In Brief
This article was originally published in The Tan Sheet
Natural Health Team makes illegal drug claims
Supplement maker Natural Health Team makes claims for 14 products that cause them to be drugs, FDA’s New Orleans district office says in a Dec. 28 warning letter. The agency reviewed the firm’s website and book, “A Physician’s Guide to Natural Health Products That Work,” and found claims including “Omega 3 fatty acids have the ability to make blood less likely to clot thus warding off heart attacks and strokes” and “Autism and schizophrenia have been helped by [Nanonized Detoxifying Formula].” The products also are misbranded because they are intended for the treatment of diseases not amenable to self-diagnosis, FDA adds in the letter to the Lacombe, La., firm.
Prestige floats $290M note for GSK brands
Prestige Brands Holdings Inc. will conduct a private placement offering of $290 million in unsecured notes. The debt, due in 2020, will help pay for the $600 million acquisition of 17 OTC brands from GlaxoSmithKline Inc. (Also see "Prestige Acquires 17 Glaxo OTC Brands, Enters Analgesics Market" - Pink Sheet, 2 Jan, 2012.). The Irvington, N.Y. firm also will take on additional secured bank debt.
LTS Nutraceuticals acquires firms
Nutritional and personal care manufacturer LTS Nutraceuticals acquires Biocalth International, Giantceuticals and HerbSource Enterprises, the firm announces Jan. 19. The combined businesses will manufacture nutraceuticals in the U.S. for sale in Asia and Europe, the Ft. Lauderdale, Fla., firm added. The acquisition of Biocalth gave LTS entry into the Asian market and the opportunity to market Biocalth’s bone health products to the U.S., CEO Jerry Rayman said in a release.
Rexall recalls product after mix-up
Rexall Inc. recalls one lot of Rexall Calcium 1,200 mg plus 1,000 IU Vitamin D3 softgels after the product was mixed up with another. The bottles actually contain Triple Strength Glucosamine Chondroitin and MSM tablets, which may contain trace amounts of undeclared shellfish because glucosamine is derived from crustacean shells, the firm announced Jan. 16. The affected lot was sold at Dollar General stores in 38 states. No adverse events have been reported. Deerfield Beach, Fla.-based Rexall is conducting an internal review to determine the cause of the mix-up.
Rep. Mack calls for FDA oversight of Novartis
Rep. Mary Bono Mack is “outraged at the lack of leadership shown by FDA” in dealing with the product mix-ups and recalls of OTCs by Novartis Consumer Health Inc., the California Republican says in a letter to FDA Commissioner Margaret Hamburg Jan. 17. The agency should have recalled Novartis products on Dec. 16, the same day the firm closed the affected Nebraska facility, Bono Mack writes. Prescription products that may have been mixed up with OTCs still have not been recalled, she notes. The agency’s management of inspections “further demonstrates the lack of predictability and consistency in interactions with manufacturers, and emphasizes the need for more FDA oversight,” she concludes. Novartis Jan. 8 recalled several OTCs that may be chipped, broken or mixed-up, but did not recall any of the Rx products that also may be mixed up (Also see "Novartis Opts For OTC Recall, With J&J/McNeil Lessons Still Fresh" - Pink Sheet, 16 Jan, 2012.).
CHPA names scientific directors
John Punzi becomes director of quality assurance and technical affairs at the Consumer Healthcare Products Association, where he will coordinate the annual Product Quality and Operations Workshop and act as liaison between industry and the U.S. Pharmacopeia for the monograph modernization initiative. The trade group also announces Jan. 16 Jay Sirois is the new director of regulatory and scientific affairs. He comes from the regulatory consultancy Pharmaceutical Development Group. Punzi, a veteran of the Department of Agriculture, and Sirois replace Rachael Roehrig and Heinz Schneider, who departed CHPA in 2011. The new hires report to VP of Scientific and Regulatory Affairs Barbara Kochanowski (Also see "People In Brief" - Pink Sheet, 12 Sep, 2011.).
Resveratrol researcher faked data
Scientific evidence continues to support the heart health benefits of resveratrol despite the recent revelation that a leading researcher of the compound was found guilty of fabricating data. The University of Connecticut Health Center found Dipak Das, a professor in its cardiovascular research center, guilty of 145 counts fabricating and falsifying data. The three-year investigation found “numerous examples of data manipulation which were not described in those papers.” The university launched the investigation in response to an anonymous tip, and says it will dismiss Das and remove his tenure. Das claims in a 2010 letter to the investigating committee that racism motivated the investigation. Das received a $100,000 grant from the National Institutes of Health to study resveratrol, the remainder of which the university declines to accept (Also see "NIH Grant" - Pink Sheet, 5 Jan, 2004.).
Fines, probation given for spiked supplements
Two firms are sentenced to fines and probation after earlier pleading guilty to selling synthetic anabolic steroids as dietary supplements. Advanced Muscle Science was fined $125,000 and must implement a testing protocol to screen for steroids in its products. R&D Holdings was fined $21,000 and may not manufacture or distribute supplements or drugs for two years from the Jan. 17 sentencing. The sentences are in line with recommendations in the firms’ November 2011 plea agreements (Also see "Regulatory News In Brief" - Pink Sheet, 21 Nov, 2011.).