NEW YORK, April 26, 2022 /PRNewswire/ — The National Advertising Division (NAD) of the BBB’s National Programs has determined that Innovix Pharma Inc., maker of OmegaVia Fish Oil and OmegaVia EPA dietary supplements, can make qualified claims regarding EPA supplementation and DHA to support heart health in addition to healthy eating and exercise. However, NAD recommended that the advertiser discontinue the disputed product performance claims and testimonials relating to heart health and triglyceride management.
The claims at issue have been disputed by Amarin Pharma, Inc., the maker of the FDA-approved cardiovascular drug Vascepa.
Heart Health Claims
The challenger took issue with Innovix’s claims and testimonials about heart health, including those related to triglyceride and blood pressure management. Examples include:
- “From triglyceride management to blood pressure, 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 tablet for excellent triglyceride management without impacting cholesterol.*”
- Testimonial: “Most people with triglycerides over 500 notice a 10-15% drop in TGs per 1000mg of omega-3 daily, assuming everything else is consistent. Is vary is the diet and the carbohydrate content in the diet. This has a HUGE impact on triglyceride levels. Activity and aerobic exercise also have an impact.”
NAD has determined that the advertiser has not provided competent and reliable scientific evidence demonstrating the effectiveness of omega-3 products on heart health. In the absence of studies of OmegaVia Fish Oil and OmegaVia EPA 500 regarding heart health and triglyceride management, NAD recommended that the disputed 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 DHA. EPA for a healthy population. NAD noted that the claims (but not the testimonial) are qualified by a disclosure at the bottom of the webpage away from the triggering claims that “clinical research suggests that the dose of omega-3s needed to help maintain healthy triglycerides is 2,000 to 5,000 mg per day when used in conjunction with a healthy diet and exercise.”
Based on the evidence, NAD has determined that the advertiser may make qualified claims about EPA and DHA supplementation to support heart health in addition to healthy diet and exercise, provided there is a clear and visible disclosure noting that the state of the science is inconclusive. .
Mood Boosting Claims
NAD has determined that the advertiser has not provided competent and reliable scientific evidence or studies conducted on its products demonstrating their impact on mood enhancement. In the absence of evidence supporting the product’s performance claims or testimonials touting the product’s positive impact on mood, NAD recommended that such claims be discontinued, including claims touting “optimal support of mood” and that consumers will see noticeable improvements in their mood (“Best for mood…the difference is amazing!;” “My mood has improved so much with your product that it is never the even with no other product.”).
NAD also considered whether the advertiser could make properly qualified health-related mood-enhancing claims based on evidence of the benefits of the ingredients in OmegaVia Fish Oil and OmegaVia EPA 500. However, NAD determined that the totality of the evidence does not support any qualified claim. that the ingredients in these products confer mood benefits in healthy people.
Company name and security warnings
NAD did not recommend a change in the company name “Innovix Pharma” in the absence of any extrinsic evidence of consumer confusion.
The challenger asked NAD to recommend that Innovix positively add warnings to its product labels associated with the use of its products (citing warning indications for prescription cholesterol-lowering drugs). NAD’s jurisdiction extends only to evaluating the truth 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 any additional risk modifications for OmegaVia Fish Oil and OmegaVia EPA 500.
Finally, the advertiser dropped all contested health 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 lipid medications. on prescription. Accordingly, NAD has not considered these claims on their merits.
In its advertiser statement, Innovix said it will “comply with NAD’s recommendations”.
All National BBB Program 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.
About National BBB Programs: National BBB programs are where businesses turn to build consumer confidence and consumers are heard. The non-profit organization creates a fairer level playing field for businesses and a better experience for consumers through the development and delivery of effective third-party accountability and dispute resolution programs. Assuming its role as an independent organization since the restructuring of the Council of Better Business Bureaus in June 2019, BBB National Programs now oversees more than a dozen national industry self-regulatory programs and continues to evolve its work and increase its impact by providing business advice and promoting best practices in areas such as advertising, marketing to children and privacy. To learn more, visit bbbprograms.org.
About the National Advertising Division: The National Advertising Division (NAD) of BBB National Programs provides independent self-regulatory and dispute resolution services, guiding the truthfulness of advertising across the United States. NAD reviews national advertising in all media and its decisions set consistent standards for truth and accuracy in advertising, providing consumer protections and leveling the playing field for businesses.
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