WARNING LETTER
Unived Inc
MARCS-CMS 611569 —
April 07, 2021
Delivery Method:
United Parcel Service
Product:
Dietary Supplements
Recipient:
Recipient Name
Amit Mehta
Recipient Title
CEO/President
Unived Inc
16491 Scientific Way
Irvine
,
CA
92618
United States
Issuing Office:
Office of Human and Animal Food Operations- West Division 5
United States
WARNING LETTER
WL 611569
Dear Mr. Mehta:
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.unived.us/ in February and March 2021 and has determined that you take orders there for the products Unived brand Colox, CalDveg, B12+D3, and D3+K2-7. We have also reviewed your Amazon.com product pages for Unived, Inc. for the Unived brand CalDveg and B12+D3 products. The claims on your website and Amazon.com product pages establish that the products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at
http://www.fda.gov.
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
Unived Colox
Unived Webpage (https://www.unived.us/product/unived-colox-natural-formulation-for-joint-pain/):
• “[W]hile blocking various pathways that lead to pain, inflammation and soreness.”
• “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.”
Unived CalDveg
Unived Webpage (https://www.unived.us/product/unived-caldveg-organic-algae-calciumorganic-algae-magnesium-plant-based-vitamin-d3-vitashine-menaquinone-k2-7-complete-bone-health-60-vegan-capsules/):
• “Vitamin K2-7 [an ingredient in CalDveg]. . .is associated with. . .reduced fractures. . .prevents calcification of arteries and blood vessels”
Amazon Webpage (https://www.amazon.com/Unived-Magnesium-Plant-Based-Vitashine-MenaquinGold/dp/B06W9DY6XT/):
• “INCREASES BONE DENSITY & REDUCES FRACTURES - Vitamin K2-7 [an ingredient in CalDveg] is associated with increase in Bone Mineral Density (BMD) and reduced fractures.”
• “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.”
• “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. Calcium, Vitamin C, Vitamin D3 and Vitamin K2-7 are all needed for intake, absorption and utilization of minerals for good bones. That is why Unived’s CalDveg is the best calcium supplement for you.”
Unived B12+D3
Unived Webpage (https://www.unived.us/product/unived-vegan-active-vitamin-b12/):
• “Introduction . . . 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 . . . 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.”
• “Vitamin D. . .It also positively influences: Immune system, helping you to fight infection. . .Anti-cancer therapy.”
Amazon Webpage (https://www.amazon.com/Unived-Vitamin-Methylcobalamin-Supports-Metabolism/dp/B075XJRHND?ref_=ast_sto_dp):
• “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.”
• “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.”
Unived D3+K2-7
Unived Webpage (https://www.unived.us/product/unived-d3k2-7-with-organic-spirulina-vitamins-d3-k2-7-60-vegan-capsules/):
• “What is Vitamin K . . . 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)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
Your Unived brand CalDveg, B12+D3, and D3+K2-7 are intended for the treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, Unived brand CalDveg,
B12+D3, and D3+K2-7 fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(a)].
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your written response should be directed to:
Sergio Chavez, Director Compliance Branch
Food and Drug Administration
Office of Human andAnimal Foods Division West 5
Los Angeles District Office
19701 Fairchild
Irvine, CA 92612
Refer to the Unique Identification Number CMS 611569 when replying.
If you have questions regarding this letter, please contact Rochelle R. Blair, Compliance Officer at rochelle.blair@FDA.hhs.gov, or (949) 608-4496.
Sincerely,
/S/
Darla R. Bracy
District Director | FDA San Francisco District
Program Division Director
Office of Human and Animal Food Operations- West Division 5
cc:
Benson Yee
Chief, Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue -MS 7602
P.O. Box 997413
Sacramento, California 95899-7435
Content current as of:
05/04/2021
Regulated Product(s)
Dietary Supplements