FDA Issues Warning Letter to New Green Nutrition After Lab Confirms Undeclared Dexamethasone in Herbal Supplement

Undeclared dexamethasone in a commercially available herbal product has drawn a formal FDA warning letter against New Green Nutrition Inc. (Flushing, NY), with the agency's laboratory analysis confirming the potent corticosteroid in the firm's "Qu Feng Huo Luo Dan" supplement, a finding that carries direct implications for supplier qualification programs and raw material testing protocols across the industry.

The letter, reference number 737576, was issued by the Center for Drug Evaluation and Research (CDER) on October 26, 2026, following an FDA website review conducted in September 2026. Investigators obtained a product sample through the firm's e-commerce site and confirmed dexamethasone through laboratory analysis. The agency flagged the steroid's known risks: immunosuppression, hyperglycemia, myopathy, and psychiatric effects, none of which were disclosed on product labeling.

Beyond the adulteration finding, FDA cited four products, "Qu Feng Huo Luo Dan," "Pearl Eye Drops," "Japan Reishi Mushroom Powder," and "Shu Jin Huo Xue Wan", as unapproved new drugs under section 505(a) of the FD&C Act (21 U.S.C. 355(a)), based on disease-treatment claims found on product packaging and the firm's website. "Qu Feng Huo Luo Dan" carried the additional designation of a misbranded drug under section 502(a), given the undisclosed active pharmaceutical ingredient.

For QA directors and compliance leads, the case reinforces a persistent gap in herbal and dietary supplement supply chains: finished-product testing alone is insufficient when supplier qualification and incoming material controls are absent. The detection method here was a standard agency sample purchase, the same mechanism used in routine market surveillance. Products making structure-function or disease claims without an approved NDA remain a high-visibility enforcement target, and e-commerce channels have become a primary vector for FDA's web-based review program.

FDA warned that failure to remediate the cited violations may result in seizure or injunction without further notice, and the agency explicitly noted the warning letter does not represent an exhaustive list of violations.

The agency's confirmed timeline from website review to warning letter issuance, approximately five weeks, signals the pace at which CDER's surveillance program can escalate a market observation into formal enforcement action.

Source: FDA CDER via FDA.gov Warning Letters database, October 26, 2026; published November 3, 2026.