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Revitalize Energy, Inc. was cited for marketing Revitalize Energizing Eye Drops as an unapproved new drug in violation of Federal Food, Drug, and Cosmetic Act sections 505(a) and 301(d), as well as misbranding violations under section 502(ee). The company sold the product without FDA approval through its website (myrevitalize.com) and Facebook page, while making therapeutic claims such as "temporarily relieves burning and irritation due to dryness of the eye" and "relieves redness of the eye due to minor eye irritations" in product labeling and marketing materials. These claims established the product's intended use as a drug requiring pre-market approval, which had not been obtained.