In Brief: Nutrition Facts Update, Valeant Sales
This article was originally published in The Tan Sheet
Executive Summary
FDA to update Nutrition and Supplement Facts labels; Valeant over performs in Q4, 2013; “probiotic” alone is a health claim, ASA; Troxyphen claims need modification, ERSP; and more In Brief.
FDA to update Nutrition and Supplement Facts labels
FDA’s proposed new Nutrition and Supplement Facts Label reflects new nutrient intake recommendations, including revised daily values for calcium, dietary fiber and vitamin D. To make space for requiring the addition of potassium and vitamin D amounts to the labeling, listing vitamins A and C will be voluntary, the agency says in twoproposed rules slated for publication in the Federal Register March 3. The proposed changes to the Daily Values and units of measure also will apply to the Supplement Facts label, FDA says. The changes are an attempt to “reflect the latest scientific information, including the link between diet and chronic diseases,” FDA adds in a Feb. 27 release.
Valeant revenue surges in Q4, 2013
With a 109% revenue increase to $2.1 billion in the fourth quarter,Valeant Pharmaceuticals International Inc. finished fiscal 2013 “with a flourish,” analysts with Aegis Capital Corp. said in a Feb. 27 note. The Laval, Quebec, firm said in a same day release that the increase helped its full-year revenue climb 66% to $5.8 billion. A major contributor to growth was a 10% increase for the October-December period and 10% for the year in organic revenue growth from subsidiary Bausch & Lomb Inc., which sells multiple OTC dry eye and allergy eye relief products in addition to eye health vitamins, contact lenses and solutions. The firm “has made significant progress in revamping the ophthalmics products line and restoring growth in emerging markets, particularly in China,” the Aegis analysts note. They add the firm has a “raptor-like acquisition strategy” with upwards of 50 potential targets. CEO J. Michael Pearson said during a same-day call that the targets include businesses in dermatology, animal health and branded generics.
“Probiotic” alone is a health claim, ASA
Simply using the term probiotic or prebiotic in supplement marketing is enough to violate the EU health claim regulations, according to the independent U.K. Advertising Standards Authority. In a Feb. 26 report, the regulator told Probiotics International Ltd. to discontinue claims Bio-Kult Candea “contains seven strains of probiotic bacteria” and Bio-Kult Cyan is a “probiotic formula” even though the advertising did not state the significant of probiotics. The firm said using the word probiotic “merely ensured that consumers were being kept informed of the ingredients in the product.” But, the regulator said the European Commission issued guidance noting the “reference to probiotic/prebiotic implies a health benefit.”
Troxyphen claims need modification, ERSP
Supplement marketer truDERMA LLC, should discontinue claims Troxyphen is “safe and clinically researched” and several ingredient claims because it did not prove the dosages of ingredients will provide the benefits, the Electronic Retailing Self-Regulation Program says in a Feb. 18 release. The Las Vegas firm also needs to discontinue claims of weight loss, increased muscle and improved BMI because it did not provide adequate support. It needs to disclose the product must be used with resistance training to achieve general claims of increased testosterone, ERSP added. The firm, however, supported claims of “increased sex drive.” The firm noted it will “give serious consideration to ESRP's recommendations.”
Wellness Support Network to pay $2.2 million in restitution
Marketer Wellness Support Network Inc. must pay $2.2 million in consumer restitution to resolve Federal Trade Commission allegations of false and misleading claims about treating diabetes with nutritional supplements. The Glendale, Calif., firm and its principals, father and daughter Robert and Robyn Held, did not prove the product claims were true, wrote U.S. Magistrate Judge Joseph Spero in his Feb. 20 order in the U.S. District Court for the Northern District of California. Spero also rejected the defendants’ assertion that their claims were adequately substantiated because their products are medical foods. The products at issue, Diabetic Pack and Insulin Resistance Pack, included vitamins, minerals and plant extracts and were sold primarily online for $76.70 for a 30-day supply. According to the complaint, WSN continued selling the products, including under different brands, after the agency ordered the firm to halt sales in 2010 (Also see "Regulatory News In Brief" - Pink Sheet, 1 Nov, 2010.).The restitution ordered against the firm covers sales between 2004 and 2012.
N.Y. proposes triclosan ban
Legislation introduced in the N.Y. State Assembly would prohibit the sale of personal care products containing triclosan. Introduced Feb. 4 by Assemblywoman Michelle Shimel, D-Great Neck, the bill would amend the state’s environmental conservation law to ban retailers, firms and individuals from selling personal-care products, cosmetics and cleaning products that contain triclosan, triclocarbon or related compounds. The bill was referred to the Committee on Environmental Conservation. Another bill introduced in February in New York would prohibit the sale of cosmetics formulated with plastic microbeads (Also see "New York Proposes Ban On Cosmetic Microbeads; California Follows Suit" - HBW Insight, 17 Feb, 2014.).
Sports nutrition appeal spreads
Sports nutrition sales are expected to hit $37.7 billion in 2019, up from $20.7 billion in 2012, thanks in part to use by a broader range of consumers, according to a report from Transparency Market Research. The firm chalks up the increase to multiple factors, including much greater appeal with consumers other than athletes and strength-training enthusiasts seeking health and lifestyle improvements. The Albany, N.Y.-based firm noted sports nutrition products increasingly are sold at supermarkets in addition to health food stores and in gyms. Meanwhile, the market outlook is becoming more geographically diverse, with solid performance already in the Asia Pacific region and longer-term growth coming from developing countries, according to the report.