December 13, 2011

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RCA Shareholder Comments on FDA's New Guidance for Supplements

Ryley Carlock & Applewhite Shareholder, Susan D. Brienza,  helped file a 45-page comment to the Agency. Those comments were recently mentioned in two different publications.  Read the accounts below.

Natural Products Insider 

New Hope 360

Jarrow: NDI Guidance is New Rule in Disguise
December 13, 2011

Posted in News,New Dietary Ingredients (NDIs),Government,Dietary Supplement Health & Education Act (DSHEA),Industry News,Food and Drug Administration (FDA),Botanicals,Probiotics
LOS ANGELES—Jarrow 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(JFI) joined the ranks of many other industry members that called for a rewrite of the New Dietary Ingredient (NDI) Draft Guidance, according to its filed comments. In it's current form, the company said the Draft Guidance is fatally flawed, contravenes established law, and would seriously damage the dietary supplement industry and consumer access.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 JFI's food and drug regulatory attorneys, Scott Polisky, Esq., and Susan Brienza, Esq., highlighted several issues from the Draft Guidance including:

Safety—Supplements 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compared to every other FDA-regulated category, the authors wrote; and thus, they said no justification exists for the Draft Guidance's claimed concerns about safety as a justification for preventive controls.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said FDA's Daniel Fabricant, Ph.D., has repeatedly invoked the Ephedra Rule to understand FDA's reasoning behind the Draft Guidance.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 Notification—Brienza 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.

Probiotics—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, 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 Analysis—The 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 Altered—The 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 Botanicals—Brienza 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) Lists—They 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 didn't 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." 

New Hope 360
Jarrow accuses FDA of 'stonewalling' on NDI guidance

Its FOIA request largely ignored, supplements maker Jarrow Formulas urges the agency to 'scuttle' NDI guidance

Dec. 12, 2011
Joysa Winter 

On Dec. 2, the formal comment period for the FDA's New Dietary Ingredient Guidance came to a close, and like a host of other companies and organizations, Jarrow Formulas filed its comprehensive comments.
But the Los Angeles supplements manufacturer is not happy about what it calls "stonewalling" by the federal agency.
On Sept. 8, the company filed a 128-item Freedom of Information Act (FOIA) request, but the agency never substantively responded to these inquiries, said Jarrow Formula's two attorneys, Susan Brienza and Scott Polisky. This refusal to answer Jarrow's questions can only be described as "stonewalling," the attorneys said.
Nonetheless, Jarrow Formulas filed a 45-page document commenting on the draft guidance by the Dec. 2 deadline. In summary, the manufacturer urged that the entire guidance be "scuttled" given its "complete contravention of DSHEA, and its misplaced and overstated arguments about 'safety.'"
Speaking to NewHope360, Polisky and Brienza summarized the company's views as follows:
 • The guidance does not merely "guide" the industry in the filing of a more complete NDI notification; instead it seeks to impose a new and unauthorized pre-approval scheme in total contravention of DSHEA.
• The guidance disregards the legal definition of a dietary supplement in Section 3 of DSHEA, the safety standard set forth in Section 4, and the clear dictates of the NDI provision in Section 8.
• The agency's attempt to apply a food additive-petition standard to supplements not only flouts the law, but ignores the remarkable safety record of supplements vis-à-vis other FDA regulated products.
In other words, "there was and is no need for this guidance," Polisky and Brienza said. "It should be withdrawn."
Jarrow wonders: Is FDA hiding details of NDI guidance?
Jarrow also made clear in its Dec. 2 filing that it reserves, "and indeed deserves the right" to file additional comments if the agency responds in any meaningful way to Jarrow's FOIA request.
"The FOIA request, the right of every American, asked key questions about FDA's assumptions and interpretations in crafting the guidance, questions that remained unanswered at the time of the Dec. 2 filing," Polisky explained.
According to Rory Lipsky, Jarrow's director of communications, the FOIA questions largely strived to understand the rationale for FDA's decisions. "How, for example, did the agency go from assuming that it would receive a mere 10-15 NDI notifications a year for novel new ingredients, to now stating that there are 55,000 products on the market that should require NDINs?"
In the 13 weeks following submission of the FOIA request, FDA produced only four items "technically" responding to these requests. They included mere copies of remarks that had already been made in the public domain, and were therefore "hardly illuminating," Brienza said.
Polisky has dubbed these responses to be "stonewalling."
Of more significance to Jarrow is the information the FDA failed to produce. For example, FDA told Jarrow that it has no earlier drafts of the guidance and no information on agency deliberations concerning the decision to contravene DSHEA, and to now consider any formulation, or even a minor change in a formulation, to be an NDI.
That, Polisky and Brienza state, is simply "unbelievable."
FDA failed to answer other requests
FDA has failed to answer other FOIA requests as well, such as the following:
 • How many products will likely wind up in the hands of the pharmaceutical industry, if at all, given that supplement ingredients are rarely patented? (Item 33)
• Has the agency considered how many supplement companies will go out of business if the guidance is implemented? (Item 34)
• Given the supplement industry's role in marketing scientific developments, such as the relationship between folic acid and neural tube birth defects, how would the guidance affect supplement innovation and affect the health of women and children? (Item 38)
• What is the basis for FDA's draconian view of probiotics? (Items 48-83)
• What documents show that ingredients or formulations that FDA would now regard as NDIs are toxic, unsafe or even constitute an unreasonable risk? (Items 96-97)
Not surprisingly, Jarrow Formulas joined the successful petition drive by Citizens for Health to collect over 12,000 petitions calling for Congress to withhold FDA appropriations until the agency withdraws the NDI Draft Guidance. Also, in September, President Jarrow Rogovin called on industry to form a new trade association to combat NDI guidance.