Inspections, Compliance, Enforcement, and Criminal Investigations

DK Vitamins 2/5/19

 

  

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WARNING LETTER
 
 
 
VIA OVERNIGHT DELIVERY
RETURN RECEIPT REQUESTED
 
February 5, 2019
 
DK Vitamins
Maria Salute
999 Pope St NW
Palm Bay, FL 32907-7757 US
 
RE: 566205
 
Dear Ms. Salute:        
                                   
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.dkvitamins.com in October 2018 and has determined that you take orders there for your products Ubiquinol CoQ10, Cognispark, Vinpurazine, Melatonin Gammadyn Mn-Co, and Zinc Picolinate Formula. The claims on your website 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 violates the Act. You may find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.  
 
Examples of some of the claims observed on your website that provide evidence that these products are intended for use as drugs include the following:
 
On the page of your website titled “Bioclinic Naturals Ubiquinol CoQ 1060sg”:
  • “Here are just a few of the many healthconditions [sic] associated with requiring supplementalCoQ10 to boost levels: … cardiovascular disease (high blood pressure, congestive heartfailure [sic], cardiomyopathy, protection during cardiac surgery, high cholesterol beingtreated [sic] by drugs, especially statins), cancer (to boost immune function and/or offsetchemotherapy [sic] side effects), diabetes mellitus, male infertility, Alzheimers [sic]  (prevention)and Parkinsons [sic] disease (prevention and treatment), periodontal disease and maculardegeneration [sic].”
On the page of your website titled “Health Concerns Cognispark 30c”:
  • “Useful for patients with post stroke, vascular dementia, suspected Alzheimers [sic] disease, Parkinsons [sic], transient ischemic attack (TIA)”
  • “Experimental uses: chronic fatigue syndrome headache, attention deficit disorder …”
On the page of your website titled “Health Concerns Vinpurazine 90t”:
  • “Post stroke/seizure recovery. Myasthenia gravis. Experimental treatment for Alzheimers [sic]  disease.”
On the page of your website titled “Intensive Nutrition Melatonin 5mg sublingual 30t”:
  • “Melatonin…reduces blood platelet aggregation and thus provides an aspirin type of protective effect on the coronaries, improving blood pressure and reducing the negative effects of hypertension.”
  • “It may have potential benefit for Alzheimer's disease as well.”
On the page of your website titled “Seroyal USA Gammadyn Mn-Co 30 unidoses”:
  • “Gammadyn Mn-Co…is indicated for conditions such as osteoporosis, inflammatory and infectious diseases, pernicious anemia, hypertension, … & Alzheimer's disease.”
On the page of your website titled “Seroyal USA Zinc Picolinate Formula 30mg 60c”:
  • “Zinc Picolinate Formula is indicated for prostatitis, low sperm count, male and female sterility and infertility, … frequent infections, colds and flus; for acne, stretch marks, heavy metal toxicity, Alzheimer's disease and dementia; and for accelerating wound healing following injury or surgery.”
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the Act [21 U.S.C. 321(p)]. 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 C.F.R. § 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 products Ubiquinol CoQ10, Cognispark, Vinpurazine, Melatonin, Gammadyn Mn-Co, and Zinc Picolinate Formula are intended for 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, Ubiquinol CoQ10, Cognispark, Vinpurazine, Melatonin, Gammadyn Mn-Co, and Zinc Picolinate Formula 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)].
 
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that all products marketed by your firm comply with all requirements of federal law, including FDA regulations.
 
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
 
We also note that your product Melatonin, which is marketed as a dietary supplement, bears directions for use as a sublingual product. However, the Federal Food, Drug, and Cosmetic Act (the Act) defines the term “dietary supplement” in section 201(ff)(2)(A)(i) of the Act [21 U.S.C. § 321(ff)(2)(A)(i)] as a product that is “intended for ingestion.” Because sublingual products are intended to enter the body directly through the skin or mucosal tissues, they are not dietary supplements and are not foods.
 
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
 
Your written reply should be directed to Shawn Goldman, United States Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions, please contact Mr. Goldman at Shawn.Goldman@fda.hhs.gov.
 
Sincerely,
/S/
William A. Correll, Jr.
Director
Office of Compliance
Center for Food Safety and Applied Nutrition

 

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