FDA WARNING_LETTER - Day Light Nutrition - August 04, 2023

The FDA issued a Warning Letter to Daylight Nutrition on August 4, 2023, following a July 2023 review of their website, www.daylightnutrition.com. The FDA determined that four products—Above the Weather, Diabetic Support Blend, Joint Well, and ViruZap—are marketed with claims that establish them as unapproved new drugs and misbranded drugs under the Federal Food, Drug, and Cosmetic Act.

The products are deemed "new drugs" because website claims indicate their intended use for the cure, mitigation, treatment, or prevention of disease (e.g., "Flu Symptoms," "Diabetic support," "PAIN & INFLAMMATION," "Natural Antiviral Support"). These products are not generally recognized as safe and effective for such uses and lack prior FDA approval, violating sections 201(p), 301(d), and 505(a) of the Act.

Furthermore, Above the Weather, Diabetic Support Blend, and ViruZap are considered misbranded under section 502(f)(1) because they are intended for conditions requiring supervision by a licensed practitioner, making it impossible to provide adequate directions for layperson use. The introduction of these misbranded drugs into interstate commerce violates section 301(a).

Daylight Nutrition must respond in writing within 15 working days, detailing specific corrective actions, steps to prevent recurrence, and supporting documentation. Failure