NAD Recommends PRN Physician Recommended Nutraceuticals Discontinue Certain Challenged Product and Ingredient Claims for Nuretin Medical Food

New York, NY – January 22, 2020 – The National Advertising Division recommended that PRN Physician Recommended Nutraceuticals discontinue certain challenged product and ingredient claims for its nuretin medical food, following a challenge by the Council for Responsible Nutrition (“CRN”).

NAD is an investigative unit of the advertising industry’s system of self-regulation and is a division of the BBB NP’s self-regulatory and dispute resolution programs.

The express claims challenged by CRN appeared online and on product labeling.  NAD noted that the challenged advertising claims are variations of the same message: the onset and effects of diabetic retinopathy may be prevented or delayed by the long-term use of nuretin.

NAD determined that the requisite level of support for the challenged nuretin claims is competent and reliable scientific evidence because the advertiser’s powerful claims causally connect taking nuretin supplements with preventing or delaying harm to vision due to diabetic retinopathy.  In support of these claims, the advertiser provided citations to the Sala-Vila study, an observational study on omega-3 fatty acid dietary intake (food and not supplements) in a Spanish population; and two animal studies.

NAD noted that the advertiser’s claims include both the benefits of the nuretin product as a whole or just the ingredients in nuretin. Thus, NAD considered the sufficiency of the advertiser’s support for both product and ingredient claims.

NAD noted that when there is substantiation only for the efficacy of ingredients in a product, but not for the product itself, any claims must be clearly expressed as ingredient claims.  With regard to its product claims, the advertiser did not submit any testing on the nuretin product itself, therefore NAD recommended that the advertiser discontinue its product claims, including:

  • “nuretin is a specially-formulated medical food that provides the right balance and doses of Omega-3 fatty acids in highly absorbable form to ensure that you are able to utilize Omega-3 essential fatty acids for protecting your eyesight.”
  • “You can’t really start taking nuretin too soon. It’s an essential nutrient that has shown an almost 50% decrease in risk of sight threatening diabetic retinopathy.”
  • “nuretin should be part of your daily regimen to slow down the advancement to diabetic retinopathy and to assist in delaying vision loss. It’s easy to swallow softgels daily to protect your eyesight.”
  • “nuretin delays onset-slows progression-reduced risk of vision loss”
  • “A specially formulated medical food to delay the onset and slow the progression to diabetic retinopathy.”
  • “Why nuretin? nuretin may delay the onset, slow the progression to and reduce the risk of vision loss associated with diabetic retinopathy.”

NAD also considered the advertiser’s express ingredient claims and whether the advertiser could modify its product performance claims into carefully tailored ingredient claims. NAD noted that while advertisers may make properly qualified claims based on ingredients in their supplements, those ingredients must be present in their products in the same amount, formulation and route of administration as the underlying ingredient studies.  However, NAD was concerned that the Sala-Vila study was not relevant to the advertiser’s claims because the Sala-Vila study participants obtained their omega-3 fatty acids from food, while nuretin supplies DHA and EPA in a supplement.  NAD noted that the advertiser did not provide any evidence that the benefits obtained from the food in the Sala-Vila study could reasonably be extrapolated to consumers taking nuretin. Therefore, NAD recommended that the advertiser discontinue its ingredient claims, including:

  • “It has been shown in clinical studies that specially formulated omega-3 fatty acids can help reduce the risk and slow the advancement of diabetic retinopathy.”
  • “Multiple clinical studies have shown that docosahexaenoic acid (DHA) may delay the onset and slow the progression of diabetic retinopathy.”

In its advertiser’s statement, PRN Physician Recommended Nutraceuticals took issue with NAD’s findings, but stated that it “will comply with NAD’s recommendations.”  The advertiser further stated, “we note that PRN had, prior to NAD’s recommendations, already voluntarily discontinued many of the package and labeling claims for nuretin cited by NAD. We have now made the further decision, in part as a response to NAD’s decision in this matter, to sell nuretin as a dietary supplement, rather than as a medical food. Therefore, in accordance with FDA regulations for dietary supplements, we shall immediately discontinue making any disease claims relative to nuretin, including the product and ingredient claims cited by NAD in this matter.”

About the National Advertising Division (NAD): NAD provides independent self-regulation overseeing the truthfulness of advertising across the U.S. NAD reviews national advertising in all media and its decisions set consistent standards for truth and accuracy.

About BBB National Programs: BBB National Programs (BBB NP) fosters trust, innovation, and competition in the marketplace through the development and delivery of cost-effective, third-party self-regulation, dispute resolution and other programs. The programs were formerly administered by the Council of Better Business Bureaus. BBB NP is the home of industry self-regulatory and dispute resolution programs that include the National Advertising Division (NAD), National Advertising Review Board (NARB), BBB EU Privacy Shield, BBB AUTO LINE, Children’s Advertising Review Unit (CARU), Children’s Food and Beverage Advertising Initiative (CFBAI), Children’s Confection Advertising Initiative (CCAI), Direct Selling Self-Regulatory Council (DSSRC), Digital Advertising Accountability Program (Accountability Program), and the Coalition for Better Advertising Dispute Resolution Program (CBA DRM). The programs are designed to resolve business issues and advance shared objectives by responding to marketplace concerns to create a better customer experience. To learn more about industry self-regulation, please visit: BBBNP.org.