Warning letter · FDA Warning Letters

APG SEVEN, INC: FDA Warning Letter 670020 (Apr 18, 2024)

Agency action: Apr 18, 2024Record ID: fda_warning_-1c4be3ae6741f2e0
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What happened

Original notice title

APG SEVEN, INC MARCS-CMS 670020, April 18, 2024

From the archived source record

BioProstate “BioProstate es una fórmula totalmente natural, la cual desinflama ydesintoxica la próstata eliminando cualquier tipo de virus y/o bacterias, regenerándola y nutriéndola.” Translated to : BioProstate is a totally natural formula, which reduces inflammation and detoxifies the prostate, eliminating any type of virus and/or bacteria, regenerating and nourishing it. Ginkgo biloba extract has long been used in traditional medicine to reduce the risk of type 2 diabetes. Hongocure ataca al hongo en cualquier parte de su cuerpo, en la piel, en las uñas, en las axilas, cuero cabelludo, partes intimas, La parte externa contaminada poco a poco empieza a regenerarse ya que el hongo esta siendo aniquilado por un fungicida natural como es Hongocure. Hongocure es la solución a sus uñas amarillentas, gruesas, o destruidas por el hongo, Hongocure elimina esa comezón y malestar en todas las áreas de su cuerpo contaminadas por los hongos.” Translated to : Hongocure is an authentic formula capable of killing the fungus in a healthy way, without negative side effects, it does not damage the liver. The contaminated external part little by little begins to regenerate since the fungus is being annihilated by a natural fungicide that is Hongocure. Hongocure is the solution to your yellowed, thick, or nails destroyed by the fungus, Hongocure eliminates that itching and discomfort in all areas of your body contaminated by fungi. 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 BioMoringa, BioDiabetin, Maca Plus, Ginkgo Biloba and BioCell products 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)].

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
No closeout listed in FDA table
Source checked
Jul 16, 2026
Record revision
b81e7a953a6f

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
BioMoringa; BioDiabetin; Anti-fungal – Antiviral; Antidepressant; Anti-inflammatory; Maca Plus; BioProstate; HongoTrap; Honbacterol; BioFlex; Ginkgo Biloba; ProHerbal Plus; BioWoman; Hongocure; BioCell; and BioCollagen Complex
Company
APG SEVEN, INC
Lot / identifier
The source does not specify this field.
Market / distribution
The source does not specify this field.