Another Test to Avoid
Stephen Barrett, M.D.
|ZYTO Corporation, of Orem, Utah, sells several devices that it claims are useful for determining what dietary supplements, herbs, or homeopathic products might be useful. The devices use a hand cradle (pictured to the right) that relays signals to and from a computer that runs ZYTO's proprietary software. ZYTO claims that the software "sends stimuli to the body using digital signatures that represent actual things" and interprets fluctuations in skin resistance that indicate "the body's degree of preference for the items being assessed." |
ZYTO's devices include the Balance, the Select (an upgrade to the Balance), the Compass, and the Elite (an upgrade to the LSA Pro). ZYTO software is programmed to recommend products from companies selected by the practitioner. One June 26, the Zyto Web site offered "product libraries" for more than 180 companies, of which at least 18 were multilevel companies. The number of lbraries that could be used depended on which ZYTO device was used. Users of the Compass or Balance were limited to one. Users of the Select or Elite devices could select as many as they wanted .
Distribution and Marketing
ZYTO's "Elite" and "Balance" systems are marketed to professionals, and its "Compass" system is marketed to distributors of health products who sell through direct sales or network marketing channels and to consumers who can lease it for $39.95 per month . A 2008 verstion of the LSA Pro manual stated:
Using the principles of biology, quantum physics, and the science of information, we facilitate meaningful communication between computers and the human body that is an evolution of bio-feedback. It is a sequence of elegance--the computer poses the question, the body answers, and not a word is spoken–giving healthcare practitioners a better tool to bring wellness to their patients .
It further stated that the device uses galvanic skin response to "measure shifts in the body's stress system and determine balancers that will move the body back to homeostasis." Balancers are said to be "stimuli sent to the body that assist in bringing the body back into homeostasis." They include homeopathic remedies, naturopathic remedies, as well as clinical therapies such as acupuncture and massage therapy .
Click here to hear a "manager at ZYTO headquarters in Utah
answer questions about the meaning of a ZYTO test report.
Testing can be done in the presence of the practitioner or done remotely though the Internet by hooking the hand cradle to the client's computer. A Compass flyer promised "technology that will skyrocket your product sales and have companies rushing to join your downline."  A flyer advertising a 2013 ZYTO regional conference stated that Michael Payne, MS specialized in remote ZYTO scans, had "remote clinics on every continent except Antarctica," and had personally scanned over 10,000 individuals.
The Elite displays graphics on the computer screen said to represent the "transparent body," "muscular body," epidermal body," "dermatomes" (to display effects of the vertebrae on the body), teeth (for dental assessments) , "5 element overlay" (for Traditional Chinese medicine assessments), and a "stress profile wheel." According to the company, dots that appear in the graphics reflect whether products are "in range" (suitable for establishing balance) or "out of range" (not suitable).  "LSA" is an abbreviation for "limbic stress assessment."
One report I have received stated that the device had found 81 "biomarkers" that were "out of range" but could be "brought into range" by using eight products. Click here to view a copy of this report.
|The picture to the right shows a screen shot from an LSA Pro Webinar on parasites. The items listed below the human figures are said to represent "Stress Sub-items." The topmost areas to the right are headed "Stressors," and the list at the bottom right is labeled "Balancers." Other Webinars cover attention deficit disorder, autism, constipation, fatigue, fungus, headaches, high blood pressure, inflammation, skin tissues, sleep, and sneezing. The contents of the printed report depends on what the practitioner decides to include.
The Balance employs the same technology as the Pro in a greatly-simplified software interface. The Balance begins with a set of preprogrammed stressors to establish which systems need attention, then automatically assesses products designed to support those areas. A former ZYTO officials says that practitioners can learn how to operate the Balance in a few minutes and learn the basics of LSA operation in a single hour, and advanced techniques in a few more . The Select is an upgrade to the Balance.
The strangest statement I have seen about ZYTO devices appears on its commonly asked questions page:
Q. Are the results reproducible?
A. No. In fact we do not expect them to be. In quantum physics this is referred to as quantum indeterminacy in which the observation or measurement itself affects the results. In effect, we have asked the body a question, received the response, and the body's energy has shifted in doing so. However, this does tell us that the first question yields the most accurate response because the body's energy has not yet changed as a result of the question-response event .
ZYTO Corp. was incorporated in 1998 by Vaughn R. Cook, OMD, who is also the company's chief executive officer. Its stock is quoted in Pink Sheets under the symbol ZYTO. Its shares began trading in 2006 at a price of $.70. The price per share was 3 cents on May 24, 2009 about 8 cents on July 6, 2011, and about 2 cents on August 26, 2015. The company deregistered on December 4, 2012, which means that it stopped issuing reports to the Securities and Exchange Commission. In 2009, the Compass System Web site stated that ZYTO's technology had been used by thousands of health professionals around the world, with over 300,000 assessments . Google searches suggest that most of the practitioners in the United States are chiropractors.
The ZYTO Institute (same address and phone number as ZYTO Corp) provides online training. Its Web site offers manuals and many hours of Webinar videos. Most of the Webinars are presented by Jane Oelke, a Michigan practitioner who is said to have a "Ph.D. in Homeopathic Philosophy and Natural Health Sciences" from the Institute of Natural Health Sciences and a "Doctor of Naturopathy" degree from Trinity College of Natural Health. Neither of these schools is accredited by a recognized accrediting agency.
In 2009, Alternative Growth Streams of Woodstock, Georgia offered ZYTO practitioners a "comprehensive set of business-building marketing tools designed exclusively to empower you to get more clients and make more money with your ZYTO technology." The tools included an e-mail mailer, direct marketing mailers, and patient handouts. The e-mailer promised that ZYTO assessments will "help you cut down on the time it takes to get better" and "improve your chances of not getting sick in the first place."
The NutriMost Program
ZYTO testing is included in the NutriMost Ultimate Fat Loss System developed by Ray Wisniewski, D.C., a chiropractor who practices in Murraysville, Pennsylvania and travels around the country to market the system to other chiropractors. The ZYTO scan is said to "create a personalized and customized plan that will address your body's top organ stressors as well as finding the best products to balance those stressors." As part of this, it is said to identify toxins that could stress your body and to prepare customized formulas that provide "energetic resonant frequencies" that have been imprinted onto a special resonent frequency carrier that "provides information to your body's cells about how to more effectively detoxify." Wisniewski's site claims that typical results are 25 to 45+ pounds of fat loss in 40 days without exercise or hunger. The U.S. Federal Trade Commission has determined that the claim that a product "safely enables consumers to lose more than 3 pounds a week for more than 4 weeks" cannot be true because that rate of loss can result in gallstones and other health complications . ZYTO scan reports state that more than twice this rate is possible. I don't believe it. Click here to see a Nutrimost ZYTO scan report.
The Better Business Bureau of Pittsburgh has given NutriMost LLC an "F" rating based on "advertising issues" and the company's failure to respond to seven complaints. In January 2013, the BBB asked Wisniewski to substantiate a long list of claims on his Weight Loss Answer Man Web site, including the "25-45 pounds in 45 days" claim mentioned above. The BBB report notes that he did not reply .
ZYTO devices can be purchased or leased with a monthly fee. Its license agreements state that "Purchaser is aware that the purpose of the equipment is to assess the body’s response to certain computer generated stimuli called ‘virtual stressors’, and is not used to diagnose, treat, or cure health conditions or diseases."  ZYTO's definition of "stress" differs from popular usage and refers to "the body’s system to maintain balance or homeostasis by counteracting stressors," which include bacteria, injuries, allergies, lack of sleep, toxins, emotional strain, traumatic events, and "even the requirements of our physical systems (like digestion, adjusting blood pressure, etc.) which are exacerbated by poor health and lack of fitness." 
ZYTO claims that its devices are comparable to a printed health questionnaire and the pen the patient uses to fill in the blanks. It further claims to have "received documentation from Underwriters Laboratories (UL), a registered FDA consulting organization, stating that ZYTO’s technology is not a medical device and therefore does not require FDA registration." 
I do not believe that is correct. If a product is labeled, promoted or used in a manner that meets the following definition in section 201(h) of the Federal Food Drug & Cosmetic Act, the FDA will consider it to be a medical device subject to regulatory controls. The official definition of a device is:
- an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is . . . .
- intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- intended to affect the structure or any function of the body of man or other animals, and which [is not a drug]. 
Under federal law, "intended use" is determined from the facts surrounding the device's marketing. It is not determined primarily by the language the manufacturer uses to describe what the device does. If a device requires software to function, the software must also be considered in determining intended use. I assume that ZYTO Corporation realized this because it did register with the FDA and received 510(k) clearance to market the device for "the measurement of galvanic skin response."  It remains illegal for any such device to be marketed as a diagnostic instrument.
ZYTO customers are led to believe and clearly expect its devices to assess the functioning of their body and to suggest products that can improve it. I believe that the FDA would consider the assessments to be a form of diagnosis and the selection of products to be a form of treatment. I do not believe that using evasive language to describe its procedures can enable ZYTO to nullify its regulatory obligations. The claim that ZYTO devices are equivalent to a history form is preposterous because fill-in forms do not send and receive electrical signals from the body or make product recommendations intended to improve body functions.
ZYTO training videos also advise practitioners to be careful to use language that does not violate laws against unlicensed practice. However, state laws generally consider making health assessments and product recommendations to be diagnosis and treatment regardless of what the practitioner calls them.
The FDA is aware that something is wrong. It inspected ZYTO Technologies near the end of in 2014 and subsequently ordered it to stop claiming that its devices are useful for diagnosing problems or selecting corrective products . In 2016, presumably as a result of FDA pressure, ZYTO announced "a voluntary recall of the ZYTO Tower and ZYTO Select and Elite software due to claims exceeding the 510(k) clearance." [16,17] It will be interesting to see whether the FDA is persistent enough to drive ZYTO testing from the marketplace.
Zyto Sued by Patients
Between 2008 and 2010, Zyto Corporation was included as a defendant in four lawsuits filed by people who, among other things, had been been tested by a Zyto device during their treatment at the South Coast Center for New Medicine. One of these suits, filed by a California woman named Susan McGreevy, alleged that:
- The clinic's director, Leigh Erin Connealy, M.D., had engaged in negligent misrepresentation by telling McGreevy that Zyto's limbic stress assessment (LSA) test would identify "stressors, such as bacteria, injury, allergies, lack of sleep, toxins, emotional strain and traumatic events" that affected her body.
- LSA testing could not identify stressors or therapies or supplements that would alleviate the supposed "stressors."
- The purpose of the misrepresentations was to induce McGreevy to "undergo an unnecessary and expensive medical treatment, as well as to induce the sale of supplements profitable to Defendants."
- Zyto's marketing of its devices for LSA testing constituted unfair competition within the meaning of California's Business and Professions Code .
A Zyto filing with the Securities and Exchange Commission states that Zyto's portion of these suits was settled in 2011 with agreements under which the company admitted no fault but paid a total of $10,000 .
The Bottom Line
Skin resistance to an electric current has no value in the diagnosis or treatment of disease. A device claimed to provide information or help with the management of hundreds of diseases and conditions could not be validated without a mountain of evidence substantiating usefulness and reliability. X-ray equipment is approved, for example, because the relationships between x-ray findings and physical findings have been studied in countless millions of cases. As noted above, however, ZYTO's results are not reproducible, which means that they cannot be validated!
ZYTO scans have no proven practical value and could cause large amounts of time and money to be wasted by people who believe the speculations. If you have been tested with a ZYTO device and would like to share your experience with me and/or discuss how to seek a refund, please e-mail me a copy of your scan with a brief summary of what happened.
- 16 commonly asked questions about ZYTO technology. ZYTO Corp. Web site, accessed May 24, 2009.
- Zyto product libraries. Zyto Corp. Web site, accessed Aug 6, 2015..
- Network marketing and sales tool. Compass System Web site, accessed May 24, 2009.
- LSA Pro 2008 User Guide. Orem, Utah: ZYTO Corp., 2007.
- Compass flyer. ZYTO Corp., copyright 2008.
- Purchase. Bioenergetic Technology Web site, accessed May 26, 2009.
- Questions frequently asked about our technology. Zyto Corp. Web site, accessed May 24, 2009.
- Gut check: A reference guide for media on spotting false weight loss claims. FTC Bureau of Consumer Protection, Jan 14, 2014.
- BBB Business Review: NutriMost LLC. BBB Web site, accessed March 29, 2015.
- Compass licensing agreement. Accessed online on May 25, 2009.
- Stress is your friend. Bioenergetic Technology Web site, accessed May 26, 2009.
- Pink Sheets, Section One, Issuer's initial disclosure obligations. Undated, issued during 2008.
- Is the product a medical device? FDA Web site, March 1, 2010.
- 510(k) Summary. K11308, Aug 30, 2011.
- Mitchell LM. Warning letter to Vaughn R. Cook, May 8, 2015.
- Class 2 device recall: ZYTO Tower. FDA Web site, July 1, 2016.
- Class 2 device recall: ZYTO Select software and ZYTO Elite software. FDA Web site, July 1, 2016.
- First amended complaint. Pamela McGreevy vs. Cavitat Medical Technologies, Robert Jones, Sough Coast Cnter for New Medicine, Lehigh Erin Connealy, M.D., Alireza Panahpour, D.D.S., Zyto Corp, and Does 1-50. Superior Court of the State of California for the County of Orange. Case No. 30-2010-00368271, filed Nov 3, 2010.
- Zyto Corporation. 10Q Filing with the Securities and Exchange Commission, Sept 30, 2011. (See: 18:R15 Subsequent events.)
This article was revised on July 7, 2016.