The action marks an extension of Amarin’s vigorous defense of its turf for Vascepa, which is an EPA-based drug in ethyl ester form that manufacturer refers to as ‘eicosapent ethyl.’
Amarin began a series of legal actions to defend the turf for Vascepa, which was approved in 2012 for the treatment of hyperlipidemia.
Amarin failed in a bid to revive patents on Vascepa, which was first approved in 2012. Generic versions of the drug are now on the market after the US Supreme Court declined last year to hear Amarin’s case against two drug makers.
Failed bid for ITC ruling
After Amarin failed to get FDA approval for additional indications for Vascepa it also initiated a number of actions against supplement companies. In once case, Amarin sued two companies for allegedly using the results of Amarin's studies to market their dietary supplements. That strategy culminated in the drug company’s failed bid to get the International Trade Commission to ban the import of EPA and DHA supplements in ethyl ester form. Amarin had maintained that these forms of EPA and DHA were in effect unapproved drugs.
In the latest action, Amarin filed a challenge with the National Advertising Division, part of BBB National Programs, over claims being made by Innovix Pharma Inc., manufacturer of OmegaVia Fish Oil and OmegaVia EPA dietary supplements.
Amarin challenge some specific claims related to the management of high triglycerides and blood pressure. Those included:
- “From triglyceride management to blood pressure, when it comes to heart health, Omega-3 supplements like these – when combined with a healthy diet and exercise – provide powerful support.*”
- “500 mg of EPA Omega-3 per pill for excellent triglyceride management without impacting cholesterol.*”
- Testimonial: “The Most people with triglycerides above 500 notice 10-15% drop in TG per 1000 mg of daily Omega-3, provided everything else is constant. However, what does vary is diet and the carbohydrate content within the diet. This has a HUGE impact on triglyceride levels. Activity and aerobic exercise has an impact too.”
The NAD ruling found that Innovix did not provide specific substantive scientific support for the above claims. However, NAD said that Innovix did relate the claims to a disclaimer that read: “Clinical research suggests that omega-3 dosage needed to help maintain healthy triglycerides is 2000-5000 mg per day when used as part of healthy diet and exercise.”
Based on the evidence, NAD determined that the advertiser can make qualified claims about EPA and DHA supplementation to support heart health in addition to a healthy diet and exercise, provided that there is a clear and conspicuous disclosure noting that the state of the science is inconclusive.
But NAD found that the above testimonial was not supported by a connection to the disclaimer and so recommended that it be dropped.
Amarin had also gone as far as to suggest that the company’s moniker, including the word ‘pharma’ as it does, would mislead consumers about the nature of the company’s products and demanded that the name be changed.
Amarin also demanded that Innovix be required to use drug-like warning statements on its labels. NAD declined to recommend a name change, saying no evidence had been presented that showed consumers were confused. It also said its authority does not extend to the drug warnings question.
Mood, depression claims dropped
As part of the ruling NAD also recommended that certain claims relating to mood support be dropped. Finally, the advertiser discontinued all of the challenged health-related claims that touted the products’ ability to treat depression, significantly improve heart health by lowering triglycerides and blood pressure, and comparisons of the product to prescription lipid medication. Therefore, NAD did not review these claims on the merits.
In its advertiser statement, Innovix stated that it “will comply with NAD’s recommendations.”