On September 23, the Food and Drug Administration sent Rima Laibow and Ralph Fucetola at the Natural Solutions Foundation a warning letter claiming that their allegedly nano (colloidal) silver based “Dr. Rima Recommends™ The Silver Solution” product violates the Federal Food, Drug, and Cosmetic Act (FFDC Act).
Earlier in September, I wrote about Rima Laibow’s promotion of the use of her nano silver product as a preventative and cure for ebola in Nigeria.
The FDA warning letter cites the therapeutic claims made of nano silver as a violation of the Federal Food, Drug, and Cosmetic Act:
The therapeutic claims on your websites establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
According to the letter:
Your “Personal Protection Pack,” “Family Protection Pack,” “Dr. Rima Recommends™ The Silver Solution,” and “CBD Organic Dark Chocolate Bars” products are not generally recognized as safe and effective for the above referenced uses and therefore, these products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
Furthermore, your products identified above are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, these products are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. §352(f)(1)], in that their labeling fails to bear adequate directions for use. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
…
In addition, it is unlawful under the FTC Act, 15 U.S.C. § 41 et seq., to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made. See FTC v. Direct Mktg. Concepts, 569 F. Supp. 2d 285, 300, 303 (D. Mass. 2008), affd,624 F.3d 1 (1st Cir. 2010); FTC v. Nat’l Urological Group, Inc., 645 F. Supp. 2d 1167, 1190, 1202 (N.D. Ga. 2008), affd,356 Fed. Appx. 358 (11th Cir. 2009); FTC v. Natural Solution, Inc., No. CV 06-6112-JFW, 2007-2 Trade Cas. (CCH) P75,866, 2007 U.S. Dist. LEXIS 60783, at * 11-12 (C.D. Cal. Aug. 7, 2007). More generally, to make or exaggerate such claims, whether directly or indirectly, through the use of a product name, website name, metatags, or other means, without rigorous scientific evidence sufficient to substantiate the claims, violates the FTC Act. See In re Daniel Chapter One, No. 9239, slip op. 18-20, 2009 WL 516000 (F.T.C.), 17-19 (Dec. 24, 2009)
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The FTC strongly urges you to review all claims for your products and ensure that those claims are supported by competent and reliable scientific evidence.
The FDA cite 30 claims that the Natural Solutions Foundation are marketing nano silver as a drug in violation of the FFDC Act, including:
“As of now it is said that there is no treatment against Ebola, and that is not true. In fact there is a well-known, well characterized, nutrient. That is Nano Silver…. [I]t does kill every pathogen against which it has been tested, worldwide, without exception. There is no other effective solution …Nano Silver …is unlimited in its effectiveness …[and is a] safe, non-toxic …and available solution against Ebola and every other communicable disease….”
“[] Nano Silver inhibits every disease organism it has ever been tested against, without exception.”
“Nano Silver is the world’s only hope against Ebola and the other antibiotics/anti viral resistant pathogens.”
“[W]ith regard to Nano Silver[‘s impact against the Ebola virus] there is both clinical experience and research, namely the DTRA-funded study….. That report suggests, in vitro, a significant inhibition of viral action with Nano Silver 10 PPM.”
The FDA warned against fraudulent ebola treatment products in August – this (and two similar letters) is a next step toward preventing their use.
Interestingly, the mechanism used is not to refute directly the claims being made by the Natural Solutions Foundation and Laibow, but to to hold them to the regulatory standards that all therapeutic drugs are legally required to adhere to in the US – starting with “show us the data”.
As the FDA say in their letter, “The FTC strongly urges you to review all claims for your products and ensure that those claims are supported by competent and reliable scientific evidence.”
And Natural Solutions Foundation’s response?
“Thanks for your interest in Nano Silver. As you know, there is a concerted effort to make it unavailable despite the fact that our Dr. Rima Recommends(TM) Nano Silver 10 PPM is completely legal! For that reason we are providing work-arounds.” [from website, accessed 7:54 am October 5]
That workaround is to mail Natural Solutions Foundation directly with your order and your money:
Screenshot of http://drrimatruthreports.com/cbds-nano-silver-and-paypal-censorship – Oct 5, 8:00 AM
The full FDA warning letter can be read here.
More articles on ebola from the RSC2020 Science Notes are short comments and reflections on stories that grab my attention – browse them all here.
It seems anyone this suppressive of nano silver must be in the big drug business and doesn t want competition .
Truth is, it works. Been taking it for years and using both inhaled aerosol and sinus irrigation; both stopping colds and flus in hours. Topical gel heals almost suddenly. Guess what? I used it on MRSA. Gone in 3 days. Doctors never knew. This is the beginning of Big Pharma’s push to eradicate any competition. You don’t need ‘experts’ to see for yourself what this can do. Just use it, you’ll see. Nothing can mutate against it either. Another blatantly lied about fact. It just doesn’t work like that. AND IN SUCH SMALL AMOUNTS IT IS RATHER BENIGN PHYSIOLOGICALLY AND ENVIRONMENTALLY AND DISINGENUOUS TO CLAIM OTHERWISE. Shame many will die, but many will not because of Dr. Rima’s work. She’s been in Big Pharma’s bullseye for her work against the Codex Alimentaris. Another Draconian effort to curb our health choices.
It is likely the FDA will shut down any sales of nano or ionic silver used as a drug. They can simply demand the results of clinical testing on humans for the exact product being sold which likely can not be provided.
Ebola virus is not a problem at all (like any other viruses – HIV/AIDS, Colds, Flues, Malaria, Yellow Fever, etc.) and can be eradicated in a matter of a few days – I got the all viruses, bio-weapons and cancers devastating destroyer to cure and prevent everyone, if I am paid 50 billion EURO for the whole world – Doing a simple exercise for just a minute a day, everybody will stay absolutely healthy all the time (Just like me), all life long – never getting sick of any diseases even for a second, as any viruses, any bio-weapons, any cancers, diabetes and strokes are killed the moment they touch us and by that made absolutely none-existent for everyone of us.
The FDA is on a witch hunt funded by MERCK. Dr. Laibow was merely stating what a 2009 declassified Dept of Defense study showed, which was that Nano Silver 10ppm inactivated the Ebola virus. But the CDC can’t run their Ebola fear campaign if consumers learn the truth about silver. MERCK knows the truth and is funding ‘activists’ to petition the FDA to regulate nano silver as a pesticide to block it from consumers. The problem is that it’s already being used in a wide array of consumer products, like dental cement. Nano silver is prized for its anti-bacterial properties. Hippocrates ‘the father of medicine’ extolled the healing properties of silver -look it up!
Before I forget to mention it, you should all know that MERCK just bought Sigma-Alrich for 17 billion dollars. Sigma-Alrich is a research lab that conducted studies on nano silver, and found it to contain cancer fighting properties. Can’t have that available over the counter. Science papers on all this info can be found on the web -for now!
One last thought, if U.S. govt agencies like the FDA were credible the EPA would put a stop to public water fluoridation. The Lancet has classified fluoride as a neurotoxin, in the same category as lead, mercury and arsenic. Yum! And not one, but 2 Harvard studies showed fluoride damages the central nervous system and lowers the IQ’s of children. Parkinson’s and dementia are through the roof but the public is told that the industrial grade fluoride that’s dumped into our public water systems are SAFE to ingest. In fact, it’s good for you! Still, not a peep from MERCK about the dangers of fluoride-because they cannot patent it for use in their drugs like nano silver.
This is a story about medical tyranny, but don’t expect mainstream media to report that.
Yet another article by a fanatic brain washed by the dogma of big drug companies. We do not believe a single word you say!
The FDA NEEDS TO HAVE ITSELF REMOVED FROM OUR COUNTRY. THEY ARE CROOKS FOR THE DRUG COMPANIES. THEY ARE NOT PROTECTING THE COUNTRIES INTEREST. THEY ARE ONLY PROTECTING THE DRUG COMPANIES. THE UNIVERSITY OF PENNSYLVANIA DID A STUDY ON NANO SILVER. IT SHOW IT KILLED VIRUSES AND BACTERIA. THEY SHOULD HAVE NO ABILITY TO REGULATE CLAIMS ON THE PRODUCT AND ITS ABILITY TO kILL EBOLA. IT HAS ALREADY BEEN PROVEN UNDER THE ELECTRON MICROSCOPE. THE FDA NEEDS TO BE PUT IN JAIL FOR THIS ONE FOR MURDER.
i absolutely agree with all the comments here, Big Pharma are trying to brainwash us, don’t use this don’t use that, it’s not FDA approved. We have been taking Dr. Rima’s Nano Silver from a week now – not because we have Ebola – but for detoxing from old infections for a start – and we’ve been feeling great, especially my wife! Wake Up People!
I read that NASA USES IT FOR THEIR WATER PURIFICATION IN SPACE? BEEN USED FOR CENTRIES IN WATER BARRELLS TO KEEP IT PURE? READ
BEING USED IN HOSPITALS TOO. ARE VACCINES PROVEN FACTS WITH SCIENTIFIC DATA RESEARCH DONE BEFORE GIVEN TO THE PUBLIC????
(moved from original post to here due to subject)
Few if any suggest long term use of colloidal silver nano particles. It should be considered a treatment. It can be absorbed in the mouth if swished under the tongue. It stopped E. Coli in my dog when Cipro used with Keflex did not stop the very visible blood in his urine. The vet was rather surprised. Silver has a long history of curing infections. My understanding is that it will not cause argeria when properly used and if it did produce it, what is more important, possibly killing Ebola or bluing and would it blue a dark complexioned skin? Where is the evidence that It is harmful to health if used properly? There are plenty of studies that support its use; do a good old google and decide if the evidence is credible. Silvadene is a topical nano silver that doctors prescribe for burns and severe burn victims are place in tubs of it and this has been effectively done for years. I used it on a two square inch hot oil burn that caused skin to literally fall off my stomach. I did not use the Keflex also prescibled and the skin healed without any infection or scaring. I believe the pharmaceutical industry fears incredible losses in profit if this information becomes widely known.
While all of you blame pharma, let’s be very clear: It’s the government.
Pharma pays taxes, while the FDA keeps regulating as well, and like any cop, looks for something to claim out of place and get a fine from Pharma for, and if they can protract their administrative process with press releases and public spectacle, the FDA can get a big settlement, and that’s on top of the tax money from the pharma, or bureaucrats regulating insurance, or banking, or fast food, or pollution…. You get my drift?
I won’t deny pharma looks for high profits. We also can’t deny that there are gold digging lawyers, fraudulent lawsuit, and corrupt judges that Pharma pays for, whether they were wrong or not, since they’re always under scrutiny and cost of liability insurance or more employees as part of the settlement or a ruling, eats at those profits quickly. Additionally, we also can’t deny that phrama does spend money on R & D, both to do harm (military contracts) and to cure, both for the public and military.
I’m sorry but I cannot get upset over a company who likely has been blackmailed by government and its regulations, which might even tell it how to do what it does — the company can’t make smaller doses or use safer ingredients, and certainly changing a formula is costly, because the government will want all the same fees, tests done, etc., from scratch to submit the changed formula, FDA don’t care if it’s safer based on ingredients, they care about their fees and their fines.
Here’s a good example. Between the royalties, the federal, and the state taxes, license fees, and liability insurance, the government makes more off of an oil well than the person or business that owns it. If you want to think the person who wrote this article is brainwashed, ask yourself (and verify what I am saying is true, that’s great), “if the government does this to oil, why wouldn’t they do it to everything else, even individuals?”
Do a Google search on government suing BP for lost royalties from the oil spill, because the government gets 10-30% (depending on the contract) in royalties after leasing (for a highest bidder fee paid to BLM) the land to the oil company, that’s royalties from the very wellhead itself on every drop coming out of that well. Yet the government balked at the Governor of Louisiana over paying for 20 berms, only paying for 4. Remember government gets taxes from the company, and its employees, and subsidiary businesses and their employees, etc. as well. This is how the regulatory regime works and beliefs to the contrary keep us, the end user of the products and services, paying through the nose, and often for something with horrible side effects or almost entirely ineffective when it comes to treatments for illness.
Also silver would mess up the Affordable Care Act’s requirement that people must have (and therefore purchase) insurance, on the idea they’ll go to the emergency room or need x number of visits, things we who use silver will be less likely to do, or will require less visits to be healed up, because we are using silver. Remember the Supreme Court decided the ACA penalty “operates” as a tax….LIke I said, all the way down to the individual.