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Jarrow Formulas And The International Probiotics Association Meet With FDA

In a productive meeting with the Office of Regulatory Affairs, DDSP and others after Expo East, Jarrow explained the need for ongoing future stakeholder meetings on key supplement industry issues.

LOS ANGELES -- October 26, 2015 -- Following a strongly critical letter from Jarrow Formulas to FDA's then-Acting Director Stephen Ostroff, M.D., regarding misrepresentations about the safety of probiotics for use with infants, the FDA's Deputy Director of CFSAN invited the company to meet with the agency.  Jarrow's letter had also been copied to numerous Senators, Congress members and press outlets.  Several weeks later, a delegation affiliated with Jarrow Formulas, Inc. (JFI), and led by Jarrow L. Rogovin, had a cordial and productive meeting with five officials from FDA at CFSAN headquarters in College Park, MD, on September 21, 2015.

The meeting concerned issues of importance to the dietary supplement industry:  probiotics, and in particular how this category will be handled by the Revised NDI Draft Guidance (now in progress), the recent revisions to California's Proposition 65 and its impact on supplements, and the need for FDA to be more forceful in publicizing enforcement actions against bad players who misrepresent their illegal products as dietary supplements.  At the end of the meeting, Ted Elkin, Deputy Director for Regulatory Affairs at CFSAN, had agreed in principle to the value of future public stakeholder meetings on these and other issues affecting the industry.

The JFI delegation was led by Jarrow L. Rogovin, President/Founder, Jarrow Formulas, Inc., and Chair of the Board/Founder, Jarrow Industries, Inc. (JII), and included:  Mohammad Khalid, Ph.D., President, JII; Silvano Arnoldo, Probiotic Consultant, JFI; George Paraskevakos, Executive Director, International Probiotics Association (IPA); and JFI's three regulatory attorneys, P. Scott Polisky, Susan D. Brienza, Ph.D., and Carol R. Brophy.

With Mr. Elkin moderating for the FDA,  the other officials from the FDA were: Robert Durkin, Esq., Acting Director, Division of Dietary Supplement Programs (DDSP); Cara Welch, Ph.D., Acting Deputy Director DDSP; David Shapinsky, Deputy Director for Communications and Public Engagement (OFVM); and Kari Barrett, Advisor for Strategic Communications and Public Engagement, (OFVM).  In his introductory remarks, Mr. Elkin stated that the goal of CFSAN is to elevate the Division to the level of an Office within CFSAN, and then filling the various high-level vacancies would have priority.  The agency views the change from Division to Office reflects the importance and role of the industry and would assist the agency in its own effort to have the industry seen by the public as being effectively regulated.

After brief introductions Jarrow Formulas summarized its history of involvement with legislation and regulation of the industry:  The industry’s first ever meeting between companies and the agency was organized by Jarrow Formulas in 1994.  The company actively lobbied to pass DSHEA and played the key role in what was written into the Act as the President's Commission on Dietary Supplements, which set forth the initial guidelines for the agency.  Jarrow Formulas was a leading voice in educating and creating industry support for the passage of the Serious Adverse Event Reporting Act and was the initiating co-founder of the International Probiotics Association.  Over the years, the company and its regulatory attorneys have propounded numerous FOIA Requests.

The first topic of concern was the FDA's Safety Alert of Dec. 9, 2014, linking a preterm baby's death to a probiotic supplement, and then cautioning health practitioners about use of probiotic supplements in all infants.  The JFI speakers presented evidence showing that an incomplete investigation led to an inaccurate Safety Alert, which should be removed from the Agency's website.  The facts and peer-reviewed science show that it was not the probiotic supplement, but rather the hospital environment itself which appeared to be the source of contamination, likely the ventilation system.

As to the entire probiotic category, both JFI and IPA urged that the revised NDI Guidance forthcoming should address Probiotics in harmony with both DSHEA and the high level of evidence of safety.  The group indicated its belief that the DDSP should consider the probiotic issues raised in 36 items concerning probiotics in Jarrow Formulas' September 2011 Freedom of Information Act request.  Of the 128 total Requests, two-thirds were answered by the FDA "We have searched our files and find no responsive information."  The International Probiotics Association's written meeting statement added it was in support of Jarrow Formulas’ FOIA Request regarding probiotics.

Of great interest and importance was the FDA informing the group that the next version of the NDI (New Dietary Ingredient Guidance) was going to be a Draft and not a Final Guidance.  Acting Deputy Director Dr. Cara Welch responded to Jarrow Rogovin’s questions that there would be another comment period as well.  The FDA's representatives indicated that there were hundreds of comments on the first draft including FOIA Requests, that were all being carefully considered and the process was taking a substantial amount of time.  The delegation thanked the officials for this information and expressed its appreciation for the agency's diligence.

The third issue concerned California's Safe Drinking Water and Toxic Enforcement Act, better known as "Prop 65," which sets allowable levels of heavy metals, drastically lower than those of the FDA or that state's own previous levels.  In particular, with the newly proposed lower thresholds for lead and other heavy metals to be permitted under an August amendment, Prop 65 will more dramatically affect both the supplement and food industries nationally and even worldwide.  As explained in detail by both an oral presentation and a lengthy detailed legal memorandum by Carol R. Brophy, Esq., Prop 65 poses a very real threat to the FDA's legal authority, especially as to the regulation of supplement quality.  The new standards will seriously disrupt interstate commerce and international trade.  The new state regulations conflict irreconcilably with federal law and policy and erodes FDA's congressional mandate.  The delegation stated a stakeholder meeting on the matter is urgently needed and should include the California Chamber of Commerce.

Jarrow Formulas applauded recent FDA enforcements against marketers promoting and selling adulterated and/or chemically spiked products including otherwise illegal drugs masquerading as dietary supplements that have resulted in jail sentences.  Jarrow urged the agency to take the next step and better publicize these enforcement actions and particularly the outcomes of criminal cases.  Failure to do so gives the misimpression that the industry is unregulated.

Mr. Rogovin noted that too often the FDA has remained silent in the face of the relentless drumbeat of misinformation and misconceptions about supplements and their regulation and that this silence needlessly damages the image of the industry as well.

The meeting ran overtime and ended on a positive note.  The dialogue then continued in informal one-on-one conversations after the formal agenda was over.  Overall, summarized Jarrow Rogovin, "The meeting was characterized by a spirit of welcoming and fostering dialogue between the Agency and the supplement industry, and both sides hope to keep the momentum of this open conversation going.  This is also a period of opportunity for the industry.  The Agency would be gratified by the industry supporting the elevation of the Division to an Office.  This is an historic opportunity for the industry to negotiate with the agency.  My company has accomplished a great deal, but other elements in the industry sector need to get creative, energized and involved."


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 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 company’s complete line of nutritional products includes vitamins, minerals, probiotics, standardized herbal concentrates, amino acids, enzymes and enteral nutrition products.  www.jarrow.com

List of Attachments:

Link to Oct. 15, 2015 follow-up letter to the FDA:  http://www.jarrow.com/eMarketing/Jarrow-Letter-to-FDA-Ted-Elkin-et-al-follow-up-to-Sept-21-2015-meeting.DOC


Rory Lipsky

Marketing Director, Jarrow Formulas, Inc.

(310) 204-6936 or 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.