FDA WARNING_LETTER - Natures Boost LLC - December 08, 2020

The FDA issued a Warning Letter to Nature's Boost LLC on November 20, 2020, following reviews of their websites, www.natures-boost.com and www.bloodboostformula.com, in June, July, and November 2020. The FDA determined that the products "Blood Boost Formula" and "Turmeric Curcumin" are unapproved new drugs and misbranded drugs under the Federal Food, Drug, and Cosmetic Act.

The products are deemed drugs because website claims and personal testimonials indicate their intended use for the cure, mitigation, treatment, or prevention of disease. As "new drugs," they require prior FDA approval, which they lack, violating sections 301(d) and 505(a) of the Act.

Furthermore, "Turmeric Curcumin" is misbranded under section 502(f)(1) because it lacks adequate directions for use by a layperson, as its intended uses are not amenable to self-diagnosis or treatment without a licensed practitioner's supervision. This misbranding violates section 301(a).

The letter requires prompt corrective action within fifteen working days, including a written explanation of steps taken to prevent recurrence of violations. Failure to comply may result in legal action, including product seizure and/or injunction.