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WARNING LETTER

APG SEVEN, INC MARCS-CMS 670020 —


Delivery Method:
VIA Electronic Mail
Product:
Drugs

Recipient:
Recipient Name
Mr. Alejandro Maldonado
Recipient Title
President
APG SEVEN, INC

12030 SW 129th Court, Suite 205
Miami, FL 33186
United States

apgseveninc@gmail.com
gianluccamal@hotmail.com
Issuing Office:
Division of Human and Animal Food Operations East IV

United States


WARNING LETTER

24-HAFE4-WL-01 / CMS No. 670020

Dear Mr. Maldonado:

This is to advise you that the Food and Drug Administration (FDA) obtained samples and labeling of your dietary supplement products “BioMoringa” and “BioDiabetin,” purchased via the telephone number listed on your website at www.alpagi.net. FDA also reviewed your website in April 2024 and your Facebook social media website, Productos naturales Alpagi | Facebook. This social media website directs consumers to call the same phone numbers listed on your website, www.alpagi.net, to purchase your products. The claims on your product labels and other labeling establish that your products BioMoringa, BioDiabetin, Maca Plus, BioProstate, Immune Support, HongoTrap, Honbacterol, BioFlex, Ginkgo Biloba, ProHerbal Plus, BioWoman, Hongocure, BioCell, and BioCollagen Complex are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.

Examples of some of the claims that establish the intended use of your products as drugs include the following:

BioMoringa

  • From your product label:

    o “Anti-fungal – Antiviral”
    o “Antidepressant”
    o “Anti-inflammatory”

  • “Nuestro producto, BioMoringa se está revelando como un recurso muy valioso para prevenir la desnutrición y múltiples patologías, como diabetes, osteoporosis, cáncer, hipertensión, anemia, enfermedades del sistema inmunológico, sistema nervosa, lupus, entre otros por su gran acción regenerador a nivel de las células del cuerpo.” Translated to: Our product, BioMoringa, is proving to be a very valuable resource to prevent malnutrition and multiple pathologies, such as diabetes, osteoporosis, cancer, hypertension, anemia, diseases of the immune system, nervous system, lupus, among others due to its great regenerative action at the level of the body's cells.
  • “Combate la osteoporosis.” Translated to: Fights osteoporosis.
  • “Destruye las células cancerígenas.” Translated to: It destroys cancer cells.

BioDiabetin

  • “BioDiabetin tiene efectos reductores de azúcar, anoréxicos, tiene la propiedad de aumentar la producción de insulina del páncreas, por lo que se reducen los niveles de azúcar en la sangre, permitiendo que el gasto calórico se obtenga de las otras fuentes.” Translated to: BioDiabetin has sugar-lowering, anorexic effects, it has the property of increasing insulin production of the pancreas, so blood sugar levels are reduced, allowing caloric expenditure to be obtained from other sources.
  • “Mejora el nivel de azúcar en la sangre, la presión sanguínea, y los niveles de colesterol.” Translated to: It improves blood sugar, blood pressure, and cholesterol levels.
  • “Previene la formación de células cancerígenas. Evitando el cáncer de colon.” Translated to: Prevents the formation of cancer cells. Avoiding colon cancer.

Maca Plus

  •  “La maca es rica en polifenoles y glucosinolatos antioxidantes, que pueden ayudar a protegernos de las células cancerosas, inhibiendo su crecimiento.” Translated to: Maca is rich in antioxidant polyphenols and glucosinolates, which can help protect us from cancer cells by inhibiting their growth.
  •  “Alivia dolores óseos, previene artritis y artrosis.” Translated to: It relieves bone pain, prevents arthritis and osteoarthritis.

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.
  • “Limpia, desinflama la próstata.” Translated to: It cleanses and reduces inflammation of the prostate.
  • “Elimina toxinas y bacterias de la próstata.” Translated to: It removes toxins and bacteria from the prostate.
  • “Eleva el sistema de defensa en contra las bacterias que atacan la próstata.” Translated to: It boosts the defense system against bacteria that attack the prostate.
  • “Ayuda con los síntomas de la próstata agrandada como aumento en la frecuencia al orinar por la noche o disminución del flujo urinario.” Translated to: It helps with symptoms of an enlarged prostate, such as increase in the frequency of urination at night or decreased urinary flow.

Immune Support

  • “Cuenta con propiedades que alivian o mejoran la circulación sanguínea e inflamación de articulaciones.” Translated to: It has properties that relieve or improve blood circulation and joint inflammation.
  • “Potente antibacteriano y antiviral contra los patógenos bacterianos.” Translated to: Powerful antibacterial and antiviral against bacterial pathogens.

HongoTrap

  • “Hongotrap es una fórmula natural que tiene como función principal eliminar hongos y las cepas de hongos (nidos) que se encuentran en la sangre y especialmente en el área infectada” Translated to: Hongotrap is a natural formula whose main function is to eliminate fungi and fungal strains (nests) found in the blood and especially in the infected area.
  • “Acción fungicida a nivel de la sangre.” Translated to: Fungicidal action at the level of the blood.
  • “Evita futuros contagios.” Translated to: Prevent future infections.

Honbacterol

  • “Las infecciones de los hongos no son sólo a nivel de la piel, sino también a nivel sanguíneo. Los ingredientes de Honbacterol han sido elegidos con alto control de calidad y con la concentración adecuada para la eliminación definitiva de este microorganismo que justamente se encuentra en la sangre. Logrando la eliminación del mismo. Honbacterol es eficaz en todo tipo de hongos, de uñas, piel, cabeza, genitales, etc.” Translated to: Fungal infections are not only at the level of the skin, but also at the blood level. The ingredients in Honbacterol have been chosen with high quality control and with the right concentration for the definitive elimination of this microorganism that is found in the blood. Achieving the elimination of it. Honbacterol is effective on all types of fungus, nails, skin, head, genitals, etc.
  • “Aniquila los hongos” Translated to: Annihilates fungi
  • “Evita futuros contagios.” Translated to: Prevent future infections.
  • “Ayuda con los hongos formados en la piel.” Translated to: It helps with fungus formed on the skin.

BioFlex

  • “Con este producto aliviarás el dolor en cartílagos y en articulaciones, además de proteger el tejido cartílago articular, para mantener la movilidad de tu cuerpo en todo momento.” Translated to: With this product you will relieve pain in cartilage and joints, as well as protect the articular cartilage tissue, to maintain the mobility of your body at all times.
  • “Regeneración de los cartílagos dañados.” Translated to: Regeneration of damaged cartilage.
  • “Ayuda con las enfermedades como la artritis y artrosis.” Translated to: It helps with diseases such as arthritis and osteoarthritis.
  • “Antiinflamatorio de articulaciones, tendones y cartílagos.” Translated to: Anti-inflammatory of joints, tendons and cartilage.

Ginkgo Biloba

  • “Ginkgo biloba ayuda a la activación de la circulación sanguínea. Evitan la activación de las plaquetas y con ella la coagulación sanguínea. Por lo tanto, ‘los suplementos de Ginkgo biloba pueden ser beneficiosos en personas con tendencia a padecer coágulos.El extracto de ginkgo biloba se ha utilizado durante mucho tiempo en la medicina tradicional para reducir el riesgo de diabetes tipo 2. Uno de los beneficios del ginkgo biloba son sus propiedades antioxidantes, que son útiles para disminuir los radicales libres que pueden desempeñar un papel en el desarrollo de la diabetes tipo 2.” Translated to: Ginkgo biloba helps in the activation of blood circulation. They prevent the activation of platelets and with it blood clotting. Therefore, Ginkgo biloba supplements may be beneficial in people prone to blood clots. Ginkgo biloba extract has long been used in traditional medicine to reduce the risk of type 2 diabetes. One of the benefits of ginkgo biloba is its antioxidant properties, which are helpful in decreasing free radicals that can play a role in the development of type 2 diabetes.
  • “Sus hojas cuentan con propiedades que alivian o mejoran la circulación sanguínea e inflamación de articulaciones.” Translated to: Its leaves have properties that relieve or improve blood circulation and joint inflammation.
  • “Mejora y previene la diábetes.” Translated to: Improves and prevents diabetes.

ProHerbal Plus

  • “Es una combinations de plantas y vitaminas las cuales son la alternativa natural para tratar la inflamación de la próstata, regenerando los tejidos de las vías urinarias, evitando asimismo, el agrandamiento de la próstata infecciones en la misma.” Translated to: It is a combination of plants and vitamins which are the natural alternative to treat inflammation of the prostate, regenerating the tissues of the urinary tract, thereby preventing the enlargement of the prostate and infections in it.
  • “Fortalece las vías urinarias.” Translated to: Strengthens the urinary tract.
  • “Combate la inflamación en vías urinarias y próstata.” Translated to: Fights inflammation in the urinary tract and prostate.
  • “Previene infecciones e inflamaciones.” Translated to: Prevents infections and inflammation.

BioWoman

  • “Evita la descalcificación de los huesos causados por la osteoporosis.” Translated to: Prevents bone decalcification caused by osteoporosis.

Hongocure

  • “Hongocure es una fórmula auténtica capaz de matar al hongo en forma sana, sin efecto secundario negativo, no daña el hígado. 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. Hongocure attacks the fungus in any part of your body, on the skin, in the nails, in the armpits, scalp, intimate parts. 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.
  • “Ataca el hongo desde la raiz.” Translated to: It attacks the fungus at the root.
  • “Antimicrobiano, antibacteriano y antifungal.” Translated to: Antimicrobial, antibacterial and antifungal.

BioCell

  • “Biocell esta indicado especialmente para fatiga crónica, fibromialgia, diabetes, hipertensión, inflamaciones, problemas del sistema inmunológico y mucho más.” Translated to: Biocell is especially indicated for chronic fatigue, fibromyalgia, diabetes, hypertension, inflammation, immune system problems and much more.

BioCollagen Complex

  • “Desinflama articulaciones.” Translated to: Reduces joint inflammation.
  • “Regenera cartílagos, ligamentos y tendones.” Translated to: Regenerates cartilage, ligaments and tendons.

Your social media website, Productos naturales Alpagi | Facebook, also contains evidence of intended use of your products for the cure, mitigation, treatment, or prevention of disease. For example, your Facebook post on May 3, 2023, states, “Con la BioMoringa podrás prevenir patologías como diabetes, cholesterol, cáncer, ayuda en el Sistema inmunológico” (translated to: With BioMoringa you can prevent pathologies such as diabetes, cholesterol, cancer…”). The post further directs consumers to call your store to order the product.

Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. 321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.

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). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.

Your products BioMoringa, BioDiabetin, Maca Plus, Ginkgo Biloba and BioCell are intended for prevention or treatment of one or more diseases that are not amenable to self-diagnosis, prevention, or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. 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)]. 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)].

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. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

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. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Your written response should be directed to the U.S. Food and Drug Administration, attention to: Mr. Ramon A. Hernandez, Program Division Director, 466 Ave. Fernández Juncos, San Juan, Puerto Rico 00901-3223. You may email a copy of your response with appropriate attachments to the email address: orahafeast4firmresponses@fda.hhs.gov. If you have any questions regarding this letter, please contact, Ms. Gina Eng, Compliance Officer, at (954) 759-7715 or via email at Gina.Eng@fda.hhs.gov.

Sincerely,
/S/

Ramon A. Hernandez
Program Division Director
Office of Human and Animal Food Operations
East IV Division

 
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