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| PATTON BOGGS LLP                          | 1660 Lincoln Street      |
|                                           |                          |
| ATTORNEYS AT LAW                          | Suite 1900               |
|                                           |                          |
| May 20, 2002                              | Denver, CO 80264         |
|                                           |                          |
|                                           | 303-830-1776             |
|                                           |                          |
|                                           | Facsimile 303-894-9239   |
|                                           |                          |
|                                           | www.pattonboggs.com      |
|                                           |                          |
|                                           | James R. Prochnow        |
|                                           |                          |
|                                           | 303-894-6123             |
|                                           |                          |
|                                           | j                        |
|                                           | prochnow@pattonboggs.com |
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### [VIA E-MAIL http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm]{.underline}

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| Dockets Management Branch (HFA---305)                                 |
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| Food and Drug Administration                                          |
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| 5630 Fishers Lane, rm. 1061                                           |
|                                                                       |
| Rockville, MD 20852                                                   |
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**Re: Comments of Jarrow Formulas, Inc. Docket No.: 02N-0062, New
Dietary Ingredient Pre-market Notification\--Procedures**

To Whom It May Concern:

Our law firm represents Jarrow Formulas, Inc. ("JFI"), 1824 S. Robertson
Blvd., Los Angeles, CA 90035-4317. JFI distributes dietary supplements
throughout the United States.

\[1\] We believe the collection of information by the FDA as required by
§413(a) of the Federal Food Drug and Cosmetic Act ("FFDCA") would be
quicker and more efficient if the FDA would, by the release of a draft
Level 1 guidance document, pursuant to 21 C.F.R. §10.115(g)(1)(ii) (C),
which allows input from the industry before the FDA implements that
guidance document, or by means of other non-binding policy
announcements, inform manufacturers and distributors of dietary
ingredients and dietary supplements ("the NDI submitters") of various
specific factors which it believes it can require, pursuant to 21 C.F.R.
§190.6(b)\["the Regulation"\], from those distributors or manufacturers
before a NDI notification can be fully processed.

Submitters routinely provide more information to the FDA as a part of
their NDI notifications, and the FDA routinely requests more information
from those submitters than appears to be required by the actual language
of the Regulation. The guidance document should include a segment which
should eliminate much of this "give and take by alerting manufacturers
and distributors of that information which should be included in their
initial notification. For example:

> \(A\) The guidance document should inform a potential submitter of
> whether it must or should submit a diagram or other molecular
> information about the precise chemical structure of the new dietary
> ingredient.
>
> \(B\) The guidance document should inform the reader of whether a
> chart or other protocol for summarizing side effects or adverse event
> reports concerning the use of the NDI should be included.
>
> \(C\) The guidance document should contain detailed information about
> the use of published articles or studies, whether published or not,
> which are, in whole or in part in a language other than English.

\[2\] In our judgment, the FDA appears to be requiring a standard of
proof of "other evidence of safety" which is higher or more rigorous
than that required by §413(b) of the FFDCA. The nature and quantity of
the information required by §413 (a)(2) and the implementing regulation,
21 C.F.R. §190.6 (b)(4) is largely dependent upon the FDA's
interpretation of the phrase "reasonably expected to be safe". What
evidence of safety results in a reasonable expectation of safety?

The Congress' choice of (i) "reasonable expectation of safety" rather
than "reasonable certainty of safety", "a conclusive basis" or other
more rigorous standards, (ii) language significantly different from that
which it chose when enacting the Food Additives Amendment of 1958, and
(iii) a notification rather than a pre-market approval protocol, are
strong indications of Congress' intent that the FDA should be using a
more flexible, less stringent standard for its assessment of safety of
NDIs than that which it uses for food additives or GRAS substances. In
addition, the three Congressional choices above suggest that the FDA has
an affirmative duty to recommend, in advance of any submissions, the
full scope of the type of evidence which the FDA expects will comprise
each such submission and, additionally, once a submission is made, what
additional evidence or type of evidence would cure an inadequate
submission, and result in the FDA not taking any action to prevent the
marketing of that NDI.

\[3\] JFI has the following practical suggestions for managing the early
stages of the procedure, "to enhance the . . . utility . . . of the
information to be collected" by the Agency for an evaluation of an NDI
Notification:

> \(A\) Assign a file number and a FDA contact person for each
> Notification.
>
> \(B\) Contact the submitter of the Notification with this information
> within 10 days of receiving the Notification.
>
> \(C\) Have the FDA contact person perform a preliminary review of the
> Notification, and respond to the submitter within 20 days if
> the Notification is deficient in some obvious way.
>
> \(D\) Provide affirmative suggestions or recommendations about the
> submission of additional evidence of safety in order for the FDA to
> complete its processing of the Notification and to decide that the
> proposed NDI has a reasonable expectation of safety.

In our judgment, the FDA's review of the NDI notifications should be
made in the context of DSHEA which, as set forth in the Congressional
findings in Section 2 of DSHEA, state that consumers are entitled to
have more access to more information about dietary supplements and
increased access to dietary supplements themselves.

Sincerely,

James R. Prochnow

James R. Prochnow

JRP:csp