CAMLAW: Complementary and Alternative Medicine Law Blog

FDA on RIFE Technology

The FDA website has a lot of material on use of the RIFE machine, not all easy to find.

One can search the "device advice" product classification database for name of a particular establishment (manufacturer) or for the name "RIFE." One can also search the warning letters, or the FDA website generally.

Doing the latter yielded over 160 results, many in the adverse events department. Here is a sampling:

Subject: complaint about resonant light, inc. Makers of rife machine. Over a year ago pt purchased a rife machine from a donald l tunney and co now named resonant light technologies, inc. The device was purchased for $3000 usd. Pt was convinced device would help cure fibromyalgia. They had been told about the device by a chiropractor. Pt then spent time searching out materials about this technology on the internet. Desperate for relief from the pain and discomfort of illness pt purchased this device for their own personal use. Pt and rptr have two young children who rptr is concerned have been exposed to the emmissions from this device. Originally, pt would only operate the device when the children were away from the home at school. As they became more desperate they started to run the device for hrs at a time and would run the device when the children were in the house. Whenever rptr arrived home from work and found the children in the house with the device running rptr attempted to get them outside or take them to another location. This device consists of a 200 watt amplifier connected to a square-wave frequency generator that is used to supply a signal to a cb radio tuned to channel 14. The energy pulses are then pumped into a gas tube that contains an arc that hums and glows. Since the device was put into operation by pt there have been a number of disturbing observations that further fueled rptr's concern for their children's and spouse' safety and health. Spouse would hear nothing of rptr's concerns and rptr has focused on protecting their children as best they could. The device has been responsible for interference on the electrical devices throughout the home, namely the radios, vcr and television. The lamp in the next room to this device is of the type that with a touch it turns on and off. When the rife machine is operating the lamp will continuously cycle through its three intensity settings, growing lighter and darker over and over again as the device pulses. When rptr arrives home and the device is operational there are times when they can tell the device is on from the driveway because it causes pulsed static on the car radio. At the start of last summer rptr had to disable the cable modem that had been operating in their home. The cable co and rptr were able to identify the problem that was shutting down the "head" device that serviced about 100 homes in their area of town. Since the cable frequency was close to a cb channel 14 frequency the boosting of the signal strength and modulation of the pulsed frequency signals caused a feedback up the coaxial cables that fed the home and overloaded the cable co's equipment. Rptr was told by the tech and engineer from the cable co that prior to notifying rptr the cable co had been able to measure signals emmanating from the house with hand-held equipment at the telephone pole nearly 75 feet from the home. As rptr has worked to learn more about this device pt has weeded through literally hundreds of web pages and posting touting the miracle of this technology. There has been no miracle in rptr's household and rptr is particularly concerned about the potential that their children may have been exposed to rf radiation that may damage their dna. According to some of what rptr has read the rf radiation emmitted from a cell phone at 3. 5 watts has been potentially implicated in cell damage. The whole premise of the rife technology is that the energy radiated disturbs cells. The mfr and "experts" on this technology claim is it is specifically based upon frequency. Rptr worries that they are correct in some respects that the energy does have a cellular impact and wrong as to the limited nature of the impact. (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=425016)

"RIFE MACHINE" ENERGY WELLNESS

Consumer stated that he purchased an electronic machine known by various names which include "engery wellness", "frequency wellness instrument", "rife machine", "rife generator", et al. He bought the machine because it was touted as a cure for hiv-aids; as well as disease. Sales person told him that the machine was a "resonance generator", and it would kill "pathogens and organisms. " he was told that there was a 30 day "free trial. " in reading a pamphlet, the consumer learned later that the machine was not fda approved. He returned the machine and hopes that he will get a full refund. (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=756346)

There are also generic FDA articles such as this one on health fraud:

You don't have to look far to find a health product that's totally bogus--or a consumer who's totally unsuspecting. Promotions for fraudulent products show up daily in newspaper and magazine ads and TV "infomercials." They accompany products sold in stores, on the Internet, and through mail-order catalogs. They're passed along by word-of-mouth.

And consumers respond, spending billions of dollars a year on fraudulent health products, according to Stephen Barrett, M.D., head of Quackwatch Inc., a nonprofit corporation that combats health fraud. Hoping to find a cure for what ails them, improve their well-being, or just look better, consumers often fall victim to products and devices that do nothing more than cheat them out of their money, steer them away from useful, proven treatments, and possibly do more bodily harm than good.

"There's a lot of money to be made," says Bob Gatling, director of the program operations staff in the Food and Drug Administration's Center for Devices and Radiological Health. "People want to believe there's something that can cure them."

FDA describes health fraud as "articles of unproven effectiveness that are promoted to improve health, well being or appearance." The articles can be drugs, devices, foods, or cosmetics for human or animal use.

FDA shares federal oversight of health fraud products with the Federal Trade Commission. FDA regulates safety, manufacturing and product labeling, including claims in labeling, such as package inserts and accompanying literature. FTC regulates advertising of these products.

Because of limited resources, says Joel Aronson, team leader for the nontraditional drug compliance team in FDA's Center for Drug Evaluation and Research, the agency's regulation of health fraud products is based on a priority system that depends on whether a fraudulent product poses a direct or indirect risk.

When the use of a fraudulent product results in injuries or adverse reactions, it's a direct risk. When the product itself does not cause harm but its use may keep someone away from proven, sometimes essential, medical treatment, the risk is indirect. For example, a fraudulent product touted as a cure for diabetes might lead someone to delay or discontinue insulin injections or other proven treatments.

While FDA remains vigilant against health fraud, many fraudulent products may escape regulatory scrutiny, maintaining their hold in the marketplace for some time to lure increasing numbers of consumers into their web of deceit.

How can you avoid being scammed by a worthless product? Though health fraud marketers have become more sophisticated about selling their products, Aronson says, these charlatans often use the same old phrases and gimmicks to gain consumers' attention--and trust. You can protect yourself by learning some of their techniques.

The following products typify three fraudulent products whose claims prompted FDA to issue warning letters to the products' marketers, notifying them that their products violated federal law. Two of the products also were added to FDA's import alert list of unapproved new drugs promoted in the United States. Products under import alert are barred from entry onto the U.S. market.

Take a look at these products' promotions. They are rife with the kind of red flags to look out for when deciding whether to try a health product unknown to you.

Here are some more entries on RIFE:

RIFE TECHNOLOGY BEAM RAY

The complainant is concerned that their sibling is paying a lot of money for a quack treatment with an unapproved device to cure them of infection with 40 different organisms. The complainant didn't have any direct info about the product or treatment; just that provided by sibling in a personal email. The product is the rife technology beam ray (which has been around for 60+ years). They were told the device is approved for veterinary use but not human use. To get around this, the pt has to hold a small animal while receiving treatment. Caregiver allegedly sells the device also, but because it is unapproved, they sell it in pieces instead of as a single unit. The complainant spoke to someone at ftc and was told that ftc has taken action against a distributor/practitioner. (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=422685)

This is from a 1994 FDA Consumer article still on the FDA website: "RIFE generator promoters claim that they can insert a person's photograph into their device and diagnose medical conditions. FDA has not approved the marketing of this device, nor is there any scientific basis for this claim."

One also needs to review the FTC site regarding enforcement actions relating to advertising and claims.

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