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Regulatory

Regulatory

In two filings submitted to the International Trade Commission, CRN argued that Amarin was “financially motivated” to expand its near monopoly over a subset of omega-3 products; if successful, CRN says, Amarin’s complaint would make it much more difficult and costly for consumers to access those products.

The company also secured self-affirmed GRAS status for its ingredient back in 2016.

China’s FDA also granted TSI Group expanded Novel Foods usage beyond existing approvals for sports nutrition and medical foods to encompass use in beverages, candies, and baked goods.

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.

The NPN enables Fruit d’Or’s Cran Naturelle and Cran d’Or cranberry seed oils to make claims as a source of omega-3 and omega-6 fatty acids, antioxidants, oleic acid, and “maintenance of good health.”

According to the company, these patents are expected to “fuel the company’s rapid growth in the cosmetic industry” given consumer demand for products like sunscreen lotions and hair growth formulations.

The prospect that dietary supplements might help bend the healthcare cost curve is worth examining.

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