mineral oil has zero caloric content nutritionally
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 reviwer of her error.
This is from yahoo website
Generic - Mineral Oil
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.
Doesn't mean anything. molecules (mineral oil) can interact with other molecules (statins) to effect absorption and subsequently the effectiveness of the second molecule. It has nothing to do with calories or nutritional content of mineral oil.
I hope Amarin doesn't frame the argument in this sense because they would be laughed out of the meeting.
I disagree. They already have published data showing that mineral oil does not affect fat soluble vitamin absorption. WHich refuted the argument that they interfere with statin absorption. In fact, these points were referenced by both FDA and AMRN. Thus, the major assertion by the reviewer was the possibility that mineral oil affects the lipid levels directly. The answer is no- she is in error.