FDA WARNING_LETTER - Molecular BioLife International, Inc. - April 15, 2021

The FDA issued a Warning Letter to Molecular Biolife on April 15, 2021, following a review of their website, www.molecularbiolife.com, from March to April 2021. The FDA determined that the company was taking orders for "Shark 2 Collagen" and "Balanced Kollagen," which are marketed with claims establishing them as unapproved new drugs and misbranded drugs under the Federal Food, Drug, and Cosmetic Act (the Act).

The products are deemed drugs under section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)] due to claims on the website and associated white papers indicating their intended use in the cure, mitigation, treatment, or prevention of diseases. Examples of such claims for Shark 2 Collagen include treating cancer, osteoarthritis, rheumatoid arthritis, psoriasis, lupus, eczema, and various pain and inflammatory conditions. For Balanced Kollagen, claims include preventing chronic illnesses, relieving pain, preventing joint disorders, rebuilding organs, reducing anxiety, and treating conditions like osteoarthritis, CJD symptoms, rheumatoid arthritis, lupus, gout, fibromyalgia, osteoporosis, and obesity.

Since these products are not generally recognized as safe and effective for their claimed uses, they are considered "new drugs" under section 201(p) of the Act [21 U.S.C. 321(p)]