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WARNING LETTER

Date:               June 22, 2021

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 website at the Internet address www.pacificcenterofhealth.com on June 2, 2021. The FDA has observed that your website offers Immune Builder, High Risk Environment Pack- NO SYMPTOMS, Anti-Viral Herbal Formula, Anti-Viral Herbal Pack – ACUTE ILLINESS, Kitchen Sink, Lung Formula Dry Cough, Lung Formula Wet Cough, Colloidal Silver and Post COVID-19 Recovery products for sale in the United States and that these products are intended to mitigate, prevent, treat, diagnose, or cure COVID-19[1] in people.  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). 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.[2] In addition, on March 13, 2020, there was a Presidential declaration of 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 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 any unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.

Some examples of the claims on your labeling, including 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:

• “These herbal formulas are specifically formulated for combating COVID-19 . . ..” [from your webpages www.pacificcenterofhealth.com, https://www.pacificcenterofhealth.com/store/p16/High_Risk_Environment_Pack-NO_SYMPTOMS_%2AGF_-_4oz.html, https://www.pacificcenterofhealth.com/store/p14/Anti-Viral_Herbal_Formula_%2AGF.html, www.pacificcenterofhealth.com/store/p21/Kitchen_Sink.html, https://www.pacificcenterofhealth.com/store/p6/lfdc.html, and https://www.pacificcenterofhealth.com/store/p4/lw.html]
• “Take as a preventative measure right now to boost your immune system . . . If you become sick, discontinue and begin taking ANTI-VIRAL HERBAL FORMULA . . . specifically formulated for combating COVID-19 . . .” [from your webpage www.pacificcenterofhealth.com/store/p17/ib.html]
• “Anti-Viral Herbal Pack-ACUTE ILLNESS . . . Helps with symptoms of illness, fever, body aches, etc. . . . CONTAINS: Anti-Viral Formula . . . specifically formulated for combating COVID-19 . . .” [from your webpage www.pacificcenterofhealth.com/store/p18/Anti-Viral_Herbal_Pack-ACUTE_ILLNESS_%2AGF_-_4ox.html]
• “Post COVID-19 Recovery . . . Helps to restore lung function . . .” [from your webpage www.pacificcenterofhealth.com/store/p20/Post_Illness_Recovery_4oz.html]
• “One package for everything we have to combat COVID-19 . . . 2 - Immune Builder . . . 2 – Anti-Viral Herbal Formula . . . 2 – Colloidal Silver . . . 1 – Lung Formula (wet) . . . 1 – Lung Formula (dry) . . . 1 – Post COVID-19 Recovery . . .” [from your webpage www.pacificcenterofhealth.com/store/p21/Kitchen_Sink.html]
• “These herbal formulas are specifically formulated for combating Covid19 [sic] . . ..” [from shipped labeling]

You should take immediate action to address 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 [email protected] describing the specific steps you have taken to address these violations.  Include an explanation of each step being taken to prevent the recurrence of any violations, as well as copies of related documentation.  Failure to adequately correct any violations 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/fraudulent-coronavirus-disease-covid-19-products. Once you have taken actions to address the sale of your unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, and any appropriate corrective actions have been confirmed by the FDA, the published list will be updated to indicate that your firm has taken such corrective actions.

This letter notifies you of our concerns and provides you with an opportunity to address them. If you cannot take action to address this matter completely within 48 hours, state the reason for the delay and the time within which you will do so. 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 may be detained or refused 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 products referenced 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 [email protected].  

 

Sincerely,

/S/

Donald D. Ashley
Director
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration