National Advertising Division Refers Health-Related Advertising Claims for Prolacta’s Human Milk Fortifier to Regulatory Agencies

New York, NY – July 15, 2024 – BBB National Programs’ National Advertising Division will refer advertising claims made by Prolacta Bioscience, Inc. for its Human Milk Fortifier to the Federal Trade Commission (FTC) and Food and Drug Administration (FDA) for review. The referral was made after Prolacta declined to participate in the industry self-regulation process.  

Mead Johnson & Company, LLC challenged Prolacta’s claims that its human milk-based fortifier products have been shown in clinical studies to be more effective at improving health outcomes in premature infants as compared to cow milk-based fortifier products.

Express Claims

• Claim that “Compared to cow milk-based fortifiers, an Exclusive Human Milk Diet (EHMD) with Prolacta’s 100% human milk-based nutritional products has been clinically proven in multiple clinical studies to” produce certain health benefits.
• “When used as part of an exclusive human milk diet (EHMD), Prolacta’s nutritional products are clinically proven to improve health outcomes and reduce hospital costs for critically ill, extremely premature infants as compared to cow milk-based fortifier…”
• “When used as part of an EHMD, our nutritional products are clinically proven to increase survival and reduce the overall cost of care compared to cow milk– based fortifiers . . . in extremely premature infants.”
• “Prolacta products used as a part of that EHMD, as compared to cow milk–based fortifiers, have been shown in clinical studies to benefit critically ill, premature infants in the NICU weighing ≤1250g at birth in many ways…”

Implied Claims

• Prolacta’s HMF products have been proven through rigorous scientific testing to provide better health outcomes than all cow milk-based HMFs, including those manufactured by Mead Johnson.

Prolacta declined to substantively respond to the challenge. Due to Prolacta’s decision to not participate in the NAD self-regulatory process for these claims, NAD will refer the matter to the FTC and FDA for review and possible enforcement action.

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 (NAD) of BBB National Programs provides independent self-regulation and dispute resolution services, guiding the truthfulness of advertising across the U.S. NAD 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.   

National Advertising Division Refers Health-Related Advertising Claims for Prolacta’s Human Milk Fortifier to Regulatory Agencies

New York, NY – July 15, 2024 – BBB National Programs’ National Advertising Division will refer advertising claims made by Prolacta Bioscience, Inc. for its Human Milk Fortifier to the Federal Trade Commission (FTC) and Food and Drug Administration (FDA) for review. The referral was made after Prolacta declined to participate in the industry self-regulation process.  

Mead Johnson & Company, LLC challenged Prolacta’s claims that its human milk-based fortifier products have been shown in clinical studies to be more effective at improving health outcomes in premature infants as compared to cow milk-based fortifier products.

Express Claims

• Claim that “Compared to cow milk-based fortifiers, an Exclusive Human Milk Diet (EHMD) with Prolacta’s 100% human milk-based nutritional products has been clinically proven in multiple clinical studies to” produce certain health benefits.
• “When used as part of an exclusive human milk diet (EHMD), Prolacta’s nutritional products are clinically proven to improve health outcomes and reduce hospital costs for critically ill, extremely premature infants as compared to cow milk-based fortifier…”
• “When used as part of an EHMD, our nutritional products are clinically proven to increase survival and reduce the overall cost of care compared to cow milk– based fortifiers . . . in extremely premature infants.”
• “Prolacta products used as a part of that EHMD, as compared to cow milk–based fortifiers, have been shown in clinical studies to benefit critically ill, premature infants in the NICU weighing ≤1250g at birth in many ways…”

Implied Claims

• Prolacta’s HMF products have been proven through rigorous scientific testing to provide better health outcomes than all cow milk-based HMFs, including those manufactured by Mead Johnson.

Prolacta declined to substantively respond to the challenge. Due to Prolacta’s decision to not participate in the NAD self-regulatory process for these claims, NAD will refer the matter to the FTC and FDA for review and possible enforcement action.

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 (NAD) of BBB National Programs provides independent self-regulation and dispute resolution services, guiding the truthfulness of advertising across the U.S. NAD 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
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