"I was delighted to see Innovix Pharma make a formulation change and perhaps discontinue their omega-3 acid ethyl esters. I just got my bottle with lot number OV160335 EXP 05/12/19. The enteric capsules in my bottle were large weighing about 1.95430 g with dimensions of about 25.54 mm long by 10.74 mm diameter at the widest part. I had a little trouble swallowing my capsule probably because I have a small throat and you may not experience the same as I did. I purchased this product in good faith thinking that the advertising of the product saying “IFOS 5-star certified. Independently certified by third-party for your peace of mind. Each batch tested for purity, potency, and freshness.” When I visited the IFOS website I did not find my lot listed as of August 25, 2016. My other lot, the ethyl ester form, OV150201, was also missing from IFOS. I am wondering if the marketing of my lots that I purchased is misleading. Now, I am not sure if the label contents on my lot are correct as “IFOS 5-star certified” perhaps this is just an oversight on Innovix Pharma side and maybe Nutrasource did not update the listings as of my review August 25, 2016. This seems to be a great marketing tool for those companies who pay the subscription fee to have their dietary supplements verified for concentration and more importantly for the impurities PCBs, etc.

Also, I just read the new August 2016 NDI guidance “Contains Nonbinding Recommendations Draft-Not for Implementation” “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues” which is in the public domain and in my opinion you might enjoy reading this to understand why the FDA issued this guidance. What caught my eye was page 20-21 that I quote: “12. If I change the manufacturing process for a dietary ingredient that was marketed in the U.S. prior to October 15, 1994, does that make the ingredient an NDI?
The answer depends on the extent to which the manufacturing process change affects the resulting ingredient. As discussed in a separate FDA guidance on manufacturing changes, such changes may affect the identity of the food substance or its safety and suitability for certain conditions of use. Manufacturing changes may also affect the purity of a food substance, such as the amounts of impurities and contaminants in the food substance.
Any changes in your manufacturing process that alter the identity of the ingredient will convert a previously marketed dietary ingredient into an NDI. Manufacturing changes that alter the physicochemical structure or properties, purity and impurities, or biological properties (such as bioavailability or toxicity) of the ingredient result in an NDI.”

Perhaps there is an exemption for certain dietary supplements and I am sure that supporters of OmegaVia will set me straight.

See my photo on the dietary ingredients for the ethyl ester and the triglyceride product and they are both “Pharmaceutical Grade Oil (85% Omega-3” and all the other concentrations are identical. In my opinion, same dietary ingredient with different chemical identities shows a change in the identity of the ingredient i.e. ethyl ester change to triglycerides. Now, in my opinion, the amount of providing free acid equivalent EPA and DHA are different. My ethyl ester bottle with lot number ov150201 is the ethyl ester form and in my opinion, I paid for 780 mg of EPA-ethyl ester and 260 mg DHA-ethyl ester and not the free fatty acids of EPA and DHA. A typical capsule from my bottle with lot OV150201 weighs about 1.94270 g and is 24.55 mm long and width 11.20 mm.

Assume that your digestion system will convert 100% of all the ethyl ester forms to the free fatty acid form intermediate, then, your free fatty acid content can be determined by converting the ethyl ester forms to the common units of “free fatty acid equivalents”. For EPA-EE of 780 mg multiply by 0.9151 = 714 mg and DHA-EE multiply by 0.9213 = 240 mg. For the rTAG product same mass, EPA-rTAG to convert to free fatty acid equivalents, multiply by 0.9598 = 748 mg and for DHA-rTAG to free fatty acid equivalents, multiply by 0.9629 = 250 mg. Although these differences may seem trivial, they add up over the long term. Pennies add up if you compare other products (chemical forms) based on price/mg. You can find these conversion factors on the GOED website “GOED Guidance Documents Issue Date June 16, 2016”. Then, if there is a difference between the absorption of the ethyl ester and rTAG, the true free fatty acid equivalent may be different.

An interesting clinical study comparing various omega-3 acid sources showed that the product with residual ethyl esters, DAGs, and MAGs performed the best in terms of bioavailability. See "The bioavailability of eicosapentaenoic acid from reconstituted triglyceride fish oil is higher than that obtained from the triglyceride and monoglyceride forms" Asia Pac J Clin Nutr 2010;19 (4):499-505 for details.

For some products, the IFOS listing of EPA and DHA does list the units and is based on what the manufacturer’s labels report. It is not clear what values are “reported as” (triglycerides, ethyl ester, or free fatty acid) are being reported on the IFOS website. UnoCardio website has the actual Nutrasource breakdown of the “Essential Fatty Acid Profile” where they show “Fatty Acid as TG” in units of mg per cap and “Product Type: Ultra Refined – rTriglyceride form”. However, there is an error for DHA where the Nutrasource fatty acid profile reports “DHA 360 mg/capsule but the consumer report says 380 mg/capsule and says “IFOS Compliance YES”. It would be great if OmegaVia could also post this information for their IFOS rated products that they got from Nutrasource.

Anyway, I am giving this product four stars based on the above information and the fact that it is a new formulation and a change from ethyl esters to rTAG. If the advertised 5 Star IFOS rating is posted for my lots, I will change my rating to 5 Stars. In my opinion, there are other products sold her on Amazon that have an established history of rTAGs such as NutriGold, UnoCardio, Nordic Natural’s brands, Quell, and Viva Labs (“Viva Labs Omega 3 Fish Oil Supplement, 180 Softgels - The HIGHEST Concentration Omega 3 Capsules, 2,200mg Fish Oil/serving”) sold here on Amazon to name a few. If the labels change, I reserve the right to change my rating.

Based on my First Amendment rights, all my statements are truthful and are not misleading and can be verified based on the bottle labels, NDI, DSHEA, and IFOS website as of August 25, 2016. Are the First Amendment rights for Innovix Pharma also upheld even though there is no IFOS listing for my lot as marketing advertised? Also, in my opinion, my lot ov150201 ethyl ester says “Made in USA” but according to the label “Concentrated and Purified in Europe” contradicts the FTC definition of made in USA and even the Ca law. My triglyceride bottle does not make the “Made in USA” but also says “Concentrated and Purified in Europe”.

The above is my experience with Innovix Pharma OmegaVia and your experience may be different. I have given their DHA rTAG five stars and ordered several bottles to give to friends and I occasionally take the product myself. You should do your own research on whether this product is good for you and not base your decision to purchase or not to purchase on my experience with my lot. In my opinion, I do not recommend taking more than 2,000 mg/day omega 3 dietary supplements. Consult with your health care professional if you want to take more than 2,000 mg/day. Again, all the information I have provided is factual and not misleading. I purchased this product in good faith knowing that the labels were truthful and not misleading.

I am just a consumer challenging the labels and factual information. Take a look at the label changes for OmegaVia “Pharmaceutical Grade Fish Oil” to current label “Pharmaceutical Grade Omega-3”.

I have always complimented RWM for his excellent reviews and dedication to details. I realize that RWM has many reviews and typos are typical as I have made some myself. We will always agree to disagree.

Finally, my concern is truthful labels. In my opinion, if the labels of dietary supplements don’t list the chemical form, then the consumer can’t make a choice whether they want the ethyl ester form or the triglyceride form. Look at the transformation changes of Innovix Pharma’s product line change from ethyl esters to rTAG. They must know something right. Again, I have no personal gripe with Innovix Pharma. Provide truthful labels that in my opinion are not misleading that could cause your products to be misbranded."

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