Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/savvy-holistic-health-dba-holistic-healthy-pet-605915-04072020
Timestamp: 2020-08-06 22:41:59
Document Index: 338769914

Matched Legal Cases: ['§ 355', '§ 321', '§ 360', '§ 360', '§ 351', '§ 352', '§ 331']

Savvy Holistic Health dba Holistic Healthy Pet - 605915 - 04/07/2020 | FDA
Savvy Holistic Health dba Holistic Healthy Pet MARCS-CMS 605915 — April 07, 2020
perthoffice@hampl.com.au
CC: perthoffice@hampl.com.au –
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 https://holistichealthypet.com/ on March 25, 2020 and April 2, 2020, respectively. The FDA has observed that your website offers “China Oral Nosode” also called “China Corona Nosode” and the “CV Respiratory Kit,”[1] both under the description, “AN330 – CORONA VIRAL IMMUNE SUPPORT AND/OR ACTIVE RESPIRATORY INFECTION FOR ALL AGES,” for sale in the United States and that these products are intended to mitigate, prevent, treat, cure or diagnose COVID-19[2] in people.[3] Based on our review, 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). FDA also observed that these products are intended for use in the mitigation, treatment, or prevention of COVID-19 in animals, which makes them drugs under section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. § 321(g)(1)(B). The products 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 FD&C Act, 21 U.S.C. §§ 360b, 360ccc, and 360ccc-1. Therefore, the products are unsafe within the meaning of section 512(a) of the FD&C Act, 21 U.S.C. § 360b(a), and adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. § 351(a)(5). 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 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.[4] In addition, on March 13, 2020, the President declared a national emergency in response to COVID-19.[5] 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 and animals. As described below, you sell products that are intended to mitigate, prevent, treat, diagnose or cure COVID-19 in people and animals. 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.
The product description “AN330 –CORONA VIRAL IMMUNE SUPPORT AND/OR ACTIVE RESPIRATORY INFECTION FOR ALL AGES. Holistic Animal Remedies … For all Species”
“Homeopathic China Oral Nosode COVID-19 . . . The world is in ‘panic mode’ due to the new Coronavirus, but homeopaths are not nearly as concerned about it…and for good reasons. Homeopathic treatment has had a long history of success in treating various viruses.”
“EXAMPLE SUPPORT PROTOCOL … CV ACTIVE INFECTION . . . 1. Using a few drops of the HomeoprophylaxisChina [sic] oral nosode to each cup of herb dosing . . . 3. Vitamin C – special form of vitamin C * add a teaspoon in each cup of herbal dosing.”
The “PREVENTION OR IF UNWELL with (COVID-19) Virus” “Help Sheet” at https://cdn.shopify.com/s/files/1/0206/5861/8468/t/4/assets/330COVID-19-SARS-CoronaVirusSUPPORT-HUMAN-1583308491241.pdf, accessible from your website from the “HELP SHEET PDF FILE” tab, in part, provides a “Vitamin C ..[sic] dosing guide for Humans” for “TREATING FLU, BRONCHITIS, PNEUNOMIA, SARS (COVID-19) Corona Virus”
You should take immediate action to correct the violations cited in this letter. This letter is not meant to be an all-inclusive list of 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-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.
[1] The “CV Respiratory Kit” includes five items: “Homeoprophylasis China Oral Nosode 200C,” “Herbal CV-2,” “Herbal CV-3,” “Herbal CV-4,” and “Liposomal Vitamin C.”
[3] Although this product is marketed on a website that focuses on pet products, your “AN330 – CORONA VIRAL IMMUNE SUPPORT AND/OR ACTIVE RESPIRATORY INFECTION FOR ALL AGES” webpage says the products are “For all Species.” Further, the description under the “HEALTH INFO” tab includes information about and recommendations for viral infections and COVID-19 in people. Also, your “HELP SHEET PDF FILE” tab links to a document titled “PREVENTION OR IF UNWELL with (COVID-19) Virus that states “Vitamin C . . dosing guide for Humans.”
[4] Secretary of Health and Human Services Alex M Azar, Determination that a Public Health Emergency Exists. Jan. 31, 2020. (Accessible at https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx).
[5] 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/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/).