FDA WARNING_LETTER - Unived Inc - May 04, 2021

The FDA issued Warning Letter WL 611569 to Unived, Inc. after reviewing their website (unived.us) and Amazon.com product pages in February and March 2021. The FDA determined that Unived brand Colox, CalDveg, B12+D3, and D3+K2-7 products are unapproved new drugs and misbranded drugs under the Federal Food, Drug, and Cosmetic Act.

The products are deemed drugs because claims on the website and Amazon.com pages indicate they are intended for use in the cure, mitigation, treatment, or prevention of disease. Examples of such claims include: Unived Colox for blocking pain and inflammation; Unived CalDveg for increasing bone density, reducing fractures, and preventing osteoporosis and arterial calcification; Unived B12+D3 for preventing anemia, reducing homocysteine levels, and combating mental health disorders; and Unived D3+K2-7 for preventing arterial calcification and various ailments.

These products are considered "new drugs" because they are not generally recognized as safe and effective for their stated uses and lack prior FDA approval. Furthermore, Unived CalDveg, B12+D3, and D3+K2-7 are misbranded because they are intended for conditions not amenable to self-diagnosis or treatment, making it impossible to provide adequate directions for layperson use.

Introducing or delivering these unapproved new drugs