Warning letter · FDA Warning Letters, Historical Archive

Herbal Alchemist: FDA Warning Letter (Oct 31, 2017)

Agency action: Oct 31, 2017Record ID: fda_warning_-442149fe72cc9e15
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What happened

Original notice title

Natural Alchemist 10/31/17

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, “Herbal Alchemist CBD (Cannabidiol) Capsules” 10mg, 25mg, 50mg, and “Herbal Alchemist 300mg Hemp Oil drops” 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)]. The above violations are not meant to be an all-inclusive list of deficiencies in your products or their labeling. You should take prompt action to correct the violations. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction. Please notify this office in writing within fifteen (15) working days from your receipt of this letter as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur in the future. If you need additional information or have questions concerning any products distributed through your website, please contact the FDA. If you have any questions concerning this letter, please contact Tammy Hancock, Compliance Officer at 510-337-6737. Attn: Will Claren 3565 South Las Vegas Blvd Suite 392 Las Vegas, NV 89109 ___________________________ [1] See “Sativex Commences US Phase II/III Clinical Trial in Cancer Pain,” available at [see original source] and “GW Pharmaceuticals Receives Investigational New Drug (IND) from FDA for Phase 2/3 Clinical Trial of Epidiolex in the Treatment of Dravet Syndrome,” available at [see original source]

What the official notice says to do

Check the original notice for the instructions that apply to the named product, company, and affected lots.

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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
f54b3777f792

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 →

What is affected

Product
Herbal Alchemist CBD (Cannabidiol) Capsules; Herbal Alchemist 300mg Hemp Oil drops
Company
Herbal Alchemist
Lot / identifier
The source does not specify this field.
Market / distribution
The source does not specify this field.