Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
Talk to a SpecialistLoading…
Talk to a SpecialistTalk to a SpecialistOmega Wonders LLC was cited for marketing dietary supplements Cardia 7 Heart Health OMEGA 7 and Advanced Tear Health OMEGA 7 as unapproved drugs by making disease claims on their websites and Amazon product pages, violating the Federal Food, Drug, and Cosmetic Act. The company's websites contained claims that the products support healthy cholesterol and CRP levels and customer testimonials describing use for treating conditions like familial hypercholesterolemia, which established the products as drugs intended for disease treatment or mitigation rather than as dietary supplements. These marketing claims rendered the products misbranded and unlawfully introduced into interstate commerce without FDA approval.