Welcome to the FDA’s history vault, containing more than 10,000 items from FDA’s history.
Among the artifacts are tools used by those who carry out the agency’s mission, which
highlights advances in science and technology, and many of the deceptive and dangerous foods,
medicines, and so-called medical products that FDA has helped remove from commerce and
that have led to important changes in laws and regulations.
This week’s episode, a shocking exerciZe.
Most Americans associate the U.S. Food and Drug Administration with its responsibility
to protect the safety and effectiveness of prescription drugs and medical devices.
But since 1938 the agency also has had important legal authority, to protect American consumers
from devices that might, as Congress broadly wrote in that law, “affect the structure
or any function of the body.”
What this oversight included, was devices marketed as therapeutic, but that often had
no medical benefits, and sometimes even were dangerous.
The number of these types of products skyrocketed after World War II.
That’s because at the end of the war there was suddenly a large amount of military surplus
electronic parts, such as knobs, and dials, and meters.
When these parts were made available to the civilian population, they served as inspiration
for a generation of inventive “gadgeteers.”
The number of worthless, fraudulent, and in some cases harmful medical devices, far outnumbered
the devices in use in medicine.
One of the most notorious of these devices that FDA removed from the market was called
the Relaxacizor.
Invented in 1938 by electrical engineer William J. Browner, the prototype delivered an electrical
impulse, what he called a “peak wave.”
This so-called wave, he claimed, induced a quick and sharp contraction followed by relaxation.
Originally sold in beauty salons but soon enough, he created models for both men and
women that were sold in suitcases for home use.
They all ranged between somewhere between $100 and $400 a piece so they were quite expensive
even then.
It was a very complicated device to put on someone.
You needed belts and you had little electrodes that had to be perfectly fitted and lots of
tubing and cords and finally you had and finally you had buttons and dials to adjust the frequency
and the strength of each of the electrodes that were there.
There were different models, this is obviously the pink one, for, aimed or mostly for women.
It had a gel attached to it to help with the placing of the electrodes.
So this is one that we know was seized in 1964 by inspectors.
This was actually a commercial model.
It wasn’t one of the ones for home use, necessarily.
The advertising was both intriguing and suggestive.
But as a so called passive exercise machine that the product was most heavily marketed
by the company.
Its advertisements included testimonials, women and men in provocative poses, and unauthorized
endorsements by models and stars.
Modern television fans may have seen the Relaxacizor featured in a couple of episodes of the popular
series “Mad Men” when Don Draper’s advertising agency was hired to name the product and create
an advertising campaign for it.
The combination of ads that were both suggestive, on the one hand, and promised effortless weight
loss on the other resulted in sales that were at least 400,000 or more over a 10 year period.
Once it became that popular, and received that much outlandish publicity FDA felt like
they had to take action against the product, which they did.
During a five month trial, at least 40 witnesses testified that they had suffered harm from
the machine.
And medical experts agreed that the device posed a danger to the general public.
In particular, they felt it could cause miscarriages and aggravate pre-existing medical conditions
including epilepsy, hernia, ulcers, and varicose veins.
In April, 1970, Judge William P. Gray, of the U.S. District Court in Los Angeles ruled
that the device was dangerous and issued a permanent injunction against its sale.
This wasn’t the end of it, however.
FDA remained concerned about the number of Relax-i-cizors that were remained on the market.
The agency took the unusual step of issuing a public warning poster that was distributed
for display in post offices and other popular venues.
The high cost of prosecuting this and other types of fraudulent device cases helped spur
passage of the 1976 Medical Device Amendments.
The sheer quantity of these quack medical devices has dropped off dramatically obviously
but FDA still is responsible for making sure that fraudulent and dangerous and ineffective
medical devices are not on the American market.
The FDA’s collection provides a journey through American history and documents the
critical role played by one of the nation’s oldest public health agencies in support of
its mission to promote and protect American health.
We hope you enjoyed your visit.