Monday, October 14, 2013 9:02:45 PM
A key issue raised was that the 4 ml mineral oil in the placebo pills may have caused an increased in lipid profiles. Mineral oil is not lipid. Lipid refers to fats and store energy in the form of fatty compounds made up of fatty acids. Mineral oil is not lipid. Mineral oil is inert and made up of CH not Acids (COOH- which are part of lipids- require fatty acids) and is poorly absorbed. It's net nutritional value is 0 calories. Just because it's referred to as oil does not mean it is absorbed fatty acid. In this regard, FDA reviewer appears to be confusing lipid with oil. Chemically or biochemically, mineral oil does not affect lipid composition ( such as LDL cholesterol) or synthesis. I hope AMRN address this issue in this manner to educate the FDA reviewer of her error.
This is from fit bid website
Nutrition Facts
Generic - Mineral Oil
Servings:
Calories 0 Sodium 0 mg
Total Fat 0 g Potassium 0 mg
Saturated 0 g Total Carbs 0 g
Polyunsaturated 0 g Dietary Fiber 0 g
Monounsaturated 0 g Sugars 0 g
Trans 0 g Protein 0 g
Cholesterol 0 mg
Vitamin A 0% Calcium 0%
Vitamin C 0% Iron 0%
*Percent Daily Values are based on a 2000 calorie diet. Your daily values may be higher or lower depending on your calorie needs.
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