Can the supplements sold by DK Vitamins actually have an effect on illnesses and conditions like Alzheimer’s, Parkinson’s, or high blood pressure? Did you buy the company’s supplements because of these claims?
The company makes drug-like claims for a number of products it sells. These are named in a Warning Letter that the Food and Drug Administration (FDA) recently sent the company:
- Ubiquinol CoQ10
- Melatonin Gammadyn Mn-Co
- Zinc Picolinate Formula
Why did the FDA send this Warning Letter? The letter says, “The claims on your website establish that the products are drugs under … the Federal Food, Drug, and Cosmetic Act … because they are intended for use in the cure, mitigation, treatment, or prevention of disease.”
Before such drugs can be sold in interstate commerce, they must be approved by the FDA through a long process that includes clinical trials to make sure they are both safe and effective for persons with the conditions they are meant to treat.
The Warning Letter quotes a number of statements that the company makes about its products:
- On Cognispark: “Useful for patients with post stroke, vascular dementia, suspected Alzheimers [sic] disease, Parkinsons [sic], transient ischemic attack (TIA)”
- On Melatonin: “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.”
- On Zinc Picolinate Formula: “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.”
Also, the company markets melatonin as a dietary supplement even though it is a sublingual. “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.”
Finally, the FDA requires that drugs be labeled with adequate directions for use. However, serious illnesses (such as Alzheimer’s or the other diseases mentioned in connection with these supplements) 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. “
The Warning Letter requires that the company make changes and report back within fifteen working days.
It’s a positive thing if the company makes such changes. But what about the people who have already seen these claims and have bought these supplements? Is a class action needed to get them refunds?
If you bought any of the products listed above, we’d like to know whether you were influenced by the drug-like claims the company made for them. Fill out the form on this page and let us know about your experience.Article Type: Investigation