What happened
Original notice title
Unived Inc MARCS-CMS 611569, April 07, 2021
From the archived source record
Supplementing with CalDveg may reduce their risk of osteoporosis and may help prevent other bone related disorders.” • “Being a balanced bone health supplement, CalDveg not only prevents bone related disorders like osteoporosis but also averts calcification of arteries that occur due to inappropriate supplementation.” • “To ensure a healthy bone building process and prevent your bones from weakening and being afflicted by disease, you need an appropriate combination of the right nutrients. Vitamin D3. . .research has now revealed its relevance in. . .prevention and cure of various ailments.” • “Why B12+D3. . .Vitamin B12. . .Vitamin B12 also helps prevent a type of anemia called megaloblastic anemia that makes people tired and weak.” • “Functions of B12. . .It helps keep levels of the amino acid homocysteine in check, which may help decrease heart disease risk” • “5-MTHF . . . These include depression, peripheral neuropathy, myelopathy, restless legs syndrome, insomnia, dementia. . .endogenous, organic psychosis, and schizophrenia-like syndromes.” • “Vitamin D. . .It also positively influences: Immune system, helping you to fight infection. . .Anti-cancer therapy.” Amazon Webpage ([see original source] • “Adequate levels of B12 vitamin. . .can lower the risk of neurodegenerative diseases. Vitamin K2. . .main roles are to. . .prevent calcification of the arteries.” • “What is Vitamin D. . .However, research has now revealed its relevance in overall health, prevention and cure of various ailments.” • “Functioning. . .It also positively influences:. . .Immune system, helping you to fight infection. . .Anti-cancer therapy.” • “Without adequate levels of vitamin D you are likely increasing your risk of diseases ranging from heart disease and Alzheimer’s to weak bones and diabetes.” Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)].
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- 6314f95dd867
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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