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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-52/
- Published: 2021-02-02T12:00:00.000Z
- Updated: 2026-09-14T16:44:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148580

FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.

**American Global Health Products**, Bellevue, WA (1/22) FDA says its review of the firm’s Web site and Facebook page indicated the company takes order for several AloeCure brand products. The agency says the company makes claims for the products that establish that they are intended for use in the cure, mitigation, treatment, or prevention of disease and thus are legally considered unapproved new drugs. It also says the products are misbranded because they don’t have adequate directions for their intended use. American Global was told to respond with a list of specific actions it has taken to correct the violations and prevent their recurrence. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/american-global-health-group-llc-610283-01222021?ref=fdaweb.com).  

**Entia Biosciences**, Sherwood, OR (1/6): An FDA review of the firm’s Web site ([*www.totalnutraceutical.com*](http://www.totalnutraceutical.com/?ref=fdaweb.com)) has determined that it markets the following unapproved drugs: Lion’s Mane All Natural Supplement, Antrodia Mushroom Powder, Maitake Mushroom Powder, Reishi Mushroom Powder, Cordyceps Mushroom Powder, and Cordyceps All Natural Mushroom Dietary Supplement. FDA says that claims on the Web site establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. For example, one product was claimed to help lower cholesterol, and another product was claimed to have anti-inflammatory properties. The agency told Entia Bio to take prompt action to correct or implement corrections to the violations cited in the Warning Letter. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/entia-biosciences-inc-610493-01062021?ref=fdaweb.com).