FDA Issues Warning Letter to New York Tong Ren Tang Over Three Unapproved Drug Products

Jing Cheong Asia Inc., operating as New York Tong Ren Tang, received an FDA warning letter dated October 26, 2026, after agency reviewers identified three unapproved new drugs being marketed through the company's e-commerce website, a finding that carries seizure and injunction exposure and signals the continued reach of FDA's online surveillance program.

The letter, issued by the Center for Drug Evaluation and Research (CDER), identifies "Ofloxacin Eye Drops," "Jingzhi Niuhuang Jiedu Pian," and "Gui Pi Wan" as unapproved new drugs under section 505(a) of the FD&C Act, 21 U.S.C. 355(a). Product labeling on the firm's website, including therapeutic claims translated from Chinese, provided the evidentiary basis for drug-intent classification under 21 CFR 201.128. The violations were documented during a website review conducted in September 2026.

FDA flagged the ophthalmic product as the most acute public health concern. Ofloxacin Eye Drops were labeled for bacterial conjunctivitis, keratitis, corneal ulcers, dacryocystitis, and post-operative ocular infections, indications that require demonstrated sterility assurance and regulatory approval precisely because the ocular route bypasses several of the body's natural defense mechanisms. Distributing such a product without an approved application under 21 U.S.C. 331(d) represents a direct violation of interstate commerce provisions.

For QA directors and regulatory affairs leads at legitimate manufacturers, the enforcement action is a marker of how FDA's website surveillance program converts publicly accessible product claims into documented violations. Therapeutic language on product pages, even when translated from a foreign language, constitutes labeling evidence of intended drug use. The two traditional Chinese medicine products cited, Jingzhi Niuhuang Jiedu Pian and Gui Pi Wan, carried claims referencing aplastic anemia, thrombocytopenic purpura, measles, and mumps, each sufficient to trigger drug classification under the FD&C Act.

The agency's warning letter explicitly notes that the listed violations are not exhaustive, and that failure to respond adequately may result in regulatory or legal action without further notice. Firms distributing products through online channels, including those with heritage or traditional formulations, should treat this action as a prompt to audit website content against 21 CFR Part 201 labeling standards and confirm that no marketed product carries therapeutic claims without a corresponding approved application or recognized exemption.

FDA's reference number 738200 will serve as the compliance benchmark against which New York Tong Ren Tang's corrective response is measured.

Source: FDA Center for Drug Evaluation and Research via FDA.gov Warning Letters database, October 26, 2026; published November 3, 2026.