HEALTH

Hi-Tech Pharmaceuticals launches Fastin Rapid Release diet aid

BY Michael Johnsen

NORCROSS, Ga. — Hi-Tech Pharmaceuticals is launching its Fastin Rapid Release diet aid beyond its exclusive debut with Rite Aid, the company announced Tuesday. 
 
Hi-Tech has initiated a multi-million dollar advertising campaign to support the launch. 
 
"The nationwide launch of Fastin Rapid Release is an important development for men and women who struggle with being overweight with and need help with weight management beyond diet and exercise," stated Jared Wheat, Hi-Tech's president and CEO. "Fastin Rapid Release really is the pre-eminent diet aid on the market right now because, unlike most of the weight-loss supplements, on the market, it actually has two product-specific studies that provide evidence of efficacy. One study was conducted on Fastin Rapid Release and its effects on the metabolic rate. The second study was an eight-week weight loss and fat loss study that showed it caused people to lose 208% more weight and 385% more fat than placebo." 
 
Fastin Rapid Release is made with "Explotab technology" for an immediate burst of the active ingredients, providing rapid onset of energy and thermogenesis, the company stated.

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New dry mouth solution Salese hits market

BY Michael Johnsen

SANTA CLARA, Calif. — Nuvora on Monday announced a solution for dry mouth called Salese. 
 
“The duration of existing lozenge treatments is too short to be effective. For truly effective treatment of oral care issues and relief arising from dry mouth, you have to have the right ingredients and literally bathe the tissues in the mouth over a sustained period of time," stated Jerry Gin, Nuvora CEO. "Most oral care products remain in the mouth for only a very brief time and are then swallowed or spit out, ending up where they don’t really do much good.”
 
Salese uses a patented sustained release drug delivery technology that provides continuous relief from dry mouth, Gin said. The lozenges last significantly longer than typical treatments, offering hours of dry mouth relief by restoring a moist mouth feel, while treating the oral cavity with a controlled release of substantially lower therapeutic doses of natural active ingredients. 
 
“When dry mouth happens, then there’s not enough saliva to wash away bacteria, and this can trigger bad breath and a cascade of oral health problems – cavities, gingivitis and periodontitis, on top of other health issues,” Gin said. “These natural ingredients in Salese, in addition to offering relief for dry mouth, promote oral health by killing plaque bacteria with xylitol and essential oils, neutralize acids from bacteria that cause cavities, and freshen breath by using zinc to capture volatile sulfur compounds from bacteria that cause bad breath (halitosis).”
 
According to the company, as many as 70 million Americans suffer from dry mouth and 75% of prescription drugs (approximately 1,800 medications) cause it. 
 
 

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CRN: GNC, NY AG agreement a ‘disservice to consumers’

BY Michael Johnsen

 

 
 
NEW YORK — Attorney General Eric Schneiderman on Monday announced a "landmark agreement" with Pennsylvania-based GNC to implement new standards in authenticating herbal supplements, ensuring their purity, and educating consumers about their chemical content. However, industry has characterized the agreement as a "disservice to consumers" and a "giant charade."
 
Under the agreement, GNC will perform DNA barcoding on the “active” plant ingredients used in its products; implement testing for contamination with allergens, both before and after production; and post prominent signage advising consumers of the processed, chemical nature of extracts. GNC will be required to implement these new procedures in all of its more than 6,000 stores nationwide, making this agreement the first in the nation to require testing standards for herbal supplements that includes DNA barcoding.
 
“The agreement announced today between the New York Attorney General and GNC performs a real disservice to consumers because it wrongly perpetuates the misdirected notion that DNA barcode testing is appropriate for herbal supplements, when it is not," argued Steve Mister, president and CEO for the Council for Responsible Nutrition. "Moreover, the agreement gives credence to the New York AG’s misguided allegations based on its own DNA barcode testing that legitimate quality concerns existed about the products marketed by four retailers, when there were none. DNA barcode testing remains a flawed method for across-the-board testing for analyzing the quality of botanical ingredients and finished products. Today’s announcement substitutes reasoned judgment of scientists and federal experts with a politically-motivated mandate that does not advance the conversation around the quality of dietary supplements."
 
Natural Producst Associaton CEO and executive director Daniel Fabricant, former director of the Division of Dietary Supplement Programs at the Food and Drug Administration, characterized the action as a "giant charade." "We still want to see the attorney general’s research," he said, "because the more we learn, the more this action looks like a giant charade. At this point, the only result of this unfounded witch hunt was to pull safe products off the shelves and inconvenience thousands of customers in New York. Meanwhile, the Food and Drug Administration has been incredibly silent during the whole affair, which should tell us a lot about the merits of this incursion."
 
Since the announcement this morning, GNC has restored its full assortment of Herbal Plus products to all GNC stores in New York State. ANd GNC has preserved the specific product lots of the five products that were the subject of the Attorney General's inquiry for use in defending the company against the lawsuits that have been filed subsequent to the NYAG’s Feb. 2 letter. 
 
"We appreciate GNC’s efforts to address the consumer confidence concerns that have been raised by this investigation. This agreement allows GNC to return its products to store shelves while appeasing the New York AG and subduing the class action litigation that has arisen in the wake of the faulty tests," Mister said. "However, federal law already requires dietary supplement manufacturers to adhere to good manufacturing practices, including meeting product specifications for identity, purity, strength and composition, and to perform ‘at least one appropriate test’ for the identification of raw materials. FDA, the federal agency charged with enforcing these requirements, does not require DNA barcode testing for plant identification of dietary supplements, nor does it use DNA sequencing by itself for identification of herbal extracts."
 
That's part of the problem, however. Attorney General Schnedierman questioned federal oversight of the dietary supplement industry. "We came into this sector and taken this approach because the federal regulatory regime is simply not good enough to protect American consumers," Schnedierman charged. 
 
Last month, Attorney General Schneiderman sent cease-and-desist letters to GNC, Target, Walgreens and Walmart, after a study commissioned by his office failed to detect identifiable genetic material for the plants depicted on the labels in most of the four retailers’ herbal supplement products. The study further detected DNA associated with plants not listed on the labels, as well as the presence of potential allergens. Earlier this month, joined by the Connecticut and Indiana state attorneys general and the Puerto Rico Secretary of Consumer Affairs, Attorney General Schneiderman formed a coalition to further investigate the business practices of the herbal supplement industry.
 
“This agreement provides stronger consumer protections for these GNC supplements and highlights the relative weak federal standards," said Indiana Attorney General Greg Zoeller, whose office is not party to today's agreement but is part of the multistate coalition. "Hopefully this will lead others in the supplement industry to follow suit and encourage the FDA to review the existing national standards that are currently in place that has resulted in attorneys general making efforts to ensure better consumer protections for dietary and herbal supplements."
 
“When it comes to consumer health, we expect companies to reach a high safety bar," Schneiderman said. "Without tests and safeguards, including those that rule out dangerous allergens, these supplements pose unacceptable risks to New York families. I urge all herbal supplements manufacturers and retailers to join GNC in working with my office to increase transparency and put the safety of their customers first.”
 
That transparency should cut both ways, Mister argued. "Despite widespread calls for transparency and compelling arguments that the DNA barcode testing is faulty, the New York AG’s office has refused to release its DNA barcode testing results," he noted. "The announcement further entrenches a state attorney general’s office in a regulatory matter in which it has no expertise and substitutes face-saving requirements for meaningful advancement of the industry.” 
 
"The federal regulations in place to oversee dietary supplements are more than adequate," Fabricant said. "While dietary supplements are considered food by the FDA, the dietary supplement cGMPs are far more rigorous than food cGMPs. The FDA has full regulatory authority over this industry, and when it finds an issue with a product, it takes action to protect the public health and remove the product from commerce. The actions by the New York attorney general set a dangerous precedent of state officials stepping on the toes of the federal government, and removing products from store shelves without having the adequate regulatory authority and proper scientific understanding to do so," Fabricant continued. "What’s more, NPA is concerned that these actions could lead to each state instituting its own identity testing standards, preempting federal authorities already in place. It may also set a precedent for class action lawsuits over a state requirement, which has neither federal support nor scientific merit when applied to botanical extracts and finished dietary supplement products."

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