Beeyoutiful.com, LLC

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Your Vitex w/ Dong Quai, Berry Well, Cranberry Power Cleanse, Tummy Tuneup, Colostrum Transfer Factor, Methylated Folate, Prostate Health—Clinical Strength, D3, Vitamin K2 + D3, Dino Bones, Dynamic Duo A + D, Liquid D3, B-Better, Gentle C, CoQ10, Glucosamine/MSM, Bone Ami, Bio B12, Liquid B12, Bromelain, Magnesium Citrate, Omega-3, Odorless Garlic, Selenium Secure, Biome Blast (Yeast Assassin), and Caprylic Acid products are not generally recognized as safe and effective for the above-referenced uses and therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)].

Passage 2

Your Vitex w/ Dong Quai, Berry Well, Cranberry Power Cleanse, Tummy Tuneup, Colostrum Transfer Factor, Prostate Health—Clinical Strength, D3, Vitamin K2 + D3, Dino Bones, Dynamic Duo A + D, Liquid D3, Gentle C, CoQ10, Bio B12, Liquid B12, Bromelain, Magnesium Citrate, Omega-3, Odorless Garlic, Selenium Secure, and Biome Blast (Yeast Assassin) products are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, your Vitex w/ Dong Quai, Berry Well, Cranberry Power Cleanse, Tummy Tuneup, Colostrum Transfer Factor, Prostate Health—Clinical Strength, D3, Vitamin K2 + D3, Dino Bones, Dynamic Duo A + D, Liquid D3, Gentle C, CoQ10, Bio B12, Liquid B12, Bromelain, Magnesium Citrate, Omega-3, Odorless Garlic, Selenium Secure, and Biome Blast (Yeast Assassin) fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)].