Biorica International Corp.
FDA issued a warning letter to Biorica International Corp. (Hollywood, FL) regarding its Plaquex® Oral Dietary Supplement, finding that marketing claims on multiple websites and Facebook pages established the product was intended to treat, prevent, or mitigate diseases including cardiovascular disease, high cholesterol, liver and kidney disease, psoriasis, and potentially cancer. Because the product is not generally recognized as safe and effective for these uses, FDA determined it constitutes an unapproved new drug under section 201(p) of the Act and is also misbranded under section 502(f)(1) for lacking adequate directions for use. FDA demanded a written response within 15 working days and warned that failure to comply could result in seizure or injunction.
Flagged claims (6)
Stop buying lecithin and generic phosphatidylcholine products. Most will do more harm than good and actually increase plaque build-up in your arteries and cause fatty liver disease…You can help your body heal itself. Plaquex® Oral is a beautiful way to do just that…Imagine visiting your doctor one day as he smiles and says "Your cholesterol is back to normal!"…Plaquex® Oral can give you all this and more.
Can Plaquex® help prevent cancer?...Conclusion…In conclusion we can surmise that supplying phospholipids of the kind used in Plaquex® improves cell membrane function including the function of Sodium-potassium ATPase, and thus helps to maintain negative voltage in the cell preventing dedifferentiation of the cell into cancer cells.
A revived treatment to prevent heart attack, stroke, amputations and other nasty things like liver a [sic]
In 2006 Plaquex® Oral Gel Capsules were added to the treatment regimen. They improve blood lipids and liver and kidney function and thereby aid in the prevention of plaque deposits in between IV treatment sessions and after the infusion series is completed.
Can Plaquex® help prevent cancer?...When I linked the facts of these three independent information sources, the thought came to me, that Plaquex® – Phosphatidylcholine – may be able to prevent cancer.
Plaquex Oral is indicated for lowering cholesterol levels, triglyceride levels and to improve liver function but also as a[n] additional treatment to Plaquex infusions to prevent re-formation of plaque in the blood vessels after removal. Plaquex Oral is also used in kidney disease as studies show that it increases creatinine and urea clearance in conjunction with Plaquex infusions. Studies in patients with Psoriasis and Neurodermitis show that skin manifestations recede faster and stay in remission longer than with placebo.
Required actions (2)
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.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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