WARNING LETTER

Date: March 6, 2020

TO: admin5@n-ergetics.com - Brad Brand, Derill J Fussell, and Linda Fussell

 Xephyr LLC dba N-Ergetics

 339 W. 12th Street

 Atoka, OK 74525-2807

RE: Unapproved and Misbranded Products Related to Coronavirus Disease 2019 

(COVID-19)

This is to advise you that the United States Food and Drug Administration (FDA) and the 

Federal Trade Commission (FTC) reviewed your website at the Internet address www.nergetics.com in February 2020. The FDA has determined that your website offers colloidal silver 

products for sale in the United States and that these products are intended to mitigate, prevent, 

treat, cure or diagnose COVID-191 in people. FDA has determined that these products are 

unapproved new drugs sold in violation of section 505(a) of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). Furthermore, these products are misbranded 

drugs under section 502 of the FD&C Act, 21 U.S.C. 352. The introduction or delivery for 

introduction of these products into interstate commerce is prohibited under section 301(a) and 

(d) of the FD&C Act, 21 U.S.C. § 331(a) and (d).

The Secretary of Health and Human Services, under section 319 of the Public Health Service 

Act, 42 U.S.C. § 247d, has determined that a public health emergency exists nationwide as a 

result of confirmed cases of COVID-19. Therefore, FDA is taking urgent measures to protect 

consumers from certain products that, without approval or authorization by FDA, claim to 

mitigate, prevent, treat, diagnose, or cure COVID-19 in people. As described below, you sell 

products that are intended to mitigate, prevent, treat, diagnose or cure COVID-19 in people. We 

request that you take immediate action to cease the sale of such unapproved and unauthorized 

products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19. 

Some examples of the claims on your website that establish the intended use of your products 

and misleadingly represent them as safe and/or effective for the treatment or prevention of 

COVID-19 include: 

• “Coronavirus 2019-NCoVat, Treatment Has A Home Remedy. This Chinese Wuhan Flu 

Pneumonia has a non-traditional remedy that has successfully killed coronaviruses from 

the flu virus to pandemic diseases, in vitro, for over 100 years. . . . If colloidal silver has 

killed coronavirus strains in past laboratory test, then the current coronaviruses should 

also be killed. Protect your immune system try Colloidal Silver 1100 PPM Immune 

Support”

 1 COVID-19 is the official name for the disease that is causing the 2019 novel coronavirus outbreak, first 

identified in Wuhan, China.
Xephyr LLC dba N-Ergetics Warning Letter Page 2 of 3 pages

• “The seven coronaviruses that can infect people are: Common human coronaviruses 1. 

Human coronavirus 229 E (alpha coronavirus) . . . 2. Human coronavirus NL 63 (alpha 

coronavirus) or HCoV-NL 63 . . . 3. Human coronavirus HCoV-OC 43 (beta coronavirus) 

(and HCoV-229E,) . . . 3. Human coronavirus HKU1 (beta coronavirus) . . . and a novel 

coronavirus, coronavirus HKU1 (CoV-HKU1) . . . 4. Human coronavirus MERS-CoV 

(beta coronavirus) . . . 5. Human coronavirus SARS-CoV (beta coronavirus) . . . 6. 

Human coronavirus 2019 Novel (never seen before) Coronavirus (2019-nCoV) (beta

coronavirus) is a virus (more specifically, a coronavirus) . . . The virus has made the 

gigantic mutation of now infecting human to human making it one of the most dangerous 

pandemic viruses. . . . Colloidal Silver is still the only known anti-viral supplement to kill 

all seven of these Human Coronaviruses.”

• “Preventing The Contraction Of The Novel Coronavirus is Elementary. . . . Even though 

there are no vaccines available to combat these coronaviruses, there is a home remedy 

of Colloidal Silver 100 ppm that has worked effectively on coronaviruses successfully for 

the last 123 years. . . . In the mean time (sic) there are some tips to prevent contracting 

the coronavirus: . . . Use Home remedy, Colloidal silver 1100 PPM, to support immune 

system”

• “What is Coronavirus Treatment and Prevention? . . . Colloidal silver 1100 PPM, Home 

remedy for 123 years! (testing showed every known coronavirus killed in 4 min. in vitro) . 

. . Although there are 650,000 deaths a year from enfluenza, (sic) the regular flu and 

infects over 2,000,000 deaths from pneumonia a year, these two viruses pale in 

comparison to the potential danger to the coronavirus flu. It is very contagious and quick 

to kill. Colloidal Silver kills all viruses.”

You should take immediate action to correct the violations cited in this letter. The violations 

cited in this letter are not meant to be an all-inclusive list. It is your responsibility to ensure that 

the products you sell are in compliance with the FD&C Act and FDA's implementing regulations. 

We advise you to review your websites, product labels, and other labeling and promotional 

materials to ensure that you are not representing your products for a COVID-19 related use for 

which they have not been approved by FDA and that you do not make claims that misbrand the 

products in violation of the FD&C Act. Within 48 hours, please send an email to COVID-19-

Task-Force-CDER@fda.hhs.gov describing the specific steps you have taken to correct these 

violations. Include an explanation of each step being taken to prevent the recurrence of 

violations, as well as copies of related documentation. Failure to immediately correct the 

violations cited in this letter may result in legal action, including, without limitation, seizure and

injunction. 

FDA is advising consumers not to purchase or use certain products that have not been 

approved, cleared, or authorized by FDA and that are being misleadingly represented as safe 

and/or effective for the treatment or prevention of COVID-19. Your firm will be added to a 

published list on FDA's website of firms and websites that have received warning letters from 

FDA concerning the sale or distribution of COVID-19 related products in violation of the FD&C 

Act. This list can be found at http://www.fda.gov/consumers/health-fraud-scams/fraudulentcoronavirus-disease-covid-19-products. Once you have taken corrective actions and such 

actions have been confirmed by the FDA, the published list will be updated to indicate that your 

firm has taken appropriate corrective action.

If you cannot complete corrective action within 48 hours, state the reason for the delay and the 

time within which you will complete the corrections. If you believe that your products are not in 

violation of the FD&C Act, include your reasoning and any supporting information for our 

consideration. 
Xephyr LLC dba N-Ergetics Warning Letter Page 3 of 3 pages

If you are not located in the United States, please note that products that appear to be 

misbranded or unapproved new drugs are subject to detention and refusal of admission if they 

are offered for importation into the United States. We may advise the appropriate regulatory 

officials in the country from which you operate that FDA considers your product(s) listed above 

to be unapproved and misbranded products that cannot be legally sold to consumers in the 

United States.

Please direct any inquiries to FDA at COVID-19-Task-Force-CDER@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. 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. 

There currently are no vaccines, pills, potions, lotions, lozenges or other prescription or overthe-counter products available to treat or cure coronavirus disease 2019 (COVID-19). Thus, the 

claims cited above are not supported by competent and reliable scientific evidence. You must 

immediately cease making all such claims. In addition, you are advised to review all claims for 

your products and immediately cease making claims that are not supported by competent and 

reliable scientific evidence. Violations of the FTC Act may result in legal action seeking a 

Federal District Court injunction and an order may require that you pay back money to 

consumers. Within 48 hours, please send an email to Richard Cleland, Assistant Director of the 

FTC’s Division of Advertising Practices, via electronic mail at rcleland@ftc.gov describing the 

specific actions you have taken to address the FTC’s concerns. If you have any questions 

regarding compliance with the FTC Act, please contact Mr. Cleland at 202-326-3088. 

 

Sincerely, 

________________

Donald D. Ashley

Director

Office of Compliance

Center for Drug Evaluation and Research

Food and Drug Administration

 

 

Sincerely,

 

 

________________

 Richard A. Quaresima

Acting Associate Director 

Division of Advertising Practices

 Federal Trade Commission