CRITICALNutrition / SupplementsFDA Warning Letter · July 9, 2025

Revitalize Energy, Inc.

Atlas ID: 2025-07-fda-revitalize-energy-inc-j2d32h

FDA issued a warning letter to Revitalize Energy, Inc. (Pittsburgh, PA) regarding its Revitalize Energizing Eye Drops, finding the product to be an unapproved new drug and misbranded under the FD&C Act. The product's website and Facebook marketing made drug claims — including relieving eye strain, boosting focus, fighting screen fatigue, and protecting against cataracts — using active ingredients (menthol, camphor, caffeine, taurine) not permitted under the applicable OTC monograph M018. The product's labeling also falsely displayed FDA logos with claims of 'FDA COMPLIANT,' 'MADE IN A FDA REGISTERED FACILITY,' and 'FDA GRAS APPROVED,' creating a misleading impression of FDA approval. FDA demanded written corrective action within fifteen working days and warned that failure to comply may result in seizure and injunction.

Flagged claims (10)

FDA GRAS APPROVED

FDA trademark misuse · false-fda-approval-claim

MADE IN A FDA REGISTERED FACILITY

FDA trademark misuse · false-fda-approval-claim

Revitalize also includes a proprietary blend of stimulants designed to alleviate the effects of screen fatigue.

Unsubstantiated efficacy · unapproved-drug-claim

Revitalize is the first eye drop designed to fight screen fatigue. Our patented formula relieves eye strain, boosts focus, and refreshes tired eyes in seconds.

Unsubstantiated efficacy · unapproved-drug-claim

FDA COMPLIANT

FDA trademark misuse · false-fda-approval-claim

After applying Revitalize, users will feel a deep cooling sensation to stimulate the tear duct and help with the absorption of the remaining ingredients. From there users will feel their eyes refreshed and stimulated. That is our inactive ingredients interacting with the focus adjustment mechanism of the eye.

Unsubstantiated efficacy · structure-function-drug-claim

Instant Energy & Screen Fatigue Relief…Refresh tired eyes with our energizing eye drops…

Unsubstantiated efficacy · unapproved-drug-claim

Why did we formulate Revitalize to include caffeine? Aside from its energetic benefits, its antioxidant benefits protects from cataracts caused by UV-B rays.

Cure claim · disease-prevention-claim

Camphor…To Cool & Refresh

Unsubstantiated efficacy · non-monograph-active-ingredient-claim

Our energizing formula is built for people who live on screens. Every ingredient is selected with purpose and designed to relieve eye muscle fatigue, boost focus, and refresh tired vision…. Caffeine & Taurine: To Energize…Menthol & Camphor: To Cool and Refresh

Unsubstantiated efficacy · unapproved-drug-claim

Required actions (2)

Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.

Response required · 15 days

Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

Injunction

Source

www.fda.gov · FDA Warning Letter

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