Anna Health, LLC
FDA issued a warning letter to Anna Health, LLC (Tampa, FL) in March 2021 after reviewing the company's website and finding that four products — Fucoidan, Prostate Health, Children Liquid Vitamins, and Immune Health — were marketed with disease-treatment claims that rendered them unapproved new drugs under the FD&C Act. The Immune Health product specifically claimed to protect against COVID-19, triggering urgent enforcement concern. FDA determined all four products were also misbranded for lacking adequate directions for use. The company was directed to respond within 15 working days with corrective steps, and was warned that failure to comply could result in seizure or injunction.
Flagged claims (16)
Improves…urinary flow.
Fucoidan…triggers the natural immune system to attack and kill cancer cells.
Relieves symptoms of BPH (Enlarged Prostate).
Protects against prostate cancer.
Fucoidan is a powerful anticancerous supplement from the Sea.
Fucoidan suppresses the generation of new blood vessels around cancer cells, cutting off their nutrient supply. This also prevents the cancer cells from spreading.
Radix Rehmanniae Preparata (Sheng di) …treats anemic symptoms…antiinflammation… reduces hypertension, hyperlipidemia
Amur Corktree (Huang bai) …prevents prostate enlargement…reduces inflammation…anti-cancer
Reduces urinary urgency.
Helps Boost Your Immune System Against: Coronavirus…Influenza…Bronchitis…Dyspnea…Common Cold
Serenoa Repens (Saw palmetto) …treatment of benign prostatic hyperplasia (BPH)…reduces urinary problems…useful with prostate cancer
Eliminates children symptoms of anemia, anorexia…
[R]educes anxiety and attention deficit.
Fucoidan reduces side effects of chemotherapy and radiation.
COVID-19 Influenza
Fucoidan provides an anticancer effect by way of inducing apoptosis.
Required actions (3)
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.
We request that you take immediate action to cease the sale of any unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.
Failure to adequately address this matter may result in legal action, including, without limitation, seizure and injunction.
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