What happened
Original notice title
Shot of Joy LLC MARCS-CMS 665936, September 25, 2023
From the archived source record
Food and Drug Administration (FDA) reviewed your website at [see original source] in September 2023 and determined that you take orders there for various Shot of Joy brand kratom and kava products, including “Classic – Kratom & Kava Shot,” “Relax – Kratom & Kava Shot,” “Focus – Kratom Shot,” “Kava Only Shot,” “Kratom Gummies,” and “Classic Kratom & Kava Gummies.” Based on our review, these products are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). The marketing and sale of unapproved opioid addiction treatment products is a potentially significant threat to the public health. Unapproved New Drugs Your kratom and kava products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. The violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction. Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. 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.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- 04a862e79d99
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
Sources, dates, and coverage →