In Brief
This article was originally published in The Tan Sheet
Executive Summary
POM, agency grilled during appeal to FTC board; Swander buys Physicians Formula; FDA again warns about Reumofan; Parrillo warned on GMPs, response; Potential botulism prompts Protica recalls; more news In Brief.
Commissioners doubt POM claims, FTC order
The Federal Trade Commission board questions FTC’s proposed action against [POM Wonderful LLC] as rigorously as they grill the firm about substantiation for POM products’ health claims. The commissioners Aug. 23 considered arguments from agency and the firm in appeal of an FTC administrative law judge’s decision that while POM inadequately substantiated ads for its pomegranate products, FTC cannot require randomized controlled trials to substantiate nutrient claims (Also see "Judge Knocks Down FTC Substantiation Bar In POM Wonderful Case" - Pink Sheet, 28 May, 2012.). Each of the five commissioners asked POM’s counsel, Washington attorney Edward Lazarus, to explain how and why the firm’s product claims should not be considered disease claims. “If all the ads literally said is POM Juice is healthy, I don’t think we’d be here today,” said commission Chairman Jon Leibowitz.
However, while the commissioners acknowledged the role of randomized, controlled trials in health claim substantiation, they questioned FTC’s proposal that POM gain FDA approval of its claims and conduct RCTs. “We don’t want [POM] to be the judge of science,” said Heather Hippsley, an assistant director of FTC’s Division of Enforcement. Still, the commissioners were skeptical of requiring FDA’s collaboration. “Do you have a plan B?” Commissioner Julie Brill asked. No timetable for the commissioners’ decision is set, but FTC anticipates the board will decide quickly. In the event POM appeals with the ruling, the case would be filed in federal court; FTC, however, cannot appeal.
Swander buys Physicians Formula Holdings
Swander Pace Capital adds high-margin skin care, including the sunscreen brand Sun Shield to its consumer-products portfolio in a $65 million acquisition of Physicians Formula Holdings Inc. The deal announced Aug. 15 is subject to closing condition and stockholder approval, but stockholders with approximately 22% of outstanding shares already agreed to vote for the deal. Swander Pace also owns Insight Pharmaceuticals LLC, which makes Anacin analgesics, MONISTAT antifungals and e.p.t. pregnancy tests (Also see "Insight Acquires Monistat In Third Deal With McNeil For Women’s OTC Drugs" - Pink Sheet, 5 Sep, 2011.).
Parrillo Performance warned on GMP problems, response
FDA warns Fairfield, Ohio, dietary supplement manufacturer Parrillo Performance for failure to comply with good manufacturing practice regulations and failure to submit an “adequate” response to a document summarizing violations. The amended Aug. 13 warning letter cited violations including failure to establish component specifications and missing identity testing, discovered during inspections of the firm’s plant Feb. 13 through Feb. 29. The firm must respond within 15 days of receipt of the letter, specifying steps it will take to correct violations. The firm contacted FDA after a June warning letter for the same violations, but the agency said Parillo “failed to provide detailed information and documentation that would assist us in evaluating whether you have implemented the necessary corrections” (Also see "In Brief" - Pink Sheet, 13 Aug, 2012.).
FDA again warns about tainted Reumofan Plus
FDA received dozens of additional adverse event reports, including death and stroke, for Reumofan Plus and Reumofan Plus Premium since the agency in June warned about unlabeled prescription ingredients in the products marketed as supplements. The agency Aug. 21 said tests subsequent to the June warning showed the prescription muscle relaxant methocarbamol in the products, made in Mexico by Riger Naturals, in addition to previously identified diclofenac sodium and dexamethasone. The agency said consumers should stop taking these products and if they have used them, consult a health care provider (Also see "In Brief" - Pink Sheet, 11 Jun, 2012.).
Potential botulism prompts Protica recalls
Protica Inc. recalls Body Choice Protein Shots, Nutritional Resources Protein Wave and ProBalance Protein to Go French Vanilla Latte and Milk Chocolate Shake due to potential botulism contamination. FDA said Aug. 23 the potentially contaminated products, spread across 38 lots manufactured between September 2011 and June, were discovered during a process parameters investigation. The recalled products – in bottles, cups or vials in sizes between 2.5 and 6 ounces – were distributed nationally through retail and direct mail. The recall follows a Feb. 17 warning letter the Whitehall, Pa., firm received on good manufacturing practices violations of failing to reject a product that failed bacterial contamination tests, and to quarantine the affected product or to followup on the review (Also see "Regulatory News In Brief" - Pink Sheet, 9 Apr, 2012.).
USANA redesigns brand image
USANA Health Sciences Inc. is “refreshing” its 20-year-old brand identity with new corporate branding and the tagline: “Your Health. Your Life. Your Way. During its international convention Aug. 15-18, USANA said the USANA “globe” logo represented the Salt Lake City firm's global reach and depicts individuals engaging in healthy activities. “Our new logo, packaging and brand positioning illustrates our strong foundation in research, represents our focus on customized health products and appeals to a larger demographic of consumers,” the firm says. USANA also launched two new products – BiOmega Jr. omega-3 supplements for children and Go Nuts 'n' Berries Nutrition Bar.
Creative Edge revenues reach $1.54 million
Creative Edge Nutrition, a nutritional supplement company focusing on active lifestyles, reports total revenues of $1.54 million for the three-month period ended June 30. Gross profit reached $912,732, said the Madison Heights, Mich. Firm, which recently began trading over-the-counter on markets that do not require Securities & Exchange Commission registration. The firm has committed to expand aggressively through acquisitions and organic growth, and most recently bought assets, manufacturing, distribution agreements and intellectual property from Science Defined Nutrition (Also see "In Brief" - Pink Sheet, 21 May, 2012.).