What happened
Original notice title
Flora Inc MARCS-CMS 613310, June 07, 2021
From the archived source record
J Clin Psychopharmacol. 2009 Aug;29(4):378-82. A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). Accordingly, Sleep•Essence, Cardio•Essence, Elderberry+, Elderberry Crystals, Flor•Essence, Hydro-Therm Pumpkin Oil, and Pumpkin Oil products fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)]. You should take prompt action to address the violations noted in this letter and establish and implement procedures that will prevent the recurrence of these violations and any other violations. Failure to promptly address the matters specified above may result in legal action without further notice, including, without limitation, seizure of violative products and/or injunction. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete addressing these violations within 15 working days, 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 Act, include your reasoning and any supporting information for our consideration. 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.
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
- 9e1c950e2586
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 →