Often, I am asked why companies don’t share more information about their health-related products. People are either surprised or don’t believe that companies are not legally allowed to state potential benefits—even when the benefit may be well documented. The following two examples show just how difficult it is for companies to talk about their products.
1) A walnut packager had decided to list the heart-health benefits of eating walnuts on their packaging. The nutrients in walnuts are well known to support the heart. The packager received a letter from the US Food and Drug Administration (FDA) stating they were in violation of the law because they were selling an unapproved drug.
2) A manufacturer of a pillow with the herb lavender inside of it included the story of the traditional uses of lavender to help induce relaxation and sleep, with their product. They too were sent a letter citing it was against the law to market an unapproved medical device.
These two stories are by no means rare and illustrate how far regulators will go and how silly they can be. Only a minority of cases the FDA investigates are what we would consider true fraud. Fraudsters are individuals and bogus fly-by-night companies that set up shop, make wild claims that are exaggerated or false, take our money and then get out of town. Contrary to what governments would have you believe, these companies are not typical. There will always be about 1% of any population of people or companies that finds a way to abuse the system and health companies are no exception. Unfortunately what happens is that ALL companies selling products become suspect and regulators view them and treat them in the same category as those who are truly unscrupulous and criminal.
In my experience, in most cases, advertising infractions are made by good people following their heart and sharing truthful information about the benefits of a product—benefits based on users’ experience, empirical evidence, new theories and real-time science. This form of evidence is unacceptable to regulators, not because it is bad evidence, but because of economic and political influences.
Take the case of one highly controversial product that has been in use around the world: The Hulda Clark Zapper. About a decade ago, there was a tremendous amount of regulatory push to remove these devices and all information surrounding the Zapper, from the marketplace. The push seemed to quiet down until recently when I was sent a copy of a letter showing the renewed efforts by UK regulators. Their letter stated:
Dear Sir Madam
I am a compliance inspector working for European Regulatory Affairs within the Medicines and Healthcare products Regulatory Agency, currently investigating the supply of Dr Clark Zappers to and for use on UK consumers and it has come to my attention that your website sells Dr Clark zappers.
The intended purpose for Dr Clark human use zappers is mainly the treatment of numerous illnesses including cancer and HIV so they are medical devices and as they depend on a source of electricity are classified as Class IIa medical devices requiring Notified Body Certification which they do not have.
As the zapper is intended to treat cancer, it is not possible for the device to be legal to sell due to the cancer act of 1939.
I would be grateful if you would therefore remove it from offer and exposure for sale on your website within 7 days and supply me with full name and contact details of where you purchased them from.
Failure to remove Dr Clark Zappers from sale will result in enforcement action including deletion of domain “deleted name.com”
Companies that have experienced enforcement action know what a heavy emotional toll it takes. It can involve threats, bullying, physical action by police and in some cases even jail. Regulators don’t go after consumers buying the products, but they do limit access to products by making sure they aren’t sold in the first place. This means going after those that sell or promote the product. In the above case, the owner of the business stopped selling Zappers, as many other companies have done as well. This is despite the fact there is still a strong demand by the public for the product.
This letter also makes reference to the Cancer Act of 1939. Most countries, like the US and Canada have legislation preventing the marketing of any product that is for treatment of a Schedule A list of diseases. What is interesting in the letter above is that the UK has a law specifically about Cancer advertising. The 1939 Act reads:
"An Act to make further provision for the treatment of cancer, to authorise the Minister of Health to lend money to the National Radium Trust, to prohibit certain advertisements relating to cancer, and for purposes connected with the matters aforesaid."
To be fair, even chemotherapy and radiation, which are the only approved treatments for cancer, cannot advertise either, but then again, they don’t have to when they have a monopoly as cancer treatments across the globe. The fact that the UK government lends money to the Radium Trust, and prohibits advertising related to cancer, certainly seems to give radium producers a sweetheart deal. It was much the same beginning in North America. Radium gained its start in cancer treatment in the US early in the 20th century, when the tycoon of radium was the principal backer of Sloan Kettering Hospital, which was to specialize in cancer treatment, specifically with the use of radium.
The truth is there is really no way to combat an entrenched system based on back room deals of the past and present day monopolies. The only power we have as consumers is to inform ourselves to make the best choices for our own health.
What we can do as companies is:
1) Let word-of-mouth advertising do the job.
2) Be mindful of the politics.
3) Support each other by sharing information and having each other’s backs.
4) Help to educate consumers on the issues surrounding health freedom.