FDA WARNING_LETTER - Tiber Laboratories

The FDA issued a Warning Letter to Mr. Henson's firm, following a previous letter to (b)(4), regarding drug products manufactured by (b)(4) and distributed by Mr. Henson's firm, including (b)(4) and (b)(4). These products are deemed "new drugs" under section 201(p) of the Act because they are not generally recognized as safe and effective. The firm lacks FDA-approved applications for these new drugs, leading to violations of sections 301(a) and (d) and 505(a) of the Act for introducing unapproved new drugs into interstate commerce. Additionally, the products are misbranded under section 502(f)(1) of the Act because their labeling fails to bear adequate directions for use, as they are intended for conditions not amenable to self-diagnosis and treatment by laypersons (21 C.F.R. § 201.5). The products are also cited as adulterated under 21 U.S.C. § 351(a)(2)(B), further prohibiting their interstate commerce under 21 U.S.C. § 331(a). The FDA emphasizes that these violations are not exhaustive and may apply to all unapproved drug products marketed by the firm. The firm is required to promptly investigate and correct all identified violations and prevent recurrence. A written response detailing corrective actions, including supporting documentation and timelines, is due within fifteen working days. Failure to comply may result in legal action, such as seizure or injunction, and could impact future federal contracts.