+-------------------------------------------+--------------------------+
| PATTON BOGGS LLP                          | 1660 Lincoln Street      |
|                                           |                          |
| ATTORNEYS AT LAW                          | Suite 1900               |
|                                           |                          |
| September 13, 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.fda.gov/dockets/ecomments**

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| Dockets Management Branch (HFA---305)                                 |
|                                                                       |
| Food and Drug Administration                                          |
|                                                                       |
| 5630 Fishers Lane, rm. 1061                                           |
|                                                                       |
| Rockville, MD 20852                                                   |
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**Re: Comments of Jarrow Formulas, Inc. and Jarrow Industries, Inc. for
Docket No.: 02N-0209, On First Amendment Issues**

To Whom It May Concern:

Our law firm represents Jarrow Formulas, Inc. ("JFI"), 1824 S. Robertson
Blvd., Los Angeles, CA 90035-4317, and Jarrow Industries, Inc., 12246
Hawkins Street, Santa Fe Springs, CA. 90670-3365 ("JII"). Throughout
this document, these two companies shall be referred to, collectively,
as "Jarrow." JII manufactures and packages dietary supplements for JFI,
formulates dietary supplements and does contract manufacturing for other
dietary supplement companies. JFI markets and distributes dietary
supplements throughout the United States.

These Comments concern commercial speech as it relates to dietary
supplements, and focus on structure/function claims only. In terms of
the nine questions that the Agency posed in its Notice of May 13, 2002,
these Comments focus on the last two questions:

> 8\. Do FDA's speech-related regulations advance the public health
> concerns they are designed to address? Are there other alternative
> approaches that the FDA could pursue to accomplish those objectives
> with fewer restrictions on speech?
>
> 9\. Are there any regulations, guidance, policies, and practices the
> FDA should change, in light of governing First Amendment authority?

SUMMARY AND SUGGESTIONS FOR THE FDA

\[1\] The FDA should take an expansive view of compliance, due to the
recent application of principles of the First Amendment to commercial
speech, when reviewing documented mechanism claims for dietary
supplements and when applying 21 C.F.R. § 101.93 to dietary supplement
claims. This policy will result in the interpretation of fewer claims
and more Agency and industry resources being devoted to genuine safety
issues and in the case of industry, to research and development of new
products and new claims for existing products. Interpreting documented
mechanism structure-function claims as implied disease claims or drug
claims, as the FDA has done, for example, with the Jarrow claim
"reducing platelet aggregation," is an impermissible restriction on
commercial speech and should be rectified either through an amendment to
the Final Rule \["the Regulation"\] on structure/function claims or via
a new policy statement. [See]{.underline} 65 Fed. Reg. 999 (Jan. 6,
2000) ("Final Rule"). Our position is that a less restrictive posture
concerning documented mechanism type structure/function claims increases
information and education for consumers about dietary supplements
without jeopardizing or compromising the health and safety of the public
or the First Amendment.

\[2\] The FDA's extensive structure-function regulation directly and
adversely impacts commercial speech because manufacturers and
distributors of dietary supplements are \[i\] prohibited from
transmitting truthful labeling information about individual dietary
ingredients and the combination of them to consumers and \[ii\]
"chilled" in their choices of the information which does get transmitted
to consumers on product labels and other labeling. Jarrow recognizes the
duty of the FDA to comply with all of the provisions of Section 6 of
DSHEA and Congress' intent and statutory design of the differentiation
between drugs and foods, including dietary supplements. Jarrow, however,
passionately and vigorously believes that the FDA has gone completely
overboard in its enthusiastic effort to restrict the Congressionally
mandated benefits of DSHEA and, due to that exuberance, has promulgated
impermissible provisions of the Regulation which are inconsistent with
the First Amendment as reflected by the [Western States
Pharmacy]{.underline} case and many of the cases which preceded it.

\[3\] The FDA Regulation should be amended as follows:

Current 21 C.F.R. § 101.93(g)(2) should be deleted and it should consist
of the following:

\(i\) All implied claims shall include the following or similar language
which shall immediately follow the disclosure language required by
Section 6 of DSHEA and 21 C.F.R. § 101.93(c)(1):

> "This does not imply that this product can cure, treat, prevent or
> mitigate any disease. Only a drug can do that.
>
> OR
>
> No effect on any disease is implied or has been authorized by the FDA.
>
> OR
>
> Only a drug can prevent, cure or treat a disease. This product is not
> a drug."

\(ii\) An implied claim is one which does not include a disease by name.

(iii The inclusion of the above disclosure on labeling creates a
rebuttal presumption that the statement is not an implied disease claim.

STATEMENT OF THE PROBLEM

Too often, the FDA concludes that claims which are within the documented
mechanism class of structure/function claims are implied disease claims
which result in "courtesy letters" and Warning Letters. An exemplary
case is the courtesy letter which Jarrow received from the FDA, dated
September 8, 2000; it cites the following claims:

> **Ginkgo biloba**
>
> ". . . increased cerebral circulation . . ."
>
> **CogniFlex**
>
> "Age associated cognitive decline (AACD) and compromised brain
> function . . ."
>
> **Vinpocetine**
>
> "By reducing platelet aggregation Vinpocetine increases blood flow to
> the brain . . ."
>
> **Lutein**
>
> "protect the macula from degeneration . . ."

For all of these claims, the FDA's determination was that:

> 21 U.S.C. 343(r)(6) makes clear that a statement included in labeling
> under the authority of that section may not claim to diagnose,
> mitigate, treat, cure, or prevent a specific disease or class of
> diseases. The statements that you are making for these products
> suggest that they are intended to treat, prevent, cure, or mitigate
> diseases. These claims do not meet the requirements of 21 U.S.C.
> 343(r)(6). These claims suggest that these products are intended for
> use as drugs within the meaning of 21 U.S.C. 321(g)(1)(B), and that
> they are subject to regulation under the drug provisions of the Act.
> If you intend to make claims of this nature, you should contact the
> FDA's Center for Drug Evaluation and Research (CDER), Office of
> Compliance, HFD-310, 7520 Standish Place, Rockville, Maryland 20855.

These and similar documented mechanism claims should not be deemed to be
implied drug or disease claims, in light of DSHEA and recent case law
concerning commercial speech.

STATUTORY AND REGULATORY FRAMEWORK FOR S/F CLAIMS

I. The Findings Behind DSHEA

Section 2 of DSHEA, Congressional Findings, states that dietary
supplements, in general, have a disease prevention value to the American
public:

\[3\]\[A\] there is a link between the ingestion of certain nutrients or
dietary supplements and the prevention of chronic diseases such as
cancer, heart disease, and osteoporosis; and

\[B\] clinical research has shown that several chronic diseases can be
prevented simply with a healthful diet, such as a diet that is low in
fat, saturated fat, cholesterol, and sodium, with a high proportion of
plant-based foods;

\[4\] healthful diets may mitigate the need for expensive medical
procedures, such as coronary by-pass surgery or angioplasty;

Congress, in Section 2, also emphasized that a main purpose of DSHEA is
the education of the American public about the benefits of supplements.
Significantly, in the Findings of Section 2, Congress links disease
prevention, education, and consumer choices:

\[8\] consumers should be empowered to make choices about preventive
health care programs based on data from scientific studies of health
benefits related to particular dietary supplements;

In general, freedom of speech guaranteed by the First Amendment leads to
better political and social choices among "the marketplace of ideas."
Similarly, relative freedom for less restricted commercial speech leads
to better consumer choices in the marketplace of supplements.

II\. Overview of Section 6 of DSHEA and the Regulation

\[A\] [Section 6]{.underline}

Congress enacted Section 6 of DSHEA in order to give consumers access to
more truthful information about substances they were being asked to
ingest. That section was integrated into the FFDCA as § 403(r)(6)(A) and
codified as 21 U.S.C.§ 343(r)(6)(A). Among other things, Section 6
provides that a "statement for a dietary supplement may be made if the
statement describes the role of a nutrient or dietary ingredient
intended to affect the structure or function in humans" or if it
"characterizes the documented mechanism by which a nutrient or dietary
ingredient acts to maintain such structure or function" and if two other
criteria, which are not in question here, are satisfied. Section
403(r)(6), however, in its next-to-the-last sentence, states that "A
statement under this subparagraph may not claim to diagnose, mitigate,
treat, cure or prevent a specific disease or class of diseases.

\[B\] [The Regulation]{.underline}

On January 6, 2000, the FDA issued 21 CFR § 101.93(f)and (g)(1) and
(g)(2)(i-x), the "structure-function" regulation(s)\["the Regulation"\].
When one examines the many provisions of the regulation in the context
of Section 6 of DSHEA, it becomes patently obvious that the First
Amendment was, essentially, accorded the role of a subordinate
consideration when the FDA drafted and promulgated this Regulation.

§ 101.93(g)(2) prohibits ten types of information claims, claims which
are implied, not express, in nature. Some of the provisions of §
101.93(g)(2) reflect a stronger governmental interest than others, but
it is clear that all of them are prohibitive rather than restrictive in
nature. This Regulation clearly prohibits a myriad of implied claims;
although the Regulation [could]{.underline} mandate a disclaimer such as
"This claim cannot imply any effect on a disease because it is not a
drug" or "Only authorized drug claims can claim to treat or cure a
disease; this claim has not been so authorized."

FIRST AMENDMENT LAW AS DECLARED

BY THE SUPREME COURT

Recent case law has established or, at the least, boldly reminded all of
us, including the FDA, of the parameters of commercial speech. In
[Western States]{.underline}, the Supreme Court struck down the entire
Pharmacy Compounding statute because of Congress' excessive restriction
on advertising of compounded drugs**.** [Thompson v. Western States
Medical Center]{.underline}, 122 S.Ct. 1497 (Apr. 29, 2002). In [Western
States]{.underline}, the Supreme Court enumerated the less restrictive
means the Congress could have taken to achieve the same goal,
disallowing mass manufacturing of compounded drugs, and thus
circumventing the new drug approval process.

> Several non-speech-related means of drawing a line between compounding
> and large-scale manufacturing might be possible here. First, it seems
> that the Government could use the very factors the FDA relied on to
> distinguish compounding from manufacturing in its 1992 Compliance
> Policy Guide. For example, the Government could ban the use of
> "commercial scale manufacturing or testing equipment for compounding
> drug products." It could prohibit pharmacists from compounding more
> drugs in anticipation of receiving prescriptions than in response to
> prescriptions already received. It could prohibit pharmacists from
> "\[o\]ffering compounded drugs at wholesale to other state licensed
> persons or commercial entities for resale." Alternately, it could
> limit the amount of compounded drugs, either by volume or by numbers
> of prescriptions, that a given pharmacist or pharmacy sells out of
> state. Another possibility not suggested by the Compliance Policy
> Guide would be capping the amount of any particular compounded drug,
> either by drug volume, number of prescriptions, gross revenue, or
> profit that a pharmacist or pharmacy may make or sell in a given
> period of time. It might even be sufficient to rely solely on the
> non-speech-related provisions of the FDAMA, such as the requirement
> that compounding only be conducted in response to a prescription or a
> history of receiving a prescription, and the limitation on the
> percentage of a pharmacy's total sales that out-of-state sales of
> compounded drugs may represent.
>
> The government has not offered any reason why these possibilities,
> alone or in combination, would be insufficient to prevent compounding
> from occurring on such a scale as to undermine the new drug approval
> process. Indeed, there is [no hint that the government even considered
> these or any other alternatives]{.underline}. Nowhere in the
> legislative history of the FDAMA or petitioners' briefs is there any
> explanation of why the government believed forbidding advertising was
> a necessary as opposed to merely convenient means of achieving its
> interests.

[Western States]{.underline}, 122 S. Ct. at 1506-1507 (citations
omitted, emphasis added). The time is now for a fundamental change in
how the FDA exercises its authority as to label and advertising claims,
and how the FDA regulates S/F claims. The Supreme Court in [Western
States]{.underline}, 122 S. Ct. at 1507, strongly declared that "If the
First Amendment means anything, it means that regulating speech must be
a last\--not first\--resort."

In addition to [Western States]{.underline}, the cases of [Borgner v.
Brooks]{.underline}, 284 F.3d 1204 (11^th^ Circuit 2002), [Lorillard
Tobacco Co. v. Reilly]{.underline}, 533 U.S. 525 (6-28-01), [Bioganic
Safety Brands, Inc. v. Ament]{.underline}, 174 F. Supp. 2d 1168 (D.
Colo: 11-20-01), and the spectrum of the four [Pearson v.
Shalala]{.underline} cases (1998 -- February 2, 2001) are of particular
help when evaluating the constitutionality of 21 C.F.R. § 101.93(g)(2)
as a whole.

In the [Borgner]{.underline} and [Pearson]{.underline} cases,
disclaimers were the pivotal points for each. In [Borgner]{.underline},
a Florida statute, which required the use of a disclosure that informed
ad readers that the state had not approved a particular dental specialty
(dental implants) passed First Amendment muster because, among other
things, the statute did not prohibit all advertising of such specialty,
a constitutional infirmity which previously had caused the statute to be
declared unconstitutional.

AN EXAMPLE OF THE APPLICATION OF THE FIRST AMENDMENT

TO A LABELING CLAIM

As noted previously in these Comments, the FDA informed Jarrow, in a
courtesy letter, that "By reducing platelet aggregation Vinpocetine
increases blood flow to the brain",  is not a valid structure/function
claim, but an implied disease claim.

The most likely explanation for this prohibitory action by the FDA is
its response to a public comment, about the application of proposed 21
C.F.R. § 101.93(g) to the claim "inhibits platelet aggregation". In
Comment, the FDA said:

> The agency, does agree, however, with the comment that "inhibits
> platelet aggregation" is an implied disease treatment or prevention
> claim. Although platelet aggregation is a normal function needed to
> maintain homeostasis, inhibiting or decreasing platelet aggregation is
> a well-recognized therapy for the prevention of stroke and recurrent
> heart attack (see, e.g., 63 FR 56802, October 23, 1998 (final rule for
> professional labeling of aspirin for cardiovascular, cerebrovascular,
> and rheumatologic uses); 53 FR 46204, November 16, 1988, (internal
> analgesic tentative final monograph)). Inhibiting or decreasing
> platelet aggregation is the mechanism of action of a number of drug
> products approved for the treatment or prevention of stroke and heart
> attack. Thus, the agency would consider a claim to inhibit normal
> platelet function to be an implied claim to treat or prevent these
> disease conditions.

The FDA's decision to deem either of the claims as an implied disease
claim is based upon its position, as expressed in 21 C.F.R.
§101.93(g)(2)(ii) that the action of reducing a decreasing platelet
aggregation via any substance, including a dietary ingredient, is one of
effecting a "characteristic sign or symptom" of a disease. That specific
regulation forced the FDA staff to presume and conclude that there could
be no allowable non-disease function involved in the reduction or
inhibition of platelets. The only effect commenced or declared by Jarrow
was the second part of Jarrow's claim; namely, "increases blood flow to
the brain." A decision to allow each consumer to decide how and for what
purpose or purposes a person may consume any product has been long
embraced and applauded by the FDA.

The result, therefore, of this prohibitive regulation is a deprivation
of consumer access to both information and product. If the Regulation,
as a whole, featured a standard disclaimer such as "This statement is
not intended to inform you that any disease can be affected by this
product" would protect the FDA's interest in protecting the public
health without stifling important, helpful consumer information.

CONCLUSION

The application of [Western States]{.underline} to the existing
structure-function regulation and the FDA's interpretation of it should
result in the flow of more truthful information to consumers. Clearly,
the Congress recognized that constitutional principle when enacting
Section 6 of DSHEA. What can be more important than giving to consumers
detailed, "documented" information about the means by which a dietary
ingredient or a combination of them, called the dietary supplement,
works within their bodies. As long as the manufacturer or distributor
does not claim that a disease is being directly affected, the claim
should be presumed to be lawful. In our judgment, the entire Regulation
must be reconsidered and significantly changed, in light of [Western
States]{.underline}. At a minimum, the FDA should issue a specific
request for public comment on how the regulation should be modified and
while gathering that information from the public, should announce a
suspension of the entire Regulation and regulate supplement claims by
looking solely to the plain language of Section 6 of DSHEA.

Sincerely,

James R. Prochnow

James R. Prochnow

Susan D. Brienza