Safety & Toxicity

The most common misconception about silver’s use as a dietary supplement is that it is neither safe nor effective. This is in direct contradiction to the many known benefits of silver, which are acknowledged by and employed as sanitizing methods by federal and regulatory agencies.

Sovereign Silver Bio-Active Silver Hydrosol™ is proud to be the only brand of colloidal silver to have received a Statement of Safety written by Dana F. Flavin, MD, BS, MS, Founder and Executive Director of collmed™; former Science Assistant to the Associate Bureau Director, Division of Toxicology, US FDA, Washington, DC. It’s important to keep in mind that while Sovereign Silver Bio-Active Silver Hydrosol is safe*, not all forms and brands of silver or colloidal silver products can say the same.

As with any medication or dietary supplement, the success of Bio-Active Silver Hydrosol as a dietary supplement for Immune Support* depends on correct usage. In this section you can learn more about the following:

⁃ Risks of Argyria with Silver Use

⁃ Maintaining Safe Dosage Per the EPA’s Daily Reference Dose

⁃ Is Silver a Heavy Metal?

⁃ Is Bio-Active Silver Hydrosol Nanotechnology?

⁃ Listing of Peer Reviewed Literature Supporting the Safety of Silver

Risks of Argyria
with Silver Use

120-Year History of Safe Use of Silver

A common claim is that silver poses risks of argyria (“Will it turn me blue?”). Contrary to this claim, there is a well-known journal article discussing the 120-Year History of Safe Use of Silver.

As described by the National Institute of Occupational Safety and Health (NIOSH):

Argyria is frequently described as a gray-blue discoloration of the skin, mucous membranes, and/or internal organs as a result of exposure to silver. Argyria may occur in an area of repeated or abrasive dermal contact with silver or silver compounds, or it may occur more extensively over widespread areas of skin after long-term oral or inhalation exposure. Localized argyria can occur in the eyes (argyrosis), where gray-blue patches of pigmentation are formed without evidence of tissue reaction. Generalized argyria is recognized by the widespread pigmentation of the skin due to the deposition of silver complexes and to a silver-induced increase in melanin [Hathaway and Proctor 2004].

Silver hydrosol has never been reported to cause a single case of Argyria.

The risks and toxicity associated with silver have always been attributed to extreme quantities of silver arising from silver salts or silver compounds and inhaled silver powder, none from oligodynamic silver. Oligodynamic means the toxic effect of metal ions on living cells, algae, molds, spores, fungi, viruses, prokaryotic and eukaryotic microorganisms, even in relatively low concentrations. By definition, it would be functionally impossible for oligodynamic silver to achieve toxicity levels, as determined by the Environmental Protection Agency (data last accessed 09/27/17).*

Natural Immunogenics Corp. has taken great care in establishing the safety of its silver hydrosol products. We have not only relied upon good guidance from the EPA on dosage amounts, but we have also employed independent third party experts to confirm product safety.*

Maintaining Safe Dosage

Per the EPA’s Daily Reference Dose

Maintaining Safe Dosage (Also, why 10 ppm?)

The EPA has, for health purposes, established a daily oral reference dose (RfD) for silver over a 70-year study performed on adults of an average 70Kg in weight. This RfD is 350 micrograms of silver per day. Based on this guidance, any silver over 50 ppm would put you above the established RfD taken once a day, and only a 10 ppm can be taken up to 7 times a day, but still be below the RfD.†

The total of all forms of silver exposure is used when determining any potential safety risks. For example, if you drink, on a daily basis, 350 micrograms of shavings from a metal cup, it is just “as safe”* as drinking 350 micrograms of inactive colloidal silver, or 350 micrograms of ionic silver, or 350 micrograms of silver hydrosol. While the safety profile is the same in each of these cases, the efficacy is drastically different between the four!

Keep in Mind

Is Silver a Heavy Metal?

There has been a lot of talk in the news lately about the dangers of heavy metals.

Many people are concerned that silver may be considered a heavy metal, and if it were, it would not be safe for long-term use.

The term “heavy metal” is not clearly defined. However, it is generally meant to refer to metals that are considered toxic to humans, even in low doses (e.g., mercury). Technically, silver (Ag) is listed as a “transition metal” on the periodic table. Other metals listed as transition metals include nutritional minerals you would be familiar with, such as chromium, copper, zinc and iron. These are nutrients considered essential to human health, in the proper form and dose. Form and dose are key!

What is the proper form?

Metals can be bound to different elements, which impacts their absorption and stability. For example, chromium VI, the subject of the Erin Brockovich movie from many years ago, is an extremely toxic form of chromium is carcinogenic to humans. But chromium in the form of polynicotinate is an essential, required nutrient utilized by the body to enhance insulin action. So, one could never make the statement that all chromium is safe or toxic.

Unlike chromium, silver is not yet classified as an essential nutrient in the USA, however it does provide significant health benefits* as proven in multiple research studies. The form of silver is important when considering safety. For example, silver nitrate (considered a silver salt) is used as an eye drop for newborns to prevent blindness, but it would be considered toxic to orally consume this form of silver.

NOTE: Bio-active silver hydrosol (the form of colloidal silver in Sovereign Silver) has been classified in Canada by the Natural & Non-Prescription Health Product Directorate (the risk assessment division of Health Canada, the Canadian equivalent to the US FDA) as a Trace Element, meaning an essential element for the maintenance of good health.* It is a pure mixture of silver ions and silver nano-clusters in suspension, with the highest bioavailability of silver at >98%. The particles are smaller than any other form of silver, therefore it is very effective in the low, safe 10 ppm (parts per million) concentration.*

Is Bio-Active Silver Hydrosol Nanotechnology?

Another hot topic in the media in recent times has been the risk of nanotechnology.

It’s important to understand that nanotechnology definitions include measurements of the size of particles that are on the scale of nanometers. These could be engineered nanomaterials, such as electronics components in our cell phones, or they could be naturally occurring nanomaterials, such as milk’s protein colloids that give milk its white color and provide us with a healthy protein source. While our particles are measured in nanometers, our products are not engineered nanotechnology, a defining characteristic of which is that particles are ENGINEERED at the nanoscale. Particles in our hydrosols are the result of silver’s natural equilibrium state between ions and metal particles.

The nanomaterial scientific and research community has been quite forward thinking and responsible about these risks. Over 15 years ago, researchers and funding agencies were asking the question, “If nanotechnology gives us new material properties we want to use for benefits, could those new properties potentially pose new hazards?”

Thus, the field of nanomaterial environmental health and safety (nanoEHS) research was born. Under the National Nanotechnology Initiative’s tracking of total R&D spending on nanotechnology, nearly 5% of the investment portfolio was focused on nanoEHS safety, a greater percentage than any other time in history for a disruptive technology.

Bio-Active Silver Hydrosol cannot be regarded as an engineered nanoparticle because:

⁃ Nanomaterials have always existed in the food supply.

⁃ Silver is a naturally-occurring element that is widely distributed, albeit at low concentrations, in drinking water and in food such as milk, wheat and mushrooms, and in the nanoscale. Peer reviewed literature provides evidence of naturally occurring silver colloids and silver nanoparticles in river waters in Texas (Wen et al., Environmental Science & Technology, 1997) and in Mexico (Gomez-Caballero et al., Can. Mineral, 2010), with the mechanisms of particle formation being understood to include the natural organic matter found in freshwaters (Akaighe et al., Environmental Science & Technology, 2014).

⁃ Silver hydrosol cannot be regarded as an ‘engineered nanomaterial’ because the silver ions and nanoclusters are in a naturally occurring equilibrium balance due to the purity of our product and the packaging in amber glass to prevent light or oxygen from altering that natural balance.

⁃ Silver hydrosols and products similar to it (e.g., colloidal silver) have been consumed for over 120 years in different parts of the world, with a remarkable safety record.* The few incidents of argyria have been associated with use of homemade silver-based products; abuse of such products with consumption many times the recommended dosage; the over-use of silver salts, silver proteins or compounds; or exposure via inhalation of silver dust.

⁃ There is ample historical evidence of the safe use of Sovereign Silver’s silver hydrosol, with not a single known adverse event reported in more than 19 years of sale domestically and internationally.

Listing of Peer Reviewed Literature
Supporting the Safety of Silver

Toxicity depends upon the dose and route of administration.

Many peer reviewed literature papers in the field of toxicology end up with a PR department promoting sensational headlines claiming something is toxic. But toxicity depends upon the dose and route of administration. Drinking too much water (many gallons) at one time can lead to death. Inhaling a much smaller amount of water is commonly referred to as drowning. Yet we need drinking water to stay alive.

A natural balance exists between our healthy bodies and nearly everything we encounter in the world around us.

So how does one interpret the peer-reviewed literature that has sensationalized headlines like “Water Could Kill You”?

We’re here to help you make sense of this.

We’ve taken the various units of silver exposure reported in the literature and converted them into what the equivalent to the EPA Daily Reference Dose would be.

It is not until 24,000X the EPA daily reference dose (219 gallons!) or more of the highest purity silver is consumed in one day that observable adverse effects are reported in these peer-reviewed literature studies. While these studies were not on our product specifically, we can still learn a lot about the safety profile of high purity silver from this work. One conclusion that might be drawn is that drinking 219 gallons of anything, even water, could lead to health problems.

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