ByPro Nutrition LLC
FDA issued a warning letter to ByPro Nutrition LLC (owner Dr. Robert L. Bynum) regarding their product Dodecin, a nutraceutical supplement marketed for pain and inflammation relief. The agency determined that claims on the product label, website, YouTube video, and customer testimonials established Dodecin as an unapproved new drug intended to cure, mitigate, treat, or prevent diseases such as osteoarthritis, rheumatoid arthritis, fibromyalgia, neuropathy, and lupus. Because Dodecin lacks FDA approval and fails to bear adequate directions for use, it is both an unapproved new drug and a misbranded drug under the Federal Food, Drug, and Cosmetic Act. FDA warned that failure to address the violations may result in seizure or injunction.
Flagged claims (17)
ALA is a reputable therapy for preventing nerve pain. It also detoxifies your body; fighting…toxic metals, such as Mercury.
Dodecin can also Provide:…Reduction in chronic Inflammatory Skin Conditions…Reduction in Fibromyalgia & other chronic pain syndromes
Dodecin - Pain and Inflammation Relief
Trypsin…Combined with bromelain, it helps treat conditions such as osteoarthritis.
Dodecin's benefits include:…Back and joint chronic pain relief…Reduction in Nerve (neuropathy) Pain
MSM . . . [R]eleiving [sic] many of the symptoms associated with arthritis, osteoarthritis, and rheumatoid arthritis.
Chronic inflammation and pain need to have a loading dose to suppress the over load occurring in your body. Just like steroid dosing for acute inflammation your doctor typically will give a short burst to quickly suppress the inflammation.
[F]ormulated for the management of chronic pain syndromes
Medical research studies show that Silymarin, found in Milk-Thistle, decreases inflammation of tissue and relieves associated pain.
Boswellia Seratta is used clinically to treat degenerative & inflammatory joint disorders. It reduces the white blood cell count in joint fluid, and inhibts leukocyte elastase, which is released in rheumatoid arthritis.
Curcumin inhibits inflammation in and around your joints, muscles, and other tissues, thus decreasing associated aches and pains.
I no longer use any other medication to treat my Lupus except for Dodecin.
Dodecin™, typical onset of pain control is 3 to 7 days.
Bromelain is a powerful anti-inflammitory nutrient. In recent years, numerous clinical studies have shown that bromelain is potentially more effective than many prescription drugs in relieving pain caused by inflammation.
I prefer Dodecin over chronic use of Rx or OTC NSAIDS for arthritis due to the potential renal and gastric side effects of chronic NSAID use.
When you're in pain, there's only one thing you care about - RELIEF. Thousands of people have experienced the life-changing benefits of Dodecin™.
DODECIN: The ingredients in Dodecin are formulated to address multiple pain and inflammation pathways.
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.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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