iwi
FDA issued a warning letter to iwi (Houston, TX) in November 2022 after reviewing the company's website, social media, Amazon, and Walmart pages for its 'iwi Cholesterol' dietary supplement. The agency determined that marketing claims — including that the product is 'clinically shown to decrease cholesterol' and can 'protect your heart by lowering bad cholesterol' — rendered the product an unapproved new drug and a misbranded drug under the Federal Food, Drug, and Cosmetic Act. FDA demanded written corrective action within fifteen working days, warning that failure to comply could result in seizure or injunction.
Flagged claims (6)
Protect your heart by lowering bad cholesterol
In America, an estimated 15% of the heart health related deaths (54,626) each year are linked to low intake of EPA and DHA Omega-3 fatty acids [ingredients in your iwi Cholesterol product]. DHA and EPA are shown to support heart health by decreasing plaque-forming blood lipids (i.e., triglycerides, cholesterol)…
Almega®PL, our proprietary form of EPA-only omega-3 [an ingredient in your iwi Cholesterol product]…has been clinically demonstrated in a trial with 104 participants to significantly decrease total cholesterol against placebo. In particular, 'bad' VLDL cholesterol decreased by 25% on average in just 3 months.
iwi's signature ingredient readily increases the Omega-3 Index – a biomarker for reduced cardiovascular risk.
This plant-based supplement significantly decreases total cholesterol and bad (non-HDL) cholesterol without decreasing good HDL Cholesterol…
Clinically shown to decrease cholesterol
Required actions (2)
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to address these matters. 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 these matters may result in legal action including, without limitation, seizure and injunction.
Does your site contain similar claims?
The free site audit scans your whole site against every entry in this Atlas. Most nutrition / supplements sites match 3-6 patterns.
Run my free site auditWorried about one specific page, ad, or email? Paste it into the free Claim Checker and see what the FDA and FTC would flag, with the precedent next to each one. No email required.
Check specific copy in the Claim Checker