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WARNING LETTER

IMedDo MARCS-CMS 562719 — Mar 19, 2019

IMedDo - 562719 - 03/19/2019

Product:
Animal & Veterinary
Food & Beverages

Recipient:
Recipient Name
Dr. A. Ben Goins
Recipient Title
President
IMedDo

288 Valley Estates Drive
Dream Mountain
Trenton, GA 30752
United States

Issuing Office:
Division of Human and Animal Food Operations East III

60 Eight Street, NE
Atlanta, GA 30309
United States


February 19, 2019

 

VIA UNITED PARCEL SERVICE

 

Dr. A. Ben Goins, President

iMedDo, Inc.

288 Valley Estates Drive

Dream Mountain

Trenton, GA 30752

Reference: CMS Case # 562719

 

WARNING LETTER

 

Dear Dr. Goins:         

This is to advise you that the Food and Drug Administration (FDA) reviewed your web site at the Internet address http://www.imeddo.com/ in October 2018 and has determined that you take orders there for the products NeuSilver™ Colloidal Silver by iMedDo (NeuSilver™) and NeuKids™ lower dose silver for pets and children (NeuKids™). The claims on your website establish that the products are 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)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease in humans or animals.

As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.

Unapproved New Drugs and Misbranded Drugs

Examples of some of the website claims that provide evidence that your products are intended for use as drugs include, but are not limited to the following:

On the page http://www.imeddo.com/guide.html:

NeuSilver™ and NeuKids™ 

  • “Collodial silver is known to kill bacteria, virus and fungi in vitro”
  • “[C]olloidal silver … is known scientifically to be a modern marvel for disease prevention, treatment and often times curing…” 
  •  “1 drop in water and nebulize and breath [sic] for lung infections”
  •  “1 drop … for toe or finger fungus”
  •  “High Dose 7-10 drops: Typically used temporarily for specific self-medication for food poisoning or infection with probiotics”
  •  “Very High Dose 11-40 drops: Typically used for specific self-medication colon cleanse with mandatory probiotics”
  •  “Silver … it seems to boost our immune system and keep infection in general at bay”
  • “Some of the hypothesized benefits of reaching silver homeostasis include silver’s ability to kill infection by breaking down bacterial cell walls, starving microbes and cancer of oxygen, killing infection and cancer in the lymph system”
  • “[I]f you take true colloidal silver for a week and allow it to reach homeostasis then most people report they never get a urinary track [sic] infection again!”
  •  “NeuSilver™ 1 drop a day … has also somehow resulted in allergy relief, and mold (fungal) allergies in particular”
  •  “[S]ilver in general being known to be an anti-inflammatory and boosting the immune system”
  • “[S]ilver … does have known antibiotic-like effects in medicine and biomedical science as it kills bacteria in vitro”
  • “Many people report a candida (fungus) infection following antibiotics, and have reported silver as being very handy in surviving their post-antibiotic fungus”
  • “[I]f you take iMeDo products especially NeuSilver™ … your chronic infection perhaps causing your fibromyalgia will disappear completely”

Your 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 FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. 

A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.

Your products NeuSilver™ and NeuKids™ are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, NeuSilver™ and NeuKids™ fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(a)].

Further, according to 21 CFR 310.548, any OTC drug product containing colloidal silver ingredients that is labeled, represented, or promoted for the treatment and/or prevention of any disease is regarded as a “new drug” within the meaning of section 201(p) of the Act for which an approved application is required for marketing, without which such product is also misbranded under section 502 of the Act [21 U.S.C. 352].

Unapproved New Animal Drugs

Examples of some of the website claims that provide evidence that NeuSilver™ and NeuKids™ lower dose silver for pets and children are intended for use in animals as drugs include, but are not limited to the following:

On the page http://www.imeddo.com/guide.html: 

  • “…silver's ability to kill infection by breaking down bacterial cell walls, starving microbes and cancer of oxygen, killing infection and cancer in the lymph system…”
  • “…3 drops of NeuSilver™ adult strength being a good starting point for puppy cough…”
  •  “Many people don’t give silver to their … pets unless they are sick in which case 1 drop of NeuSilver is typically appropriate for … animals under 100 lbs. … As a general guideline use 1 drop of NeuKids™ per 10 lbs of child or pet.” 

Because your NeuSilver™ and NeuKids™ products are intended to cure, mitigate, treat, or prevent diseases in animals, they are drugs within the meaning of section 201(g)(1)(B) of the Act, [21 U.S.C. § 321 (g)(1)(B)]. Moreover, these products are new animal drugs, as defined by section 201(v) of the Act, [21 U.S.C. 321(v)], because they are not generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. They are not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the Act [21 U.S.C. 360b, 360ccc, and 360ccc-1]. Therefore, these products are unsafe within the meaning of section 512(a) of the Act [21 U.S.C. 360b(a)] and adulterated under section 501(a)(5) of the Act [21 U.S.C. 351(a)(5)]. The introduction or delivery for introduction into interstate commerce of these adulterated drugs violates 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. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that you comply with all requirements of federal law and FDA 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, without limitation, seizure and injunction. 

We also offer the following comments regarding your products:

Regarding use by humans: It appears that you may want to market your NeuSilver™ and NeuKids™ products as dietary supplements. According to the product labeling, these products are intended for ingestion as well as other delivery methods. For example, “[H]ave you and your doctor been adequately informed about the possibility of using NeuSilver™ in your IV line?” “[B]etter to use a nebulizer if you want to get NeuSilver™ into your lungs.” “…1 drop on wet cotton ball in a cut off glove finger for one week overnight for toe or finger fungus…” However, the term “dietary supplement” means a product that is intended for ingestion. (21 U.S.C. 201(ff)(2)(A)(i)). Products that are not intended for ingestion do not meet the definition of a dietary supplement.

Regarding use by animals: For information on supplements for pets, please refer to Compliance Policy Guide 690.100, Nutritional Supplements for Companion Animals.

Within fifteen (15) working days of the receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within fifteen working days, state the reason for the delay and the time frame within which you will complete the correction. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration.

If you need additional information or have questions concerning any products distributed through your website, please contact the FDA. Your written response should be sent to Compliance Officer Lakisha Morton, U.S. Food and Drug Administration, Office of Human & Animal Food Operations, Division East III, 60-8th Street NE, Atlanta, GA 30309. If you have questions concerning this letter, you may contact Mrs. Morton at 404-253-1285, at lakisha.morton@fda.hhs.gov, or write her at the noted mailing address.

 

Sincerely,

/S/ 

Ingrid A. Zambrana

Program Division Director                    

Office of Human and Animal Foods

Division East III (Georgia, North Carolina, and South Carolina)

Office of Regulatory Affairs

U.S. Food and Drug Administration       

 

Cc (via UPS):

Dr. A. Ben Goins, President

iMedDo, Inc.

9191 NE 41st CT