LOS ANGELES—On behalf of Jarrow Formulas Inc., P. Scott Polisky, attorney at law, and Susan Brienza, Esq., Ryley Carlock & Applewhite, requested FDA extend the comment period for the New Dietary Ingredient (NDI) Draft Guidance from 90 days to one year. In an Aug. 29, 2011, letter to the agency, they said the Draft Guidance is too complex for such a short review time; further, they said the Draft Guidance seeks to rewrite the Dietary Supplement Health & Education Act of 1994 (DSHEA), and radically departs from previous FDA policy.
The letter contains 16 reasons why the comment period should be extended even further than the 45 extra days requested by five industry trade organizations.
In the letter, Polisky and Brienza stated the Draft Guidance is more complex than the Proposed Rule for Dietary Supplement Good Manufacturing Practices (GMP), which had a one-year comment period. And because it took 17 years to produce the Guidance, they said it is fair that industry and consumers have one year to respond. The letter contains 16 reasons the company believes the comment period should be extended, in part to allow Jarrow to properly analyze issues related to the following:
- FDA did not provide a report as to how the NDI Draft Guidance, if enacted, would affect the dietary supplement industry and the public health. To go along with this point, Polisky and Brienza said Jarrow is preparing a Freedom of Information Act Request (FOIA) to FDA regarding the impact of the proposed NDI Guidance, asking about cost, enforcement, public health effect and innovation impact. Jarrow will need time to review and analyze FDA’s response to these questions before it can properly submit comments, they argued.
- They said the Draft Guidance seeks to rewrite DSHEA, specifically Section 4 (safety and the burden of proof on FDA) and Section 8 (NDI definition).
- Like many in the industry, they took issue with the Draft Guidance requirement of an NDI notification (NDIN) for each and every supplement with an ingredient not marketed before Oct. 15, 1994. They say the intent of DSHEA was to require a NDIN for a new dietary ingredient, not finished products.
- They noted Joshua M. Scharfstein, Principal Deputy Commissioner of FDA, stated “Ingredients marketed in food prior to passage of DSHEA are not new dietary ingredients, and thus are grandfathered out of this requirement, as are many ingredients introduced into the food supply after 1994, such as those introduced for use in conventional foods," on May 26, 2010, to a committee on aging. They said this shows how the Draft Guidance departs from previous FDA thinking.
- They said the Draft Guidance is an “extreme and shocking" departure from FDA’s practice for addressing the safety of ingredients for conventional foods.
- The Draft Guidance suggests dietary supplements are not part of the food supply.
- The Draft Guidance is a departure from FDA’s 1997 Final Rule on Premarket Notification for a New Dietary Ingredient (62 FR 49826, September). “The cost to the supplement industry if the Draft Guidance is implemented would be radically higher than that estimated by FDA in its prior Final Rule," they wrote. Attorney Marc Ullman made this same point in his comments to FDA regarding the NDI Draft Guidance.
- The Draft Guidance fails to consider the cost of compliance, i.e., the monetary burden on industry and FDA, they said, adding the economic impact of the current draft guidance would be huge.
- They said requiring an NDIN where the same dietary ingredient already is marketed by another manufacturer is yet another inaccurate interpretation of DSHEA.
- Polisky and Brienza said genetically modified organism (GMO) foods—not new supplements—should be of concern for public health impact and safety issues; yet, they said the requirements for GMO foods and seeds “consist merely of a very weak premarket notification."
- The claim that FDA is concerned that new probiotics could contain pathogenic bacteria is an “ill-conceived concern," they said.
- Lastly, they said the Draft Guidance ignores the remarkable record of supplement safety.
