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# Focus Drugs Misbranded, Unapproved: FDA
- URL: https://www.fdaweb.com/focus-drugs-misbranded-unapproved-fda/
- Published: 2016-06-14T12:00:00.000Z
- Updated: 2026-09-14T21:09:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135926

FDA says that its review of several Web sites owned by Focus Laboratories, North Little Rock, AR, indicates that the company is marketing items that the agency has determined are unapproved new drugs and are misbranded. A 6/3 [Warning Letter](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm505550.htm?ref=fdaweb.com) from the agency’s Dallas District Office refers to the firm’s Tozal Complete Eye Health Formula, marketed as a medical food for age-related macular degeneration, and FreshKote, promoted as an over-the-counter monograph human drug.

The letter says that Tozal does not meet the statutory definition of a medical food and thus is misbranded. Because Tozal is intended for use in the cure, mitigation, treatment, or prevention of a disease, the agency says, it is considered a drug and thus is an unapproved new drug.

FDA also says that Web site claims for FreshKote establish that it is a drug under the Federal Food, Drug, and Cosmetic Act and thus is also an unapproved new drug. “Specifically,” the letter says, “this product is intended for uses that go beyond the labeled demulcent (lubricant eye drop) indications listed on the FreshKote product label. OTC ophthalmic drug products intended as demulcents, such as FreshKote, are subject to the Final Monograph for Ophthalmic Drug Products for OTC Use. However, this product is not labeled or formulated in accordance with this final monograph….” Also, it says, the FreshKote formulation is not consistent with the formulation requirements that describe acceptable active ingredients for demulcent drug products.

The company was told to respond with a list of specific steps it is taking to correct the violations and prevent their recurrence, documentation of each step, and a timetable for completion.