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Rend Al-Mondhiry, JD • Jennifer M. Adams, JD
Feature Articles | 24 July 2018 | Citation
This article discusses the history and implications of a lawsuit claiming that certain omega-3 fish oil products, synthetically-produced, were unlawfully labeled and marketed as “dietary supplements. The parties involved include a pharmaceutical company in Ireland, the US International Trade Commission, the US Food and Drug Administration and the US Congress. The outcome of the case could have implications beyond concentrated omega-3 products and the supplement industry as the regulatory classification of such ingredients will continue to receive attention from FDA, retailers and other industry stakeholders.
In August 2017, the dietary supplement industry received unexpected news in the form of a complaint filed by Amarin Pharma and Amarin Pharmaceuticals Ireland Ltd. (Amarin) at the US International Trade Commission (ITC). The complaint alleged that certain omega-3 fish oil products, synthetically-produced, predominantly eicosapentaenoic acid (EPA) products in ethyl ester or reesterified triglyceride form, known as “concentrated omega-3 products,” were unlawfully labeled and marketed as “dietary supplements,” as defined by the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 USC 321(ff).1 Amarin manufactures and markets Vascepa®, a drug approved by the US Food and Drug Administration (FDA) that contains 100% synthetically produced EPA in ethyl ester form. The complaint alleged that concentrated omega-3 products sold in the US as dietary supplements are not in fact “dietary supplements” under the FD&C Act, but instead, are “unapproved new drugs.”2 Therefore, according to Amarin, the “false labeling” of these products unfairly competes with Vascepa, constituting “an unfair act and/or unfair method of competition under Section 337 because, among other things, these acts violate Section 43(a) of the Lanham Act, 15 USC 1125(a) and the standards established by the FD&C Act.”3 The complaint requested an ITC investigation in accordance with Section 337,4 and issue an order barring the importation of the concentrated omega-3 products into the US. The named Respondents (akin to Defendants) in the complaint included 18 domestic and international companies either manufacturing or marketing concentrated omega-3 products. Given the popularity and wide-spread use of the products, as well as the potential and far-reaching impact on dietary supplement ingredients more generally, the Respondents and industry trade associations responded strongly and swiftly. The complaint also received significant attention from industry trade press.5,6 Even Congress weighed in, as did FDA in a surprising but, for the industry, a welcome move. As discussed below, this case was unusual from the start, from the subject matter of the complaint to the various stakeholders’ positions. For the dietary supplement industry, the final outcome has the potential to impact the uncertain status of concentrated omega-3 products and also may encourage competitors (even from outside the pharmaceutical industry) to bring similar challenges before the ITC, rather than arguing the issues before a regulatory body like FDA. More importantly, the case serves as a reminder of the key regulatory questions needing to be addressed prior to marketing a dietary supplement.
A main advantage of an ITC proceeding is the speed at which the ITC issues its determinations, typically within 12–18 months, depending on the complexity of the issues. Arguing these issues before a federal district court or waiting for FDA to make a final determination through regulation or based on a Citizen Petition takes much longer if in fact, the agency finalizes its position or actually responds to the petition. This timing, and Amarin’s history with FDA,7 undoubtedly influenced the pharma company’s decision to take on the supplement industry in this manner rather than take its chances before FDA or in court. Thus, just 10 days after Amarin filed its complaint on 30 August 2017, the Respondents and various stakeholders had filed their comments with the ITC, and the Commission began deliberating the fate of concentrated omega-3 products.
Members of Congress and FDA8 also submitted comments to the ITC asking it to decline to institute the investigation based on jurisdictional grounds, and also for public interest reasons in the case of Congress. After extending the deadline for its decision—which was not surprising given the complex nature of the issues—on 27 October 2017, the ITC announced its decision to not institute the investigation and dismissed Amarin’s complaint.
In December 2017, Amarin appealed this decision before the US Court of Appeals for the Federal Circuit. Amarin filed both a petition for writ of mandamus seeking a reversal of ITC’s determination and essentially forcing the ITC to institute the requested investigation, and a petition for review of ITC’s determination.9 Respondents DSM Nutritional Products, Pharmavite and Nordic Naturals were subsequently granted permission to intervene in the appeal. Amarin filed its opening brief in January 2018 and both the ITC and the intervenors filed their responsive briefs in March 2018. The Council for Responsible Nutrition (CRN) and the Global Organization for EPA and DHA Omega-3s (GOED) also weighed in once again, filing an amicus brief in March. The Department of Justice (DOJ), along with FDA, also filed an amicus brief in support of the ITC's decision to decline to investigate. A decision from the Circuit Court of Appeals is expected in July or August of 2018.
The ITC is an independent, quasi-judicial agency that investigates potential violations of Section 337 of the Tariff Act of 1930, which prohibits unfair acts and unfair methods of competition for imports.10 Typical investigations involve potentially “dumped” imports (those sold at less than fair market value in the US) that may threaten a US industry. The ITC also adjudicates cases involving imports allegedly infringing upon intellectual property rights. Parties representing the technology and durable goods manufacturing industries most often find themselves before the ITC, although the Commission has considered complaints involving FDA-regulated products. As noted above, the ITC’s quick timeline for its determinations likely factored into Amarin’s decision to bring its allegations before the ITC. The complaint also set forth a unique set of issues for ITC as the requested investigation and ban on the import of concentrated omega-3 products is predicated upon Amarin demonstrating these products are, in fact, “unapproved new drugs” rather than “dietary supplements” under the FD&C Act. Amarin also argued that concentrated omega-3 products are “new dietary ingredients” under the FD&C Act for which pre-market notification to FDA is required.11 In the absence of such notification, Amarin alleged that the products at issue are adulterated under the law. However, the Respondents and industry stakeholders maintained that no violation exists because FDA has not determined in fact that the accused products are not “dietary supplements.” Moreover, the determination as to whether products are “dietary supplements” can only be made by FDA, not the ITC. As further evidence, the parties pointed to FDA’s not-yet-finalized guidance that supports the contention that the agency has considered—but not concluded—whether the products are “dietary supplements” within the meaning of FD&C Act.12 As described in further detail below, FDA and the industry have been deeply entrenched in issues such as what is a “dietary ingredient” under the law, and whether such ingredients are New Dietary Ingredients (NDI) that require pre-market notification to FDA.13 These issues are far removed the from the typical trade dispute and intellectual property matters frequently coming before the ITC. However, FDA’s comments to the Commission were perhaps the most influential factor in the ITC’s decision. In its letter to ITC, FDA noted it has not made a final determination with regard to status of concentrated omega-3 products, and that Amarin’s complaint is based on “open questions of law and policy on which FDA has not reached final conclusions” and, thus, “[a]ny such findings by the Commission on those issues may conflict with later determinations by FDA."14 The agency also noted that Congress provided FDA with the exclusive authority to determine whether products are “dietary supplements” or “drugs” under the FD&C Act. FDA also distinguished the facts of this case from POM Wonderful v. Coca-Cola,15 a case that Amarin cited throughout its complaint as precedent to counter any arguments in support of FDA’s exclusive jurisdiction over the products at issue. In POM Wonderful, the US Supreme Court held that POM Wonderful could bring a Lanham Act suit against Coca-Cola based on allegations that its blueberry-pomegranate juice blend misleads consumers—despite the fact that FDA has jurisdiction over juice labeling and the juice product was labeled in compliance with FDA regulations. Here, however, FDA has not finalized a regulation that would address the status of concentrated omega-3 products, nor has FDA finalized the guidance elaborating on the agency’s interpretation of the law and its thinking on this matter. The ITC would essentially be charged with determining whether concentrated omega-3 products are legal dietary ingredients even before a final conclusion from FDA on this matter, and without the expertise of FDA officials typically involved in making such determinations.
In a brief decision issued in October 2017, the ITC stated that “[t]he FD&C Act precluded the allegations brought under the Lanham Act, and FDA is responsible for the FD&C Act’s administration.” Thus, because “Amarin’s complaint does not allege an unfair method of competition or an unfair act” under Section 337, ITC dismissed the complaint. Of note, a decision not to institute is a rare occurrence for the ITC, as the vast majority of ITC complaints result in an investigation. In this case, however, it was clear that the complicated and unsettled issues at stake, as well as FDA’s assertive stance on the matter, were key factors in the ITC’s decision. In its January 2018 opening brief, Amarin argued that it had properly pled a complaint in accordance with Section 337 and therefore, the Commission does not have discretion to decline to institute the requested investigation. Amarin further noted the language in ITC’s governing statute (Section 337), which provides in part that the ITC “shall investigate any alleged violation of this section on complaint under oath” (emphasis added).16 In addition, Amarin once again pointed to the US Supreme Court’s decision in POM Wonderful v. Coca-Cola, arguing in its brief that the Court rejected the view that FDA has exclusive authority over the labeling of FDA-regulated products and, as such, Lanham Act suits alleging false and misleading labeling are not precluded. The intervenors in the case, the ITC and interested stakeholders have maintained the Commission acted appropriately and within its legal authority when it dismissed the complaint. In their amicus brief to the appellate court, CRN and GOED defended ITC’s decision by saying to find otherwise “would require ITC to inject itself into the statutory and regulatory framework explicitly authorized to the [FDA],”17 which would cause confusion for the dietary supplement industry. The trade associations also noted that Amarin’s initial complaint failed to satisfy ITC’s pleading standard because it did not allege the elements necessary for a false advertising claim.18 As mentioned previously, DOJ and FDA also submitted an amicus brief arguing that the ITC's decision to decline to investigate was proper because the FD&C Act does not allow private parties to enforce the Act.19 The three-judge panel for the Federal Circuit Court of Appeals will ultimately decide whether the ITC had discretion to decline the investigation and is mandated to open an investigation into concentrated omega-3 products.
On the surface, Amarin’s challenge appears to be a unique situation not necessarily or generally impacting the dietary supplement industry. But the crux of the dispute is a question affecting each and every dietary supplement product: is the ingredient a “dietary ingredient” under the FD&C Act? This is an increasingly important question as it receives more attention not only from regulators, but also from retailers. Many in the industry tend to focus on the question of whether a dietary ingredient is an NDI that must be notified to FDA. While this is indeed a crucial question, it is actually Step 2 of the analysis; Step 1 includes the initial assessment of whether the ingredient actually meets the FD&C Act’s definition of “dietary ingredient” in Section 201(ff). In keeping with the theme of twos, this analysis is also composed of two prongs. First, the ingredient must fall within one of the six enumerated categories of “dietary ingredients.” Second, the ingredient cannot be precluded under Section 201(ff)(3)(B). What is ultimately at stake in the Amarin matter is whether FDA has a full and final say as to whether a substance is a “dietary ingredient” or whether entities such as the ITC can make this determination ahead of a final determination by FDA.
Amarin’s primary argument before the ITC is that concentrated omega-3 products are not “dietary ingredients” because they do not fall into one of the six categories and even if they did, they are precluded from being a “dietary ingredient” because the relevant concentrated omega-3 ingredient was studied as a drug under an Investigational New Drug Application (INDA).20 Under the preclusion provision, a substance cannot be a “dietary ingredient” is if it was “an article authorized for investigation as a new drug…for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public,” and the authorization occurred prior to the marketing of the substance as a dietary supplement or food.21 However, both the industry and the Respondents in the case maintain that concentrated omega-3 products were marketed as dietary supplements prior to the institution of any INDs involving the relevant ingredient. FDA has traditionally made the determination as to whether a substance is a “dietary ingredient” and has communicated its position in a variety of ways, including through Warning Letters, guidance documents and objections to NDI notifications. And, even in instances involving State Attorney General (AG) actions against dietary supplement companies, such actions were based on prior FDA determinations. For example, the Oregon AG’s 2015 lawsuit against General Nutrition Center alleged the company violated the state’s Unlawful Trade Practices Act by misrepresenting certain products as lawful dietary supplements when they were actually unapproved drugs.22 This action was supported by statements from FDA that the ingredients at issue did not meet the statutory definition of “dietary ingredient” under Section 201(ff). Absent FDA’s determinations on these ingredients, it is questionable whether the Oregon AG would have initiated the action against the company. In the present case, as FDA explained in its letter to ITC, these determinations should remain solely in FDA’s authority because the “complex” statutory scheme makes this an extremely case-specific analysis where a “very small difference…can mean the difference.”23 FDA went on to note that this in-depth and careful scientific review is exactly why there is no private right of action under the FD&C Act—because only FDA is equipped to make this analysis and reach a definitive conclusion.24 If the Federal Circuit Court of Appeals directs ITC to institute Amarin’s requested investigation, this in essence means FDA no longer has the sole authority to determine an ingredient’s regulatory status.
However, the implications of such a decision may be significantly broader; the most proximate effect is that moving forward, companies may be able to challenge the legal status of a competing product and potentially have it removed from the market, at least via the ITC and potentially the courts as well. This accessibility to multiple channels also would likely lead to overlapping and conflicting decisions where ITC or a court may find a substance to not be a dietary ingredient, while another court or potentially FDA, may decide it is, leading to confusion as to whose decision is the final decision. FDA’s letter to ITC discussed this exact point.25 Another concern is how broadly the decision will be interpreted—that is, would other decisions traditionally reserved for FDA now be shifted to other regulatory bodies or the courts. And, perhaps most concerning, could legal determinations that historically have been found to fall under the primary jurisdiction doctrine (i.e., FDA’s sole jurisdiction) end up the subject matter of consumer class action lawsuits? Courts thus far have not been receptive to attempts by private plaintiffs to challenge complex and unsettled FDA regulatory matters, such as whether a company should have filed an NDI notification regarding a given ingredient, and have deferred to FDA on these matters as the harm to consumers in this context is unclear. However, if the Federal Circuit Court of Appeals in this case removes the decision from FDA’s hands, courts in the future may be more willing to discount primary jurisdiction arguments and sidestep FDA altogether.
No matter the outcome of Amarin’s appeal, industry should take the opportunity now to review files and consider whether certain ingredients are, in fact, “dietary ingredients,” and whether FDA—or perhaps a competitor—could challenge the status of such ingredients. In most cases, the answer is fairly straightforward. However, as technology evolves and innovative ingredients are introduced, this determination may not be as simple as it seems. While every substance’s analysis differs, there are several key considerations to keep in mind when assessing the status of “dietary ingredients” under the FD&C Act:
The Federal Circuit Court of Appeals’ decision is not expected until late summer 2018. Despite the somewhat narrow set of facts in the case, the outcome could have implications beyond the fate of concentrated omega-3 products and the supplement industry. If Amarin’s position prevails, companies could decide to use the ITC as a forum to resolve competitive disputes involving FDA-regulated products or potentially pursue Lanham Act cases or similar actions against competitors even though the question at stake may have been traditionally reserved for FDA. However, the choice will depend on the relief sought, since a restriction on imports into the US would be the remedy in such cases. On the other hand, the Lanham Act could offer more broad relief in a case of unfair competition. Likewise, for companies unsatisfied with FDA’s approach to an issue—or the agency’s inaction—and the typically slow pace of litigation, the ITC provides an attractive and more efficient alternative. Regardless of the final decision in the Amarin matter, the regulatory classification of ingredients will continue to receive increased attention from FDA, retailers and other industry stakeholders. It is a worthwhile exercise for all companies to evaluate the regulatory status of their dietary ingredients. For many ingredients, the conclusion is clear. But for others, any questions surrounding those ingredients should be answered sooner rather than later.
Rend Al-Mondhiry, JD, is senior counsel at Amin Talati Upadhye, where she advises clients in the dietary supplement, food and cosmetic industries on a broad range of FDA and FTC regulatory and compliance matters. Rend earned her JD from the Pennsylvania State University, Dickinson School of Law and is admitted to the bars of the District of Columbia, Pennsylvania and New Jersey. She can be contacted at Rend@amintalati.com.
Jennifer M. Adams, JD, is an associate attorney at Amin Talati Upadhye. She advises dietary supplement, food, cosmetic and over-the-counter drug companies on a wide variety of FDA and FTC compliance matters, as well as advocates on their behalf with respect to challenges from FDA, FTC, State Attorney Generals and consumer class actions. She has a food science background and is admitted in Illinois and California. She can be contacted at email@example.com.
Cite as: Al-Mondhiry R and Adams J. “Update on the Amarin-ITC Case and the Issues at Stake.” Regulatory Focus. July 2018. Regulatory Affairs Professionals Society.