Unived Inc
FDA issued a warning letter to Unived Inc. (CEO Amit Mehta) regarding four dietary supplement products — Colox, CalDveg, B12+D3, and D3+K2-7 — sold on the company's website and Amazon. The agency found that marketing claims on both platforms characterized the products as intended to cure, mitigate, treat, or prevent diseases (including osteoporosis, anemia, heart disease, cancer, and neurological disorders), rendering them unapproved new drugs under the FD&C Act. Three of the four products were also deemed misbranded for lacking adequate directions for use. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.
Flagged claims (18)
Introduction . . . Vitamin D3. . .research has now revealed its relevance in. . .prevention and cure of various ailments.
What is Vitamin K . . . Vitamin K2. . .main roles are to. . .prevent calcification of the arteries.
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.
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.
It helps keep levels of the amino acid homocysteine in check, which may help decrease heart disease risk
Vitamin D. . .It also positively influences: Immune system, helping you to fight infection. . .Anti-cancer therapy.
Benefits . . . repairs connective tissues. . .COLOX poses a double blockade in the path of pain and inflammation by blocking COX-2 and 5-LOX pathways- inhibiting the production of prostaglandings [sic] & leukotrines.
INCREASES BONE DENSITY & REDUCES FRACTURES - Vitamin K2-7 [an ingredient in CalDveg] is associated with increase in Bone Mineral Density (BMD) and reduced fractures.
Adequate levels of B12 vitamin. . .can lower the risk of neurodegenerative diseases. B12 also has the ability to help regulate mood disorders. . .Vitamin D3 is integral in. . .combating mental health disorders. . .
FIGHTS ANEMIA. . .Vitamin B12 also helps prevent a type of anemia called megaloblastic anemia that makes people tired and weak.
Vitamin K2-7 [an ingredient in CalDveg]. . .is associated with. . .reduced fractures. . .prevents calcification of arteries and blood vessels
[W]hile blocking various pathways that lead to pain, inflammation and soreness.
One in four women older than 50 years suffer [sic] from osteoporosis. Men aged 65 years and above lose bone mass and their ability to absorb calcium reduces. Supplementing with CalDveg may reduce their risk of osteoporosis and may help prevent other bone related disorders.
PREVENTS & PROTECTS . . . Contains 5-MTHF which is instrumental in reducing homocysteine levels, preventing neural tube defects, improving vascular endothelial functions. It plays a key role in preventing cerfical [sic] dysplasia and protecting against neoplasia in ulcerative colitis.
5-MTHF . . . Theraputically [sic], 50MTHF [sic] is instrumental in reducing homocysteine levels, preventing neural tube defects, improving vascular endothelial functions. It plays a key role in preventing cerfical [sic] dysplasia and protecting against neoplasia in ulcerative colitis. . .Certain neurological, cognitive, and psychiatric presentations may be secondary to folate deficiench [sic]. These include depression, peripheral neuropathy, myelopathy, restless legs syndrome, insomnia, dementia. . .endogenous, organic psychosis, and schizophrenia-like syndromes.
Why B12+D3. . .Vitamin B12. . .Vitamin B12 also helps prevent a type of anemia called megaloblastic anemia that makes people tired and weak.
Required actions (3)
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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