Welcome to Jarrow Formulas

In a detailed Comment on the FDA’s Development of a List of Pre-DSHEA Dietary Ingredients (ODIs), Jarrow Formulas, Inc. offers a Modest Proposal for a Fast-track Notification system for “Middle-aged Ingredients,” and a Novel Approach for handling ODIs vs. NDIs, and NDI Notifications vs. GRAS status, based on several logical factors.

LOS ANGELES - December 7, 2017

On December 4, 2017, Jarrow Formulas, Inc. (JFI) filed a detailed Comment to FDA, expanding upon the presentations by JFIÂ’s food law regulatory attorneys, Susan Brienza, Esq., and Scott Polisky, Esq., at the FDAÂ’s October 3 Public Meeting on developing an ODI list, also attended by John OÂ’Connor, Manager, Technical Compliance and Support at JFI.

First, Jarrow Formulas disagrees that Sec. 8 of DSHEA in any way imposes a duty--on either the FDA or the supplement industry or both--to compile a list of "grandfathered" ingredients, but rather     supports the case-by-case determination of status by the developer or the manufacturer of a new dietary ingredient or new supplement. Nevertheless, if there is to be an ODI list, Jarrow is concerned with its content, its limitations, and overly restrictive burdens as to the type of evidence and documentation the Agency would demand as proof for ODI status.

Thus, in the firm's December 4, 2017 Comment to FDA re: Development of a List of Pre-DSHEA Dietary Ingredients (ODIs) Jarrow Rogovin (Founder and President of JFI) personally recommends a "novel approach" should the FDA create and consider such a list to be controlling: Rather than strict ODI vs. non-ODI distinctions, the Agency should adopt a graded process appropriate to the particular dietary ingredient, as follows.

*  If the ingredient is a probiotic, there are numerous endemic issues FDA should evaluate in any conclusion as to status, e.g., after safety screening for toxins and antibiotic resistance, a strain belonging to a “grandfathered” probiotic species should not be classified as an NDI; and a new fermentation medium does not create a new probiotic.

*  For the majority of dietary ingredients, in determining status and the appropriate level of scientific documentation, FDA should consider the specific source and type of the ingredient, as well as the number of years it has been on the market.

*  A simple extraction of a naturally-occurring constituent or component of a food should not bear the same NDIN burden as a non-food derived molecule, with the manufacturer of the ingredient extracted from a food freely able to avail itself of the Self-Affirmed GRAS process. For example, JFI’s position is that an ingredient such as Lycopene, a naturally-occurring constituent of the tomato, should not require an NDIN.

*  With a substance such as Astaxanthin, the status and thus regulatory burden would hinge on its origin, with the conclusion depending on whether it is sourced directly from algae, or from an indirect source, e.g., salmon, which consume algae.

*  By contrast, a substance not naturally-occurring in any food, but rather, a product of human metabolism, such as Melatonin, in most cases should require an NDIN if not on the market prior to October 15, 1994.

This Comment also analyzes the Agency’s troubling contradictory policy for one type of NDIs.  The FDA’s current position on supplements that contain synthetic ingredients is completely inconsistent with the Agency’s policy on food products that contain synthetic ingredients.  More specifically, the Agency’s treatment of the novel “Impossible Burger,” which contains a synthetic (indeed GMO) ingredient derived from soy, widely diverges from the Agency’s position on dietary supplements containing synthetic plant ingredients.  The discrepancy is not only demonstrated in the Agency’s varying responses concerning the GMO Impossible Burger (on the market in 43 restaurants despite a failed GRAS notice) and “bioequivalent” synthesized supplements, but extends to the Agency’s generally lax and purely voluntary policy on all GMO foods—clearly synthesized in a lab.

Finally, as stated at the October 3 Meeting, FDA should also consider our Proposal for “fast track”, simpler notifications for “middle-aged” ingredients—neither old nor new—defined being as on the market for five years or more. For post-DSHEA middle-aged dietary ingredients with a history of safe use in any country, the FDA should not require a full- blown NDIN with the attendant burdensome and expensive panoply of safety and toxicology tests currently recommended in the Revised Guidance.  Instead, a much more streamlined procedure, but one still providing the statutory (per Sec. 8 of DSHEA) safety standard for the new supplement (“reasonable expectation of safety”) should be permitted by FDA.

ABOUT JARROW FORMULAS

Jarrow Formulas is based in Los Angeles, California, and is a formulator, marketer, 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

Attachment:

Link to December 4, 2017 Comments to FDA

MEDIA CONTACT:

Scott Polisky, Esq., Regulatory Co-counsel

(917) 837-9600 or PoliskyLaw@aol.com