WARNING LETTER
KetoKerri LLC
MARCS-CMS 605897 —
September 11, 2020
Product:
Food & Beverages
Recipient:
Recipient Name
Kerri Rivera
KetoKerri LLC
284 E Chilton Dr Ste 11
Chandler
,
AZ
85225
United States
kerri@ketokerri.com
kerri@kerririvera.com
ketokerri.market@gmail.com
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
WARNING LETTER
Date: 9/11/2020
Cc:
Kerri Rivera
17544 College Port Drive
Laredo, TX 78045-8657 US
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) reviewed your websites at the Internet addresses www.kerririvera.com and www.ketokerri.com between March 12 and August 9, 2020. We also reviewed your Amazon storefront at www.amazon.com/sp?seller=A11NU8SK99UXRE and your social media website at www.facebook.com/iamketokerri, where you directed consumers to your website www.ketokerri.com to purchase your products. The FDA observed that your website www.ketokerri.com offers the products “ “KK Black Seed Oil,” “KK Breakthrough Vitamin D with Chondroitin & Oleic” (sometimes referred to on your websites as “KK Breakthrough Vitamin D with Chondroitin”), “Stonebreaker,” “KK EDTA with Selenium and Minerals,” “Zeolite,” “Ultra Liquid Zeolite,” and “DR. FITT FIRE FIGHTERS” (labeled to contain vitamin C) for sale in the United States and that, at the time we reviewed your websites, these products were intended to mitigate, prevent, treat, diagnose, or cure COVID-19
1
in people. Based on our review, these products were 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, the products were misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. § 352. The introduction or delivery for introduction of unapproved and misbranded drug products into interstate commerce violated sections 301(a) and (d) of the FD&C Act, 21 U.S.C. § 331(a) and (d).
There is currently a global outbreak of respiratory disease caused by a novel coronavirus that has been named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2). The disease caused by the virus has been named “Coronavirus Disease 2019” (COVID-19). On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS.
2
In addition, on March 13, 2020, the President declared a national emergency in response to COVID-19.3 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 sold products that were intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people.
Some examples of the past claims on your websites www.kerririvera.com that established the intended use of your products and misleadingly represented them as safe and/or effective for the treatment or prevention of COVID-19 include:
“I want to talk to you about coronavirus and ways not to get sick and if we do get sick, what can we do. … Black seed oil … helps a lot and we should all be taking it to protect against viruses …. Also, the Breakthrough Vitamin D … helps a lot … with macrophages of the immune system, which … grab the tiny pathogens like virus and helps to remove them and also lowers the inflammation. [T]he coronavirus condition is of much inflammation and viral. Also the Stonebreaker helps, it is anti-viral. And then there are other supplements that … are important when we are trying to avoid virus replication and to lower inflammation. For example, Selenium is one of these …. Also, the Zeolite helps a lot, it is also anti-viral …. [English translation of claims from your March 17 video in Spanish titled “Cómo tratar el CoronaVirus” (“How to Treat Coronavirus”) at 00:06 – 03:43, www.facebook.com/iamketokerri/videos/2832408373473520]
“Vitamin D with K I am taking in addition to Chondroitin. The … Chondroitin helps a lot because the macrophage, which is the Pac-Man of the immune system, is swallowing the small pathogens, it is super important and it also lowers nagalase. Nagalase … is an inflammatory enzyme that is … produced by viruses. So … it helps lowering everything that is virus and inflammation. … Selenium is 200 micrograms once a day. … Black Seed Oil, we all must be taking that 3 times a day for prevention.” [English translation of claims from your March 26 video in Spanish captioned “CoronaVirus Recomendaciones” (“Coronavirus Recommendations”) at 00:12 – 01:42, www.facebook.com/iamketokerri/videos/521668578533646/]
“[S]tay safe and sound and also the children. And follow the protocol is the best thing to do for children, … use Black Seed Oil, continue with the Breakthrough [Vitamin D] ….” [English translation of claims from your March 26 video in Spanish captioned “CoronaVirus Recomendaciones” (“Coronavirus Recommendations”) at 05:38 – 05:51, www.facebook.com/iamketokerri/videos/521668578533646/]
On a webpage titled, “Coronavirus: Prevention, Treatment And Quarantine Preparation” you state, “Mike Adams recommends using ONE of the following strategies to . . . kill viruses and other pathogens that may enter the body. … Vitamin C” [from your website www.kerririvera.com/coronavirus-prevention-treatment-and-quarantinepreparation/]
“Mike Adams is also recommending or talking about . . . things he would use if in fact he was sick with the coronavirus . . . Vitamin C . . . These would be the supplements that could help in case of the Coronavirus in your house or in your body.” [from your video embedded on the page titled “Coronavirus: Prevention, Treatment And Quarantine Preparation” at 04:28 – 05:17, www.kerririvera.com/coronavirus-prevention-treatment-and-quarantine-preparation/]
“We are concerned that many people around the world are being exposed to Corona virus. … I recommend everyone treat themselves with health-promoting anti-viral measures as a way of killing any low-level virus they may be incubating and also to avoid unknowingly spreading the pathogen to a more vulnerable population – like the old and sick. … My anti-viral protocols will be helpful … whether or not you are a silent carrier of Corona Virus.” [www.kerririvera.com/category/health-news]
We note that, as of the date of this letter, the claims cited above appear to have been removed and your social media site at www.facebook.com/iamketokerri appears to be down. Due to the serious public health concerns related to the marketing and sale of unapproved drugs for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, it is essential that these violations do not recur.
This letter is not meant to be an all-inclusive list of past or present violations that exist in connection with your products or operations. 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 misleadingly representing your products as safe and effective 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-CFSAN@fda.hhs.gov describing the specific steps you have taken to prevent the recurrence of future violations. If you believe that your products were not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
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, with a notation that, as of the date of this letter, your firm’s listed products are no longer sold for the prevention, treatment, mitigation, diagnosis, or cure of COVID-19. This list can be found at http://www.fda.gov/consumers/health-fraudscams/fraudulent-coronavirus-disease-covid-19-products.
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. If your violations recur, we may advise the appropriate regulatory officials in the country from which you operate that FDA considers your products referenced above to be unapproved and misbranded products that cannot be legally sold to consumers in the United States.
While reviewing your websites, we noticed that you recommend drinking a mixture of chlorine dioxide and water for the prevention and treatment of COVID-19, among other diseases. Chlorine dioxide is not safe or effective for preventing or treating COVID-19 when ingested. Moreover, ingesting this dangerous product can cause serious adverse health consequences and even death. For the sake of preventing further harm to consumers, we urge you to stop recommending that consumers take chlorine dioxide, alone or mixed with any other substance, for any medical use.
Please direct any inquiries to FDA at COVID-19-Task-Force-CFSAN@fda.hhs.gov.
Sincerely,
/S/
William A. Correll Jr.
Director
Office of Compliance
Center for Food Safety
and Applied Nutrition
____________________
1
As explained in the next paragraph, there is currently an outbreak of a respiratory disease named “Coronavirus Disease 2019” (COVID-19).
2
Secretary of Health and Human Services Alex M. Azar II, Determination that a Public Health Emergency Exists. Jan. 31, 2020. (Accessible at https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx). The declaration has been renewed for an additional 90 days twice. The most recent renewal went into effect on July 25, 2020. Secretary of Health and Human Services Alex M. Azar II, Renewal of Determination that a Public Health Emergency Exists. July 23, 2020. (Accessible at https://www.phe.gov/emergency/news/healthactions/phe/Pages/covid19-23June2020.aspx).
3
President Donald J. Trump, Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19). Mar. 13, 2020. (Accessible at https://www.whitehouse.gov/presidentialactions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/).
Content current as of:
10/01/2020
Regulated Product(s)
Food & Beverages