Hi-Tech challenges journal study criticizing its ingredient Acacia rigidula
NORCROSS, Ga. — Hi-Tech Pharmaceuticals on Tuesday responded to a report in the journal Drug Testing and Analysis that charged supplements containing the ingredient Acacia rigidula also contained BMPEA, an amphetamine isomer. The company believes the Harvard-led study is similar to the recent testing performed by the New York attorney general on many herbal extracts, in that it's a faulty test.
"Hi-Tech Pharmaceuticals has sold more than a billion doses of Acacia rigidula since 2003," said Jared Wheat, president Hi-Tech Pharmaceuticals. The company has conducted three clinical studies on the effects of Acacia rigidula and none have found any serious adverse events, he said, "other than possibly a jitter or shake which is common amongst stimulants."
A 2013 study carried out by Food and Drug Administration scientists scrutinized the testing done and methods used by Texas A&M researchers and other scientists' studies on Acacia, Hi-Tech added. "Yesterday I responded to various news outlets seeking comment on the upcoming release of the Harvard led study by Pieter Cohen, the lead researcher and an assistant professor at Harvard Medical School. However, many of these news outlets did not give equal weight to, and in some cases did not even report on, the studies performed by Texas A&M finding various methylated Phenylethylamine alkaloids in Acacia Rigidula," said Wheat.
"The testing involved in Acacia and other plants coupled with the DNA testing performed by the New York Attorney General Eric Schneiderman just leads to consumer concerns and bad science. These government entities are very good at testing pharmaceuticals, but are not familiar with botanical extracts, and the factors surrounding extraction and soil conditions that can lead to different analytical results," stated Wheat.
"I also feel this is a joint effort by big pharma and institutions to rid the marketplace of Acacia as they did with ephedrine in 2006," Wheat added. "Hi-Tech Pharmaceuticals fought the outlawing of ephedrine alkaloids and will not sit idly by while researchers and a biased media try to destroy acacia just so they can commercialize it into a prescription drug and ban it from the dietary supplement industry as they did with ephedrine alkaloids."
USA Today: Driven Sports bringing line extension of banned supplement to market
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."
AAP adopts mL dosage units in place of spoons
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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