The Council for Responsible Nutrition (CRN) and the Global Organization for EPA and DHA Omega 3s (GOED) filed the joint amicus brief in Federal Appeals Court in the case brought by Amarin. The Irish-based drug maker is seeking to force the ITC to hear a case Amarin had filed in which it sought to have certain higher concentrate esterified fish oils banned from importation because they violated Amarin’s patents and because they were deemed by the drug maker as ‘synthetic’ and therefore not legal dietary ingredients.
ITC declined case
The ITC had declined to hear the case, which had a wide array of dietary supplement finished goods manufacturers and suppliers as defendants, on Oct. 27. Among the unusual features of the case, and one that surely figured heavily in ITC’s decision, was a communication from the US Food and Drug Administration asking the commission not to take up case, as the issues involved treaded upon issues that, from FDA’s point of view, were fully within its jurisdiction.
Amarin has alleged that certain high concentrate ethyl esters and reesterified triglyceride forms of omega-3 fish oils, which now account for a significant portion of the dietary supplements on the market, violate their patents. The Dublin, Ireland-based drug maker further alleged that these should also be viewed as New Dietary Ingredients for which no NDI Notifications have been filed, thus being adulterated by definition.
The question of whether these highly purified forms of fish oils are chemically altered enough from the base versions that safety information for the latter no longer applies is a question that has never been taken up formally by FDA. The agency argued in its brief to ITC that were the commission to rule on the case, it would further muddy the already turbid waters of what’s an NDI and what isn’t.
Question should be addressed to FDA, not ITC
Steve Mister, president and CEO of CRN said this is not the first time a pharmaceutical company has moved to get formal recognition of the market protection enshrined in the DSHEA exclusionary clause. Earlier examples include red yeast rice and lovastatin, and pyridoxamine, a form of vitamin B6, which had been the subject of an ultimately unsuccessful drug development effort. But both of those petitions were addressed to FDA, which made the ultimate rulings.
The move by Amarin is unique, Mister said, and could set a potentially troubling precedent.
“I think this is the first time a pharmaceutical company has tried to do an end run around FDA,” Mister told NutraIngredients-USA.
The joint amicus brief argues that Amarin is seeking a resolution from the wrong agency. If it has questions about the regulatory status of the fish oils in question it should petition FDA, not ITC. Even if it might succeed with ITC (still very much an open question), the result would not be good for the industry or for consumers.
“Amarin has not shown it is entitled to the extraordinary and unprecedented relief it seeks from this Court—an order requiring the Commission to investigate claims predicated on interpreting a statutory definition exclusively enforced by the FDA. Amarin has not shown the FDA is unable or unwilling to take action against the Proposed Respondents, if it agreed with Amarin’s view,” the brief read.
“That outcome would undoubtedly create confusion not only for the Proposed Respondents, but the dietary supplement industry at large,” it continued.
“Amarin could have gone to FDA to petition to have these fish oils removed from the market. Instead they went to ITC, an agency that does not have any expertise in enforcing the Food Drug and Cosmetic Act,” Mister said.
As far as the NDI question is concerned, Mister said CRN has a list it prepared in 1995 of ingredients on the market at the time of the DHSEA grandfather date, which was Oct. 15, 1994. The list does not delineate ethyl ester and reesterified forms of fish oils per se. The description of many ingredients from that time period are crude and lacking in detail when compared to more modern descriptions. But Mister said CRN nevertheless believes it has ample evidence that these forms of fish oils were on the market then.