Inspections, Compliance, Enforcement, and Criminal Investigations

LifeSilver 11/19/14

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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

 

TO:     
contact@lifesilver.com
info@lifesilver.com
 
FROM: The Food and Drug Administration and the Federal Trade Commission
 
RE: Unapproved Products Related to Ebola and Notice of Potential Illegal Marketing of Products to Prevent, Treat or Cure Ebola Virus
 
 
WARNING LETTER
 
This is to advise you that in October 2014 the U.S. Food and Drug Administration (FDA) and the United States Federal Trade Commission (FTC) reviewed your website at http://www.lifesilver.com, from which you take orders for your  products, “ASAP Solution,” “Patis 30 Fortified Silver Solution,” and “ASAP Ultimate Skin & Body Care Gel” (also referred to as “ASAP 365 Skin Gel”). You also sell these products in different combinations in your “Combo Wellness Pack” and “Combo Gel Pack.” Based on FDA’s review, we have determined that your website promotes these products for conditions that cause them 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 website 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 claims from your website, http://www.lifesilver.com, that provide evidence that your products are intended for use as drugs include:
 
On your home page:
 
  • “NEW! Ebola and Virus Immunization Page CLICK HERE”
The above bullet is an actual link that directs you to the “Ebola Information – Life Silver: Patented Nanoparticle Silver” webpage, found at http://www.lifesilver.com/ebola.htm:
 
  • “EBOLA AND NANO-SILVER VIRAL IMMUNIZATION”
  • “We have learned from the ASAP H1N1, H5N1 and all sub variant studies that the nano-catalytic silver hydrosols are the best non-toxic options for preventing a viral infection.”
  • “Silver sol resonates at a frequency that can actually suppress and contain viral infections by interfering with the duplication and replication of viral infections.”
  • “To fight viruses, silver sol can be taken internally as a liquid, topically as a gel, or inhaled . . . You can expect a noticeable benefit to be felt within the first two hours and significant benefits within the first two days.”
  • “Our ASAP 365 Skin Gel provides 4 hours of protection against any form of infection when applied to the hands, face, lips and rubbed inside of the nostrils.”
  • “Our ASAP (10ppm) and Patis 30 (30 ppm) liquid sols should be used in the mini-pump mist spray bottle (or an eye dropper) to spray into and around the eyes, as this is also a route for viral infection. These sols should also be regularly used in the mini-pump nasal mist spray bottle to keep the sinuses and airways disinfected.”
  • “If . . . one begins to experience the onset of symptoms of any bacterial or viral infection, immediate oral doses of the liquid sols are advised.”
  • “[M]ultiple small doses (1 teaspoon full every 2 or 3 hours) are far more effective than a single daily large dose. This should eliminate a bacterial infection rather quickly, and will greatly reduce symptoms and healing times for viral infections. It will limit the ability of the virii [sic] to replicate and spread throughout the body.”
  • “OUR COMBO GEL PACK IS THE IDEAL, ALL AROUND EPIDEMIC PREVENTION KIT”
 
In addition, claims made on your Facebook page, which has a link to your website at www.lifesilver.com/v1, where the above-mentioned products can be purchased directly, provide further evidence that your products are intended for use as drugs:
 
On a Facebook Posting (August 1, 2014):
 
  • “EBOLA . . . The information below . . . was written for flu prevention during the swine and avian flu scares. It is relevant to the current Ebola hysteria . . . . I have been reviewing our nano-catalytic silver hydrosol virus studies, some of which are posted at our website www.lifesilver.com/v1 . . .”
  • “[Although the specter of an aerosolized Ebola is getting a lot of play in the media, the primary vector is contact. The Gargling, hand washing and nasal cleansing are all important, these methods can be enhanced by magnitudes of effectiveness by employing the new silver technology. Utilizing our silver gel product on hands, lips and coating the insides of nostrils affords 4 hours of protection, after which it should be reapplied. The eyes can be protected by drops or spraying a fine mist of the liquid silver sols into them throughout the day. Gargling and mouth rinsing with the liquid supplement then swallowing is also recommended, as is the regular use of the sols as a nasal spray mist.]”
  • “[O]ur products resonate at around 930 Hz . . . . This frequency inhibits virus replication. This ability remains constant as the silver makes first pass through the body. These products are passed completely through the body in about 24 hours, so smaller more frequent doses throughout the day are far more effective than one big daily dose.”
  • “The Ebola gestation/proliferation period in the human body, after exposure, can be as long as three weeks before symptoms present. Once you show symptoms it is a little too late, so if one should follow the prophylactic procedures above, with the addition of the nano-catalytic silver hydrosols and topical gel . . . chances are you will never become a victim.”
 
Your  products, “ASAP Solution,” “Patis 30 Fortified Silver Solution,” “ASAP Ultimate Skin & Body Care Gel,” “Combo Wellness Pack,” and “Combo Gel Pack,” 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)]. A new drug 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 and information submitted by a drug sponsor demonstrating that the drug is safe and effective. 
 
Furthermore, your  products, “ASAP Solution,” “Patis 30 Fortified Silver Solution,” “ASAP Ultimate Skin & Body Care Gel,” “Combo Wellness Pack,” and “Combo Gel Pack,” are offered for a condition that is 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 drugs are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that the labeling for these products fail to bear adequate directions for use.  The introduction or delivery for introduction of a misbranded drug into interstate commerce violates section 301(a) of the Act [21 U.S.C. § 331(a)].
 
The marketing and sale of unapproved or uncleared Ebola virus-related products are a potentially significant threat to the public health. Therefore, FDA is taking urgent measures to protect consumers from products that, without approval or clearance by FDA, claim to diagnose, mitigate, prevent, treat or cure the Ebola disease in people.
 
You should take immediate action to ensure that your firm is not distributing, and does not distribute in the future, products intended to diagnose, mitigate, prevent, treat or cure the Ebola virus that have not been approved or cleared by the FDA. The violations cited above are not meant to be an all-inclusive list of violations that exist in connection with your firm. It is your responsibility to ensure that the products you market are in compliance with the Act and FDA's regulations. We advise you to review the products you distribute, including the claims made for those products in websites, product labels, and other labeling and promotional materials, to ensure that they are not in violation of the Act. 21 U.S.C. §§ 331, 352.
 
We note that on your www.lifesilver.com website disclaimer, you state that “[t]hese products are not intended for any use other than as dietary supplements or topical dressings.” However, notwithstanding this disclaimer, the claims made on your website for your “ASAP Solution,” “Patis 30 Fortified Silver Solution,” and “ASAP Ultimate Skin & Body Care Gel” products clearly demonstrate that these products are drugs under section 201(g)(1)(B) of the Act because they are intended for use in the cure, mitigation, treatment, or prevention of disease.  Further, you recommend that the “ASAP Solution” and “Patis 30 Fortified Silver Solution” can be administered intranasal and as topical ophthalmic in addition to oral administration. Under section 201(ff)(2)(A)(i) of the Act [21 U.S.C. § 321(ff)(2)(A)(i)], a dietary supplement is defined, among other things, as a product intended for ingestion. Topical products and other products that are not intended for ingestion are not dietary supplements..
 
Within 15 working days, please send an email to EbolaTaskForce-CFSAN@fda.hhs.gov, describing the actions that you have taken or plan to take to address your firm's violations. If your firm fails to take corrective action immediately, FDA may take enforcement action, such as seizure or injunction for violations of the Act, without further notice. Firms that fail to take corrective action may also be referred to FDA's Office of Criminal Investigations for possible criminal prosecution for violations of the Act and other federal laws.
 
If you are not located in the United States, please note that unapproved and uncleared products intended to diagnose, mitigate, prevent, treat, or cure the Ebola virus offered for importation into the United States are subject to detention and refusal of admission. We will advise the appropriate regulatory or law enforcement officials in the country from which you operate that FDA considers your products listed above to be an unapproved or uncleared products that cannot be legally sold to consumers in the United States.
 
Please direct any inquiries concerning this letter to FDA at EbolaTaskForce-CFSAN@fda.hhs.gov or by contacting Mabel M. Lee at (240) 402-0972.
 
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), aff’d, 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), aff’d, 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/d9329/091224commissionopinion.pdf), pet. for review den., 2010 WL 5108600 (D.C. Cir. Dec. 10, 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 to consumers. Please notify FTC via electronic mail at healthproducts@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.
 
Sincerely,
/S/ 
Mary K. Engle
Associate Director
Division of Advertising Practices
Federal Trade Commission
  
/S/
William A. Correll
Director
Office of Compliance
Center for Food Safety
And Applied Nutrition
Food and Drug Administration

Page Last Updated: 11/19/2014
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