In Brief

Consent decree follows claim warning

Howard Sousa enters a consent decree with FDA after he failed to remove disease claims for Advanced Formula EDTA Oral Chelation capsules from the Artery Health Institute's website. FDA says in a June 30 release it warned Sousa, a New York businessman, in October 2010 to remove claims about cardiovascular disease and kidney stones for the product, which was represented as a dietary supplement (Also see "FDA Chelation Warnings Reflect Growth In Bogus OTCs, Supplements" - Pink Sheet, 18 Oct, 2010.). The agency discovered during a follow-up inspection that he failed to comply. The decree orders Sousa to remove the claims and hire an independent expert to review future claims. If Sousa violates the decree he must pay $1,000 per violation and twice the retail value of each product shipment, FDA says.

McNeil OTC recall repeats

The Johnson & Johnson subsidiary recalls one lot of Tylenol Extra Strength caplets in 225-count bottles, due to reports of a musty, moldy odor linked to chemical residue on the drugs' packaging. McNeil Consumer Healthcare announced the retail level recall of the 60,912 bottles June 28. The affected Tylenol was manufactured in February 2009 and does not fall under FDA's consent decree regarding McNeil’s manufacturing quality control (Also see "Issa Scolds FDA On Failure To Inspect McNeil Plant" - Pink Sheet, 30 May, 2011.).

FTC examining Perrigo-Paddock deal

The Federal Trade Commission has "additional questions" for Perrigo before concluding its review and clearing the private labeler's acquisition of Minneapolis-based Paddock Laboratories. Perrigo said June 29 it is working with FTC so the Allegan, Mich., firm can close its $540 million acquisition of Paddock, which makes Rx and OTC drugs ( (Also see "In Brief" - Pink Sheet, 24 Jan, 2011.), In Brief). Perrigo expects the deal to be accretive to earnings by 25 cents per share in its fiscal 2012, which began in June.

Mannatech layoffs affect 19% of U.S. staff

The nutritional product multi-level marketer lays off 64 employees, a 19% reduction of its U.S. workforce, leaving 273 domestic employees and 152 abroad following the restructuring. Mannatech also is eliminating 34 other open positions and redistributing responsibilities within its Coppell, Texas, headquarters, the firm said June 23. Co-CEO Robert Sinnott said "persistent challenges in the economy" necessitated the restructuring, which is expected to save the firm more than $12 million a year. Mannatech reported sales down 16.1% to $50.9 million in its most recent quarter ( (Also see "Sales & Earnings In Brief" - Pink Sheet, 9 May, 2011.), Sales & Earnings In Brief).

IADSA offers global overview of GMPs

The International Alliance of Dietary/Food Supplement Associations publishes the "Global Guide to Good Manufacturing Practice for Supplements," as a resource for companies and regulators around the world. The document released June 17 addresses requirements for premises and equipment, personnel and training, product and process development, transportation and distribution, and documentation. IADSA, which comprises more than 50 associations, says its GMP framework allows "for flexibility in application within any country or region."

Cott in-licenses beverage ingredients

The Tampa, Fla.-based private-label beverage maker announces June 29 a pair of licensing deals for nutritional ingredients – with Rutgers University for cranberry extracts and with ChromaDex Inc. for pTeroPure derived from blueberries. Cott Beverages subsidiary Star PhytoNutrients gained the rights to use Rutgers' patented cranberry ingredients for urinary tract health supplements and functional foods and beverages. Cott also entered a license and supply agreement to collaborate with ChromaDex on an ingredient blend targeted to food, nutraceutical and cosmetics applications. ChromaDex in May announced it self-affirmed pTeroPure as generally recognized as safe for use in foods (Also see "Ingredient Supplier Interest In Functional Foods Shows No Sign Of Let-Up" - Pink Sheet, 27 Jun, 2011.).

Youngevity grows with two acquisitions

San Diego-based supplement firm Youngevity Essential Life Sciences expands its "consumer cloud" of distributor accounts with the acquisition of Tampa, Fla.-based Bellamora, which markets skin care products, including Multi Vitamin Moisturizer and Gentle Clarifying Cleanser. Youngevity said June 27 the acquisition comes just three days after its purchase of R-Garden, a supplement company based in Kettle Falls, Wash.