Jarrow Challenges FDA Positions On Probiotics
In a 32-page Comment to the Revised NDI Guidance focusing solely on Probiotics, Jarrow Formulas opposes many of FDA’s positions, agrees with many positions of the International Probiotics Association, and urges another revision of the Guidance to comport with DSHEA. Indeed Dr. Gottlieb, the new FDA Commissioner has committed that he would enforce DSHEA “as intended by Congress.”
LOS ANGELES—May 23, 2017—Recently Jarrow Formulas, Inc. (Jarrow or JFI) filed a 32-page Comment to FDA, challenging the legality and lack of scientific basis for many of FDA’s radical departures from DSHEA on probiotics (called “live cultures” by the Agency) articulated in its 2016 Revised Draft Guidance on New Dietary Ingredients (NDIs). In particular, JFI has concerns that the Guidance seeks to limit what qualifies as a probiotic, by restricting the variety of probiotics. Jarrow’s latest Comment supplements the firm’s extensive December 12, 2016 Comment on the Revised Guidance in general, emphasizing that it is at odds with DSHEA, with applicable regulations, and with prior FDA policies and statements, in essence imposing a new and unauthorized pre-approval scheme for dietary supplements. Both Comments were co-authored by Jarrow’s two regulatory attorneys, Susan Brienza and Scott Polisky.
First, Jarrow is concerned with FDA’s classification of probiotics. In both its first 2011 Draft Guidance and its 2016 Revised Draft Guidance on NDIs, FDA omits the term probiotic and refers only to “live cultures” and “live organisms,” stressing the possible risks from “harmful pathogens,” and creating unease as to how the Agency intends to regulate the category in the future. This is troubling as probiotics are clearly dietary ingredients within the statutory definition of a dietary supplement, FDA historically has considered them as such, and the Agency’s own pronouncements and those of scores of scientists including Nobelists have recognized their safety and value to human health. Founder and President Jarrow L. Rogovin states: “The fact that the FDA has not defined Probiotics is not a reason to limit their development. They are indeed part of human ‘usual food and drink.’ The Agency’s problematic avoidance of the science in attempting to redefine the category of probiotics would eviscerate the Act of its quintessential term ‘Supplement’ and the kaleidoscopic subtleties of the term ‘dietary.’”
Second, Jarrow urges the Agency to act on the basis of sound, current science. While FDA has repeatedly described itself as a “science-based Agency,” many of the terms, specifics, background and underpinnings of its Revised Guidance, and especially the discussion of probiotics or “live cultures,” seem divorced from the current science of microbiology, gastroenterology, gynecology, immunology, food science, etc. In this regard, Jarrow challenges numerous specific Guidance positions. One such unacceptable stance, for instance, is that each new fermentation medium will produce a new probiotic and thus require an NDI Notification. This is illogical, as a change in fermentation medium does not alter the genetics of the microorganism (changing to a diet of sushi and tempura does not turn an Italian man into a Japanese man); and thus does not in any way change its safety profile.
Third, Jarrow concurs with many of the positions of the International Probiotics Association (IPA) detailed in its December 9, 2016 Comment to FDA. For example, Jarrow agrees that DSHEA does not require the industry to compile or produce a “Grandfathered List” of pre-DSHEA dietary ingredients, as the Guidance would require. Nonetheless, Jarrow concurs with the list of over 40 well-established species that IPA provided to FDA in its Comment--a list of grandfathered species known to have a long, safe history of use in foods. After being screened for toxins and antibiotic resistance, a strain belonging to such species would be considered as safe. Contrary to FDA’s position, any strain of a grandfathered species should be considered safe as well with no need for an NDIN
In sum, the Guidance contains many provisions that flout regulatory law, contemporary science, and common sense. Clearly, the Guidance, if final, would dramatically and negatively impact how new and existing probiotics are regulated, developed, and manufactured in the future, contradicting the long history of safe use of various probiotics in foods, Sections 2, 3, and 8 of DSHEA, FDA’s prior policy and officials’ statements, FDA’s own GRAS letters, and the Agency’s desire and claim to be “science-based.” Jarrow urges FDA to go back to the drawing board and revise the Guidance once more.
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 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.