Swedish Medical Products Agency Bans Ionosil Colloidal Silver

Ion Silver AB, Colloidal Silver

In another stunning victory for science-based medicine, Swedish Medical Products Agency (the regulatory body for medicine and medical products) has decided that the company Ion Silver AB must stop promoting and selling colloidal silver of the brand Ionosil together with claims that the product treats diseases such as cancer and Ebola.

As a death-blow to the colloidal silver fanaticism, the agency even refuted the classic trope of “What’s the harm?” and even went so far as to criticize anecdotal evidence and the claim that antiseptic effectiveness of waste water somehow means efficacy against human diseases.

What diseases did Ionosil Colloidal Silver falsely claim to treat?

Like most forms of alternative medicine, Ionosil Colloidal Silver claims to prevent, treat and cure a long list of diseases, such as cancer, malaria, rheumatoid arthritis, shingles, chronic obstructive pulmonary disease, Taiwan acute respiratory agent, Lyme’s disease, multiple sclerosis, Ebola virus disease, psoriasis, norovirus (winter vomiting bug) and arthritic pain.

This is an obvious sign of quackery. Diseases are usually very specific in terms of how they are caused, how they progress, what they do and what symptoms you get. This means that it is unlikely for a simplistic product like small particles of silver in a water solution to prevent, treat and cure all of them.

What is the basis for the decision made by Swedish Medical Products Agency?

Although acknowledging that colloidal silver is approved for being sold as water purification, the company has marketed it for human consumption together with false and misleading health claims. This entails that the product is, in practice, being sold as a medical product. To be able to sell a product as a pharmaceutical, it has to approved by the regulatory authorities and this requires scientific evidence for both safety and effectiveness. Since Ionosil is not an approved pharmaceutical, it cannot be sold or marketed the way that Ion Silver AB has done.

Furthermore, it concluded that diseases like cancer and malaria are serious medical conditions and quack products like Ionosil Colloidal Silver might “delude people who suffers from these diseases to use an ineffective product instead of getting a working treatment”.

In the United States, the Dietary Supplement Health and Education Act from 1994 provided a safe haven for promoters of quackery and does not require them to submit safety information to the FDA. Sweden has a more developed set of laws and regulations. Starting in the 1960s, Sweden passed a law called “Law concerning prohibitions in some cases against activities on the area of healthcare” (popularly known as “the quack law”) making it illegal for people who are not medical doctors may not

– treat HIV, tuberculosis, cancer, diabetes, epilepsy, diseases associated with pregnancy or labor
– use anesthesia, sedation, hypnosis, x-rays,
– treat children below the age of 8

etc.

This was later incorporated into the Patient Safety Law from 2010. In the case of supplements, they are considered items of foods and are thus regulated in the same way as any other food item. However, medical claims cannot be made about any supplement regardless of whether or not it is true. If medical claims are being made, the product can be redefined by the Swedish Medical Products Agency as a medical product and no longer a supplement.

Medical Products Agency responds to the “What’s the Harm?” trope

What was pleasantly surprising was that the frequently asked question section associated with the decision included a section rebutting the popular alternative medicine apologetic known as “What’s the harm?”. This trope is based on asserting that there is no harm in using alternative medicine, apparently completely oblivious to the fact that alternative “treatments” can be both dangerous and ineffective and may reduce the chance that the person seeks actual medical treatments. Here is how the Medical Products Agency responds (my translation):

Why ban, what’s the harm if I want to try Ionosil against diseases?

According to the läkemedelslagen [Law concerning pharmaceuticals, 1992], a medical product must be approved and registration before it is allowed to be sold. This is done so that there will be an objective and competent guarantee that they are effective and safe. The purpose of the law is to protect sick people from being treated with products that do not have a demonstrated effect.

In fact, the agency went further than that and even addressed another popular argument about the alleged broad-spectrum efficacy colloidal silver (my translation):

But colloidal silver is antibacterial/antiviral?

Colloidal silver exists as a water purification product, but that a product that can disinfect fluids is a completely different matter than being able to fight diseases in the body.

Patient stories about colloidal silver can in this case be misleading, if you look at a specific case you do not know if the person would have recovered even without the preparation. You also do not know how many that do not improve, these client stories are rarely passed on. Client stories may also be fictitious as part of the marketing.

What is the consequences of this decision?

A ban by the Swedish Medical Products Agency means that Ion Silver AB are not allowed to market or sell their product or colloidal silver generally under the false health claims it has been making. The ban is effective immediately and if Ion Silver AB violates the ban, they can be fined.

In a previous clash between the Medical Products Agency and the Ion Silver AB company, Ion Silver said that they would just move outside the country and continue business as usual. At the time of this writing, the largest Facebook group devoted to colloidal silver in Sweden (“Kolloidal Silver 2.0”) has over 26 000 members.

Emil Karlsson

Debunker of pseudoscience.

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