Buyer beware — Many fish oils are synthetic by Dr. Joseph Mercola for Mercola
As you probably know, fish oil has long been touted as an excellent source of docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), two marine-based omega-3 fats that are important for brain and heart health.
What may come as a surprise is that many (if not most) fish oil supplements on the market these days contain synthetic fish oil.
This little-known fact has been brought to the fore by a recent U.S. Supreme Court petition filed by Amarin Pharma Inc., the maker of a proprietary prescription formulation of fish oil called Vascepa (a highly-processed and concentrated form of EPA).
Amarin initially filed a complaint with the U.S. International Trade Commission (ITC) in 2017, charging certain fish oil manufacturers with unfair trade practices. According to Amarin:1
“… [C]ertain companies have violated the Lanham Act and other statutory provisions by importing synthetically produced omega-3 products that are falsely labeled, unlawfully marketed, and deceptively advertised as ‘dietary supplements’ when in fact the products are ‘drugs’ that have not been approved for sale in the United States.”
ITC declined, ruling Amarin’s claims were “not cognizable as a matter of law” because they’re based solely on U.S. Food, Drug, and Cosmetic Act (FDCA) violations.2 An appeals court affirmed the ITC’s decision, concluding that Amarin could not seek relief under the Tariff Act “unless and until FDA exercises its discretion to take action to enforce the FDCA.”3
As reported by Natural Products Insider,4 the U.S. Food and Drug Administration claims it has not yet determined whether fish oils are dietary supplements or new drugs, thus it cannot determine whether FDCA violations have occurred.
Amarin has now filed a “petition5 for a writ of certiorari with the U.S. Supreme Court,” Natural Product Insider reports,6 in an effort to clarify the ITC’s authority to address complaints about products regulated by the FDA. As noted in the petition:7
“The Tariff Act of 1930 grants manufacturers the right to file a complaint with the International Trade Commission alleging Lanham Act violations when an importer engages in unfair trade practices … The Tariff Act mandates that the Commission must investigate a complaint and determine whether a violation has occurred …
This Court has held that ‘Congress did not intend the’ Food, Drug and Cosmetic Act to preclude Lanham Act claims alleging false and misleading advertising for products subject to regulation by the Food & Drug Administration …
The question presented is: When a manufacturer files a Lanham Act claim under the Tariff Act for competitive injuries caused by unfair trade practices, is the claim barred as a matter of law when the International Trade Commission would need to consider the meaning of terms used in the Food, Drug and Cosmetic Act in order to determine whether the claim has merit?”
Many fish oils are synthetic ‘drugs,’ Amarin says
In a nutshell, Amarin has taken issue with the fact that many fish oil supplements contain synthetic fish oil and not all-natural substances, and as such should fall under the category of “drugs,” just like Vascepa. According to Amarin, since fish oils are marketed and sold as dietary supplements, they pose an unfair competition, and are mislabeled and mismarketed. As explained in Amarin’s petition:8
“It is well established and understood that ‘synthetic’ substances derived from natural substances that qualify as ‘dietary ingredients’ under subsections 201(ff)(1)(C), (E), and (F) of the FDCA, or synthetic copies of such natural substances, are not themselves ‘dietary ingredients’ unless they were commonly or customarily used in the conventional food supply and in compliance with law.”
According to Amarin, the FDA has failed to take action against supplement manufacturers that market fish oils that don’t actually qualify as dietary ingredients, and asserts that the FDA’s oversight was never meant to be the sole authority for ensuring proper labeling — which is why Amarin brought its complaint to the ITC. In its current petition to the Supreme Court, Amarin explains the cause for its complaint:9
“Amarin markets Vascepa®, a prescription drug that is synthetically derived from fish oil, with the active ingredient consisting of 1 gram of eicosapentaenoic acid …
Amarin has invested more than $500 million to develop this innovative product, including undertaking extensive clinical trials to support FDA-approved and planned uses of Vascepa® in the United States. Vascepa® has been hailed as a rare medical breakthrough.
Studies10,11 have demonstrated that the drug decreases triglyceride blood levels without raising bad cholesterol and reduces the risk of cardiovascular events, like cardiovascular death, heart attack, and stroke.
Unfortunately, there are large quantities of similar synthetic products derived from fish oil that meet the definition of ‘new drug’ that are not of the same manufacturing quality and have not been studied through clinical trials or approved by FDA as safe and effective.
Although the law is clear that these products are unapproved ‘new drugs’ that may not be marketed and sold as dietary supplements, FDA has failed to take uniform enforcement action under the FDCA.
Whatever the risks to public health might be, the domestic industry faces a serious threat of substantial competitive injury as these mislabeled and deceptively advertised products flood the market.”
What makes most fish oils synthetic?
As structural elements, DHA and EPA are particularly important for proper cell division and function of cell receptors. They also play an important role in anti-inflammatory reactions. These fats are ideally obtained from the consumption of small fatty fish that are free of toxins.
Unfortunately, most people opt for fish oil supplements over eating fatty fish like sardines, anchovies and herring. While this has long been thought to be a perfectly viable option, it has now become clear that the processing of fish oil is deeply problematic, rendering the final product into something far from the natural oils you get from the whole fish.
As described in a 2018 paper12 in the Transformation and Agro-Industry journal, there are many different ways to extract, refine and concentrate the omega-3s in fish oil, and as noted in the 2017 white paper,13 “From Fish Waste to Omega-3 Concentrates in Biorefinery Concept,” there are even methods by which omega-3 oils can be extracted from fish waste.
Former CEO of Twinlab, Naomi Whittel, described the crux of the problem with fish oils in my 2018 interview with her (see “processing of fish” link above):
“Even if you think the fish oil is coming from Norway or Europe, [the fish] is caught in Central and South America … The fish are then brought onto and thrown into the bottom of the boat …
By the time they get to Europe, the guts are so rancid that in order to get the omega-3s out, they have to go through a process of extracting these poisons and this rancidity. [In the end], you’re left with something that has none of the cofactors [and] it’s been heavily contaminated to clean out the rancidity …”
Whittel estimates about 98% of the omega-3 products on the market are inferior (and perhaps even toxic) due to the way the fish are caught and processed — a summary of which is provided in the graphic below.
In short, in order to render the rancid fish safe for human consumption, it must be cleaned, and what’s left at the end of this process is a synthetic ethyl ester omega-3 oil. The reason why some brands are able to provide you with higher concentrations of DHA, for example, is also because of this deconstruction and reconstruction process, and this appears to be part and parcel of Amarin’s complaint.