Hormone Gel Cannot Make Health Benefit Claims; Somaderm Agrees to Modify, Discontinue Certain Claims After ERSP Review of Its Advertising

New York, NY – Jan. 23, 2019 – New U Life, Inc., the makers of Somaderm Gel, have agreed to modify or discontinue certain health benefit claims in its online advertising of the product, following recommendations from the Electronic Retailing Self-Regulation Program.

ERSP is an investigative unit of the advertising industry’s system of self-regulation and is administered by the Council of Better Business Bureaus. The marketer’s advertising came to the attention of ERSP pursuant to an anonymous challenge.

According to the marketer, Somaderm Gel is a transdermal human growth hormone (HGH) product which purports to have a variety of health benefits. ERSP reviewed online advertising claims for Somaderm Gel and identified several claims for review, including:

• “The benefits listed below are based on clinical studies where individuals growth hormone levels were brought to a healthy level under the care and direction of a licensed medical professional. 1. *May support better mood 2.*May support healthier hair, skin & nails 3.*May promote hair growth 4.*May increase joint mobility 5. *May enhance libido 6. *May increase fat loss (especially around the mid-section 7. *May support greater muscle tone 8.* May increase strength 9.* May improve memory.”
• “… Many experts say that elevating growth hormone when you are older can bring back your levels to when you were in your 20’s. Most people experience these anti-aging benefits in as little as two weeks.”
• “SOMADERM gel is the only FDA registered transdermal human growth hormone product available without a prescription.”
• “I am shrinking and feeling great contrary to other products I have tried” [Laurie]

During the course of the inquiry, the marketer participated in the self-regulatory process and made several changes to the advertising reviewed. This included removing all consumer testimonials and expert endorsements from a “scientific advisory board.”

ERSP determined that the marketer did not adequately support claims that Somaderm Gel will confer health benefits. Specifically, the marketer failed to submit any competent and reliable evidence to demonstrate that the Somaderm Gel formula and/or transdermal administration would provide the purported health benefits of HGH. Based upon the information provided, ERSP recommended that the marketer discontinue all performance and establishment claims.

ERSP also noted that the marketer did not submit any information regarding the characterization of its product and ingredients as “homeopathic” in the advertising at issue. ERSP further advised the marketer that claims regarding whether the product or its ingredients are homeopathic should comply with applicable FDA guidelines.

As to claims that Somaderm Gel is FDA registered, ERSP determined that the marketer could make limited claims that were truthful and accurate. Specifically, the marketer could state that the marketer’s facilities are FDA registered and that Somaderm Gel has been assigned a National Drug Code (NDC) number. In its decision, ERSP noted that the advertising reviewed included detailed explanations regarding the NDC and registration of the facilities. However, ERSP also stated that the marketer should not include any claims that state or imply that the Somaderm Gel product is FDA approved.

The company, in its marketer’s statement, said, “We at New U Life take our position and standing with ERSP very seriously… [The Founder of New U Life] would like to personally acknowledge the importance of the ERSP decision and will continue to work with them and provide them with updated information to make all description accurate and fair to the consumer.”