BBB National Programs Newsroom

Direct Selling Self-Regulatory Council Refers Health-Related Product Claims by New U Life, Inc. to the Federal Trade Commission and the Food and Drug Administration

For Immediate Release
Contact: Peter C. Marinello, Vice President, DSSRC, 212.705.0126

 

New York, NY – April 7, 2020 –The Direct Selling Self-Regulatory Council (“DSSRC”) has referred certain health-related claims made by New U Life, Inc. (“New U Life” or the “Company”) for its Somaderm hGH transdermal gel to the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) for possible enforcement action after the Company failed to comply with DSSRC’s recommendations to modify or discontinue such claims. The health-related product claims at issue in DSSRC’s inquiry pertained to product efficacy as well as claims that Somaderm product was “FDA Registered” and that the product had clinical applications. In addition, the DSSRC inquiry also included a number of additional health-related claims (e.g., “Regrowth of heart, liver, spleen, kidney and other organs that shrink with age”; “14.4% loss of fat on average after six months without dieting”; “Superior immune function”; “Greater cardiac output”; “Superior immune function,” etc.) and a number of before-and-after depictions purportedly demonstrating the results received from using the product. 

DSSRC is the direct selling industry’s self-regulatory forum and a division of BBB National Program, Inc.’s self-regulatory and dispute resolution programs. The subject marketing for Somaderm came to the attention of DSSRC through its own independent monitoring of the direct selling marketplace. 

In its decision, DSSRC stated that “…there has been no substantive evidence provided by the Company to support product performance claims for Somaderm™” including the Company’s slightly revised claims that Somaderm “May support better mood; May support healthier hair, skin & nails; May promote hair growth. May increase joint mobility; May enhance libido; May increase fat loss (especially around the mid-section) May support greater muscle tone; May increase strength May improve memory.”  

Although New U Life represented that it was taking several steps to increase oversight of its salesforce and become compliant with regulatory guidance, it became apparent to DSSRC that were systemic issues at the Company that could not be addressed in the context of industry self-regulation. For this reason, DSSRC noted in its December 2019 decision that “Should DSSRC further determine that unsupported product performance and earnings claims appear on the Company website and/or continue to be disseminated in distributor posts that are accessible by consumers and potential recruits, DSSRC will have no recourse but to summarily refer this matter to the appropriate governmental agencies.”

Since the time that DSSRC published its decision in December 2019, DSSRC became aware of the ongoing dissemination of many of the same product performance, establishment and testimonial claims for Somaderm, despite the omission of any testing that would support such efficacy. Despite DSSRC’s conclusions and recommendations that the claims be discontinued, the Company continues to disseminate many of the same product performance claims that DSSRC determined were not supported by competent and reliable evidence and continues to disseminate claims stating that it is Somaderm is the “only transdermal, FDA-registered product containing homeopathic human growth hormone.” 

Moreover, in the past several weeks, DSSRC identified a number of posts made by the New U Life salesforce indicating that Somaderm is effective at treating and healing the COVID-19 virus despite the existence of any evidence indicating that the product can do so.

In sum, DSSRC has determined that New U Life has repeatedly failed to adhere to its recommendations and continues to disseminate unsupported performance and health-related including claims that Somaderm is effective to treat the coronavirus. Accordingly, has referred this matter to both the FDA and the FTC.  DSSRC’s full written report is available at: https://bbbprograms.org/programs/dssrc/dssrc-decisions.

###

About BBB National Programs (formerly ASRC Programs): BBB National Programs 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. These programs were formerly administered by the Council of Better Business Bureaus, Inc. To learn more about industry self-regulation, please visit: BBBNP.org.


Direct Selling Self-Regulatory Council Refers Health-Related Product Claims by New U Life, Inc. to the Federal Trade Commission and the Food and Drug Administration

For Immediate Release
Contact: Peter C. Marinello, Vice President, DSSRC, 212.705.0126

 

New York, NY – April 7, 2020 –The Direct Selling Self-Regulatory Council (“DSSRC”) has referred certain health-related claims made by New U Life, Inc. (“New U Life” or the “Company”) for its Somaderm hGH transdermal gel to the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) for possible enforcement action after the Company failed to comply with DSSRC’s recommendations to modify or discontinue such claims. The health-related product claims at issue in DSSRC’s inquiry pertained to product efficacy as well as claims that Somaderm product was “FDA Registered” and that the product had clinical applications. In addition, the DSSRC inquiry also included a number of additional health-related claims (e.g., “Regrowth of heart, liver, spleen, kidney and other organs that shrink with age”; “14.4% loss of fat on average after six months without dieting”; “Superior immune function”; “Greater cardiac output”; “Superior immune function,” etc.) and a number of before-and-after depictions purportedly demonstrating the results received from using the product. 

DSSRC is the direct selling industry’s self-regulatory forum and a division of BBB National Program, Inc.’s self-regulatory and dispute resolution programs. The subject marketing for Somaderm came to the attention of DSSRC through its own independent monitoring of the direct selling marketplace. 

In its decision, DSSRC stated that “…there has been no substantive evidence provided by the Company to support product performance claims for Somaderm™” including the Company’s slightly revised claims that Somaderm “May support better mood; May support healthier hair, skin & nails; May promote hair growth. May increase joint mobility; May enhance libido; May increase fat loss (especially around the mid-section) May support greater muscle tone; May increase strength May improve memory.”  

Although New U Life represented that it was taking several steps to increase oversight of its salesforce and become compliant with regulatory guidance, it became apparent to DSSRC that were systemic issues at the Company that could not be addressed in the context of industry self-regulation. For this reason, DSSRC noted in its December 2019 decision that “Should DSSRC further determine that unsupported product performance and earnings claims appear on the Company website and/or continue to be disseminated in distributor posts that are accessible by consumers and potential recruits, DSSRC will have no recourse but to summarily refer this matter to the appropriate governmental agencies.”

Since the time that DSSRC published its decision in December 2019, DSSRC became aware of the ongoing dissemination of many of the same product performance, establishment and testimonial claims for Somaderm, despite the omission of any testing that would support such efficacy. Despite DSSRC’s conclusions and recommendations that the claims be discontinued, the Company continues to disseminate many of the same product performance claims that DSSRC determined were not supported by competent and reliable evidence and continues to disseminate claims stating that it is Somaderm is the “only transdermal, FDA-registered product containing homeopathic human growth hormone.” 

Moreover, in the past several weeks, DSSRC identified a number of posts made by the New U Life salesforce indicating that Somaderm is effective at treating and healing the COVID-19 virus despite the existence of any evidence indicating that the product can do so.

In sum, DSSRC has determined that New U Life has repeatedly failed to adhere to its recommendations and continues to disseminate unsupported performance and health-related including claims that Somaderm is effective to treat the coronavirus. Accordingly, has referred this matter to both the FDA and the FTC.  DSSRC’s full written report is available at: https://bbbprograms.org/programs/dssrc/dssrc-decisions.

###

About BBB National Programs (formerly ASRC Programs): BBB National Programs 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. These programs were formerly administered by the Council of Better Business Bureaus, Inc. To learn more about industry self-regulation, please visit: BBBNP.org.


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Direct Selling Self-Regulatory Council Refers Health-Related Product Claims by New U Life, Inc. to the Federal Trade Commission and the Food and Drug Administration

For Immediate Release
Contact: Peter C. Marinello, Vice President, DSSRC, 212.705.0126

 

New York, NY – April 7, 2020 –The Direct Selling Self-Regulatory Council (“DSSRC”) has referred certain health-related claims made by New U Life, Inc. (“New U Life” or the “Company”) for its Somaderm hGH transdermal gel to the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) for possible enforcement action after the Company failed to comply with DSSRC’s recommendations to modify or discontinue such claims. The health-related product claims at issue in DSSRC’s inquiry pertained to product efficacy as well as claims that Somaderm product was “FDA Registered” and that the product had clinical applications. In addition, the DSSRC inquiry also included a number of additional health-related claims (e.g., “Regrowth of heart, liver, spleen, kidney and other organs that shrink with age”; “14.4% loss of fat on average after six months without dieting”; “Superior immune function”; “Greater cardiac output”; “Superior immune function,” etc.) and a number of before-and-after depictions purportedly demonstrating the results received from using the product. 

DSSRC is the direct selling industry’s self-regulatory forum and a division of BBB National Program, Inc.’s self-regulatory and dispute resolution programs. The subject marketing for Somaderm came to the attention of DSSRC through its own independent monitoring of the direct selling marketplace. 

In its decision, DSSRC stated that “…there has been no substantive evidence provided by the Company to support product performance claims for Somaderm™” including the Company’s slightly revised claims that Somaderm “May support better mood; May support healthier hair, skin & nails; May promote hair growth. May increase joint mobility; May enhance libido; May increase fat loss (especially around the mid-section) May support greater muscle tone; May increase strength May improve memory.”  

Although New U Life represented that it was taking several steps to increase oversight of its salesforce and become compliant with regulatory guidance, it became apparent to DSSRC that were systemic issues at the Company that could not be addressed in the context of industry self-regulation. For this reason, DSSRC noted in its December 2019 decision that “Should DSSRC further determine that unsupported product performance and earnings claims appear on the Company website and/or continue to be disseminated in distributor posts that are accessible by consumers and potential recruits, DSSRC will have no recourse but to summarily refer this matter to the appropriate governmental agencies.”

Since the time that DSSRC published its decision in December 2019, DSSRC became aware of the ongoing dissemination of many of the same product performance, establishment and testimonial claims for Somaderm, despite the omission of any testing that would support such efficacy. Despite DSSRC’s conclusions and recommendations that the claims be discontinued, the Company continues to disseminate many of the same product performance claims that DSSRC determined were not supported by competent and reliable evidence and continues to disseminate claims stating that it is Somaderm is the “only transdermal, FDA-registered product containing homeopathic human growth hormone.” 

Moreover, in the past several weeks, DSSRC identified a number of posts made by the New U Life salesforce indicating that Somaderm is effective at treating and healing the COVID-19 virus despite the existence of any evidence indicating that the product can do so.

In sum, DSSRC has determined that New U Life has repeatedly failed to adhere to its recommendations and continues to disseminate unsupported performance and health-related including claims that Somaderm is effective to treat the coronavirus. Accordingly, has referred this matter to both the FDA and the FTC.  DSSRC’s full written report is available at: https://bbbprograms.org/programs/dssrc/dssrc-decisions.

###

About BBB National Programs (formerly ASRC Programs): BBB National Programs 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. These programs were formerly administered by the Council of Better Business Bureaus, Inc. To learn more about industry self-regulation, please visit: BBBNP.org.


 

 

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