What happened
Original notice title
Fibromyalgia Treatment Group - FTG, LLC MARCS-CMS 614183, August 26, 2021
From the archived source record
After working my way through 5 doctors at a major hospital in Reno, I was diagnosed with fibromyalgia. Examples of such testimonials include: “I was having nerve pain at night I started taking neuro boost optimizer and within 3 weeks the pain was gone...a great product.” Immune Support Statements referring to Immune Support ingredients on www.nerverenew.com: “The ingredients in this formula have been shown to help:…Reduce severity & duration of infections like the common cold or flu…Reduce the risk of chronic inflammation…” “And while each one is backed by numerous studies, there’s one that stands out above the rest. A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). Accordingly, Fibrolief Support Formula, Nerve Renew, Neuro Boost Optimizer, and Immune Support fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)]. Therefore, this statement is false or misleading. Even if your Fibrolief Support Formula were not an unapproved new and misbranded drug, it would be a misbranded food under section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)]. This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action, including, without limitation, seizure and injunction.
What the official notice says to do
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Read the official notice →Status and source details
- Status recorded in the archive
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- c8e47304828b
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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