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Posted April 2, 2021

FDA Warns Sellers of Prostate, Reishi, Immune Products, and More

On March 16, 2021, the FDA issued warning letters to two companies following reviews of their websites which found statements made about the companies' products to be drug claims. These products are Prostate Health and Children Liquid Vitamins from Anna Health, LLC; Ganoderma Lucidum Red Reishi Mushroom and Papaya Leaf Extract from Duoc Thao Tre Xanh, LLC; and Fucoidan sold by both companies. In addition, both companies sold the product Immune Health with unsupported claims that it can treat coronavirus (COVID-19).

The FDA has previously stated: "There currently are no vaccines, pills, potions, lotions, lozenges or other prescription or over-the-counter products available to treat or cure coronavirus disease 2019 (COVID-19)."

More details about each recently-warned company can be found below (use the link to read the full warning letter).

  • Anna Health, LLC: Prostate Health was promoted with statements such as "Improves... urinary flow," "Relieves symptoms of BPH (Enlarged Prostate)," and "Protects against prostate cancer."
  • Duoc Thao Tre Xanh, LLC: Ganoderma Lucidum Red Reishi Mushroom was promoted with statements such as "THE WONDER MUSHROOM THAT CURES MANY DISEASES AT ONCE."

See ConsumerLab's Reviews of Prostate Supplements (Saw Palmetto and Beta-Sitosterol) and Reishi Mushroom Supplements for tests of related products.

Immune Health was promoted with statements such as "COVID-19 Influenza" and "Helps Boost Your Immune System Against: Coronavirus... Influenza... Bronchitis... Dyspnea... Common Cold."

See ConsumerLab's answer to the question: What are natural remedies for coronavirus (COVID-19)? Do supplements like zinc, vitamin C, or herbals work?

See Related Warnings:

Seller of IoWipe Warned for COVID-19 Claims

Seller of Earth Tea Warned for COVID-19 Claims

FDA Warns Dr. Paul's Lab for COVID-19 Claims

Seller of BioCBD+ Products Warned for COVID-19 and Drug Claims

FDA Warns Seller of Vitamin D and More for COVID-19 Claims