FDA WARNING_LETTER - Results RNA, LLC - August 09, 2017

On April 6, 2018, the FDA issued a Warning Letter to Results RNA, LLC, following an inspection from August 3-9, 2017, and a review of their website (www.resultsrna.com) in April 2018. The letter identified serious violations of the Federal Food, Drug, and Cosmetic Act.

The FDA determined that several products, including Ultimate Lyme Support Extra Strength, ACS 200 Extra Strength, and ACZ Nano Extra Strength, were unapproved and misbranded new drugs. Claims on the company's website and product labels indicated these products were intended for the cure, mitigation, treatment, or prevention of diseases, thus classifying them as drugs under section 201(g)(1)(B) of the Act. As new drugs, they require prior FDA approval, which they lack, violating sections 301(d) and 505(a). Additionally, products like Ultimate Lyme Support Extra Strength and ACS Nasal Extra Strength were deemed misbranded under section 502(f)(1) because they lacked adequate directions for layperson use, as they are intended for conditions requiring professional supervision. Lubrisine Eye Drops Extra Strength was also cited for not complying with the final rule for OTC Ophthalmic Drug Products (21 CFR Part 349) due to unapproved ingredients and claims.

Furthermore, several dietary supplement products were found to be