Trippo International LLC
FDA issued a warning letter to Trippo International LLC (Newington, CT) regarding its 16-ounce Super Caffeine (Anhydrous) powdered dietary supplement. The agency determined the product is adulterated under 21 U.S.C. § 342(f)(1)(A)(i) because its labeling recommends a 200 mg serving size that cannot be accurately measured with common household tools, creating a significant or unreasonable risk of illness or injury given caffeine's potential toxicity at small overdose amounts. FDA warned that failure to address the violations could result in seizure or injunction, and required a written response within 15 working days.
Flagged claims (2)
Serving Size: 200 milligrams Total Servings Per Container 2267
Recommended use 200mg up to 2 times daily. Allow 3 to 4 hours between servings. Do not exceed more than 400 mg for 2 doses per day.
Required actions (2)
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.
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