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Wednesday, January 26, 2011

PR: Sunset Health Participates in ERSP Forum; ERSP Finds Support for Certain Claims; Recommends Marketer Modify Certain Claims

The Electronic Retailing Self-Regulation Program (ERSP) has recommended that Sunset Health Products, Inc., marketer of the Hollywood Cookie Diet, the Hollywood 48-Hour Miracle Diet, the Hollywood 24-Hour Miracle Diet and the Hollywood 15-Day DeTox, modify or discontinue certain advertising claims for its products. ERSP determined that the marketer could support certain claims and noted that the marketer represented that it had voluntarily discontinued certain claims.

Advertising for the Sunset Health products came to the attention of ERSP – the direct-response industry’s self-regulatory forum, through a consumer challenge.

Based on the challenger’s submission and a review of the broadcast and online advertising for the Hollywood Diet, ERSP identified the following core representations that served as the basis of the self-regulatory inquiry:

1. The Hollywood Cookie Diet:

Consumer/Testimonials
  • “I lost 30 pounds in 2 months just using The Hollywood Cookie Diet!” [Tad A, Fort Wayne, Indiana]
  • “I had tried every diet in the book. After 7 weeks on the Hollywood Cookie Diet, I achieved my goal weight, losing 14 pounds! I’m over the moon, thank you!” [Cataline L, London England]
  • “I lost 42 pounds on the Hollywood Cookie Diet.” [Jim L, Port St. Lucie, FL]
  • “I lost 5 pounds in 3 days on the Hollywood Cookie Diet.” [Debbie L, Stamford, CT]
  • “I’m 82 and I have lost 66 pounds. I’m the envy of all my friends at my retirement home. My doctor loves The Hollywood Cookie Diet.” [Mary Ann S, Wahoo, NE]
  • “I lost 21 pounds in 13 days. I feel great and I don’t even feel hungry after eating the cookies.” [Joe S, Ozone Park]
  • “I lost 7 pounds in 2 weeks. I travel extensively, so this is a really great option for me. I feel better about myself already!” [Joanne S]
2. The Hollywood 48-Hour Miracle Diet:

Performance Claim
  • “Lose up to 10 pounds in 48 hours. Success is only 48 hours away. Lose weight naturally, while you detox, cleanse and rejuvenate your body. An ideal jumpstart to any diet.”
Superiority Claim
  • America’s # 1 liquid diet”
 Establishment Claim
  • Clinically tested”
 3. The Hollywood 24-Hour Miracle Diet

Performance Claims
  • “Lose up to 5 pounds in 24 hours! Success is only a day away. Lose weight naturally, while you detox, cleanse and rejuvenate your body. An ideal jumpstart to any diet.”
  • “…#1 selling detox diet in the world!”
 4. The Hollywood 15-Day Detox

Performance Claims
  • “When was the last time you gave your body an internal cleansing? Get rid of 5-10 lbs of toxic waste in your digestive system."
  • “The Hollywood 15 Day Detox is designed to cleanse the body while easily integrating with your daily routine.”
Following its review of the evidence in the record, ERSP recommended that Sunset Health qualify consumer testimonials for the Hollywood Cookie Diet to reflect the evidence in the record – that after two weeks on the Hollywood Cookie Diet the average amount of weight loss was approximately six pounds. ERSP noted in its decision that any consumer representation inconsistent with that amount “must be accompanied by a qualification that provides information pertaining to the marketer’s support for ‘typical’ or average results.”

ERSP determined that the testing evidence provided by Sunset Health provided a reasonable basis for the claims that its Hollywood 48-hour Miracle Diet has been “Clinically tested” and that users of the 48-Hour Miracle Diet can “Lose up to 10 pounds in 48 hours…” 

ERSP noted that the advertiser had included disclosure language that stated “In a randomized, double-blind, placebo-based clinical trial of the Hollywood 48-Hour Miracle Diet 73.3% of the thirty (30) subjects lost 6 pounds or more and 13.3% lost 10 pounds or greater,” but recommended that the triggering claim – “Lose up to 10 pounds in 48 hours…” – should be accompanied by a symbol to alert consumers to the disclosure.

Regarding the Hollywood 24-Hour Miracle Diet, ERSP determined that the advertiser could support the claim “Lose up to 5 pounds in 24 hours...” ERSP noted that the marketer voluntarily discontinued the claim “America’s # 1 liquid diet.”

Finally, regarding the Hollywood 15-Day Detox, ERSP determined that the statement “The Hollywood 15 Day Detox is designed to cleanse the body while easily integrating with your daily routine” would not create any specific product performance expectations that could be relied on by consumers.

ERSP further noted that the marketer represented it would permanently discontinue the claim “When was the last time you gave your body an internal cleansing? Get rid of 5-10 lbs of toxic waste in your digestive system.”

Sunset Health Products, in its marketer’s statement, said it “supports the mission of the National Advertising Review Council’s Electronic Retailing Self Regulation Program.”

“We appreciate the recommendations made by the ERSP and have either already implemented or are in the process of implementing each of such recommendations,” the marketer said.

Monday, January 24, 2011

PR: ERSP Reviews Advertising for Dentagen's 'Proginicin;' Recommends Marketer Discontinue Claims at Issue

The Electronic Retailing Self-Regulation Program (ERSP) has recommended that Dentagen Distribution, LLC discontinue claims in direct response advertising for “Proginicin Oral Multi-Indication/Cold Sore Treatment.”

ERSP, the electronic direct-response industry’s self-regulatory forum, is administered by the Council of Better Business Bureaus (CBBB) with policy oversight by the National Advertising Review Council (NARC).

The marketer’s advertising came to the attention of ERSP following an anonymous challenge.


ERSP reviewed online advertising for the product, which was targeted to dentists and oral hygienists, and identified a wide range of claims for review, including:
  • “…PROGINICIN, a treatment for gum disease and dental procedures based on the ingredient, Viracea.”
  • “PROGINICIN is indicated for use on any sore or infection in the oral cavity including herpetic lesions. Reported results are remarkable when used on all grades of gingivitis.”
  • “PROGINICIN can be used on cold sores. Patients report that PROGINICIN is effective in preventing some eruptions, and reduces discomfort after blistering.” 
  • “PROGINICIN is also indicated for use on gingival cuts, abrasions, herpetic lesions (including cold sores), and all grades of gingivitis, including ANUG.”
  •  “PROGINICIN is outstanding as a treatment for gingivitis. YOU AND YOUR PATIENTS WILL BE AMAZED AT HOW QUICKLY IT WORKS!”
  • “PROGINICIN may relieve cold sores symptoms. When used at the first sign of an eruption, it may prevent the eruption and painful blistering.”
  •  “The wound healing period for ulcer sores was shortened by the same amount of time with implant patients.”
  • “With treatment of PROGINICIN the period to achieve healing ranged between 3 to 5 days. Usually it takes 7 to 14 days to achieve the same grade of healing.”
  •  “Usually, gingivitis symptoms might be improved after one week, with correct dental hygiene using toothbrush and dental floss. However, with the use of PROGINICIN the main aspects of gingival inflammation, including pain, gingival bleeding and swelling disappeared in one day.”
  • “Gingivoplastic surgery is a common procedure for patients with hyperplasic gingiva. This intervention causes an inflammatory process which can be largely improved by the application of a few drops of “PROGINICIN.”
  • “The present report showed that the main aspects of mouth soft tissues inflammation including pain, gingival bleeding and swelling were largely improved in a shortened time, by the application of a few drops of “PROGINICIN,. In addition, with treatment of “PROGINICIN, the period to achieve healing was noticeably reduced, demonstrating that it is an effective treatment option.”
  • “I saw a female patient with periodontal abscess on the mesial facial of #4. I debrided the periodontal pocket and was able to slip the thin neck of the “PROGINICIN applicator under the tissue. I slowly irrigated with “PROGINICIN. Two days later the swelling was gone and the periodontal abscess was totally resolved. I know of no other product that would do this.”
  • “I can heartily recommend “PROGINICIN for the eradication of any type infected wound in and around the oral cavity.”
As support for the claims at issue, Dentagen provided ERSP with a randomized, double-blind, placebo controlled, multi-center clinical trial for a product called RELEEV, which shares the same active ingredient – Viracea – as Proginicin. The primary purpose of the clinical trial was to determine whether RELEEV was effective as a topical treatment of the herpes simplex virus. One hundred fifty-seven (157) subjects between the ages of 18 and 65 completed the study. The authors of the study concluded that when used as directed, RELEEV relieved the symptoms of cold sores and was shown to be a safe and effective treatment of recurrent herpes simplex infection when compared to placebo.

(Full text of decision available to media, upon request)

ERSP questioned in its decision whether the study’s results could serve as support for the advertising claims made for Proginicin. ERSP noted that while the products share the same active ingredient, Dentagen did not confirm that Proginicin contains the same amount of Viracea contained in RELEEV or offer evidence regarding other ingredients in Proginicin that could offset the effectiveness of the Viracea ingredient.

Further, the RELEEV study was limited to the treatment of facial cold sores, not lesions inside the mouth.

In the absence of any reliable evidence to support these express claims, ERSP recommended that the marketer discontinue all of the claims at issue.

The company, in its marketer’s statement, said “…we are in the process of reviewing our advertising for Proginicin and will use our best efforts to implement the recommendations provided by ERSP.”