WARNING LETTER
Essential Elements
MARCS-CMS 636305 —
November 14, 2022
Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Dietary Supplements
Drugs
Recipient:
Recipient Name
Mr. Ben Flohr and Ziv Haklili
Essential Elements
675 N. 2800 W #101
Lindon
,
UT
84042
United States
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
WARNING LETTER
November 14, 2022
RE: 636305
Dear Mr. Ben Flohr and Ziv Haklili:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at www.essentialelementsnutrition.com in August 2022 and has determined that you take orders there for your CholestAid product. Additionally, we reviewed product listings on your Amazon storefront at https://www.amazon.com/stores/EssentialElements/page/79EC556B-D9DC-48C2-86C3-78442954381D?ref_=ast_bln, which directs consumers to your Amazon product page to purchase your product. The claims on your websites establish that CholestAid 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 CholestAid product page at www.essentialelementsnutrition.com/product/cholesterol:
“Helps reduce LDL Levels”
"Essential elements® CholestAid helps you keep cholesterol levels under control."
"Vitamin B3, red yeast rice, and pine bark extract [ingredients in CholestAid] supply a natural way to help your body lower bad cholesterol levels"
"Encouraging higher “good” cholesterol levels, your body is better able to clear out the bad cholesterol building up within arteries and naturally manage cholesterol levels."
“Niacin and niacinamide [ingredients in CholestAid] … work by helping reduce enzymes that break down “good” HDL cholesterol while also preventing cells from releasing the low-density lipoproteins that can cause cardiovascular issues.”
"[P]ine bark extract [an ingredient in CholestAid] has been shown to help reduce blood pressure..."
“Garlic powder [an ingredient in CholestAid] has been found to help your body reduce high cholesterol.”
Claims on your Amazon website page www.amazon.com/cholesterol-support-supplement-niacinamide-CholestAid/dp/B07ZTRRXK4:
“ Helps Reduce LDL Levels”
“ [A]id your body in potentially lowering bad cholesterol levels …”
“Niacin and niacinamide [ingredients in CholestAid] … work by helping reduce enzymes that break down “good” HDL cholesterol while also preventing cells from releasing the low-density lipoproteins that can cause cardiovascular issues”
“[R]ed yeast rice [an ingredient in CholestAid]… has been shown to lower LDL cholesterol by helping inhibit cholesterol production in the liver.”
“The key ingredients in Essential elements CholestAid are the niacinamide and red yeast rice. Powerful on their own, in combination with each other and the rest of the CholestAid formula, they help improve heart health and better manage cholesterol levels. Furthermore, both have been shown in studies to help lower “bad” LDL cholesterol levels as well as triglycerides and even blood pressure.”
“CholesAid's … Coupled with encouraging higher “good” cholesterol levels, your body is better able to clear out the bad cholesterol building up within arteries and naturally manage cholesterol levels.”
Your CholestAid product is not generally recognized as safe and effective for the above referenced uses and, therefore, the 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 CholestAid 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, CholestAid 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 CFSANResponse@fda.hhs.gov.
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
Drugs