FDA WARNING_LETTER - Uustar Corporation dba Daily Vita, LLC - August 09, 2018

On March 12, 2019, the FDA issued a Warning Letter to Yanqing “Michael” Li and Chang Su, owners of a manufacturing facility at 1013 Investment Blvd., Apex, NC. This letter followed an inspection from August 6-9, 2018, and a subsequent review of their website, http://www.woohoonatural.com, in March 2019.

The FDA identified serious violations of the Federal Food, Drug, and Cosmetic Act. Several products, including WOHO Premium Select American Ginseng, Reishi King Triple Mushroom, ProstaRX-9, Joint Flex, Pure American Ginseng Capsules, and Extra Strength Lecithin, were deemed "unapproved new drugs" and "misbranded drugs." This determination was based on therapeutic claims made on product labels and the company's website, indicating their intended use for disease cure, mitigation, treatment, or prevention. These products are not generally recognized as safe and effective for their claimed uses and lack FDA approval, violating sections 201(p)(1), 301(d), and 505(a) of the Act. Furthermore, they are misbranded under section 502(f)(1) because they lack adequate directions for layperson use, and some are intended for conditions requiring professional supervision, making adequate directions impossible.

Additionally, WOHO Premium Select American Ginseng and Hsu’