FDA and FTC issued a warning letter to Pharmacy Plus, Inc. after reviewing the company's websites and observing alleged claims for its "COVID Pack" and "COVID ‘POSITIVE’ PACK" that are intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people.
Some of the alleged claims in the warning letter include:
- Your product name, “COVID PACK.”
- “This supplement pack contains a 14 day supply of four physician recommended supplements for prophylaxis, treatment and recovery from the Covid-19 virus.”
- “This kit contains the standard covid kit comprised of Vitamin D3, Vitamin C, Zinc and Melatonin but also includes a 14 day supply of Nattokinase 100mg . . . routinely prescribed for covid positive patients. Ideal to keep in the home for emergency use when a family member tests positive for the virus.”
The agencies advise the companies to take immediate action to correct the alleged violations, noting that failure to do so could result in legal action, including seizure and injunction. The agencies stress that no COVID-19 study is currently known to exist for the product identified within the warning letter, so any coronavirus-related prevention or treatment claims regarding the product are considered to be not supported by competent and reliable scientific evidence.
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This is to advise you that the United States Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) reviewed your websites at the Internet address www.vitalcarecompounder.com and https://vitalcarecompounders.ecwid.com on August 28, 2020, and September 4, 2020, respectively. The FDA has observed that your websites offers “COVID PACK” and “COVID ‘POSITIVE’ PACK” products for sale in the United States and that these products are intended to mitigate, prevent, treat, diagnose, or cure COVID-19 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. In addition, on March 13, 2020, the President declared a national emergency in response to 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 spray products and misleadingly represent them as safe and/or effective for the treatment or prevention of COVID-19 include:
- Your product name, “COVID PACK.”
- On the product page for “COVID PACK” you include the following statement:
- “This supplement pack contains a 14 day supply of four physician recommended supplements for prophylaxis, treatment and recovery from the Covid-19 virus.” [from your website at https://vitalcarecompounders.ecwid.com]
- Your product name, “COVID ‘POSITIVE’ PACK.”
- On the product page for “COVID ‘POSITIVE’ PACK” you include the following statement:
- “This kit contains the standard covid kit comprised of Vitamin D3, Vitamin C, Zinc and Melatonin but also includes a 14 day supply of Nattokinase 100mg . . . routinely prescribed for covid positive patients. Ideal to keep in the home for emergency use when a family member tests positive for the 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.
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 corrective actions to cease the sale of your unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, 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) referenced above to be unapproved and misbranded products that cannot be legally sold to consumers in the United States.
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. For COVID-19, no such study is currently known to exist for the product identified above. Thus, any coronavirus-related prevention or treatment claims regarding such product are not supported by competent and reliable scientific evidence. You must immediately cease making all such claims.
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