CDC calls for safer cough/cold delivery

Centers for Disease Control and Prevention researchers say drug-delivery innovations are needed to prevent children’s unsupervised use of cough/cold drugs. “Addressing unsupervised ingestions has the greatest potential for further reductions” in children’s cough/cold drug-related adverse events, say the researchers led by Lee Hampton, of CDC’s Division of Healthcare Quality Promotion. Their study, based on data from emergency room treatments from 2004-2011 and published in the December issue of the journal Pediatrics, noted the voluntary withdrawal of cough/cold OTCs for infants in 2007 and label changes in 2008 to warn against use with children under 4 led to a reduction in ER treatment of children for related adverse events. However, following those changes, unsupervised ingestions were reported in roughly two-thirds of the 2,138 relevant ER treatments for children under 2 and in nearly 90% of the 4,092 cases for 2- to 3-year-old children.

A previous CDC study found 3- and 4-year-olds could empty 82% of medicine bottles with child resistant caps not properly or completely fastened within two minutes. Researchers and stakeholders say industry standards are needed before manufacturers should enhance packaging Also see "Flow Restrictors Limit Children’s Access To Drugs; Standards Needed" - Pink Sheet, 31 July, 2013..

USPlabs toes FDA line

[USPlabs LLC] is recalling OxyElite Pro dietary supplements after FDA threatened the firm with a mandatory recall order. On Nov. 10, FDA noted the Dallas-based sports nutrition firm recalled certain lots of OxyElite Pro Super Thermo capsules and powder products, but the agency advises consumers not to use any supplements labeled OxyElite Pro or Versa-1.

An Oct. 11 warning letter informed USPlabs that OxyElite Pro and Versa-1 were adulterated because they contained aegeline, an ingredient that lacks a history of use or other evidence of safety. On Nov. 4, the firm said it would reformulate without aegeline, which it began using after FDA warned supplement firms about the use of DMAA. In a Nov. 6 letter FDA warned the firm about a link between the use of OxyElite Pro products and liver illnesses reported in Hawaii and other states and stating that “if the company did not initiate a voluntary recall,” FDA could order USPlabs to stop distribution ([A#05131111010]).

Loyalty program costs trim Mannatech income

Multi-level nutritional supplement marketer [Mannatech Inc.]’s net sales grew 3.3% to $44.4 million in its fiscal 2013 third quarter although it reported a net loss of $800,000, down from net income of $2.2 million in the year-ago quarter, due to the launch of a loyalty program for distributors. The Coppell, Texas-based firm on Nov. 14 said its income was affected by the loyalty program that awards distributors points for future purchases and that defers the dollar equivalent in income until the points are applied or forfeited. Mannatech said it deferred net sales of $2.5 million due to the loyalty program during the July-September period. Asia-Pacific region sales grew 23.6% to $22 million on increases in distributors and in their average revenue generated per active associate and member. Net sales for North America declined 9.7% to $18.7 million and for Europe, the Middle East and Africa declined 17.8% to $3.7 million. The firm said recruiting increased 4.4% in the quarter with around 28,800 new distributors added, bringing the total to 239,000.

Neptune disputes workplace safety fine

Neptune Technologies & Bioressources Inc. contests a Quebec workplace safety commission fine linked to the November 2012 explosion that destroyed the firm’s plant and killed three workers. Neptune said on Nov. 8 that the commission seeks payment of around $64,000 and continues its investigation, with its final report expected in 2014. President and CEO Henri Harland said the firm contends it “exercised due diligence at all times in applying, in a responsible manner, the best available workplace safety practices and procedures” and should not liable for the fine. The Laval, Quebec-based firm’s income has plummeted since the explosion at its Sherbrooke, Quebec, plant as it arranged for third-party supplies of krill fish oil, but it is rebuilding its plant and continues work on an expansion already under construction at the time of the explosion. Neptune also faces a shareholder complaint proposing a class action and alleging false and misleading statements about business prospects ([A#05130121012]).

FDA postpones OTC eyewash hearing

FDA rescheduled a public hearing to obtain information on the formulation, manufacturing and labeling of OTC emergency use eyewash products from Dec. 4, 2013, to March 7, 2014. According to a Nov. 15 Federal Register notice, the deadline is Feb. 14 for submitting electronic or written requests to make presentations and comments during the hearing at FDA’s White Oak headquarters in Silver Spring, Md. The agency in 2003 proposed a rule to add emergency first-aid eyewash drugs to the OTC monograph for ophthalmic products, including standards for minimum container volume and pH levels ([A#05130923011]).

Counterfeit supplement adulterated

FDA announces that “ExtenZe Maximum Strength,” a counterfeit version of the dietary supplement for male sexual enhancement ExtenZe, could contain Rx erectile dysfunction drug sildenafil. The agency on Nov. 12 said the counterfeit product, which appears similar to the actual product, was available online but also likely through other sources. The violative product can be identified by lot number 0512058 and the expiration date May 16 stamped on the outer carton and embossed on the blister card.

Vega nutritional shakes recalled

Vega recalls certain lots of its Vega One Nutritional Shakes and Sports Performance Protein products after trace amounts of chloramphenicol, a naturally occurring antibiotic used as a prescription drug to treat typhoid fever and eye infections, were found. The Burnaby, British Columbia, firm on Nov. 8 said no Vega product formulations include CAP as an ingredient, but an enzyme provided by a third party supplier, which constitutes less than 1% of the product ingredients, was found to contain trace amounts of the substance.

In Brief: CDC calls for safer cough/cold delivery, USPlabs toes the line, Neptune disputes fine, and more

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