ERSP recommends truDERMA discontinue certain claims supporting Troxyphen
NEW YORK — The Electronic Retailing Self-Regulation Program on Tuesday recommended that truDERMA discontinue certain claims for the company’s Troxyphen dietary supplement, including claims that the product is “safe and clinically researched.”
As support for the performance and establishment claims at issue, the marketer submitted testing on its key ingredient. After reviewing the evidence, ERSP concluded that truDERMA provided a reasonable basis for claims relating to an “increased sex drive.”
However, ERSP determined that the marketer did not provide adequate support for claims that Troxyphen will “burn excess fat” or that users will “gain muscle mass.” ERSP recommended that the marketer discontinue any claims of weight and/or fat loss, increased muscle and improved BMI.
ERSP also recommended that the marketer discontinue claims that promise quantified performance results and modify general claims of increased testosterone by disclosing that the product must be used in conjunction with resistance training.
The marketer did not provide evidence indicating that the dosages of ingredients contained in Troxyphen will provide the results specifically stated in the advertising. As a result, ERSP recommended truDERMA discontinue several ingredient claims and the claim that “Troxyphen is safe & clinically researched.”
The company, in its marketer’s statement, said, “truDERMA appreciates ESRC’s comments and direction on our advertising. We are committed to helping people lead healthier, happier lives. truDERMA will give serious consideration to ESRC’s recommendations in our advertising practices.”
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 through an anonymous competitive challenge.
Asthma solutions in demand
The one-time $100 million asthma-relief brand Primatene may make a comeback to the marketplace after a more than two-year hiatus. Primatene Mist had been withdrawn from the market in December 2011 when the agency removed all inhalers containing chlorofluorocarbons from the market.
The Nonprescription Drugs Advisory Committee will be meeting Feb. 25 to discuss data submitted by Armstrong Pharmaceuticals in support of a new drug application for the over-the-counter marketing of Primatene HFA, an epinephrine inhalation aerosol 125 mcg/actuation, as a temporary reliever of mild symptoms of intermittent asthma for consumers ages 12 years and older.
The demand for an asthma inhaler in the self-care space is there. Nephron Pharmaceuticals has been seeing quite a lift in sales of its Asthmanefrin nasal spray, which reached $17.7 million, up 987%, for the 52 weeks ended Dec. 1 across total U.S. multi-outlets, according to IRI. Asthmanefrin contains racepinephrine USP 11.25 mg, a bronchodilator.
There also are homeopathic solutions that have carved out a niche in the asthma space. At the 2013 NACDS Total Store Expo, Homeolab launched its Real Relief Asthma Nighttime product. Retailing for a suggested $11.99, the homeopathic tablets help relieve symptoms associated with asthma, including gasping for air, difficulty breathing, wheezing, coughing and excess mucus. And homeopathic supplier King Bio in 2012 launched its AsthmaCare homeopathic spray.
According to the Asthma and Allergy Foundation of America, 25 million Americans have asthma.
Segmentation on the horizon
Retailers were preparing for the imminent launch of Chattem’s Nasacort Allergy 24HR nasal spray (triamcinolone intranasal) last month, clearing out quite a bit of shelf space for the new allergy remedy.
(For the full category review, including sales data, click here.)
And with good reason. The switch of a significant name brand, prescription-only remedy to OTC aisles has traditionally meant a significant uptick in sales across the category. Nasacort, more than any of the other blockbuster allergy switches, may bring incremental sales to the category because it is the first and only nasal corticosteroid to be available without a prescription.
However, the sales potential for Nasacort Allergy 24HR nasal spray is being capped at $200 million per year vs. the $380 million per year that such tablet remedies as Claritin or Zytrec generate, or the approximate $320 million that Allegra generates, according to Laura Mahecha, industry manager at Kline Healthcare. The nasal format is not expected to become as big as the competing allergy tablets, she said, because tablets are perceived to be a preferred delivery form among consumers.
Another opportunity developing within allergy is segmentation by allergen — tree pollen is predominant in the spring, grass in the summer and ragweed in the fall. Mold is considered a year-round allergy trigger but peaks in the spring.
That’s exactly the opportunity companies are pursuing on the prescription side of the business. The Food and Drug Administration last month held a public meeting of the Allergenic Products Advisory Committee to determine the safety and efficacy of Ragwitek, a short ragweed pollen allergen extract tablet for sublingual use, which is manufactured by Merck.
In December, the same committee granted approval for Stallergenes’ Oralair, which are grass allergy tablets.