Amarin Pharma, Inc. v. ITC
Why It Made the List
Those familiar with dietary supplement regulation are often well versed in Food and Drug Administration (FDA) decisions and cases that define the line between drugs and dietary supplements. One recent case, however, involving an unusual regulatory agency for dietary supplements, is attempting to reshape those lines largely out of the spotlight of the dietary supplement industry and in a manner that could have implications across all FDA-regulated products, not just dietary supplements.
In August 2017, Amarin Pharma, Inc. and Amarin Pharmaceuticals Ireland Ltd. (Amarin) filed a complaint with the U.S. International Trade Commission (ITC) alleging that certain omega-3 fish oil products were being unlawfully labeled, marketed, and imported as dietary supplements. The complaint asked the ITC to investigate “the unlawful importation or sale in the United States of synthetically-produced omega-3 products that are predominantly comprised of EPA in either ethyl ester (‘EE’) or re-esterified (‘rTG’) form” (products at issue in the Amarin complaint are referred to as “concentrated omega-3 products” for purposes of this article). The complaint alleges that the ingredients in these products do not fall under any of the categories of dietary ingredients defined under Section 201(ff)(1) of the Food Drug and Cosmetic Act (FDCA), and, therefore, the products are not legal dietary supplements, but unapproved new drugs that are being imported into the U.S. in violation of Section 337 of the Tariff Act.
Amarin manufactures and markets a concentrated omega-3 product – Vascepa – that has been approved by FDA as a drug. Vascepa is approved by FDA as an adjunct to diet to reduce triglyceride levels in patients with severe hypertriglyceridemia. Amarin’s complaint targets companies that make and distribute concentrated omega-3 products as dietary supplements. The ITC complaint named both dietary supplement ingredient suppliers and finished product manufacturers as respondents. Respondents, industry trade associations, Congress, and even the FDA weighed-in on the important issues raised by Amarin’s complaint.
Amarin’s Complaint Alleges Violations of the Tariff Act – Requests ITC Investigation
Amarin’s ITC complaint alleges that “[t]he false labeling or promotion of [concentrated omega-3] products constitutes an unfair act and/or unfair method of competition under Section 337 [of the Tariff Act] because, among other things, these acts violated Section 43(a) of the Lanham Act . . . and the standards established by the FDCA.” Section 337 of the Tariff Act prohibits “[u]nfair methods of competition and unfair acts in the importation of articles” into the United States, where such acts could “destroy or substantially injure an industry in the United States.” The ITC’s remedy, if it finds a violation, is to exclude the violative products from entry into the United States. The Tariff Act does not specifically define what is an “unfair act” or “unfair method of competition,” but the ITC has interpreted these terms to include conduct that violates the false-advertising provisions of the Lanham Act. The Lanham Act prohibits an entity from disseminating adverting that “misrepresents the nature, characteristics, [or] qualities” of goods.
Thus, Amarin’s arguments that the products violate the Tariff Act are premised on two issues — (1) that the products are marketed in violation of the FDCA, and that importation of articles marketed in violation of the FDCA is an “unfair act” under the Tariff Act; and (2) that labeling the products as “dietary supplements” is “literally false” (as required by the Lanham Act) because the products are not dietary supplements under the FDCA and calling them dietary supplements “hides the material fact that the products are actually unapproved ‘new drugs.’”
Under the FDCA, a dietary supplement must contain a “dietary ingredient.” Dietary ingredients are defined as “(A) a vitamin; (B) a mineral; (C) an herb or other botanical; (D) an amino acid; (E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or (F) a concentrate, metabolite, constituent, extract, or combination of” any of the forgoing ingredients. According to Amarin, the concentrated omega-3 products in question “do not fall into any of the categories of ‘dietary ingredients’”.
Omega-3s used in dietary supplements could fit the definition of dietary ingredients by being a “substance for use by man to supplement the diet by increasing the total dietary intake” (subsection E cited above). Principal among Amarin’s arguments is Amarin’s assertion that these substances are synthetically produced and, as such, they do not meet the requirements of subsection E of the dietary supplement definition because these ingredients are different from other forms of omega-3s found in the diet. Nor, according to Amarin, do the concentrated omega-3 ingredients fall within any of the other categories. Amarin’s complaint argues that FDA’s policy on synthetic ingredients is longstanding and cites to FDA decisions regarding other types of synthetic ingredients, but none of these decisions involve the ingredients in question. Determining whether a substance is a dietary ingredient is a fact-specific inquiry, which requires significant understanding of the characteristics of an ingredient and the dietary ingredient definition under the FDCA and FDA policy. FDA has never issued a determination regarding whether the type of omega-3 ingredients at issue in this case are either synthetic and/or dietary ingredients.
FDA Intervenes: Letter to ITC Objecting to ITC Investigation
Given the premise of Amarin’s ITC compliant – that violations of the FDCA have caused the concentrated omega-3 products to violate the Lanham Act, which in turn cause companies importing these products to violate Section 337 of the Tariff Act – FDA expressed significant concern over Amarin’s request that the ITC investigate. FDA submitted a letter to the ITC requesting that the ITC decline to initiate the requested investigation because an investigation would require the ITC to interpret provisions of the FDCA.
FDA’s concerns with an ITC investigation were twofold – (1) that any findings by the ITC could conflict with later determinations made by FDA; and (2) that Amarin was attempting to bring a private action under the FDCA, where no right of private action is permitted.
With regard to private right of action concerns, FDA ‘s letter explained that Congress gave FDA exclusively the enforcement tools to enforce the FDCA and specifically “prohibited private parties from bringing actions to enforce the FDCA.” The letter went on to explain why the FDCA prohibits private enforcement actions. According to FDA, “FDA cannot administer and enforce the FDCA effectively if core FDA issues – such as whether a product is a ‘new drug’ or ‘dietary supplement’ under the FDCA are decided in actions brought by private parties.”
FDA highlighted that its statutory scheme is “undeniably ‘complex;” and that “determinations of whether a product is a dietary supplement require case-specific analysis, as very small differences in factors such as an ingredient’s chemical structure or history of presence in the food supply can mean the difference between dietary-ingredient status and non-dietary-ingredient status.” With regard to the ingredients in question, FDA noted that “[t]he complaint here is predicated on open questions of law and policy on which FDA has not reached final conclusions.” Thus, “[a]s pled, Complainants’ claims – unfair methods of competition under the Tariff Act based on false advertising under the Lanham Act and violations of the [FDCA] – can succeed only if the Commission finds that Respondents’ products are unapproved ‘new drugs’ rather than ‘dietary supplements’ under the FDCA.”
Finally, FDA went on to note that ITC’s initiation of an investigation “could create an incentive for other parties to file similar complaints about other FDA-regulated products,” not just dietary supplements, as “FDA’s regulatory authority is not limited to foods . . . and drugs.”
The ITC and its Swift Response
The ITC is an independent agency that investigates potential violations of Section 337 of the Tariff Act. The Tariff Act prohibits unfair acts and unfair methods of competition related to the import of products into the U.S. The ITC typically handles investigations alleging “dumping” of imports (i.e., selling imports in the U.S. for less than their fair market value) and intellectual property infringement. Although the ITC has handled complaints involving FDA-regulated products, most companies that find themselves involved in an ITC dispute are technology and durable goods manufacturers – making this a very unusual case for the ITC.
On October 27, 2017, less than three months after Amarin filed its complaint, the ITC issued a decision declining to institute an investigation, finding 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.” As such, “Amarin’s complaint does not allege an unfair method of competition or an unfair act cognizable under” the ITC’s rules. The decision was very short (less than a page), but notable because of the finding that FDA has primary jurisdiction for interpreting the meaning of terms used in the FDCA. Entities cannot usurp this jurisdiction by using other statutes such as the Tariff Act or Lanham Act as enforcement vehicles. The ITC’s decision also is notable because a decision not to institute an investigation is rare for the ITC.
Amarin’s Appeal to the Federal Circuit
Amarin subsequently appealed the ITC’s determination to the Federal Circuit in December 2017, requesting that this Court review the ITC’s ruling and grant a writ of mandamus forcing the ITC to investigate import practices for concentrated omega-3 products. The ITC, as well as ingredient suppliers and product manufacturers were granted permission to intervene in the appeal. Oral arguments were heard in June 2018 by a three-judge panel who will ultimately decide whether the ITC should be required to investigate Amarin’s allegations. Over a year has passed since Amarin filed their appeal with no decision reached yet from the Federal Circuit, suggesting that the court is grappling with the complex jurisdictional and procedural issues raised in this case.
Amarin’s Arguments on Appeal
In Amarin’s December 2017 opening brief, it argued that (1) it had properly pled a compliant that met Section 337’s requirements, thus, the ITC did not have discretion to decline an investigation; and (2) the ITC is required to investigate all properly pled complaints because of language in Section 337 that states that the ITC “shall investigate any alleged violation of this section on complaint under oath.”
As Amarin argued in its complaint to the ITC, Amarin continued to assert that the company had a cause of action under the Lanham Act because concentrated omega-3 products were not dietary supplements. To address criticisms that had arisen when Amarin filed its complaint with the ITC about FDA jurisdiction, Amarin argued that the landmark POM Wonderful v. Coca-Cola Supreme Court decision paved the way for Lanham Act lawsuits involving questions about label statements regulated by the FDA. According to Amarin, POM Wonderful is applicable here because the Supreme Court in that case rejected the view that FDA has exclusive authority over the labeling of FDA-regulated products and Lanham Act lawsuits alleging false and misleading advertising are not precluded by the FDCA.
Issues of FDA Jurisdiction
One of the most important issues in this case is whether the ITC has the authority to interpret the meaning of a term that is defined under the FDCA. As noted above, Amarin’s arguments that the ITC has jurisdiction over this issue is centered on its assertion that POM Wonderful permitted these types of actions.
Unlike the current action, however, POM Wonderful dealt with the question of whether courts could impose additional requirements on a food product to ensure labeling for the product did not deceive consumers. It did not, as is the case here, ask the court to interpret whether a product complied with FDA regulatory requirements. In fact, whether the defendant’s product was labeled in accordance with FDA requirements was never an issue in POM Wonderful; rather, the question before the Court was whether additional labeling, that went beyond the FDA requirements, could be imposed to ensure the labeling was not false or misleading.
FDA addresses this very issue in its letter to the ITC, by noting that “the Staff believes that a cause of action is likely not precluded by the FDCA if it does not require the Commission to directly apply, enforce, or interpret the FDCA.” In the Federal Circuit appeal, the Department of Justice (DOJ), on behalf of the FDA, filed an amicus brief addressing the jurisdictional issue.
The DOJ’s brief echoed the arguments made by the FDA to the ITC in fall 2018. Namely that (1) determining whether a substance is a “‘dietary supplement’ under the FDCA can involve difficult and complex analysis”; and (2) “‘[t]he FDCA leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with’” the FDCA.
The DOJ’s amicus brief explained the limits of POM Wonderful and enforcement under the FDCA noting that “private parties may bring suit to remedy violations of statutes that create private causes of action, so long as those suits are not attempts to enforce the FDCA.” As noted above, the DOJ distinguished the current action from POM Wonderful on the labeling at issue in the cases explaining that “[t]hat is why, for example, false advertising about the content of fruit juice can be remedied in a private action under the Lanham Act, where the claim does not seek to prove or remedy a violation of the FDCA’s juice-labeling provisions but instead rests on allegations entirely independent of the FDCA.”
Amarin’s arguments are also contradicted by established case law finding that the FDCA “preclude[s] Lanham Act claims [where] in order to determine the falsity or misleading nature of the representation at issue, the court would be required to interpret and apply FDCA statutory [and] regulatory provisions.” Concerns with Amarin’s attempt to use the ITC to interpret and enforce FDCA provisions were also raised by trade associations who argued that requiring the ITC to move forward with an investigation “would require ITC to inject itself into the statutory and regulatory framework explicitly authorized to the [FDA].”
For the dietary supplement industry specifically, this case highlights the difficult question these companies may face when determining if a substance is a dietary ingredient. Dietary supplement companies should be careful not to lose sight of the definition of dietary ingredient in Section 201(ff) of the FDCA, which lays out six explicit categories that a substance must fit into to be considered a dietary ingredient. Companies should also be aware of FDCA language that prevents a substance from being considered a dietary supplement under Section 201(ff)(3)(B) of the FDCA, even if it fits into one of those six categories, which addresses substances that have previously been approved as drugs or investigational new drugs. For example, this is the section that FDA has recently cited for its position that CBD cannot be used in dietary supplements.
For FDA-regulated products generally, this case is important because it could open other channels by which companies can challenge labeling, marketing, and distribution of products for issues that previously were seen as only within FDA’s jurisdiction. This could mean that a company could use the ITC, or even courts, to bring a challenge against a competitor for alleged violations of the FDCA — amounting to a private right of action for competitors under the FDCA.
* Megan Olsen is Assistant General Counsel at the Council for Responsible Nutrition (CRN), where she advises on legislation, regulatory compliance and advocacy, and international policy development. In addition, she works with CRN’s science department to prepare challenges to dietary supplement advertising through CRN’s Advertising Review Program with the National Advertising Division (NAD). Prior to joining CRN, Ms. Olsen held the position of special counsel for Wiley Rein LLP in Washington, DC.
 Complaint: Certain Synthetically Produced Predominantly EPA Omega-3 Prods in Ethyl Ester or Re-esterified Triglyceride Form, Docket No 3247, Aug. 30, 2017.
 Amarin indicates in its complaint that it is not alleging that the import or sale of common fish oil, or EE or rTG forms that are not predominantly comprised of the omega-3 acid EPA, violate Section 337 or other laws. Amarin’s complaint was confined to a narrow subset of fish oil products on the market, as defined above.
 Tariff Act of 1930, 19 U.S.C. § 1337(b).
 Complaint at Para. 1.
 19 U.S.C. § 1337(a)(1)(A)(i).
 19 U.S.C. § 1337(d).
 See e.g., Initial Determination, In re Certain Insulated Sec. Chests, USITC Inv. No. 337-TA-244, 1087 WL 451338, at *2 (June 17, 1986).
 15 U.S.C. § 1125(a)(1)(B).
 21 U.S.C. § 201(ff)(1)(A)-(F).
 Complaint at Para. 63.
 Complaint at Para. 65 to 68.
 Letter from FDA to L. Barton, U.S. ITC, Oct. 6, 2017.
 USITC, About the USITC, https://www.usitc.gov/press_room/about_usitc.htm.
 Amarin Pharma Inc. v. ITC, 18-1247
 19 U.S.C. § 1337(b) (emphasis added).
 POM Wonderful LLC v. Coca-Cola Co., 134 S. Ct. 2228 (2014).
 FDA Letter citing Staff Response to Respondents’ Motion for Summary Determination Dismissing Claims Precluded by the FDCA in In the Matter of Certain Potassium Chloride Powder Prods., Inv. No. 337-TA-1013, EDIS Doc. I.D. 593245 at 4 n.2 (Oct. 21, 2016).
 Amarin Pharma Inc. v. ITC, 18-1247 (Fed. Cir. March 26, 2018) (Brief for the United States as Amicus Curiae Supporting Appellee) citing Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 349 n.4 (2001).
 United States Amicus Curiae at 15.
 Hi-Tech Pharms, Inc. 230 F. Supp. 3d at 1330 (quotation and citation omitted).
 Amarin Pharma Inc. v. ITC, 18-1247 (Fed. Cir. March 23, 2018) (Brief of Amicus Curie for Council for Responsible Nutrition and Global Organization for EPA and DHA Omega-s in Support of Appellee for Dismissal).