Madison One Acme Inc – FDA Warning Letter, Mar 21, 2017

The FDA inspected Madison Once Acme, Inc. (dba Solstice Medicine Company) in early 2017, identifying multiple violations. Several products, including Sheng Fa capsules and Qing Chun Bao Anti-aging Oral Liquid, are classified as unapproved new drugs (21 U.S.C. 321(g)(1)(B), 321(p)) due to therapeutic claims on the company's website, requiring FDA approval which they lack (21 U.S.C. 331(d), 355(a)). Additionally, products like Qing Chun Bao Anti-aging Oral Liquid are misbranded (21 U.S.C. 352(f)(1)) as they lack adequate directions for use for conditions not amenable to self-diagnosis, violating 21 U.S.C. 331(a). Dietary supplement operations also showed deficiencies. The firm, as a distributor/labeler, failed to establish product specifications (21 CFR 111.70(f)) and ensure quality control approval for product release (21 CFR 111.127(h), 111.140(b)(2)). Labeling issues included incorrect total carbohydrate declaration (21 CFR 101.9(c)(6)), an unqualified weight declaration, improper "Percent Daily Values" statement use (21 CFR 101.9(c)), and incorrect heavy bar placement on Supplement Facts labels (21 CFR 101.36(e)(6)). The company must correct all violations and respond within fifteen working days, or face enforcement actions like seizure or injunction.