HEALTH

NY AG’s office affirms GNC supplements in full compliance with FDA regs

BY Michael Johnsen

PITTSBURGH — GNC Holdings on Monday announced that it has reached an agreement with the New York Attorney General regarding the company’s Herbal Plus products. The agreement affirms that the relevant GNC products were in full compliance with the federal Food and Drug Administration “Current Good Manufacturing Practices” and acknowledges GNC’s full cooperation with the Attorney General’s inquiries.
 
“As our testing demonstrated, and this agreement affirms beyond any doubt, our products are not only safe and pure but are in full compliance with all regulatory requirements,” said Michael Archbold, CEO GNC. “A robust testing regime, careful sourcing regimen and detailed manufacturing specifications have always been core elements to ensuring that we provide our customers with high quality products. Our customers trust and value our products, and we are steadfastly committed to maintaining that trust and confidence. As an industry leader we have always gone above and beyond the minimum requirements in pursuing quality for our consumers, and we will continue to lead the efforts for higher standards. This is good for consumers, good for the industry and good for GNC.” 
 
"GNC’s deal with the NYAG successfully turns a lingering negative into a positive, in our view," noted Sterne Agee analyst Charles Grom. "To this end, the lifting of the C/D order/subsequent ability to re-stock Herbal Plus items on GNC shelves in N.Y. is certainly welcomed news. More importantly, however, we think GNC’s leadership in raising testing standards should garner positive media attention; improve consumers’ confidence in GNC products; and placate regulators, which should result in a more benign regulatory/headline risk environment." 
 
In its response to the NYAG’s inquiry, and as highlighted in the agreement, GNC provided the results of rigorous tests conducted both internally and by independent third parties. These tests provided conclusive evidence that GNC’s products are safe, pure, properly labeled and in full compliance with all regulatory requirements. The testing also demonstrated that the company’s products contain all herbal extracts listed on their respective labels. In addition, a former senior FDA GMP expert performed a comprehensive review of GNC’s manufacturing processes for the products at issue and found them to be in compliance with all applicable requirements. Accordingly, GNC has restored its full assortment of Herbal Plus products to all GNC stores in New York State. 
 
GNC has preserved the specific product lots of the five products that were the subject of this inquiry for use in defending the company against the lawsuits that have been filed subsequent to the NYAG’s Feb. 2 letter, despite the fact that there is no prohibition against the sale of such products. The company believes these lawsuits are completely without merit and will defend itself aggressively. Identical products to those that have been preserved remain available for sale to consumers at GNC stores in New York State. 
 
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CHPA: Kentucky bans sale of DXM to minors

BY Michael Johnsen

WASHINGTON — The Consumer Healthcare Products Association on Thursday welcomed Kentucky legislation that prohibits the sale of OTC medicines containing dextromethorphan to minors, enacted last week. 
 
“CHPA extends our gratitude to Gov. [Steve] Beshear, the bill sponsors – Reps. [Fitz] Steele, [Tim] Couch and [Sal] Santoro – and Kentucky Senate Judiciary Chairman Whitney Westerfield  for being leaders in the fight against teen cough medicine abuse,” stated Scott Melville, CHPA president and CEO. 
 
“When this law goes into effect, Kentucky will be the seventh state to address this problem by limiting teen access," he said. "Along with ensuring that teens will no longer be able to purchase these medicines with the intent to abuse them, this law will also help generate more parental and community awareness of dextromethorphan abuse. Often, this behavior flies under the radar, but thankfully this will not be the case in Kentucky once this law is enacted.”
 
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CRN supports FDA with ban on bulk sale of caffeine to consumers

BY Michael Johnsen

WASHINGTON — The Council for Responsible Nutrition on Thursday announced an update to its recommended guidelines for caffeine-containing dietary supplements that discourages the marketing and sale of powdered pure caffeine directly to consumers.
 
“Our member companies are taking responsible steps to protect consumers,” said Steve Mister, president and CEO, CRN, "by following the advice of the Food and Drug Administration and asking the industry to support the agency’s consumer advisory that warns of safety concerns for consumers purchasing powdered pure caffeine in bulk. Even though our member companies do not sell this ingredient directly to consumers, as industry leaders we are demonstrating support for FDA’s efforts and urging the entire industry to do the same.”
 
CRN has added a section to its caffeine guidelines specifically calling on its members not to market powdered pure caffeine to consumers. The addition clarifies that it is not intended to limit marketing or selling of powdered pure caffeine in bulk form as a business to business transaction.
 
“Caffeine is one of the most studied and safest ingredients on the market. Powdered pure caffeine itself is a legal and legitimate ingredient for ingredient suppliers to sell to manufacturers who understand how to appropriately measure and formulate it at safe levels to be used as an ingredient in finished dietary supplement products,” Mister said. “But for consumers, there’s no legitimate use for powdered pure caffeine, and given its very high concentrated form, there’s a real potential safety issue.”  
 
According to FDA’s December 2014 consumer advisory, these products “are essentially 100% caffeine,” with “a single teaspoon of pure caffeine [being] roughly equivalent to the amount in 25 cups of coffee.”
 
CRN’s updated recommended guidelines for caffeine-containing dietary supplements are available on the association’s website. The original guidelines were released in April 2013 and included recommendations on disclosure of total caffeine content; label advisories for conditions of use; serving size and daily intake recommendations; and restraints against marketing in combination with alcohol. CRN members were expected to comply within 12 months of its release. Today’s update is effective immediately. 
 
CRN’s science-based guidelines on caffeine-containing dietary supplements have been developed as part of the association’s self-regulatory initiatives. CRN also has recommended guidelines for iodine in multivitamin/mineral supplements for pregnancy and lactation; and for labeling of protein in dietary supplements and functional foods; as well as best practices for enzyme dietary supplement products.
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