FDA WARNING_LETTER - Konec Inc.

The FDA issued a Warning Letter to Konec, Inc. concerning its marketing of unapproved new drugs, specifically Nitroglycerin Tablets (0.3 mg, 0.4 mg, and 0.6 mg). The agency determined these products are "new drugs" under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) because they are not generally recognized as safe and effective for their labeled uses. The primary violations include the introduction or delivery of these unapproved new drugs into interstate commerce without an FDA-approved application, contravening sections 301(d) and 505(a) of the Act. Additionally, the products are deemed misbranded under section 502(f)(1) because their labeling fails to bear adequate directions for use, as they are intended for conditions not amenable to self-diagnosis. The introduction of these misbranded products into interstate commerce further violates sections 301(a) and (d). Konec, Inc. is required to notify the FDA within fifteen working days of receipt of the letter, detailing plans to cease these violative activities. The FDA outlined an enforcement discretion period: it does not intend to initiate enforcement actions for manufacturing continuing up to 90 days post-letter date, or for shipments continuing up to 180 days. This discretion is conditional and will not apply if other violations occur, manufacturing/distribution volume increases, or new health risks emerge. Failure to correct these violations promptly may lead to legal actions like seizure and injunction, and impact federal contract awards.