What happened
Original notice title
Hanna's Herb Shop MARCS-CMS 569309, March 05, 2019
From the archived source record
Aside from risks like permanent damage to the liver, nervous system, and muscles other side effects include: Kidney failure, Amnesia, Homicidal impulses, Hostility, Short temper and irritability, Nausea, Weakness, Constipation, Problems sleeping, Inability to walk, Cramping or tingling in legs, Nerve Damage, Temperature regulation difficulties, Erectile dysfunction, Liver abnormalities, Headaches, Rashes or flushing of skin, Dizziness, Diarrhea . . . Avoiding the Side Effects of Statins.” These statements are followed by a picture of Kroeger Herb Kolester and the statement “we want to offer some alternatives to these drugs . . . The University of Maryland Medical Center has reported that Hawthorn may be as effective as the leading prescription drugs in treating heart failure.” Marshmallow Root, Cert. 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). Organic, Kroeger Herb Circu Flow, and Aloe Vera Juice (Inner Leaf) products 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)]. The violations cited in this letter are not intended to be an all-inclusive statement 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 violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and/or injunction.
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
- 5611d67af55c
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.
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