Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistMolecular BioLife International, Inc. marketed collagen products (Shark 2 Collagen and Balanced Kollagen) as drugs without FDA approval by making disease claims on their website, including assertions that the products treat osteoarthritis, rheumatoid arthritis, psoriasis, lupus, eczema, ulcerative colitis, and cancer. The company violated the Federal Food, Drug, and Cosmetic Act by introducing these unapproved drug products into interstate commerce based on therapeutic and preventive claims that established them as drugs under FDA definition. The violations were identified through FDA's review of the company's website between March and April 2021, where claims directly linked the collagen products to treating, mitigating, or preventing disease.