Fibromyalgia Treatment Group - FTG, LLC
FDA issued a warning letter to Fibromyalgia Treatment Group - FTG, LLC (James L. Sparling, Manager) in August 2021 for marketing four products—Fibrolief Support Formula, Nerve Renew, Neuro Boost Optimizer, and Immune Support—with disease-treatment claims that rendered them unapproved new drugs and misbranded drugs under the FD&C Act. The websites made explicit claims about treating fibromyalgia, neuropathy, depression, cancer, diabetes, and other conditions without FDA approval, and falsely stated that their manufacturing facility was 'FDA approved.' FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure and injunction.
Flagged claims (20)
This extract is a natural alternative to aspirin that is safer and less irritating to the stomach lining.
Studies have shown this ingredient to be more effective than placebos in treating depression.
Keep reading to learn how our breakthrough formula uses the latest research to repair damaged nerves
Bioperine…has immune-suppressing, tumor-inhibiting, and antidepressant effects.
Reversed immune system paralysis in patients whose immune systems had been compromised from sepsis.
Reduce chronic joint or muscle aches and stiffness
It is an essential ingredient in reducing the symptoms of fibromyalgia.
What Enables The Ingredients In Fibrolief To Be So Effective At Relieving The Pain And Symptoms?
Curcumin is a potent anti-oxidant with insanely powerful anti-inflammatory and pain relieving properties. This marvel of nature has virtually no side-effects and offers vast benefits to fibromyalgia sufferers. . ..
…powerful anti-inflammatory and soothing properties to quickly reduce discomfort and swelling…safe alternative for acute pain relief comparable to acetaminophen.
Reduce severity & duration of infections like the common cold or flu…Reduce the risk of chronic inflammation…
The University of Maryland Medical Center states, 'SAMe can be effective in reducing…depressed mood.'
Boswellia is a popular herb used for its benefits in fighting inflammation. Its anti-inflammatory effects involve many processes that the body uses to help heal itself, and could correlate to benefiting many chronic illnesses, such as arthritis and fibromyalgia.
Reduce Debilitating Body Aches, Stiffness, Fatigue & More
It helps your nerve pain (even if you've been suffering for years) by giving you the exact nutrients that unclog micro blood vessels, nourish weak nerve fibers, and help restore the function of your entire nervous system.
B vitamins and R-ALA are absolutely essential ingredients in helping to reduce the symptoms of fibromyalgia and ease nerve pain.
I am going to show you how these ingredients have been shown to improve fibromyalgia symptoms and help you return to a normal life.
The University of Maryland Medical Center states, 'SAMe can be effective in reducing symptoms of fibromyalgia - including pain, fatigue, morning stiffness, and depressed mood.'
Our manufacturing facility is FDA approved. . ..
Beta-glucans are used clinically against diabetes, cancer, and high cholesterol, as well as to boost the immune systems of people whose immunity has been compromised by radiation, chemotherapy, stress, and other conditions.
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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