Amarin will file citizen petition to FDA asserting ethyl ester omega-3s are not legally supplements


In comments submitted to FDA, Amarin Pharma, maker of the omega-3 drug Vascepa, stated its intentions to file a citizen petition to FDA asserting that ethyl ester omega-3s are not legally allowed to be marketed as dietary supplements. 


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Amarin Pharma, maker of the omega-3 drug Vascepa, intends to file a citizen petition to FDA asserting that ethyl ester omega-3s are not legally allowed to be marketed as dietary supplements. The news was brought to Nutritional Outlook’s attention by the Global Organization for EPA and DHA Omega-3 (GOED; Salt Lake City, UT) in an email the group sent to members.

Based on comments submitted by Amarin to FDA following the public meeting “Responsible Innovation in Dietary Supplements,” the pharmaceutical company expresses its concern that the line between pharmaceutical drugs and dietary supplements is becoming less distinct.

“Enforcing the structural and marketing limitations on dietary supplements will preserve the statutory distinctions between ‘drugs’ and ‘dietary supplements.’ Failing to preserve these distinctions would be inconsistent with the statute’s structure and design, expose the public to unsafe and/or ineffective products, and create disincentives for drug development and innovation, such that the therapeutic benefit of certain substances may never be realized,” writes Amarin. “Significantly, given that up to 50% of FDA-approved drugs over the last 30 years have either directly or indirectly been derived from natural products, the public health impact of such a failure could be substantial. If [FDA] fails to take action now to enforce the statute and protect consumers, in 30 years the drug and dietary supplement marketplaces could be almost indistinguishable in important respects.”

With regard to the Citizen Petition, Amarin writes: “Amarin plans to engage in the Citizen Petition process within weeks, explaining that a product with synthetic eicosapentaenoic acid (“EPA”) – that is, chemically concentrated forms of EPA that are not found in natural substances – cannot be lawfully marketed as a dietary supplement. Such marketing would be inconsistent with the law (and FDA’s past actions enforcing the law). Synthetic omega-3 does not comply with the structural limitations on dietary supplements in DSHEA (i.e., synthetic omega-3 does not meet the definition of “dietary supplement” in the Act because (1) it does not qualify as a “dietary ingredient,” and (2) it is excluded from the definition of “dietary supplement” by the exclusionary clause).”

This isn’t the first time Amarin has targeted ethyl ester omega-3 supplements. In September of 2017, the company filed a lawsuit with the International Trade Commission (ITC) to investigate companies manufacturing omega-3 eicosapentaenoic acid (EPA) fatty acid concentrates, in either ethyl ester or re-esterified form, because they are synthetic and should not be considered dietary ingredients. The next month, the ITC chose not to investigate the complaint filed by Amarin who then filed for an appeal. This appeal was denied in May of 2019.

When Amarin filed its original complaint, FDA urged ITC not to investigate the complaint, as it was FDA’s authority, not ITC’s to determine whether or not a product is a dietary ingredient. FDA, for its part, had not yet reached any conclusion about whether or not the omega-3 concentrate ingredient in question were dietary ingredients, and did not want an ITC decision to contradict its own.

Amarin’s efforts underscore the competitive relationship between the dietary supplement and pharmaceutical industry.

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