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)

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:

 

The full FDA warning letter can be read here.

[button color=”blue” size=”medium” url=”http://www.riskscience.umich.edu/category/ebola/” ] More articles on ebola from the RSC [/button]


2020 Science Notes are short comments and reflections on stories that grab my attention – browse them all here.

Andrew Maynard