On April 18, 2024, the FDA issued a Warning Letter to APG SEVEN, INC following a review of the company’s product labels, website, and social media, which found statements about the company’s BioMoringa, BioDiabetin, Maca Plus, BioProstate, Immune Support, HongoTrap, Honbacterol, BioFlex, Ginkgo Biloba, ProHerbal Plus, BioWoman, Hongocure, BioCell, and BioCollagen Complex products to be drug claims.

For example, BioCollagen Complex products were promoted with statements such as (translated from Spanish to English), “Reduces joint inflammation” and “Regenerates cartilage, ligaments and tendons.”

For more information about related products, see ConsumerLab’s Reviews of Collagen and Joint Health Supplements.

BioMoringa products were promoted with statements such as, “Anti-fungal — Antiviral,” “Antidepressant,” and (translated from Spanish to English) “Fights osteoporosis.”

For more information about related products, see ConsumerLab’s answers to the questions:

What are the best supplements for depression and anxiety?

Do any supplements or diets help prevent or treat osteoporosis?

BioDiabetin products were promoted with statements such as (translated from Spanish to English) “It improves blood sugar, blood pressure, and cholesterol levels,” “It relieves bone pain, prevents arthritis and osteoarthritis,” and “Prevents the formation of cancer cells. Avoiding colon cancer.” Maca Plus products were promoted with statements such as, “Maca is rich in antioxidant polyphenols and glucosinolates, which can help protect us from cancer cells by inhibiting their growth.”

For more information about related products, see ConsumerLab’s Reviews of Cholesterol-Lowering Supplements and Maca Supplements.

Also see ConsumerLab’s answers to the questions:

Which supplements help with arthritis?

Is it true that some vitamins or supplements can cause cancer?

BioProstate products were promoted with statements such as (translated from Spanish to English), “It helps with symptoms of an enlarged prostate, such as increase in the frequency of urination at night or decreased urinary flow.” BioFlex products were promoted with statements such as “Regeneration of damaged cartilage.”

For more information about related products, see ConsumerLab’s Review of Prostate Supplements.

Ginkgo Biloba products were promoted with statements such as (translated from Spanish to English), “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.”

For more information about related products, see ConsumerLab’s Review of Ginkgo Biloba Supplements.

Also see:

Which supplements and foods can help lower or control blood sugar?

The FDA also stated in its letter that it considers most of these products to be “new drugs” because they are not recognized as safe and effective for their intended use. Additionally, most products were also found to be misbranded because the products fail to bear adequate directions for their intended use.

The company must respond to the FDA in writing within 15 days of receipt of the warning explaining the specific steps taken to address these violations.

For more information, use the link below.

Warning Letter: APG SEVEN, INC

See related recalls and warnings:

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