Natural Solutions Foundation 9/23/14
|UNITED STATES OF AMERICA
FEDERAL TRADE COMMISSION
BUREAU OF CONSUMER PROTECTION
WASHINGTON, D.C. 20580
|DEPARTMENT OF HEALTH
AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
SILVER SPRING, MD 20993
SEP 23 2014
VIA OVERNIGHT DELIVERY
RETURN RECEIPT REQUESTED
Natural Solutions Foundation
58 Plotts Road Newton, NJ 07860
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 email@example.com.
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)
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 firstname.lastname@example.org, 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.
Mary K. Engle
Division of Advertising Practices
Federal Trade Commission
William A Correll
Office of Compliance
Center for Food Safety
And Applied Nutrition
Food and Drug Administration
Diana Amador Toro
New Jersey District Office
Food and Drug Administration