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# Firm Selling Misbranded, Unapproved Drugs: FDA
- URL: https://www.fdaweb.com/firm-selling-misbranded-unapproved-drugs-fda/
- Published: 2022-02-01T12:00:00.000Z
- Updated: 2026-09-14T17:30:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151046

An FDA review of a Web site and Internet address maintained by Applied Health Solutions, Scottsdale, AZ, determined that the firm markets branded products that are considered to be drugs based on claims made for them at the Web site. A just-released 10/22/21 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/applied-health-solutions-inc-616778-10222021?ref=fdaweb.com) gives pages of examples of the Web site claims for the products and says the products are not generally recognized as safe and effective for their claimed uses and thus are legally considered to be unapproved new drugs.

The products also are misbranded, FDA says, because they do not bear adequate directions for their intended uses.

Applied Health was told to respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, with documentation of the steps and a schedule for completing the corrections.