December 13, 2011
LOS ANGELESJarrow Formulas Inc. (JFI) joined the ranks of many other industry members that called for a rewrite of the New Dietary Ingredient (NDI) Draft Guidance, according to its filed comments. In it's current form, the company said the Draft Guidance is fatally flawed, contravenes established law, and would seriously damage the dietary supplement industry and consumer access. The company said the document is actually a new rule in the guise of a Guidance. It should be completely revised or rewritten as a proposed rule, the company argued.
The 45-page document, written by JFIs food and drug regulatory attorneys, Scott Polisky, Esq., and Susan Brienza, Esq., highlighted several issues from the Draft Guidance including:
SafetySupplements have an extraordinary safety record when compared to every other FDA-regulated category, the authors wrote; and thus, they said no justification exists for the Draft Guidances claimed concerns about safety as a justification for preventive controls. They also noted FDA has only issued six warning letters regarding NDI notifications (NDINs) in the 17 years since the Dietary Supplement Health and Education Act of 1994 (DSHEA, all concerning a steroid precursor, androstenedione not a dietary ingredient). They said this further shows preventative controls are not necessary.
They said DSHEA clearly states the proper standard for evaluating NDINs is "reasonable expectation of safety," with the burden of proof on FDA, not a risk-benefit analysis, which is used to ban supplements post market. They said FDA's Daniel Fabricant, Ph.D., has repeatedly invoked the Ephedra Rule to understand FDA's reasoning behind the Draft Guidance. The attorneys said The Ephedra Ban Preamble states FDA conducted a risk-benefit analysis using the "unreasonable risk" standard. The unreasonable risk standard is appropriate only in a determination that a supplement is adulterated, they reiterated, not for a NDIN. VIRGO's Jon Benninger explored this issue in a blog post.
Further, they noted DSHEA already provides FDA the opportunity to rapidly respond to a dangerous supplement as well as requires regulatory safeguards such as GMPs (good manufacturing practices) and adverse event reports (AERs).
Supplement vs. Ingredient NotificationBrienza and Polisky argued the Draft Guidance contravenes established law by attempting to rewrite the NDI provisions of DSHEA's Sec. 8 that requires a NDIN for every NDI not every multi-ingredient supplement containing an NDI. Further, they said the Draft Guidance seeks to subvert the dictates of 21 C.F.R. Sec. 190.6, the regulation enumerating the requirements for premarket notification of a new dietary ingredient.
ProbioticsProbiotics 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, they wrote. They noted some probiotics have even been accepted by FDA as GRAS (generally recognized as safe), which has a higher safety threshold than dietary supplements. They said the reclassification of probiotics as biologics is unreasonable and would put probiotics out of reach as dietary supplements, while putting them in an regulatory category where approval is all but impossible.
Economic AnalysisThe Draft Guidance, if implemented in its current form, would devastate the supplement industry and further harm the U.S. economy, Brienza and Polisky said. They also said FDA failed to perform a proper economic impact analysis, while they said an analysis by an economics and law professor estimated up to $1 million as the cost of an NDIN, under the tests required by this Draft Guidance.
Chemically AlteredThe attorneys said FDA vastly expands the definition of chemical alteration in the Draft Guidance so that far more ingredients must be subject to FDA "approval." They said the agency does this without legal authority. They took particular issue with the fact that "nanotechnology" is not defined in the Draft Guidance, yet the document said any application of it that changes chemical properties triggers an NDI.
Synthetic BotanicalsBrienza and Polisky called FDA's assertion that synthetic botanicals are not dietary ingredients "is absurd" and has "no basis whatsoever" in the language of DSHEA or science.
Old Dietary Ingredient (ODI) ListsThey said it is "inconceivable" to dismiss all industry grandfathered lists that showed ingredients that were on the market prior to DSHEA's passing and thus do not require NDINs. They said many of these lists were backed by solid evidence.
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 didnt get it right," Brienza said. 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. "
Polisky added that JFI deserves the right to expand its comments, if and when FDA responds in a substantial manner to its 128-item Freedom of Information Act (FOIA) request, which was filed to FDA on Sept. 8, 2011. The FOIA request challenged certain assumptions and interpretations in Draft Guidance; solicited certain documents; and asked a number of questions regarding an NDI definition, probiotics and costs.
The FOIA request, the right of every American, asked key questions that still remain unanswered." JFI said FDA has only sent four "meager" responses to the company regarding the FOIA request, and said the agency has given no answers of substance. The submitted comments said FDA's lack of a response to the FOIA request was one of the reasons the company asked for a one-year comment period, a request that was not granted by FDA. JFI said it cannot fully submit comments until FDA adequately responds to the FOIA request.
Jarrow Rogovin, founder of the company, stated: The [Draft] 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."
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