What happened
Original notice title
Hekma Center, LLC MARCS-CMS 637652, June 02, 2023
From the archived source record
Urinary system diseases such as urine detention, kidney and bladder stones, overactive bladder (OAB), urinary tract infections and prostatitis. … 7. Moreover, it helps to know the glucose levels in the blood and avoid getting diabetes mellitus. Cinnamon . . . may help remove bile salts, thus may help with any damage that may occur to colon cells and reduces the risk of having various colon diseases. 2. to balance blood sugar level . . . 3-6 grams of cinnamon a day reduces blood sugar level 29%, which very much may help patients with diabetes type 2. 3. to reduce cholesterol level. Crohn's disease, Ulcerative colitis, and gastroenteritis. 6. . . . chronic diarrhea, vomiting, nausea and others, and for renal infection and renal toxicity. 7. 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, Lymf (Galium aparine), Natural Supplements for Cardiomyopathy, Magic1 (Moringa oleifera), Natural Supplements for Diabetes Mellitus, Cinna (Cinnamomum Zeylanicum), Natural Supplements for High Blood Pressure – Hypertension, kraph (Apium graveolens), Natural Supplements for Stroke – CVA, Cam1 (Silybum marianum), Danshen (Red sage), Multiple Sclerosis Package, and Smile Package 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 this misbranded drug violates section 301(a) of the Act [21 U.S.C. 331(a)]. This letter is 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.
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
- 1799c04bfca2
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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