FDA WARNING_LETTER - LifeGuard Health LLC

The FDA issued a Warning Letter to LifeGuard Health, LLC, specifically addressing their products Cardio Omega Benefits, Flex Omega Benefits, and Kid's Omega Advantage. The FDA reviewed the company's website, http://www.lifeguardforlife.com, and determined that the products are promoted for conditions that classify them as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)].

The therapeutic claims on the website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease, violating the Act. Examples of claims include: * **Cardio Omega Benefits:** Promoted for "Cardiovascular Disease," "High Cholesterol," and "Diabetes," with claims of reducing cardiovascular events, improving insulin resistance, and lowering cholesterol. * **Flex Omega Benefits:** Promoted for "Rheumatoid Arthritis," "Fibromyalgia," "Back, Neck & Joint Pain," "Arthritis," "Psoriasis," "Osteoarthritis," "Irritable Bowel Syndrome," "Alzheimer Disease," and "Lupus," with claims of anti-inflammatory and pain-relieving properties, and benefits for Alzheimer's. * **Kid's Omega Advantage:** Promoted for "preventing and managing childhood diseases such as asthma,