Corrective Statement Regarding Omax’s Press Release on Amarin’s Reduce-It Study
On September 27, 2018, Omax issued a press release describing the results of Amarin’s REDUCE-IT™ study, which examined the impact of Vascepa®, Amarin’s FDA-approved omega-3 pharmaceutical drug, on treating cardiovascular disease. REDUCE-IT™ was a global study of 8,179 statin-treated adults with elevated cardiovascular risk and demonstrated to a statistically significant level that taking 4 grams of Vascepa® a day reduced, by approximately 25%, the risk of major adverse cardiovascular events (“MACE”) (a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina requiring hospitalization).
Omax wishes to clarify:
- Amarin’s REDUCE-ITTM study was conducted on Vascepa®, an FDA-approved drug, comprised of pure icosapent ethyl, a single omega-3 acid. Amarin has informed Omax that, as a drug, Vascepa is manufactured subject to FDA’s standards for drug manufacturing to protect the single omega-3 acid ethyl ester active ingredient. The REDUCE-ITTM study was designed to determine whether 4 grams daily of Vascepa reduces the risk of major adverse cardiovascular events in at-risk patients on statin therapy.
- The REDUCE-IT study was not designed to test the efficacy of Omax3 Omega-3 dietary supplements.
- As a general matter, under federal law and California law, dietary supplements may be lawfully marketed to supplement the diet, but they cannot be lawfully marketed to treat, mitigate, or prevent disease, such as cardiovascular disease. In 2004, FDA issued a policy stating that it would not object to promotions of omega-3 supplements using the language “Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease” – so long as the statement is qualified with those terms and other factors are met. Applicable factors include that manufacturers may not recommend use of more than 2 grams per day of omega-3 dietary supplements, so as to ensure that the total daily intake from conventional food and dietary supplements together do not exceed 3 grams. FDA established this maximum use level because of concerns over possible adverse effects of fish oil consumption on bad cholesterol, bleeding time, and glycemic control. FDA does not permit omega-3 dietary-supplement manufacturers to make claims related to coronary heart disease or any other cardiovascular disease that are not qualified in the same manner. Since 2004, FDA has not publicly revisited the qualified health claim. The FDA’s most recent statement about the qualified health claim can be found here: https://bit.ly/2Vbl5Id. In addition, under certain federal and state laws, dietary supplements cannot be marketed with claims that imply or suggest they are substitutes for a product that is a therapy for a disease, such as Vascepa.