Recipient:

Recipient’s name

April Hart and Bill Krovetsz

Bespoke Apothecary LLC

300 Sullivan Crest Road
Elmira, New York 14901
United States

[email protected]

WARNING LETTER

Object: 641573

Date: September 28, 2022

Subject: Unapproved and mislabeled products related to coronavirus disease 2019 (COVID-19)

We inform you that the United States Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) reviewed your website at the Internet address www.bespokeapothecary.com on September 7, 2022 and September 26, 2022, respectively . We also reviewed your social media websites at https://www.facebook.com/bespokeapothecaryatddf/ and https://www.instagram.com/bespoke_apothecary/, where you direct consumers to your website, www.bespokeapothecary .com, to buy your products. The FDA has observed that your website offers your COVID Kit and Post Virus Recovery Herbal Tea products for sale in the United States and that these products are intended to mitigate, prevent, treat, diagnose, or cure COVID-19.1 at people’s Place. 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 USC § 355(a). Further, these products are mislabeled drugs under FD&C Section 502, 21 USC § 352. 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 USC § 331(a) and (d).

There is currently a worldwide outbreak of respiratory disease caused by a novel coronavirus which 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 public health emergency declaration related to COVID-19 and mobilized HHS operating divisions.2 Additionally, on March 13, 2020, there was a presidential declaration of a national emergency in response to COVID-19.3 Therefore, the FDA is taking urgent action to protect consumers from certain products that, without FDA approval or clearance, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. As described below, you sell products intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. We urge you to take immediate action to cease the sale of any unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.

Here are some examples of claims on your websites that establish the intended use of your products and misrepresent them as safe and/or effective for the treatment or prevention of COVID-19:

  • “COVID Kit . . . A customizable kit (we will need to discuss symptoms) containing a mix of herbal teas, tinctures, tonics, drinks, etc., to help you.” [from your webpage https://shop.bespokeapothecary.com/product/c-o-v-i-d-kit]
  • “Carefully designed for the many people suffering from various symptoms after Covid-19, in particular, but any viral infection. Filled with thoughtful herbs focused on heart and mental health, brain fog, respiratory issues and fatigue. [from your webpage https://shop.bespokeapothecary.com/product/post-c-v-i-d-virus-recovery-herbal-tea and from a product photo on a May 10, 2022 post on your Social Media webpage https://www.facebook.com/bespokeapothecaryatddf/]
  • “Plants focused on heart and mental health, brain fog, respiratory issues and fatigue. . . #postcovid, #postcovidsyndrome, #longcovidrecovery, #longcovidsymptoms [from a May 10, 2022 post on your Social Media webpage https://www.instagram.com/p/CdY2vH6pT60/]

You should take immediate action to resolve this issue. This letter is not intended to be an exhaustive list of violations that exist in connection with your products or operations. It is your responsibility to ensure that the products you sell comply with the FD&C Act and the implementing regulations of the FDA. We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you do not misrepresent your products as safe and effective for the use related to COVID-19 for which they are not intended. have not been approved by the FDA and that you are not making claims that mislabel products in violation of FD&C law. Within 48 hours, please email [email protected] outlining the specific steps you have taken to remedy any breach. Include an explanation of each action taken to prevent the recurrence of any violation, along with copies of related documentation. Failure to adequately correct any breach may result in legal action, including without limitation seizure and injunctive relief.

The FDA is advising consumers not to purchase or use certain products that have not been approved, cleared, or cleared by the FDA and are misrepresented as safe and/or effective for the treatment or prevention of COVID-19. Your company will be added to a list posted on the FDA website of companies and websites that have received warning letters from the FDA about selling or distributing COVID-19-related products in violation of the law FD&C. This list is available at http://www.fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-disease-covid-19-products. Once you have taken steps to address the sale of any unapproved and unauthorized product for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, and all appropriate corrective actions have been confirmed by the FDA, the published list will be updated. to indicate that your company has taken such corrective action.

This letter informs you of our concerns and gives you the opportunity to respond to them. If you cannot take action to fully resolve this matter within 48 hours, state the reason for the delay and the time frame within which you will do so. If you believe your products are not in violation of FD&C law, 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 of the wrong brand or unapproved new drugs may be held up or refused if offered for import into the United States. We may notify the appropriate regulatory authorities in the country from which you operate that the FDA considers your product(s) referenced above to be unapproved and mislabeled products that cannot be legally sold to consumers in the United States.

Please direct inquiries to the FDA at [email protected]

FTC Cease and Desist Request: Also, it is illegal under the FTC, 15 USC § 41 et seq., to advertise that a product can prevent, treat, or cure a human disease unless you have competent and reliable scientific evidence. , including, where appropriate, well-controlled evidence. human clinical studies, proving claims to be true at the time they are made. For COVID-19, no such studies are currently known for the products identified above. Thus, any claims of prevention or treatment related to the coronavirus concerning these products are not supported by competent and reliable scientific evidence. You must immediately stop making all such claims. Violations of FTC law may result in lawsuits seeking a federal district court injunction and an order requiring you to refund money to consumers. Further, pursuant to the COVID-19 Consumer Protection Act, Section 1401, Division FF, of the Consolidated Credits Act, 2021, PL 116-260, merchants who make misleading statements about treatment, cure , prevention or mitigation of COVID-19 are subject to a civil penalty of up to $46,517 per violation and may be required to reimburse consumers or provide other remedies under Section 19 (b) FTC, 15 USC § 57b(b). Within 48 hours, please email Richard Cleland, Deputy Director of the FTC’s Advertising Practices Division, via email at [email protected] certifying that you have ceased making unsubstantiated claims for the products identified above. If you have any questions regarding FTC compliance, please contact Mr. Cleland at 202-326-3088.

Sincerely,
/S/

Caroline Becker
Director
Office of Unapproved Drugs and Labeling Compliance
Center for Drug Evaluation and Research
Food and drug administration

Sincerely,
/S/

Serena Viswanathan
Associate Director
Advertising Practices Division
Federal Trade Commission

_____________________

1 As explained in the following paragraph, there is currently an outbreak of a respiratory disease named “Coronavirus Disease 2019” (COVID-19).

2 Secretary of Health and Human Services, Determination that a Public Health Emergency Exists (originally posted January 31, 2020, then renewed), available at https://www.phe.gov/emergency/news/healthactions/phe/ Pages/default.aspx.

3 Proclamation on Declaring a National Emergency Regarding the Novel Coronavirus (COVID-19) Outbreak (March 13, 2020), available at https://trumpwhitehouse.archives.gov/presidential-actions/proclamationdeclaring-national-emergency-concerning -novel -coronavirus disease (COVID-19/.