Paisley Farm, LLC dba Paisley Farm & Crafts – FDA Warning Letter, Feb 8, 2019

The FDA inspected Paisley Farm & Crafts in Lawrenceburg, TN, from February 4-8, 2019, and subsequently reviewed their website and Facebook page in April 2019. The inspection and review revealed significant violations regarding their Moringa Oleifera Leaf Powder and Moringa Oleifera Seed Powder products.

The FDA determined that the products are unapproved new drugs under section 201(g)(1)(B) of the Act due to disease treatment claims on their Facebook page. These products are not generally recognized as safe and effective for their intended uses and lack FDA approval, violating sections 301(d) and 505(a). They are also misbranded drugs under section 502(f)(1) because they lack adequate directions for use, as their intended purposes are not amenable to self-diagnosis or treatment.

Even if marketed as dietary supplements, the products would be adulterated under section 402(g)(1) due to numerous Current Good Manufacturing Practice (CGMP) violations (21 CFR Part 111). These include failure to establish product specifications (21 CFR 111.70(e)), label and packaging specifications (21 CFR 111.70(d), 111.70(g)), and written procedures for quality control (21 CFR 111.103), manufacturing (21 CFR 11