FDA WARNING_LETTER - Images Unlimited Products, d.b.a. Cellect Products & Oglethorpe, Ltd. - August 21, 2019

The FDA issued a Warning Letter to Mr. & Mrs. Eichhorn, owners of Essentials Factor, following an inspection from August 9-21, 2019, and a review of their product labels and website (www.essentialsfactor.com). The letter identifies serious violations of the Federal Food, Drug, and Cosmetic Act.

The primary violations include marketing unapproved new drugs and misbranded drugs. The "kit" (Multi-Mineral and Vitamin Blend powders and Cod Liver Oil Gel Caps) and Olive Leaf Extract with Whole Colostrum Capsules are deemed unapproved new drugs due to therapeutic claims on the website for conditions like cancer, autism, renal failure, hypertension, and various infections. These products are also misbranded because they lack adequate directions for use by a layperson for conditions requiring professional supervision.

Additionally, the company's dietary supplements are adulterated due to serious Current Good Manufacturing Practice (CGMP) violations. Specifically, quality control personnel released products (Strawberry Flavored Powder Mix, Unflavored Powder Mix) that exceeded heavy metal specifications. The company also failed to prepare batch production records for labeling operations and lacked written master manufacturing records for each unique dietary supplement formulation. The FDA emphasized the firm's ultimate responsibility to ensure CGMP compliance, even when contracting out manufacturing.

Furthermore, several Essentials Factor brand dietary supplements are misbranded due to labeling deficiencies, including: - Failure to include a domestic address or phone number for adverse event reporting. - Failure