Fibromyalgia Treatment Group - FTG, LLC

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Your Fibrolief Support Formula, Nerve Renew, Neuro Boost Optimizer, and Immune Support products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. § 331(d), § 355(a)].

Passage 2

Your products Fibrolief Support Formula, Nerve Renew, Neuro Boost Optimizer, and Immune Support are intended for prevention or treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. 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)].

Passage 3

Additionally, your website www.fibromyalgiatreatmentgroup.com/landers/1/ includes the statement, “Our manufacturing facility is FDA approved. . ..” FDA does not approve dietary supplement manufacturing facilities. 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)].