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Nonetheless, Jarrow Formulas filed a 45-page document commenting on the draft guidance by the Dec. 2 deadline.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 "It should be withdrawn.”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.