WARNING LETTER
iwi
MARCS-CMS 636312 —
November 14, 2022
Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Dietary Supplements
Recipient:
iwi
2800 Post Oak Blvd Suite 5858
Houston
,
TX
77056
United States
contact@iwilife.com
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
WARNING LETTER
November 14, 2022
RE: CMS# 636312
Dear Madam/Sir:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://iwilife.com/ in October 2022 and has determined that you take orders there for your iwi Cholesterol product. We also reviewed your social media website, www.facebook.com/MyiwiLife/, which directs consumers to your website, https://iwilife.com/, to purchase your product. Additionally, we reviewed your Amazon and Walmart product pages for iwi Cholesterol at www.amazon.com and www.walmart.com, respectively, where your product is available for purchase. The claims on your websites establish that iwi Cholesterol is a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)] because it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at
www.fda.gov.
Examples of some of the website claims that provide evidence that your product is intended for use as a drug include the following:
On your iwi Cholesterol product page at https://iwilife.com/products/natural-cholesterol-supplement:
“Clinically shown to decrease cholesterol”
“Protect your heart by lowering bad 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.”
The product’s name (iwi Cholesterol) is an implied claim that it reduces cholesterol.
On your Amazon product page at www.amazon.com:
“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…”
On your Walmart product page at www.walmart.com:
“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…”
On your Facebook page at www.facebook.com/MyiwiLife/:
March 28, 2022: “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)…”
Your iwi Cholesterol product is not generally recognized as safe and effective for the above referenced uses and, therefore, this product is a “new drug” under section 201(p) of the Act [21 U.S.C. 321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
Your product iwi Cholesterol is intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your product safely for its intended purposes. Accordingly, iwi Cholesterol fails to bear adequate directions for its intended use and, therefore, the product is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of this misbranded drug violates section 301(a) of the Act [21 U.S.C. 331(a)].
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your product. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address these matters may result in legal action including, without limitation, seizure and injunction.
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. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your product is not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your written reply should be directed to Dr. Aaron Dotson, Compliance Officer, United States Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835 or via email at CFSANResponse@fda.hhs.gov. If you have any questions, you may also email at
Sincerely,
/S/
Ann M. Oxenham
Director
Office of Compliance
Center for Food Safety
and Applied Nutrition
Food and Drug Administration
Content current as of:
11/17/2022
Regulated Product(s)
Dietary Supplements