Healthtex Distributors, Inc.
FDA issued a warning letter to Healthtex Distributors, Inc. (Miami, FL) following a January–February 2023 inspection of their dietary supplement warehouse. The agency found serious CGMP violations — including no written quality control procedures, no identified QC personnel, and inadequate holding/distribution procedures — rendering their Dr. Sana Cod Liver Oil and Dr. Sana Orange Blossom Flower Water products adulterated. Additionally, both products were found misbranded due to incomplete ingredient declarations, missing bilingual label requirements, improper nutrition facts formatting, absent adverse event reporting contact information, missing dietary supplement identity statements, and structure/function claims lacking the required FDA disclaimer. FDA demanded written corrective action within 15 working days and warned that failure to comply may result in seizure or injunction.
Flagged claims (5)
the product label fails to declare the common or usual name of each ingredient in accordance with 21 CFR 101.4(g)
the label makes structure function claims but fails to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b)
the label does not include a statement of identity as a "dietary supplement" as required by 21 CFR 101.3(g)
the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement
the product label contains information in two languages but does not repeat all of the required information in both languages
Required actions (2)
Please notify FDA in writing, within fifteen (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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