What happened
Original notice title
Synaptent, LLC MARCS-CMS 610683, November 09, 2021
From the archived source record
Most clinical trials support the role of garlic supplementation in lowering blood pressure.” Unapproved New Drugs Your products are not generally recognized as safe and effective for the above-referenced uses and, therefore, these products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. Misbranded Drugs 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, your products Berberine HCL, Magnolia Bark Extract, Tongkat Ali Extract, Tribulus Terrestis Extract and Garlic Extract 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)]. Misbranded Dietary Supplements Your Baicalin, Curcumin, DHM, and Milk Thistle Extract products are misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving size declared on the labeling is incomplete. Conclusion 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. This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction. Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any 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
- Response listed; no closeout listed
- Source checked
- Jul 16, 2026
- Record revision
- 3b6c0155b47e
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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