Vitamin A Supplements Review, Including Beta-Carotene and Cod Liver Oil

Testing Methods:

1. Analysis of vitamin A in supplements and fish liver oil products by HPLC (High Performance Liquid Chromatography) or other appropriate methods determined by CL.
2. Heavy metals: Analyses for lead, arsenic, and cadmium performed using Inductively Coupled Plasma-Mass Spectroscopy (ICP-MS) for supplements containing whole herbs and/or more than 250 mg of minerals per daily dose and all fish liver products.
3. Determination of Peroxide (PV), anisidine (AN) and calculation of TOTOX values by AOCS method (CD 8-53 & 18-90 respectively) or other methods as appropriate in fish liver oil products.
4. Non-chewable, non-capsule, and non-time-release formulations analyzed for disintegration utilizing United States Pharmacopeia (USP) <2040> recommendations entitled "Disintegration and Dissolution of Nutritional Supplements.".

Passing Score:*

1. Contain at least 100% and no more than 150% of its claimed amount of total vitamin A (beta-carotene and retinol combined) as well as meet any claimed ratio of beta-carotene to total vitamin A. However, an overage must not cause the product to exceed any Tolerable Upper Intake Levels (UL).
2. Heavy Metal Contamination:
   Lead**: Not exceed the following limits for elemental lead:
   • Products marketed for use by children may not exceed the State of California's Prop 65 limits for lead in dietary supplements of 0.5 mcg per recommended daily serving with an additional allowance of 0.8 mcg if the product contains more than 1,000 mg/day of calcium.
   • Products with a single serving weights of less than 5 grams which are not marketed for use by children, may not exceed the State of California's Prop 65 limits for lead in dietary supplements of 0.5 mcg per recommended daily serving with an additional allowance of 0.4 mcg if containing 250-999 mg/day of any combination of elemental calcium, magnesium and potassium or 0.8 mcg if containing more than 1,000 mg/day of any combination of these minerals. An additional allowance of 0.5 mcg is provided if containing 250-999 mg/day of whole herb (not extract) or 1.0 mcg if containing 1000 mg/day or more of whole herb (not extract). However, total lead allowance will not exceed 2 mcg.
   • Products with single serving weights of 5 grams or more which are not marketed for children may not exceed 2.5 mcg per serving or 4.0 mcg per daily serving.
   Cadmium**: If marketed for use by children, may not exceed 3.0 micrograms of cadmium per recommended daily serving (based on Canada's limit for a child weighing 75 lbs.). If not marketed for use by children, may not exceed 4.1 micrograms of cadmium per recommended daily serving (based on the State of California's Prop 65 limit).
   Arsenic: Contain less than 10 micrograms of total arsenic and no more than 5 micrograms of inorganic arsenic per daily serving (EPA and state of New Jersey limits - based on 1 liter of water).
3. Have a peroxide value (PV) of no more than 20 meq/kg, an anisidine value (AV) of no more than 60 and a TOTOX value of no more than 60 (calculated as (2 x PV) + AV) (GOED 2012).
4. If tested for PCBs (polychlorinated biphenyls): Total PCBs (i.e. all 209 PCB congeners) must be less than 0.09 mg/kg (GOED 2012). Dioxin-like PCBs include the sum of 4 individual non-ortho PCBs and 8 mono-ortho PCBs. For fish body oil concentrates (> 80%), fish liver oil no more than 6 pg/g (proposed EU).
5. If a tablet or caplet, must meet recommended USP <2040> parameters of disintegration for dietary supplements (excluding capsule, enteric coated, chewable and time-release products).
6. Be in compliance with FDA labeling requirements.