Essential Elements
FDA issued a warning letter to Essential Elements (Lindon, UT) in November 2022 regarding their CholestAid dietary supplement, sold at essentialelementsnutrition.com and on Amazon. The agency determined that marketing claims about lowering LDL cholesterol, managing blood pressure, and improving heart health rendered the product an unapproved new drug under the FD&C Act. FDA also found the product misbranded because it lacked adequate directions for use for conditions requiring licensed practitioner supervision. The letter demands written corrective action within 15 working days and warns that failure to comply may result in seizure or injunction.
Flagged claims (11)
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.
Garlic powder [an ingredient in CholestAid] has been found to help your body reduce high cholesterol.
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.
[P]ine bark extract [an ingredient in CholestAid] has been shown to help reduce blood pressure...
[R]ed yeast rice [an ingredient in CholestAid]… has been shown to lower LDL cholesterol by helping inhibit cholesterol production in the liver.
[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.
Helps reduce LDL Levels
Essential elements® CholestAid helps you keep cholesterol levels under control.
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.
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. 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.
Failure to adequately address these matters may result in legal action including, without limitation, seizure and injunction.
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