Fibromyalgia Treatment Group - FTG, LLC – FDA Warning Letter, Sep 21, 2021
On August 26, 2021, the FDA issued a Warning Letter to Mr. Sparling after reviewing websites (www.fibromyalgiatreatmentgroup.com/landers/1/, www.fibrolief.com, www.neuropathytreatmentgroup.com, www.nerverenew.com) and a social media page (www.facebook.com/fibrolief) in August 2021. The FDA determined that the products Fibrolief Support Formula, Nerve Renew, Neuro Boost Optimizer, and Immune Support are unapproved new drugs and misbranded drugs under the Federal Food, Drug, and Cosmetic Act.
The products are considered drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)] due to claims on the websites and testimonials indicating their intended use for the cure, mitigation, treatment, or prevention of disease. As "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)], they require prior FDA approval, which they lack, violating sections 301(d) and 505(a) [21 U.S.C. § 331(d), § 355(a)].
Furthermore, the products are misbranded under section
ID · 3084ca48-7605-474e-8e11-12dbdc1a8f6c
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