InnoMark, Inc.
FDA issued a warning letter to InnoMark, Inc. (Saint George, UT) following a March 2023 facility inspection, citing multiple serious violations of dietary supplement cGMP regulations (21 CFR Part 111) and misbranding under the Federal Food, Drug, and Cosmetic Act. The company's products were found to be adulterated due to failures in establishing product and component specifications, identity testing, supplier COA qualification, and incomplete master manufacturing and batch production records. Product labels were also found to be false or misleading, declaring ingredients not present in the products, omitting ingredients that were present, and failing to comply with Supplement Facts labeling requirements. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.
Flagged claims (6)
Your use of "Best Used By" dates on the product labels should be supported by data that demonstrates the product's shelf life.
The (b)(4) and (b)(4) product labels do not bear a symbol next to the structure/function claim linking the claim to the disclaimer, in accordance with 21 CFR 101.93(d). Furthermore, the disclaimer fails to be enclosed in a box on the (b)(4) product, in accordance with 21 CFR 101.93(d).
the product label states that the (b)(4) product contains "(b)(4)," and "(b)(4)," but the BPRs you provided to our investigator for (b)(4), lot number (b)(4) do not list any of these ingredients as being added to the product, demonstrating that these ingredients are not present in the (b)(4) product.
FDA's view is that "evaporated cane juice" is not the common or usual name for sugar or cane sugar.
The individual packet of (b)(4) Stick is misbranded within the meaning of sections 403(y) of the Act [21 U.S.C. § 403(y)] because the packet label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement.
the (b)(4) product is formulated with (b)(4). However, none of these ingredients are declared on the (b)(4) product's label.
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.
If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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