National Advertising Division Finds Innovix Pharma Qualified Claims Supported; Recommends Certain OmegaVia Performance Claims be Discontinued
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New York, NY – April 26, 2022 – The National Advertising Division (NAD) of BBB National Programs determined that Innovix Pharma Inc., manufacturer of OmegaVia Fish Oil and OmegaVia EPA dietary supplements, can make qualified claims about EPA and DHA supplementation to support heart health in addition to a healthy diet and exercise. However, NAD recommended that the advertiser discontinue the challenged product performance claims and testimonials relating to heart health and triglyceride management.
The claims at issue were challenged by Amarin Pharma, Inc., the manufacturer of the FDA-approved cardiovascular drug Vascepa.
Heart Health Claims
The challenger took issue with Innovix’s heart health claims and testimonials, including those related to triglyceride and blood pressure management. Examples include:
- “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.”
NAD determined that the advertiser did not provide any competent and reliable scientific evidence demonstrating the efficacy of the Omega-3 products on heart health. In the absence of any studies on OmegaVia Fish Oil and OmegaVia EPA 500 relating to heart health and triglyceride management, NAD recommended that the challenged product performance claims and testimonials be discontinued.
NAD also considered whether the advertiser could make properly qualified health-related efficacy claims about the benefits of the ingredients in OmegaVia Fish Oil and OmegaVia EPA 500 on heart health based on the recommended doses of DHA and EPA to a healthy population. NAD noted that the claims (but not the testimonial) are qualified by a disclosure at the bottom of the webpage far from the triggering claims that “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.
Mood Boosting Claims
NAD determined that the advertiser did not provide competent and reliable scientific evidence or any studies conducted on its products demonstrating their impact on mood improvement. In the absence of evidence to support product performance claims or testimonials touting the product’s positive impact on mood, NAD recommended that those claims be discontinued, including claims touting “optimum mood support” and that consumers will see noticeable improvements in their mood (“The best for mood… the difference is unbelievable!;” “My mood has improved so much with your product, it is never the same with any other product.”).
NAD also considered whether the advertiser could make properly qualified health-related mood-boosting claims based on evidence of the benefits of ingredients in OmegaVia Fish Oil and OmegaVia EPA 500. However, NAD determined that the totality of the evidence does not support any qualified claims that the ingredients in these products confer any mood-boosting benefits in healthy individuals.
Company Name and Safety Warnings
NAD did not recommend a change in the “Innovix Pharma” company name in the absence of any extrinsic evidence of consumer confusion.
The challenger asked NAD to recommend that Innovix affirmatively add warnings to its product labels associated with the use of its products (citing warning indications for prescription cholesterol-reducing drugs). NAD’s jurisdiction extends only to assessing the truthfulness and accuracy of advertising claims made in national advertising. Therefore, in the absence of any safety claims in Innovix’s advertising, NAD did not recommend additional modifications to the risks of OmegaVia Fish Oil and OmegaVia EPA 500.
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.”
All BBB National Programs case decision summaries can be found in the case decision library. For the full text of NAD, NARB, and CARU decisions, subscribe to the online archive.
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