WARNING LETTER

Date March 6, 2020

TO: jennifer@purevitalsilver.com – Jennifer Hickman, Colloidal Vitality LLC

 3183 Forest Creek Dr.

 Melbourne, FL 32901

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.purevitalsilver.com in February 2020. We have also reviewed your Facebook website at 

www.facebook.com/purevitalsilver where you direct consumers to your website 

www.purevitalsilver.com to purchase your products. The FDA has determined that your website 

offers essential oil 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 websites 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: 

• “So it’s actually widely acknowledged in both science and the medical industry that ionic 

silver kills coronaviruses. And it’s now known that the Chinese are employing ionic silver 

in their fight against the spread of the coronavirus.” [from a February 17, 2020 post on 

your Facebook website http://www.facebook.com/purevitalsilver]

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

in Wuhan, China.
Colloidal Vitality LLC Warning Letter Page 2 of 3 pages

• “It is always good to go on the offense – taking a tsp or two twice daily of Structured 

Silver Advanced Formula helps fight the pathogens we are exposed to on a daily basis.

The structured silver circulating in your blood attaches to bacteria, yeast, and viruses 

rendering them ineffective and boosting your immune system . . . It’s important to note 

that although there are increasing numbers of cases being reported of corona virus, 

most of the fatalities are from older and younger folks with compromised immune 

systems.” [from February 6, 2020 comments that you made on a post on your Facebook 

website http://www.facebook.com/purevitalsilver]

• “Wellness!! Vital Silver!!! Simple!!! Go on the offense this year against viruses including 

the Coronavirus – it’s simple!” [from a February 6, 2020 post on your Facebook website

http://www.facebook.com/purevitalsilver]

• “The Silver is flying off the shelves as folks stock up due to the increased awareness of 

the coronavirus.” [from a February 4, 2020 post on your Facebook website

http://www.facebook.com/purevitalsilver]

• “Structured Silver allows a silver particle-cluster of silver to kill multiple bacteria, viruses, 

and yeast/candida pathogens throughout the body until it is safely excreted.” [from your 

website www.purevitalsilver.com]

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-ForceCDER@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. 

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 
Colloidal Vitality LLC Warning Letter Page 3 of 3 pages

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