What happened
Original notice title
Vacunda & Design 3/20/17
From the archived source record
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, Sinai Cannabis Oil, Sinai Soursop Oil, and Sinai Soursop + CBD fail to bear adequate directions for their intended uses 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)]. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex and Epidiolex.1 FDA considers a substance to be “authorized for investigation as a new drug” if it is the subject of an Investigational New Drug application (IND) that has gone into effect. The violations cited in this letter are not intended to be an all-inclusive list of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including but not limited to seizure and/or injunction. In addition to the above violations, we have the following comments: Your Sinaí Soursop Oil promotional material asks, “¿Por que el Aceite de Guanabana Sinai es mas efectivo?” “D – Registrado y monitoreado por el FDA.” English translation “Why is Sinai soursop oil more effective?” “D - Registered and monitored by the FDA.” This statement seems to imply that your product is superior to other products because you have registered with the FDA and because FDA has inspected your facility.
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
- Historical warning letter; closeout not established by annual index
- Source checked
- Jul 16, 2026
- Record revision
- 3746ff781446
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 →