Bob
28th September 2014, 02:17
It was pointed out in the silver thread (http://projectavalon.net/forum4/showthread.php?73942-Potential-of-silver-to-treat-Ebola&p=880960&viewfull=1#post880960), IF one starts making claims using the word CURE, and talking about using a product as a DRUG, that such would incur such consequences as FDA says, make a drug claim, and one will need to comply with drug requirements. It's not rocket science, there have been issues since the 30's-50's about using the word "CURE"..
(Source for the following Article (http://www.washingtonpost.com/news/to-your-health/wp/2014/09/24/fda-warns-three-companies-against-marketing-their-products-as-ebola-treatments-or-cures/))
"One company targeted by the FDA, Natural Solutions Foundation, had materials on related Web sites promoting the company's products as cures to several serious diseases and viruses, including Ebola.
"On one YouTube video posted to the Natural Solutions Foundation account, the written text complains that the "WHO, FDA, the New York Times, etc., have gone on a rampage of disinformation [sic] to keep you in the dark about natural ways to dispose of dangerous microbes without damaging your beneficial bacteria."
"The video features Rima Laibow, the company's medical director, claiming that the Natural Solutions product, Nano Silver, can "inactivate viruses like the HIV Virus, the Hepatitis B and C virus, Influenza viruses like H1N1, and Ebola virus."
"According to the FDA, all three companies have 15 days to respond to the documented violations and notify the agency of any corrective actions. If the companies are unable to correct those violations within 15 days, they're required to explain why and provide a timeline for completion."
"If they don't take corrective action, the FDA could take any number of enforcement actions against the companies. Those include seizure, or possible criminal charges."
The FDA also went after Young Living Essential Oils, and dōTERRA International LLC , besides Natural Solutions Foundation with warning letters.
The FDA essentially pointed out: "The products in question, the letters note, are not FDA-approved drugs, yet their marketing makes the sort of claims that only approved drugs may make -- that they can be used to treat, mitigate, prevent and cure diseases." (there are other letters to others in violation of FDA rules on the referenced site as well).
===================
The letter to Natural Solutions Foundation:
Reference #14-NWJ-11
Dear Dr. Laibow:
This is to advise you that in August 2014 the U.S. Food and Drug Administration (FDA) and the United States Federal Trade Commission (FTC) reviewed your websites at http://www.drrimatruthreports.com and http://www.nsfinarketplace.com, from which you take orders for several of your products, including your "Dr. Rima Recommends™ The Silver Solution" (also referred to as "Silver Sol Nano Silver™") and "CBD Organic Dark Chocolate Bars" (also referred to as "High Potency CBD Hemp Oil™"). You also sell these two products together as a "Personal Protection Pack" and "Family Protection Pack."
Based on FDA's review, we have determined that your websites promote these products for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §321(g)(1)(B)].
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.
Examples of some of the claims from your website, that provide evidence that your products are intended for use as drugs include:http://www.drrimatruthreports.com,
On the home page you have a YouTube video embedded titled, "URGENT MESSAGE to EBOLA-STRICKEN NATIONS' HEADS OF STATE." In the video you state:
• "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...." (00:35- 2:12)
On your "Smoking Gun: US Suppressing Ebola Therapy Since 2009" page, which is accessed from a link on your home page:
• "2009 DOD Funded Study Finds Nano Silver Inhibits Ebola Virus"
• "[] US GOVERNMENT RESEARCH SHOW[S] THAT THERE IS A CURE FOR EBOLA ...AND IT IS NANO SILVER. ..." ·
• "They DID come up with a cure, prevention and treatment for it [Ebola]: 10 PPM Nano Silver."
• "[] Nano Silver at 10 PPM IS the definitive prevention and therapy for Ebola virus...
• [T]here is a cure, treatment and prevention for Ebola virus"
• "[N]ano silver was known ...as the definitive antiviral agent against Ebola virus[]"
• "[] NANO SILVER, at 10 PPM, effectively kills the Ebola virus."
• "[T]here IS a ...cure and prevention for Ebola Virus."
• "[T]he CBD will alleviate the terrible pain of the disease while the silver works its wonders...."
On your "Dr Rima Recommends™"page, which is accessed from a link on your "Smoking Gun: US Suppressing Ebola Therapy Since 2009" page:
• "Conventional Antibiotics won't do much against genetically engineered or resistant organisms.... But safe, gentle and effective nano silver kills disease organisms in a different way- and works against everything it has ever been tested against. ...This is powerful natural protection you need for yourself ad [sic] your family. Choose the Personal Protection Pack or the Family Protection Pack...."
• "Silver Sol Nano Silver™, the 'Universal Infection Solution'.... It kills only the organisms that cause disease.... Item its a frequency similar to the lamps in hospitals that kill deadly germs ...and also interferes with the metabolism of the disease organisms in such a way that they cannot become resistant to it."
Under the "Breaking News" heading on your home page you provide links to: The page, "Ebola Threat: Dr. Rima Recommends Nano Silver!":
• "[T]here is good reason to believe that there already is a natural solution for, and prevention against, the terrifying novel Ebola virus.... That nutrient substance is Nano Silver...."
The page, "Dr. Rima: 'Why the UN, CDC and WHO Want You to Believe Ebola Has No Cure or Treatment":
• "[] 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."
• "Nano Silver ...and offered to provide a protocol ...so they could stop the Ebola outbreak. ..."
• "Why ...Nano Silver and CBD? Because if you do get Ebola, you will be in great pain and while Nano Silver takes care of the disease, I simply do not want you to suffer."
The page, "Dr. Rima: 'Beware Ebola Disinformation"':
• "[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." .
• "Ebola virus, specifically, is inactivated/neutralized by the application of Nano Silver 10 PPM.... It cannot invade cells to force them to reproduce it. The nutrient appears to regulate cell wall permeability, so the virus cannot penetrate the cell membrane."
• "There is ...no research showing that colloidal silver is effective against Ebola virus. . . . [T]he research declassified in 2009 by the Defense Department makes it quite clear that exactly the opposite is true of NanoSilver 10 PPM (the product is effective against Ebola virus]."
• "Now we know more about the specific therapeutic benefits of Nano Silver in he case of Ebola."
You also have an "Advanced Nano Silver 10 PPM Nutritional Pro-Immunity Protocol for Immune Support in Epidemic Situations Including Ebola, MERS, Malaria and Similar Conditions," available with newsletter subscription on your website, http://www.drrimatruthreports.com. Examples of some of the claims from the protocol include:
• "All evidence suggests that Nano Silver 10 PPM will help where vaccines do not exist or fail and are [sic] beneficial even when the immune system is impaired, such as in AIDS."
• "Nano Silver 10 PPM offers a potentially beneficial therapy against virtually all types of viruses, bacteria and other pathogens (including malaria, and dengue)...."
Examples of some of the claims from your website, that provide evidence that your products are intended for use as drugs include:http://www.nsfmarketplace.com,
On the home page:
• "Nano Silver 10 PPM has been shown by US Defense Department research to effectively inactivate/neutralize the Ebola virus. Our Nano Silver 10 PPM is the identical silver used in that research. That is why we can say with confidence that Dr. Rima Recommends™ The Silver Solution (Nano Silver 10 PPM) has been shown to deal effectively with the Ebola virus."
• "In fact, every disease causing organism against which it has been tested, all around the world has been killed (bacteria, parasites) or inactivated (viruses) by this amazing solution."
In addition, a claim on your Twitter page, https://twitter.com/NaSolFoundation,which has a link to your website, http://www.drrimatruthreports.com, where products can be purchased directly, provide further evidence that your products are intended for use as drugs:
• On August 2, 2014: "Ebola does have a cure." Further, claims made on your Facebook page https://www.facebook.com/NaturalSolutionsFoundation, which also has a link to your website at http://www.drrimatruthreports.com,where products can be purchased directly, provide additional evidence that your products are intended for use as drugs:
Posts on your Facebook page include the following:
• On August 3: "Nano Silver Inhibits Ebola Virus"
• On August 1: "Rima E. Laibow MD, Natural Solutions Foundation Medical Director, saying Nano Silver likely to address genetically novel Ebola virus, offers hope for nations impacted by the West African Ebola outbreak and the rest of the world."
• On August 1: "EBOLA DOES HAVE A CURE!"
• On July 29: "THERE IS A NATURAL THERAPY WITH HELP FOR EBOLA"
FDA also notes that http://healthfreedomusa.org and http://www.healthfreedomportal.org automatically redirect to http://www.drrimatruthreports.com.
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)].
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products or their labeling. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including seizure and/or injunction.
Please notify this office in writing within fifteen (15) working days from your receipt of this letter as to the specific steps you have taken to correct the violations noted above. Your response should include any documentation that would assist in evaluating your corrections. If you cannot complete all corrections within 15 working days, please explain the reason for the delay and the date by which each such item will be corrected.
Your response should be sent to U.S.Food and Drug Administration,Kerry Kurdilia, Compliance Officer, Food and Drug Administration, 10 Waterview Blvd, 3rd Floor, Parsippany, NJ 07054. If you have any questions with regard to this letter, please contact Ms. Kurdilla at 973-331-4908 or email kerry.kurdilla@fda.hhs.gov.
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)
http://www.ftc.gov/os/adjpro/d9329/0...opinion.pdf,WL 5108600 (D.C. Cir. Dec. 10, 2010). pet. for review den., 2010
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.
Violations of the FTC Act may result in legal action seeking a Federal District Court injunction or Administrative Cease and Desist Order.
An order also may require that you pay back money on consumers.
Please notify FTC via electronic mail at healthproduct@ftc.gov, within fifteen (15) working days of receipt of this letter, of the specific actions you have taken to address FTC's concerns. If you have any questions regarding compliance with the FTC Act, please contact Richard Cleland at 202-326-3088.
--important references to understand why this is happening:
http://projectavalon.net/forum4/showthread.php?73942-Potential-of-silver-to-treat-Ebola&p=865086&viewfull=1#post865086 - "Nigeria INSISTS the Ebola Cure may be this new nano-silver DRUG" Nigeria was apparently told that the nano-silver is a DRUG, so they used the word "DRUG" (possibly by doctors, or possibly by correspondence from the supplier) and they made the word DRUG quite known across the world; then they said afterwards they believed that DRUG to be too uncertain as to how to use such. (ref (http://projectavalon.net/forum4/showthread.php?73942-Potential-of-silver-to-treat-Ebola&p=865558&viewfull=1#post865558))
skuzzy
28th September 2014, 03:13
That is a great post about nano silver. it has for awhile now made sense to me that we can easily defeat pretty much all ailments on the biological level, even those artificially created on purpose to hurt/kill us.
Does MMS also work for ebola? i am under the impression it will, based on the chemistry, i just have not looked into it yet. i also heard that ebola can not survive more than an hour or so in an air conditioned climate, 22 degrees celcius. that would make sense why it is contained to hot humid areas. perhaps that is what they were 'testing' for in Feb or so in Africa i heard? the us DoD supplied millions for tests with ebola and then suprise, oops, ebola breaks out in march, not just in july or whenever. Could they have been trying to modify the virus so that it can survive in a broader range of climates? i also read that it can not survive outside the body very long. if true, where did this outbreak come from? where did the outbreak decades ago come from? if all that is true, where did ebola come from???
i cant wrap my head around the fda. look at it this way: is someone claims a cure for, lets say cancer, why does he have to pay millions to the fda for trials and tests? if he is merely a con man fleecing the people and his cure doesnt work, well he wont be in business for long, word will spread he is a fraud. but if his claim is true and he does have a cure for cancer, well hey now, there you go. demanding millions for tests is a trick, to keep our diseases steady allowing us to live with the condition but just barely so we can pay for the drugs. then that drug stops working well and you need a stronger, more expensive more debilitating drug. the cycle perpetuates until you can no longer pay for the fda's scam and you die. and then your family has to pay thousands to burry you.
if it wasnt so evil, i would applaud such an elaborate, succesfull EXTREMELY profitable system. but it IS evil. but it is ending too :)
Ahnung-quay
28th September 2014, 13:59
Given the fact that alchemists down through time have used the silver stone to prevent and treat disease and the gold stone to extend life span, and this is documented by many alchemical writings, I tend to agree that nano silver may be a preventative and cure for all diseases, including the common cold.
As noted in Bob's post above, the FDA has probably had a hand in developing and testing the Ebola virus.
I may just be ordering some nano silver....
TrumanCash
28th September 2014, 15:23
According to the insane FDA officials any substance that is "intended for use in the cure, mitigation, treatment, or prevention of disease" is a drug and is therefore subject to their control and regulation. This definition makes water a "drug"! Water is the cure for dehydration which can cause death. They want to make anything that causes a change in the body to be labeled a drug. This is totally absurd because every thing you put into your body (e.g., food and water) produces changes in your body.
When the FDA sends one of those threatening letters and you don't make the demanded changes in your website, you will have to spend tens if not hundreds of thousands of dollars fighting them in court.
Jonathan Emord is a constitutional attorney who has taken on the FDA several times on this same issue (freedom of speech) and beat the FDA using the "first amendment" as a defense.
Under the common law if there is no injured party there can be no lawsuit or criminal charges. Unfortunately, the common law has been usurped by corrupt "politicians" who have gradually replaced common law with "political" codes; hence, we are in a "police" (policy) state with unconstitutional "political" entities like the FDA taking away our natural rights.
TLC
conk
29th September 2014, 17:59
"We don't care if it works. It is illegal, because we said so"!
I've often thought the government should notify us of suspicious remedies, even make stark, dark warning about some things. But ultimately we should have the final say about what we use in our own health management. The government should never have this much authority, as they do now.
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