New York, NY – June 6, 2024 – In a challenge brought by MacuHealth LP, BBB National Programs’ National Advertising Division determined that Vision Elements, Inc. substantiated shelf-life stability and safety claims for its Early Defense dietary supplement.
However, the National Advertising Division (NAD) recommended that other challenged claims be discontinued or modified.
Vision Element’s Early Defense product contains a triple carotenoid formula as its active ingredient, along with other excipients, and is marketed to support healthy eyesight.
Published Studies Claim
The National Advertising Division (NAD) determined that one reasonable takeaway from Vision Element’s claim “Science-Driven Formulas developed from peer-reviewed, published studies” is that Early Defense’s formula is the same as that tested in peer reviewed published studies.
Since there was no evidence in the record that Early Defense’s formula has been the subject of peer-reviewed published studies, NAD recommended the claim be discontinued. NAD noted that nothing in its decision prevents Vision Elements from claiming that the ingredients were developed from peer-reviewed published studies provided that the claim is properly substantiated.
Performance Claims
The National Advertising Division (NAD) concluded that there was no evidence to support the challenged claim that Early Defense “helps maintain healthy eyesight and visual performance” because the studies and meta-analysis relied on by the advertiser were not conducted on the Early Defense product. Therefore, NAD recommended the claim be discontinued but noted that nothing in its decision prevents Vision Elements from tailoring its claims to the benefits specific ingredients in Early Defense can provide, as long as the claims are substantiated by competent and reliable scientific evidence.
NAD also recommended that Vision Elements remove the patient testimonial from its website stating, “I have been taking Early Defense capsules since January… I have great clarity, contrast and colour tone” due to a lack of evidence in the record.
Bioavailability and Absorption Claims
MacuHealth challenged the claim “Liquid-Filled Hard Capsules: Advanced encapsulation technology helps protect the carotenoids through shelf-life and aid absorption.”
The National Advertising Division (NAD) found Vision Element’s evidence shows that liquid-filled hard capsules are generally accepted by scientists to help maintain a product’s shelf-life stability without impacting absorption. Therefore, NAD determined that Vision Elements has a reasonable basis for the claim “Liquid-Filled Hard Capsules: Advanced encapsulation technology helps protect the carotenoids through shelf-life” but recommended it modify the portion of the claim that the technology will “aid absorption” to better fit the evidence.
NAD concluded the claim that “Vision Elements liquid-filled capsules naturally enhance carotenoid absorption and bioavailability with a combination of olive oil and non-GMO sunflower lecithin” is not supported by the record and recommended it be discontinued.
Shelf-Life Stability & Safety Claims
The National Advertising Division (NAD) found that testing of the Early Defense product for harmful substances, the FDA’s Generally Recognized As Safe (GRAS) information on individual ingredients and product testing on Early Defense for potency, even after the product is on shelves, is enough to constitute competent and reliable scientific evidence that multiple tests are conducted to assess for safety and potency.
Therefore, NAD found that Vision Elements substantiated claims that:
- “Purity content and shelf-life stability are proven over and again through extensive ongoing quality control testing”; and
- “Multiple tests are performed throughout the production process to ensure safety and potency.”
In its advertiser statement, Vision Elements stated that it agrees to comply with NAD’s recommendations although it respectfully disagrees with certain of NAD’s conclusions.
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. This press release shall not be used for advertising or promotional purposes.
About BBB National Programs: BBB National Programs, a non-profit organization, is the home of U.S. independent industry self-regulation, currently operating more than a dozen globally recognized programs that have been helping enhance consumer trust in business for more than 50 years. These programs provide third-party accountability and dispute resolution services that address existing and emerging industry issues, create a fairer playing field for businesses, and a better experience for consumers. BBB National Programs continues to evolve its work and grow its impact by providing business guidance and fostering best practices in arenas such as advertising, child-and-teen-directed marketing, data privacy, dispute resolution, automobile warranty, technology, and emerging areas. To learn more, visit bbbprograms.org.
About the National Advertising Division: The National Advertising Division of BBB National Programs provides independent self-regulation and dispute resolution services, guiding the truthfulness of advertising across the U.S. The National Advertising Division reviews national advertising in all media and its decisions set consistent standards for advertising truth and accuracy, delivering meaningful protection to consumers and leveling the playing field for business.
Contact Information:
Name: Jennie Rosenberg
Email: jrosenberg@bbbnp.org
Job Title: Media Relations
