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Essential elements4/1/2023 ![]() Prescription drugs, as defined in section 503(b)(1)(A) of the Act, can only be used safely at the direction, and under the supervision, of a licensed practitioner. “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). FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.Ī drug is misbranded under section 502(f)(1) of the Act if the drug fails to bear adequate directions for its intended use(s). 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. 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. ![]() “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.”.Furthermore, both have been shown in studies to help lower “bad” LDL cholesterol levels as well as triglycerides and even blood pressure.” 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. “The key ingredients in Essential elements CholestAid are the niacinamide and red yeast rice.“ed yeast rice … has been shown to lower LDL cholesterol by helping inhibit cholesterol production in the liver.”.“Niacin and niacinamide … 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”.“ id your body in potentially lowering bad cholesterol levels …”.“Garlic powder has been found to help your body reduce high cholesterol.”."ine bark extract has been shown to help reduce blood pressure.". ![]()
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