Jarrow Formulas Sends Letter To Acting Commissioner Ostroff
LOS ANGELES – August 10, 2015 – Jarrow Formulas®, a 38 year old dietary supplement formulator and supplier, sent Acting FDA Commissioner Stephen Ostroff, MD a letter requesting the agency properly investigate the October 2014 death of an infant due to a fungal contaminated probiotic supplement. Jarrow Formulas urges the agency not to repeat its irresponsible handling of the Total Body and Wright Lab selenium incident that took place in 2008. The agency did not investigate the 2008 incident and Jarrow Formulas is concerned the agency appears not to have investigated the October, 2014 death of an infant, but rather attempted to attack the probiotic industry in a December 9, 2014 press release:
http://www.fda.gov/downloads/BiologicsBloodVaccines/SafetyAvailability/UCM426233.pdf
Jarrow Formulas has a long history of actively advocating on behalf of the dietary supplement industry, and most recently rebutted the use of and reliance on DNA barcoding. "We are now asking FDA to do a proper and necessary investigation into all ingredients and facilities to uncover the cause of the contamination," says Jarrow Rogovin, President of Jarrow Formulas. "Since the true cause of the contamination has not been discovered, we want to know what the Agency is doing to enforce its own GMP requirements, as opposed to just issuing a safety alert and diminishing the credibility of the dietary supplement industry."
Mr. Rogovin also points out that a similar scenario in which the agency neglected to investigate both a manufacturer and a lab occurred in 2008 and there were several near deaths and some permanent injuries due to overdoses of selenium. "We donÂ’t want a repeat of the Total Body incident," says Mr. Rogovin. "We just want the Agency to enforce its own regulations."
Jarrow FormulasÂ’ products can be found at fine health shops and vitamin stores nationwide. For more information, please visit www.jarrow.com.
Updates:
The FDA sent a letter dated August 7, 2015, the State Attorneys General and Greg Zoeller and Eric Schneiderman, respectively of Indiana and New York, who were attempting a broad attack on the supplement industry. Consistent with positions expressed in the widely circulated response of Jarrow Formulas, including copies to the relevant heads of the FDA, the agency wrote the attorneys general that the agency has issued cGMPs regulations, 21 CFR 111, and that there no need of further regulation, nor, implicitly, interference or grandstanding by the two attorneys general.
Chalk up one for the majority of the industry, which is adhering to the GMP regulations.
August 10, 2015, in response to Jarrow Formulas letter to Acting Commissioner Stephen Ostroff, M.D., Ted Elkin, Deputy Director for Regulatory Affairs, Center for Food Safety and Applied Nutrition of the FDA, inviting Jarrow Formulas to arrange for a meeting with his office. Jarrow Formulas has invited George Paraskevakos, Executive Director of the International Probiotic Association, and others to attend along with Jarrow FormulasÂ’ food and drug regulatory counsel P. Scott Polisky, Esq. and Susan D. Brienza, Esq.
ABOUT JARROW FORMULAS
Jarrow Formulas is based in Los Angeles, California, and is a formulator and supplier of superior nutritional supplements. The company was founded in 1977 and today it markets its products in the United States and throughout the world. Jarrow Formulas' goal is to promote optimal health based on sound scientific research data. The companyÂ’s complete line of nutritional products includes vitamins, minerals, probiotics, standardized herbal concentrates, amino acids, enzymes and enteral nutrition products. www.jarrow.com.
JARROW FORMULAS, INC. MEDIA CONTACT:
Rory Lipsky
Senior Director of Business Strategy, Jarrow Formulas
(310) 204-6939
rory@jarrow.com
http://www.fda.gov/downloads/BiologicsBloodVaccines/SafetyAvailability/UCM426233.pdf
Jarrow Formulas has a long history of actively advocating on behalf of the dietary supplement industry, and most recently rebutted the use of and reliance on DNA barcoding. "We are now asking FDA to do a proper and necessary investigation into all ingredients and facilities to uncover the cause of the contamination," says Jarrow Rogovin, President of Jarrow Formulas. "Since the true cause of the contamination has not been discovered, we want to know what the Agency is doing to enforce its own GMP requirements, as opposed to just issuing a safety alert and diminishing the credibility of the dietary supplement industry."
Mr. Rogovin also points out that a similar scenario in which the agency neglected to investigate both a manufacturer and a lab occurred in 2008 and there were several near deaths and some permanent injuries due to overdoses of selenium. "We donÂ’t want a repeat of the Total Body incident," says Mr. Rogovin. "We just want the Agency to enforce its own regulations."
Jarrow FormulasÂ’ products can be found at fine health shops and vitamin stores nationwide. For more information, please visit www.jarrow.com.
Updates:
The FDA sent a letter dated August 7, 2015, the State Attorneys General and Greg Zoeller and Eric Schneiderman, respectively of Indiana and New York, who were attempting a broad attack on the supplement industry. Consistent with positions expressed in the widely circulated response of Jarrow Formulas, including copies to the relevant heads of the FDA, the agency wrote the attorneys general that the agency has issued cGMPs regulations, 21 CFR 111, and that there no need of further regulation, nor, implicitly, interference or grandstanding by the two attorneys general.
Chalk up one for the majority of the industry, which is adhering to the GMP regulations.
August 10, 2015, in response to Jarrow Formulas letter to Acting Commissioner Stephen Ostroff, M.D., Ted Elkin, Deputy Director for Regulatory Affairs, Center for Food Safety and Applied Nutrition of the FDA, inviting Jarrow Formulas to arrange for a meeting with his office. Jarrow Formulas has invited George Paraskevakos, Executive Director of the International Probiotic Association, and others to attend along with Jarrow FormulasÂ’ food and drug regulatory counsel P. Scott Polisky, Esq. and Susan D. Brienza, Esq.
ABOUT JARROW FORMULAS
Jarrow Formulas is based in Los Angeles, California, and is a formulator and supplier of superior nutritional supplements. The company was founded in 1977 and today it markets its products in the United States and throughout the world. Jarrow Formulas' goal is to promote optimal health based on sound scientific research data. The companyÂ’s complete line of nutritional products includes vitamins, minerals, probiotics, standardized herbal concentrates, amino acids, enzymes and enteral nutrition products. www.jarrow.com.
JARROW FORMULAS, INC. MEDIA CONTACT:
Rory Lipsky
Senior Director of Business Strategy, Jarrow Formulas
(310) 204-6939
rory@jarrow.com
*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
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*These statements have not been evaluated by the Food and Drug Administration. This product is
not intended to diagnose, treat, cure or prevent any disease.
