Regulatory

Amarin’s ITC complaint alleges that synthetically produced omega-3 products that are predominantly composed of EPA in either ethyl ester or re-esterified form are not considered “dietary ingredients” under Section 201(ff)(1) of the Federal Food Drug and Cosmetic Act, and thus, are not legal dietary supplements but unapproved new drugs.

Attorney Scott Bass, who helped draft the DSHEA law of 1994, says that Congress did not intend “dietary substances” only to be limited to ingredients that are nutritional-and that this should mean that synthetic botanicals and probiotics count as dietary ingredients and be eligible for use in dietary supplements.