FDA WARNING_LETTER - New Green Nutrition, Inc. - August 31, 2021

The FDA issued a Warning Letter to Xiang Lu Peng (NewGreenUSA.com) on October 14, 2021, following a review of their website and social media in August 2021. The letter states that "Xiao Ke Wan," "Diabetee-Care," and "Specific Jiang Tang Remedy" are unapproved new drugs and misbranded.

The products are deemed drugs under section 201(g)(1) of the FD&C Act due to claims on the website, social media, and product labels indicating intended use for diagnosis, cure, mitigation, treatment, or prevention of disease, and/or affecting body structure/function. Examples include "maintain blood glucose level," "regulate blood sugars by strengthening the pancreas," "Indicated for . . . type II diabetes," and "reducing the content of the blood sugar and urine sugar."

These products are "new drugs" per section 201(p) of the FD&C Act, lacking general recognition of safety and effectiveness. Their introduction into interstate commerce without FDA approval violates sections 301(d) and 505(a).

Furthermore, the products are misbranded under section 502(f)(1) because their labeling lacks adequate directions for use by a layperson, as they address conditions not amenable to self-diagnosis/treatment. "Xiao Ke Wan" is also misbranded under section 503(b