenic Cosmetics;” http://www.fda.gov/cosmetics/labeling/claims/ucm2005203.htm

[2] Castillo, Stephanie, Making Hypoallergenic Peanuts, Newsweek, Oct. 18, 2014; www.newsweek.com/2014/…/making-hypoallergenic-peanuts-278109.html.

[3] Chung, S.-Y., W. Yang, K. Krishnamurthy. (2008). Effects of pulsed UV-light on peanut allergens in extracts and liquid peanut butter. Journal of Food Science, 73(5): C400-C404.

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