HEALTH

USA Today: Driven Sports bringing line extension of banned supplement to market

BY Michael Johnsen

ARLINGTON, Va. – Driven Sports is bringing back to market a line extension of its one-time banned supplement Craze called Craze v2, according to a report published Wednesday by USA Today
 
Sports nutrition distributor Predator Nutrition confirmed that its first shipment of Craze v2 arrived Wednesday in a FaceBook post
 
USA Today reported that the supplement's introduction has raised eyebrows across the industry given the company's recent history. "A controversial maker of sports supplements, undeterred by a long-pending federal criminal charge, is poised this month to sell a new version of a popular workout powder pulled from the market in 2013 after tests found it contained a methamphetamine-like compound," USA Today reported. "Driven Sports, a New York-based firm run by convicted felon and supplement designer Matt Cahill, plans to begin selling Craze v2 in April in the United States and Europe, according to postings by the company on its Facebook page and Internet promotions by Predator Nutrition, a marketing partner in the United Kingdom."
 
The Food and Drug Administration last year requested a sit-down with Driven Sports to discuss all of the products the company plans to market in a warning letter concerning Craze
 
"I worry that we continue to see a stream of stimulants coming out of this same company," Steve Mister, president and CEO of the Council for Responsible Nutrition, told USA Today. "There are numerous ways under the statute that FDA could go after this company and this is a lack of willpower to enforce the law to protect consumers, this is not a fault with the law."
 
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AAP adopts mL dosage units in place of spoons

BY Michael Johnsen

 

 
 
CHICAGO — The American Academy of Pediatrics last week urged parents, physicians and pharmacists to use only metric measurements on prescriptions, medication labels and dosing cups to help ensure kids receive the correct dose of medication. Medication should not be measured in teaspoons or tablespoons, especially not spoons taken from a kitchen drawer.
 
“Spoons come in many different sizes and are not precise enough to measure a child’s medication,” stated pediatrician Ian Paul, lead author of the policy statement, “Metric Units and the Preferred Dosing of Orally Administered Liquid Medications,” in the April 2015 Pediatrics. “For infants and toddlers, a small error – especially if repeated for multiple doses – can quickly become toxic.”
 
Each year more than 70,000 children visit emergency departments as a result of unintentional medication overdoses. Sometimes a caregiver will misinterpret milliliters for teaspoons. Another common mistake is using the wrong kind of measuring device, resulting in a child receiving two or three times the recommended dose.
 
“One tablespoon generally equals three teaspoons. If a parent uses the wrong size spoon repeatedly, this could easily lead to toxic doses,” Paul said.
 
One recent study demonstrated that medication errors are significantly less common among parents using only mL-based dosing rather than teaspoons or tablespoons.
 
The updated 2015 policy statement recommends:
 
  • Standard language should be adopted, including mL as the only appropriate abbreviation for milliliters. Liquid medications should be dosed to the nearest 0.1, 0.5, or 1 mL;
  • How often a dose is needed should be clearly stated on the label. Common language like “daily” should be used rather than medical abbreviations like ‘qd’, which could be misinterpreted as ‘qid’ (which in the past has been a common way for doctors to describe dosing four times daily);
  • Pediatricians should review mL-based doses with families when they are prescribed;
  • Dosing devices should not have extra markings that can be confusing, and should not be significantly larger than the dose described on the label, to avoid two-fold dosing errors; and
  • Manufacturers should eliminate labeling, instructions and dosing devices that contain units other than metric units.
 
“We are calling for a simple, universally recognized standard that will influence how doctors write prescriptions, how pharmacists dispense liquid medications and dosing cups, and how manufacturers print labels on their products,” Paul said.
 
This recommendation aligns with the Consumer Healthcare Products Association’s voluntary codes and guidelines on “Standard Terminology and Format for Labeling of Volumetric Measures on OTC Pediatric Orally Ingested Liquid Drug Products” which specify that for liquid products intended to be given to children less than 12 years of age, “mL” only should be used for dosing directions and on dosing devices. These guidelines were last updated on Nov. 14, 2014.
 
“CHPA and our member companies commend the American Academy of Pediatrics for its endorsement of the exclusive use of metric based dosing (mL only) to avoid dosing errors,” CHPA VP regulatory and scientific affairs Barbara Kochanowski said.“As noted in a July study published in Pediatrics, teaspoon and tablespoon units can be confusing for some parents, potentially leading to kitchen spoon use instead of the standard dosing device that comes with the medicine. Our association believes mL only labeling along with encouraging parents to read and follow the label every time will help decrease medication errors.”

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UL Consumer Products launches supplement verification program

BY Michael Johnsen

CANTON, Mass. – UL Consumer Products on Tuesday announced the launch of its Verification Program for dietary supplements.
 
"Consumers want to trust what is in the product they are taking; retailers require assurance that the products on their shelves are of the highest quality; and suppliers need to provide that trust and assurance," stated Sajeev Jesudas, president of UL Consumer United States. "Recently, the dietary supplements industry has come under increased scrutiny. From a best practice perspective, an approach that drives transparency into industry quality assurance programs can help increase consumer knowledge, drive brand awareness and loyalty, and support bottom-line improvements. The UL Verification Program for dietary supplements is a major milestone for UL and a natural fit for an industry in transition."   
 
Clients who participate in the Verification Program and qualify based on the UL ClearView program guidelines may use UL's new Verified Mark on their products, packaging and promotional items. The UL Verified Mark provides third-party verification. The UL Verified Mark confirms that the ingredients listed on the label are in the product. 
 
"Extensive research revealed that a UL Verified Mark would be welcomed by the dietary supplements industry and many current UL clients have indicated they would place a high value on the opportunity to earn the UL Verified Mark," says Michael O'Hara, general manager of global nutraceuticals for UL. "Because UL plays such an important role in the marketplace as a safety certifier, the core of UL's business, the new UL Dietary Supplements Verification Program is designed and intended to enhance our current safety certification programs."
 
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