Entia Biosciences, Inc
FDA issued a warning letter to Entia Biosciences, Inc. (operating via totalnutraceutical.com) in January 2021 for marketing six mushroom-based dietary supplement products — including Lion's Mane, Antrodia, Maitake, Reishi, and two Cordyceps products — with disease treatment and prevention claims that caused them to be classified as unapproved new drugs under the FD&C Act. The website claims referenced anti-inflammatory effects, cancer-fighting properties, cholesterol reduction, blood sugar regulation, and recovery from chemotherapy, among others. FDA also found the products misbranded for lacking adequate directions for use. The letter demanded corrective action within 15 working days and warned that failure to comply could result in seizure and/or injunction.
Flagged claims (18)
... enhanced recovery from chemotherapy
Found to also have cancer fighting properties
the Antrodia mushroom has long been used as a potent anti-inflammatory for a variety of conditions including liver disease, hypertension ... It is also used to help increase the body's defenses and prevent illness
Relief of viral infections ...
Strong anti-inflammatory properties
Anti-inflammatory
Helps to lower cholesterol
Prevention of heart disease
Cholesterol reduction
It has been linked to having positive implications towards reducing cholesterol levels and inflammation
Faster recovery from bronchitis and respiratory diseases ...
Anti-tumor ...
Reduce high blood pressure
Anti-inflammatory properties,
Cordyceps has long been used to treat a variety of health conditions. Its properties range from promoting lower cholesterol to balancing blood sugar levels.
Promotes balanced blood sugar,
Lower high cholesterol
Prevention of prostate cancer
Required actions (3)
Within fifteen ( 15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
You should take prompt action to correct or implement corrections to the violations cited in this letter.
Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and/or injunction.
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