FDA WARNING_LETTER - Be Natural Organics, LLC

The FDA issued a Warning Letter to Be Natural Organics, LLC. following a review of their website (benaturalorganics.com) in April 2017. The agency determined that several products, including Calendula Cream Soap, Chamomile Balancing Mist, CoQ10 Eye Protection Cream, Gentle Face Lotion, Amaretto Body Scrub, Pomme D?Or Anti-Aging Cr?me, Daily Botanical Enzyme Peel, Squalane Serum, and Sea Kelp Moisturizer, are marketed with claims that establish them as unapproved new drugs. These claims, found on the website, indicate the products are intended for use in the cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or function of the human body, violating sections 201(g)(1)(B) and/or 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act). Specifically, the products are deemed "new drugs" under section 201(p) of the Act because they are not generally recognized as safe and effective for their intended uses. Introducing or delivering such unapproved new drugs into interstate commerce violates sections 301(d) and 505(a) of the Act, as prior FDA approval based on scientific data is required. The FDA mandates prompt corrective action to address all identified violations, including reviewing all product labeling and claims to ensure compliance. The firm must respond in writing within fifteen working days, outlining specific steps taken to correct violations and prevent recurrence. Failure to comply may result in legal action, including product seizure and injunction.