The manufacturer, which we did not name in our original reporting, is called Safer Medical of Montana, Inc., and the company manufactures at least two products: Prescript-Assist and Pet Flora. Both are sold on Amazon.com and both use "leonardite" as their No. 1 ingredient.
Correction: An earlier version of this story incorrectly stated the company name as "Safer Products of Montana, Inc." The correct name is "Safer Medical of Montana, Inc."
Leonardite is a mined mineral matrix known as "oxidized lignite coal." It's mined in North Dakota and Wyoming, where various suppliers sell it as "leonardite." This mined mineral matrix is known to contain both lead and aluminum at significant concentrations, as has now been confirmed by two labs: CWC Labs and Midwest Laboratories.
Importantly, leonardite is not typically sold for internal consumption. It's also not recognized by the FDA as safe for internal consumption. It's essentially a form of coal, which means a probiotic product is actually a "coal supplement" that's deceptively marketed as a probiotics supplement. If you think you need to eat more coal to stay healthy, you've been hoodwinked.
In our ICP-MS testing at CWC Labs, an ISO-accredited laboratory, we found that leonardite contains 10,000 ppb of lead and 3,500,000 of aluminum. This is consistent with the range of findings also published by a leonardite producer, Leonardite Products, LLC, according to mineral analysis results posted on their website.
Leonardite Products also posts a safety data sheet that warns against consuming leonardite internally, saying:
Section 4: First Aid Measures
Ingestion: If conscious, drink large quantities of water. Do not induce vomiting. Take immediately to a hospital or physician. If vomiting occurs, administer additional water. If unconscious or in convulsions, take immediately to a hospital. Do not attempt to induce vomiting or give anything by mouth to an unconscious person.
For whatever reason, Safer Medical of Montana, Inc., decided to use a non-dietary ingredient as the No. 1 ingredient in their products, which include "Prescript-Assist" (marketed for humans) and "Pet Flora" (marketed for dogs). Both products use leonardite as the primary ingredient, which is why both products have a dark, blackish color. Both are sold on Amazon.com, which utterly fails to adhere to any semblance of public safety or ethics when it comes to retailing health products.
Here's a photo of the ingredients label for their Prescript-Assist product. Notice that the No. 1 ingredient is leonardite:
And here's a look at the two products they sell, both of which are made with leonardite as their No. 1 ingredient:
Leonardite supplier confirms it's not labeled for internal consumption nor sold for internal consumption
As part of our investigation into the Prescript-Assist probiotic supplement sold by Amazon.com, we spoke with Cherie Harms, the President of Leonardite Products, LLC. She confirmed to Natural News that leonardite is not sold for internal consumption. It is only labeled for -- and sold for -- use as a soil amendment.
Leonardite Products, LLC, even posts its own heavy metals analysis of its product, confirming the range of concentration of elements we found in our own laboratory testing.
When I told Cherie Harms about the fact that a dietary supplement manufacturer was using leonardite as the No. 1 ingredient in a dietary product, she replied, "I'm guessing the FDA isn't going to be very happy about this." She affirmed that her company does not sell leonardite for use in dietary supplements or animal feed. She also confirmed that potential customers frequently ask her about using leonardite as a feed supplement, and she tells them no, it isn't intended for that use.
Leonardite Products, LLC, appears to be ethically run and its products are honestly labeled along with commonsense safety precautions. We have no issue with the Leonardite Products company or other producers of leonardite. They agree with us that leonardite is not intended to be eaten by consumers. Leonardite is high in humic acid, which is why gardeners choose it for use in their garden soils.
Leonardite is not recognized by the FDA as a safe ingredient for oral consumption
This decision by Safer Medical of Montana to use oxidized lignite coal appears to be in violation of FDA regulations. Dietary supplement manufacturers are not allowed to formulate dietary products with any random substance they wish to insert into a capsule. Just because something is mined out of the ground doesn't make it automatically safe for human consumption, especially considering that many mined substances may contain lead, arsenic, mercury, cadmium or other toxic elements.
The FDA's GRAS database does not list leonardite as being recognized as a safe ingredient for dietary supplements, indicating that the FDA does not recognize leonardite as a safe substance to use in dietary supplements. Since leonardite is not a food -- nor is it derived from food -- it appears that the use of leonardite in a dietary supplement marketed for internal consumption is a gross violation of FDA regulations and commonsense safety standards.
Instead of removing leonardite from their products following the CWC Labs investigation into their products, Safer Medical of Montana, Inc. hired a law firm to threaten Natural News and CWC Labs, demanding that we remove the article and video which documented the lead and aluminum levels found in their products. In the threatening legal letter, Safer Medical of Montana's law firm states that we are trying to "scare" people by using parts per billion numbers instead of parts per million. For example, we report 10,000 ppb of lead instead of 10 ppm.
This only shows the scientific illiteracy of the company and its law firm, since heavy metals analysis results via ICP-MS are always expressed in parts per billion. That's the default setting in all the software systems that run ICP-MS instruments.
Furthermore, 10,000 ppb is equivalent to 10 ppm. These are the same figures. One is not higher or lower than the other. We even explained this in our original article, offering a shortcut for unit conversion that readers could be clearly and accurately informed of what the reported concentration levels mean.
Safer Medical of Montana is trying to silence our science lab and violate our right to warn the public about a hazardous ingredient that violates FDA regulations
In sending CWC Labs and Natural News a threatening legal demand, Safer Medical of Montana is clearly trying to silence our important work in the public interest and suppress our truthful scientific findings about the concentrations of lead and aluminum found in their products and in their No. 1 ingredient, leonardite.
This is blatant censorship and the attempted muzzling of one of the most important consumer science organizations in the world: Natural News. Over the years, we've blown the whistle on lead in zeolites, lead in rice protein powder from China and heavy metals in fast food water. We've tested beer for glyphosate and shared the results, showing that there's no concern at all about the glyphosate levels in beer. Under way right now are tests for aluminum in camping cookware and glyphosate in flax. We have much more to share with the public, but one deceptive supplement manufacturer in Montana wants to silence us forever so that they can keep selling oxidized coal as a dietary supplement.
Safer Medical of Montana wants Natural News silenced so that nobody will know they're using an oxidized lignite coal ingredient that's loaded with lead and aluminum as their No. 1 ingredient. Instead of cleaning up their products, they threaten the food scientists who discovered what they were selling. Notably, we are the only organization that blew the whistle on this scam. Even the FDA wasn't aware of this before now (but they will be fully informed soon).
I can't say I'm surprised. Every time we publish honest, truthful information about heavy metals in a product, we are threatened with legal action. Dozens of companies have tried to sue us for printing the truth about their contaminated products, but none have succeeded.
It turns out that the courts still recognize the First Amendment right to tell the truth about product composition in America. Safer Medical of Montana needs to study the "Streisand Effect" and learn why trying to sue First Amendment publishers will catastrophically backfire, whipping up even more awareness about their deceptive practices and consumer distrust of their brand. In the first article, we didn't even mention the name of this company. Now we've gone public with it. And there's much more to come if they want a public war.
Interestingly, their tactics resemble those of Monsanto, a bully corporation full of evil people who use threats and intimidation to try to silence any science that shows their products to be harmful or hazardous. Recent news has found that Monsanto ran a full time black-ops team to threaten and intimidate journalists, scientists and activists, including Reuters journalists. My name was on that same list, and I've been death-threated, bullied, stalked and intentionally slandered. Some dishonest supplement company in Montana barely even gets my attention... that is, until they try to silence us. Now I'm more determined than ever to expose this company, its founders, its deceptive practices and its attempts to silence whistleblowers who are working to protect the public from its hazardous products.
It is my professional, science-based view that leonardite, while safe for use as a soil amendment, is hazardous when used in a dietary supplement. Using it in a dietary supplement is also a violation of FDA regulations, which is why I repeat my demand that the FDA seize this product from all retail operations, including Amazon.com, in the interests of protecting the public from toxic heavy metals exposure.
Safer Medical of Montana needs to realize that we cannot be threatened into silence. Your product is made with an ingredient that contains alarming levels of lead, a toxic heavy metal linked to neurological problems, and we are filing laboratory-backed complaints with both the FDA and the FTC to expose your deception and hopefully force you to reformulate your products using ingredients that are intended for human consumption, not sold as bulk soil amendments.
If you wish to retract your lawsuit threat and apologize to CWC Labs and Natural News, we will be happy to help you test the heavy metals of a reformulated product that you might wish to roll out as a replacement for your "coal supplement" that you are now deceptively selling as a probiotics supplement.
Yes, Safer Medical of Montana is selling hazardous, potentially harmful products and trying to silence whistleblowers who are warning the public
We stand behind our original reporting which described these heavy metals-contaminated products as "hazardous" and potentially "harmful." The aluminum levels found in these products are, indeed, quite crazy. In fact, it's crazy that a dietary supplement manufacturer in Montana would use oxidized coal lignite coal -- never recognized by the FDA -- as the primary ingredient in its products.
The fact that Safer Medical of Montana is using legal threats to try to silence our reporting us further proof of their total lack of business ethics and their evil nature, which is no doubt reflected in the hazardous nature of their products. If you want to eat coal that's sold by evil people, buy your products from "Safer Medical of Montana" (a hilarious contradiction if there ever was one). Maybe they should reconsider their name, don't you think?
Join us, if you wish, in telling Safer Medical of Montana to stop selling "coal supplements" that contain high lead and aluminum, marketed as a dietary supplements. You can reach them at this contact page. If you do post a comment with them, be polite. We do not condone threatening behavior, even though that's what they are now exhibiting towards us.
Have you been harmed by Safer Medical of Montana products?
Have you consumed Prescript-Assist or Pet Flora made by Safer Medical of Montana? Have you suffered harmful effects, heavy metals exposure or digestive problems? We are gathering evidence to submit to the FDA and the FTC as part of our effort to protect the public from dishonest, deceptive dietary supplement promoters that use potentially hazardous ingredients in their formulations.
If you've think you've been harmed by Prescript-Assist or Pet Flora, both made by Safer Medical of Montana, contact Natural News and tell us your experience. We will compile the complaints and forward to the FDA and FTC for further action.
You may also report a safety violation directly to the FDA at their safety reporting portal at this link.
You may also submit a consumer complaint to the FTC over deceptive marketing practices by using this link.
In the mean time, we will continue to blow the whistle on unscrupulous dietary supplement manufacturers who use deceptive practices and potentially hazardous ingredients that may harm consumers. We will not be silenced by evil people selling unsafe products.
Mike Adams (aka the "Health Ranger") is the founding editor of NaturalNews.com, a best selling author (#1 best selling science book on Amazon.com called "Food Forensics"), an environmental scientist, a patent holder for a cesium radioactive isotope elimination invention, a multiple award winner for outstanding journalism, a science news publisher and influential commentator on topics ranging from science and medicine to culture and politics.
Mike Adams also serves as the lab science director of an internationally accredited (ISO 17025) analytical laboratory known as CWC Labs. There, he was awarded a Certificate of Excellence for achieving extremely high accuracy in the analysis of toxic elements in unknown water samples using ICP-MS instrumentation.
In his laboratory research, Adams has made numerous food safety breakthroughs such as revealing rice protein products imported from Asia to be contaminated with toxic heavy metals like lead, cadmium and tungsten. Adams was the first food science researcher to document high levels of tungsten in superfoods. He also discovered over 11 ppm lead in imported mangosteen powder, and led an industry-wide voluntary agreement to limit heavy metals in rice protein products.
Adams has also helped defend the rights of home gardeners and protect the medical freedom rights of parents. Adams is widely recognized to have made a remarkable global impact on issues like GMOs, vaccines, nutrition therapies, human consciousness.
Please contact us for more information.
