FDA WARNING_LETTER - Black Seed Herb, Inc.

On July 11, 2017, the FDA issued a Warning Letter to Black Seed Herb, Inc. following an inspection from August 30 to September 21, 2016. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111), rendering products like Diabalance Herbal Blood Sugar Balance Tablets and Quick Slim with pure Hoodia Gordonii Capsules adulterated.

Furthermore, a review of the company's website (myblackseed.com) in April 2017 found that several products, including Diabalance and Quick Slim, were marketed with claims indicating their intent for disease treatment or prevention, classifying them as unapproved new drugs under section 201(g)(1)(B) of the Act. These products are also misbranded because they lack adequate directions for use by a layperson, violating sections 301(d), 505(a), 301(a), and 502(f)(1) of the Act.

Key CGMP violations include failure to establish finished product specifications (21 CFR 111.70(e)), specifications for received products (21 CFR 111.70(f)), and written master manufacturing records (MMRs) (21 CFR 111.205(a)). The company also failed to