Time Challenger Labs International, Inc.
FDA issued a warning letter to Time Challenger Labs International, Inc. (Round Rock, TX) following a December 2024 facility inspection and May 2025 website review, finding that five herbal tincture products — Adrenal Boost, Chaga, Brain & Vein, Thyroid Support, and UTI — were marketed with disease treatment and drug-effect claims that rendered them unapproved new drugs under the FD&C Act. The company also committed multiple repeat CGMP violations (no product specifications, no master manufacturing records, no batch production records, no quality control procedures) causing its dietary supplements to be adulterated. Additionally, its Resveratrol product label was misbranded for failing to identify the product as a dietary supplement and omitting plant-part sourcing information. FDA warned that failure to correct these violations may result in seizure or injunction.
Flagged claims (15)
[S]upport the immune system's ability to kill bacteria.
It works by helping the blood pressure, the heart circulation and relaxing the heart . . . help strengthen a weak heart.
[P]owerful antibacterial and antifungal properties.
[U]sed for bladder infections and other urinary tract problems, bleeding, and shortness of breath.
[P]owerful antioxidant . . . some blood pressure lowering activity . . . reducing the formation of cholesterol
[B]lood pressure lowering activity by relaxing of the blood vessels farther from the heart . . . lower cholesterol by increasing the excretion of bile, reducing the formation of cholesterol, and enhancing the receptors for LDLs.
[S]timulates digestion and supports the liver.
Chaga is commonly used for the moderation of the signs of malignant and abnormal cell growth.
[U]sed for fatigue, anxiety, depression, psychiatric disorders, Alzheimer's disease, and improving memory and intelligence.
[U]sed for heart conditions, including heart failure, irregular heartbeat, and heart symptoms due to anxiety.
[H]elp to support the health of the Thyroid whether you have issues with Hyper or Hypo Thyroid issues.
[T]reat inflammation, including arthritis & osteoarthritis . . . aid blood circulation.
Adrenal Boost is commonly used to increase energy and for hormonal balance.
[U]sed for chest pain (angina), fluid retention . . . weak heart function (heart failure) . . . heart stimulant.
[R]emedy used for signs of a urinary tract infection.
Required actions (3)
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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