FDA WARNING_LETTER - Young Health Products, LLC - January 31, 2018

The FDA issued a Warning Letter to Young Health Products LLC after reviewing their website in November 2017 and January 2018. The FDA determined that products including Lugol’s Solution 2%, Liquid Vitamin D3, Probimune, Flax Seed & Omega 3-6-9 Fish Oil, Balance Drops, Whey Protein, and Fruit of the Spirit are unapproved new drugs and misbranded drugs under the Federal Food, Drug, and Cosmetic Act.

The products are deemed drugs because website claims and testimonials, including those in "The Young Health Revolution" booklet, indicate intended use for disease cure, mitigation, treatment, or prevention. Examples of claims include "Helps synthesize thyroid hormones" for Lugol's Solution 2% and "Reduce GI Inflammation" for Probimune. Testimonials describe improvements in conditions like osteoarthritis and Type 2 diabetes.

These products are considered "new drugs" because they are not generally recognized as safe and effective for their claimed uses, requiring prior FDA approval. Additionally, Balance Drops, Whey Protein, Flax Seed & Omega 3-6-9 Fish Oil, Fruit of the Spirit, and Lugol’s Solution 2% are misbranded as they lack adequate directions for use by a layperson for conditions requiring professional supervision.

Young Health Products LLC must respond in writing within fifteen business days, detailing corrective actions and their prevention of recurrence. Failure to comply may result in further FDA actions like injunction or seizure.