National Advertising Division Finds Certain Claims for Early Defense Dietary Supplement Supported; Recommends Others be Modified or Discontinued

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. Per NAD/NARB procedures, this release shall not be used for advertising or promotional purposes.

 

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