Several Texas chiropractors, including one in the Austin area, have become franchise owners of a Pennsylvania-based weight-loss program that received an F rating from the Better Business Bureau for the past three years and uses a device that federal regulators are investigating.
In marketing materials, NutriMost says it uses the ZYTO Hand Cradle and related software to scan “more than 400 million communications that occur per second in the body,” thus identifying hormonal imbalances and “the very narrow Ultimate Fat Burning Zone.” Patients receive nutritional supplements, a food plan and other assistance to lose 20 to 40 pounds in just 40 days, the materials say.
Such marketing prompted the Food and Drug Administration to send a warning letter to ZYTO’s manufacturer in May, saying the FDA approved the device for measuring “galvanic skin response,” not for diagnosing health conditions.
Galvanic skin response, commonly used in lie-detector testing, measures changes in the electrical resistance of the skin during stress, strong emotion or other stimuli. Sweat from the palms increases conductivity.
As many Americans make shedding pounds their top new year’s resolution, programs that promise fast, dramatic results are consumer catnip.
The Federal Trade Commission, which works with the FDA to investigate deceptive advertising, said weight-loss programs, particularly those that rely on supplements, are a $25 billion industry that “all too often” makes false or unproven claims. The FTC said it has filed more than 120 cases challenging supplement advertising in the past decade.
NutriMost is growing and has 185 franchises in 47 states, company spokesman Kevin Popovic said. Most of the NutriMost providers are chiropractors, he said, including founder Ray Wisniewski, known as “Dr. Ray.”
After the American-Statesman asked NutriMost about the F rating, based on advertising claims and unresolved customer complaints, the company contacted the BBB and Wisniewski said in an email through Popovic he was trying to resolve a tiny number of complaints. While the BBB awaits the company’s responses, it took down the F on Wednesday and put up “no rating,” said Warren King, president of the Pittsburgh-area BBB.
“They’re not going to get an A because of their advertising,” King said.
Wisniewski told the Statesman his program is “the most advanced and innovative weight-loss system there is.” Because he’d been so busy developing it and assisting others, “I didn’t realize that it was necessary or prudent to respond to the extremely small number of unsubstantiated claims to the BBB,” he said.
He added that the BBB seems to have an issue with the program’s guarantee of at least 20 pounds lost in 40 days. “This may seem outside the normal, but our system works that well, and we have repetitively documented this with third-party sources that clients do indeed lose 20 to 45-plus pounds in 40 days,” he said.
Clients eat about 500 calories a day, and their providers use various technologies to help “determine the best natural means to balance the body and shift it toward the optimal fat burning state,” he said. The FTC warns consumers to be wary of claims that they can safely lose more than 3 pounds a week for more than a month.
A Georgetown woman, who spoke to the Statesman on the condition of anonymity, said she paid $2,500 upfront to NutriMost Austin last year and lost 17 pounds in two weeks. When she felt nauseated and dizzy, she asked what to do in emails to NutriMost Austin, led by chiropractor Genene Prado, said the woman, who forwarded the emails.
She got no advice, she said, although Prado did respond when the woman asked why her supplement bottles had identical labels.
“Your bottles were embedded with resonant frequencies,” was the response.
When the woman quit the program early, she said she gained back most of the weight.
“I feel so stupid,” she said. “If you eat 500 calories a day for 40 days, obviously, you will lose” weight.
Prado has promoted her franchise on TV, radio and in Statesman ads. She was disciplined in 2009 and 2014 by the Texas Board of Chiropractic Examiners for advertising violations. Prado’s use of a “fat-melting” laser and her offer to treat diabetics, reported by the Statesman in 2010, also drew the board’s scrutiny. Without elaborating, the chiropractic board said in its 2014 disciplinary order that she ran a Statesman ad “for services outside of a chiropractor’s scope of practice.”
Prado didn’t return calls to the Statesman to discuss her NutriMost business. Nor did chiropractor Rob Vasquez, who offers NutriMost programs in San Antonio and Grapevine. Franchises also have popped up in Dallas, Fort Worth and Amarillo.
ZYTO draws scrutiny
Chiropractors and medical doctors have long tussled over turf in Texas. Chiropractors treat the musculoskeletal system; treating a patient for weight loss isn’t part of a chiropractor’s scope, said Patricia Gilbert, executive director of the chiropractic board.
The board is aware of NutriMost but can’t say, because of confidentiality rules, whether it’s investigating anyone, Gilbert said.
She added that Texas chiropractors who own a NutriMost business aren’t allowed to use their chiropractic credentials to attract or treat weight-loss patients.
The FDA, which regulates medical devices, said it has “an open investigation” into the maker of the ZYTO Hand Cradle.
The FDA said in its warning letter last year to ZYTO Technologies Inc. in Utah that its “promotion of the ZYTO Hand Cradle for use in diagnosing a disease or condition, predicting biological responses to a wide range of virtual stimuli including drugs and nutritional supplements, or determining whether someone responds to a specific allergen fall outside of the device’s cleared intended use to measure galvanic skin response and constitutes a major change or modification to the device’s intended use.”
ZYTO officials said they responded to the FDA’s concerns and are following all rules. The company also has discontinued two products the FDA called accessories, the ZYTO Laser and ZYTO Tower, ZYTO general counsel Adam Ford said.
“We are absolutely fully compliant with FDA regulations,” Ford said. “The ZYTO Hand Cradle measures galvanic skin response, and that’s all it ever does. It provides that data. Our software analyzes that data, and that’s an ongoing discussion with the FDA on what the software can do.”
He noted that the company has an A+ rating from the Better Business Bureau.
As for NutriMost, Ford said, “I honestly can’t tell you how Dr. Ray uses this, and it’s not something ZYTO approves or monitors. … We have over 3,000 devices out there.”
ZYTO hasn’t released any scientific studies on the device’s performance, Ford said. Nor could the Statesman find any peer-reviewed studies evaluating the effectiveness of the device or the NutriMost program.
FDA spokesman Devin Koontz said that until ZYTO is reinspected, which can take months, he can’t say whether the firm is in good standing. “I have been advised that until we conduct our reinspection, the case is considered an open investigation,” Koontz said by email.
Scans and supplements
Stephen Barrett, a retired psychiatrist who has created 25 consumer websites, including Quackwatch and Device Watch, said he’s been investigating the ZYTO device and NutriMost for the past year and received more than a dozen consumer complaints.
He pointed to the ZYTO website, which says the company designed software so that it could match patients to products that chiropractors sell. “Each practitioner has the ability to limit the available products to include only the specific inventory items they choose,” the site says.
He says in an article on Device Watch that “skin resistance to an electric current has no value in the diagnosis or treatment of disease.” To prove otherwise would take “a mountain of evidence substantiating usefulness and reliability.”
Results of patient ZYTO scans cannot be reproduced, unlike an X-ray of a broken arm, which will still show the fracture in X-rays done minutes apart.
Asked to explain, ZYTO Technologies Inc. Vice President George Wright said that’s because the device measures energy, which is constantly changing.
“We feel your body is able to respond in a positive or negative way to a stimulus,” he said. “We can measure the body’s response, whether it’s a positive or more coherent response or a negative or less coherent response. It generates a report. … What it does is provide qualified practitioners with information they can use to make better decisions.”
Wisniewski said in the email to the Statesman that he uses ZYTO technology but developed his own software to do the analysis.
“The biggest lie in weight loss is: Eat Less and Exercise More,” he wrote. “The reality is that some of the ‘skinniest’ people that you know are probably the biggest eaters and the reason is that it’s not about the amount of calories that you eat or the amount of exercise that you do, it’s all about the speed of your metabolism. Your metabolism is determined by your hormones, neurotransmitters, vitamins, minerals; essentially it’s all about your body chemistry and that’s what the NutriMost program is all about, balancing body chemistry.”
His biographical sketch on franchise websites says, in part, “Although Dr. Ray has been traditionally trained as a Doctor of Chiropractic, he presents and offers NutriMost services as member only services under his Pastoral Medicine License # L29076049. Dr. Ray is a Christian who believes that God created this body with an amazing healing power and there is nothing outside the body, that is as powerful as the power that God put inside the body. … The NutriMost services are pastoral health services and should not be confused with state regulated services.”
He said in an email that, in addition to chiropractors, NutriMost providers include physicians, dentists, acupuncturists and naturopaths.
ZYTO said it sells the device to licensed health care providers, but that doesn’t include pastoral licenses from the Pastoral Medical Association in Irving. “The Pastoral Medical Association is a private ecclesiastical membership association with a mission to promote scripture based health and wellness concepts,” its website says.
ZYTO sold the device to Wisniewski in his role as a chiropractor, said Ford, the company’s lawyer.
“I don’t know of any single system where we sold to anyone under a pastoral license,” Ford said. “I want to emphasize that the ZYTO device does a specific thing and does it well. If one of our users is mispromoting that, I will certainly get on top of that.”
FTC: Questionable weight-loss program claims
• Causes weight loss of 2 pounds or more a week for a month with no dieting or exercise.
• Causes substantial weight loss no matter what or how much one eats.
• Causes permanent weight loss, even after the product is discontinued.
• Blocks the absorption of fat or calories to provide substantial weight loss.
• Safely allows weight loss of more than 3 pounds a week for more than four weeks.
• Enables all users to lose substantial weight.
• Ties weight loss to wearing a product on the body or rubbing it into the skin.