FDA WARNING_LETTER - Long Life Unlimited - January 31, 2018

The FDA issued a Warning Letter to Long Life Unlimited, LLC, after reviewing their website in January 2018. The FDA determined that products sold, including Balance 600, D-Limonene, Rapha Remedy, and others, are unapproved new drugs and misbranded under the Federal Food, Drug, and Cosmetic Act.

The products are deemed drugs because website claims, such as those for Balance 600 reducing high cholesterol and stabilizing blood sugar, D-Limonene treating cancer and acid reflux, and Rapha Remedy addressing various skin conditions and infections, indicate intent for use in the cure, mitigation, treatment, or prevention of disease, or to affect body structure/function. The "Cancer Protocol" webpage and customer testimonials further support these claims.

These products are considered "new drugs" because they are not generally recognized as safe and effective for their claimed uses, requiring prior FDA approval which they lack. Additionally, they are misbranded because they fail to bear adequate directions for use by a layperson, as their intended uses (e.g., diabetes, cancer, MRSA) require supervision by a licensed practitioner.

The FDA requires Long Life Unlimited, LLC to take prompt action to correct these violations. The company must notify the FDA in writing within fifteen working days of the specific steps taken to correct the violations, including supporting documentation. Failure to comply may result in enforcement actions such as seizure or injunction.