FDA WARNING_LETTER - Lifetech Resources LLC

The FDA issued a Warning Letter to Lifetech Resources LLC for manufacturing, distributing, and promoting RapidLash, NeuLash, and NeuveauBrow, which are deemed unapproved new drugs and misbranded drugs and cosmetics. The products are promoted for eyelash and eyebrow growth, with claims like "lengthen and thicken lashes" and "promote cell regeneration" on their websites and promotional materials.

These products contain isopropyl cloprostenate, a synthetic prostaglandin analog, which affects body structure/function, classifying them as drugs under 21 U.S.C. § 321(g)(1)(C). As new drugs (21 U.S.C. § 321(p)), they lack FDA approval, violating 21 U.S.C. §§ 355(a) and 331(d). RapidLash and NeuLash are also prescription drugs (21 U.S.C. § 353(b)(1)(A)) due to potential harmful effects (e.g., lowering intraocular pressure, ocular irritation, iris color change, Pregnancy Class C), requiring professional supervision.

The products are misbranded drugs (21 U.S.C. § 352) because they lack adequate directions for lay use (21 U.S.C. § 352(f)(1)) and contain misleading safety claims ("Passed the Safety Status