Jarrow Formulas, Inc. Files Comments Regarding NDIs and Tells FDA to Scuttle Draft Guidance

LOS ANGELES — December 12, 2011 — Jarrow Formulas, Inc. (JFI), a leading dietary supplement formulator and marketer, filed its Comments on the FDA’s NDI Notification Guidance, December 2, 2011, asserting that the NDI Draft Guidance is fatally flawed, contravenes established law, and would seriously damage the dietary supplement industry and consumer access.

In a targeted 45-page document JFI’s food and drug regulatory attorneys, Scott Polisky, Esq. and Susan Brienza, Esq., surgically dismantle the FDA’s latest assault on the supplement industry.  JFI’s Comments analyze several key issues including:

  1. Supplements have an extraordinary safety record when compared to every other FDA-regulated category; and thus, no justification exists for the Guidance’s claimed "concerns" about safety as a justification for “preventive controls.”

  2. With scant attention by FDA to NDIs or NDINs in the 17 years since DSHEA, and only 6 Warning Letters (all concerning a steroid precursor, androstenedione —not a dietary ingredient), why is FDA now attempting to scare consumers into believing that the Guidance is necessary for “preventive controls,” and using the pretext of "safeguarding the public health” for a Draconian pre-approval requirement?

  3. The Guidance contravenes established law, disregarding the expansive dietary supplement definition set forth in Section 3 of DSHEA, ignoring the safety standard and burden of proof requirement unambiguously expressed in Section 4, and attempting to rewrite the NDI provisions of Section 8 that without question demand that only a new dietary ingredient needs an NDIN, not every multi-ingredient supplement containing an NDI. Further, the Guidance seeks to subvert the clear dictates of 21 C.F.R. Sec. 190.6, the regulation enumerating the requirements for premarket notification of a new dietary ingredient.

  4. DSHEA clearly states that the proper standard for evaluating NDINs is "reasonable expectation of safety," with the burden of proof on FDA.  The unreasonable risk standard is appropriate only in a determination that a supplement is adulterated.   The risk/benefit analysis used in the Ephedra Rule—repeatedly invoked by Dr. Fabricant—is not applicable at all, and was actually used to ban a substance post-market, not to decide whether to simply “acknowledge” an NDI Notification.

  5. Probiotics are clearly dietary ingredients as defined by DSHEA, and have been shown to be safe and effective (in foods such as cheeses and yogurt, as well as in supplements).  There is no reason for the dramatic, radical reclassification of probiotics as biologics.  This would put probiotics out of reach as dietary supplements, while putting them in an illogical regulatory category where approval is all but impossible.

  6. The Guidance, if implemented in its current form, would devastate the supplement industry and further harm the U.S. economy.  The FDA failed to perform a proper economic impact analysis, while an analysis by an economics and law professor estimates up to $1 million as the cost of an NDIN, under the tests required by this Guidance.

“The comments submitted on behalf of JFI clearly show that the NDI Draft Guidance has been extremely low priority for 17 years; the FDA then worked under the 180-day Congressional mandate, and still didn’t get it right.” said attorney Susan Brienza. “The Draft Guidance does not merely guide the industry in the filing of a more complete NDI notification, but instead seeks to impose a new regulation.  To paraphrase Shakespeare, a rule by any other name is still a rule.”

“In submitting Comments to FDA, JFI told FDA that it reserves and indeed deserves the right to expand its Comments, if and when FDA responds in a substantial manner to JFI’s 128-item FOIA request,” said attorney Scott Polisky.  “The FOIA request, the right of every American, asked key questions that still remain unanswered.”  The FOIA was served on the FDA over three months ago and the FDA has to date declined to send the vast majority of the requested documents.

Jarrow Rogovin, founder of the company, stated:  “The Guidance goes directly against the grain of U.S. hopes and goals at this point in our history, and is truly an escort to the guillotine for the supplement industry and a gross violation and disrespect of the will of the American people.”

Jarrow Formulas, Inc., based in Los Angeles, California, is a formulator and marketer of superior nutritional supplements.  The company was founded in 1977; and today it sells its products in the U.S. 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.

Rory Lipsky
Marketing Director, Jarrow Formulas, Inc.
(310) 204-6936
*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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