FDA WARNING_LETTER - JusByJulie.Com LLC - December 25, 2019

The FDA issued a Warning Letter to Jus By Julie following a December 2019 review of their website, http://www.jusbyjulie.com. The agency determined that products such as Bye Bye Bloat, 3 Day Cleanse, 5 Day Jus ‘Til Dinner Cleanse, and Ginger Citrus Shot are marketed with claims that establish them as unapproved new drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act). These claims suggest the products are intended for the cure, mitigation, treatment, or prevention of diseases, including inflammation, digestive issues, cancer, and diabetes. Since the products are not generally recognized as safe and effective for these uses, they are considered "new drugs" under section 201(p) of the Act. Introducing these unapproved new drugs into interstate commerce violates sections 301(d) and 505(a) of the Act. Furthermore, the 3 Day Cleanse and 5 Day Jus ‘Til Dinner Cleanse products are deemed misbranded under section 502(f)(1) of the Act because they lack adequate directions for use (21 CFR 201.5), as they address conditions requiring professional supervision. The introduction of these misbranded drugs into interstate commerce violates section 301(a) of the Act. The company is required to take prompt action to correct all violations and respond in writing within fifteen working days, detailing corrective steps and prevention measures. Failure to comply may lead to legal action, including seizure and injunction.