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| March 25, 2002                            | Susan D. Brienza         |
|                                           |                          |
|                                           | 303-894-6146             |
|                                           |                          |
|                                           | sbrienza@pattonboggs.com |
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### VIA E-MAIL AND FEDERAL EXPRESS

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| Office of Information and Regulatory Affairs, OMB,                    |
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| # Attn: Desk Officer for FDA                                          |
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| New Executive Office Bldg.                                            |
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| 725 17th St. NW., rm. 10235                                           |
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| Washington, DC 20503                                                  |
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| Attn: Desk Officer for FDA                                            |
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**Re: Comments of Jarrow Formulas, Inc. on FDA's Consumer Survey**

**as to Label Claims of Foods and Supplements; Docket No.: 02N-0063**

Dear Desk Officer for FDA:

Patton Boggs LLP represents Jarrow Formulas, Inc. ("JFI"), which is a
Los Angeles-based company that develops, manufactures, markets, and
sells dietary supplements. JFI, therefore, has an interest in
determining precisely how consumers interpret label claims, especially
claims and symbols on dietary supplement labels. Thus, JFI applauds the
Food and Drug Administration ("FDA" or the "Agency") in its current
consumer survey project, which seeks to determine how label claims on
foods and dietary supplements are actually viewed, read, and interpreted
by the consumer [in practice]{.underline}. JFI is especially interested
in how consumers read and interpret a certification or quality seal or
logo on a product label---both with and without a disclaimer. On behalf
of JFI, we offer the following Comment, which is focused on point (3) of
the Federal Register Notice of February 21, 2002: "ways to enhance the
quality, [utility]{.underline}, and clarity of the information to be
collected." (Emphasis added.)

**Introduction to JFI's Position on Seals and Logos as Label Claims**

JFI's position is that certification seals and logos constitute label
claims that directly or indirectly promote: the quality, safety, purity,
naturalness, and/or efficacy of the product bearing that seal or logo on
the label. In this Comment, we believe that the most important input we
can provide to the Agency consists of our proposed questions for the
survey, which are included herein. However, we also believe that it is
important for the FDA to understand and appreciate JFI's concerns about
the many dietary supplement certification programs and seals which are
proliferating, and which have been engendered in part by the absence of
an official Final Rule on GMPs for dietary supplements from this Agency.
The dietary supplement industry---and the consumer---now has to contend
with certification programs and seals or logos from:

-   the National Nutritional Foods Association ("NNFA") GMP
    Certification Program and Seal

-   the National Sanitary Foundation ("NSF") Dietary Supplement
    Certification Program

-   the United States Pharmacoepia (U.S.P.) testing and seal

-   ConsumerLab.com Product Review and "Approved Quality" Seal

```{=html}
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-   A.C.E.R.I.S. (Academy of Clinical, Environmental, Research and
    Informational Sciences)

What one commentator has termed the "alphabet soup" of seals is
extremely confusing, misleading, and actually deceptive to the
reasonable consumer. JFI feels most strongly about the misleading
character of the NNFA GMP seal, for the reasons set forth below; and
recently the NNFA has partnered with the NSF, so that certified
companies may use a double seal. In addition, the NNFA requires a
disclaimer to be used with its GMP seal (also discussed below), but this
disclaimer---rather than truly disclaiming any express claims or implied
claims made by the seal, and rather than curing the problem of a
misleading seal---actually renders the NNFA GMP seal either
contradictory, or deceptive, or both.

The recent statement of Lester Crawford, Deputy Commissioner of the FDA,
quoted in *The Nando Times* (Online), concerning the labeling of GMO
foods is equally applicable to JFI's concerns with respect to
certification seals for dietary supplements. Mr. Crawford stated, \"If
it\'s on the label, it has to be true, and it\'s up to us \[FDA\] to be
sure that it is.\" *The Nando Times* (Online), Phillip Brasher, AP Farm
Writer, March 21, 2002. \[Bracketed material added.\]

**JFI Concerns as to Certification Programs and Seals Generally**

The seals and logos which are the subject of this letter are indeed
[label claims]{.underline}, are also misleading and deceptive
representations, and are vitally important to and influence millions of
consumers of dietary supplements, as well as retailers. In 1996, a
survey by New Hope Natural Media and The Hartman Group concluded that,
in 1997, 70% of all American households purchased dietary supplements.
FDA's Final Rule on Structure-Function Claims, 65 [Federal]{.underline}
[Register]{.underline} 1000, at 1048 (Jan. 6, 2000). In March of 1999,
the FDA's estimate was that dietary supplement sales in 1997 were \$12.7
billion. "Economic Characterization of the Dietary Supplement Industry -
Final Report" at p. 4. These numbers have increased in the past four
years. As sales of supplements increase, the number of products bearing
certification seals or quality seals on the label have also increased.
Consequently, the consumer is confronted with a variety of seals on
product labels---some accompanied by disclaimers and some not, some
disclaimers in prominent print and some not.

First, logo-based certification programs have the tendency, if not the
actual effect, of diluting corporate and brand names. Since the NNFA has
been blatantly coercive in promoting its seal, the dilutional effect is
highly objectable. Second, Jarrow L. Rogovin, the President of JFI, has
been very active in communicating to the industry the following points:
(i) he believes that consumers assume that dietary supplements which are
touted as being of very high quality consist only of naturally-derived
([i.e.]{.underline}, non-synthetic) ingredients; (ii) the use of a
certification seal or logo is an example of a method of promotion of a
"high quality" message; and (iii) not all supplements which bear such a
seal or logo do, in fact, contain the non-synthetic ([i.e.]{.underline},
natural) form of an ingredient when available.[^1] As a result,
consumers may be misled into believing that a logo-bearing synthetic
product is superior to a non-logo-bearing natural product, even though
the natural product is actually superior. Risk of this confusion is
heightened in situations where a company which sells natural dietary
supplements refuses to adopt a certification logo for reasons of company
pride and its own brand-name strength. Third, a certification logo on
one product of a particular company may cause consumers to make
inferences of quality with respect to other products of that company,
which may not have been produced under the same standards or even in the
same manufacturing facility as the logo-bearing product.

JFI is mindful that this invitation from the FDA for Comments was as to
[label]{.underline} claims, and that, in general, the FDA's regulatory
province centers on labels and labeling, while the Federal Trade
Commission's (FTC's) regulatory province centers on promotional
materials. JFI is also aware of the shared jurisdiction and the
memorandum of understanding between these two agencies, and the
cooperation and synergy of the FDA and FTC in their monitoring of
regulatory violations as to dietary supplements, e.g., a recent joint
statement decrying both the labeling and the promotion of "Herbal
Antibiotics" to combat anthrax. However, despite the difference in
missions of the two agencies, JFI's position is that certification seals
or logos on dietary supplement labels become clearly promotional, and
this is one of the many causes for its grave concern.

**NNFA GMP Certification Program and Seal**

The NNFA Board of Directors developed its own GMP program between 1997
and 1999 (the "NNFA GMP program" or "program") in a attempt at industry
self-regulation. Instead of the program consisting of educational
development and training appropriate to a non-profit trade association,
the NNFA undertook the creation of a commercial program to be used in
labeling. Accordingly, the NNFA GMP program was inaugurated publicly on
July 10, 1999, with a press conference at the Association's annual
convention and trade show, MarketPlace'99 in Las Vegas. In an article
dated two days later, July 12, 1999, then Executive Director of the
NNFA, Michael Q. Ford, is quoted as saying, "Rather than waiting any
longer for the federal government \[FDA regulatory action\], NNFA
decided to take action to ensure consumer safety." See [Tab
1]{.underline}. Despite the expression of concern for consumer safety,
the NNFA's promotional efforts have been relentlessly commercial. The
two other major dietary supplement trade associations, the American
Herbal Products Association and the Council for Responsible Nutrition,
have not endorsed or embraced NNFA's GMPs.

The most prominent and best known feature of that program is the NNFA
GMP seal. It can be placed on each product label and ad of a company
which has been certified as having met NNFA's GMP requirements. This is
a circular seal, approximately the size of a quarter, bearing the words
"Good Manufacturing Practices" in small type above the acronym GMP in
large letters, as well as the NNFA acronym. See NNFA brochure which is
attached at [Tab 2]{.underline}. Before the seal can be used on a
product label or in an ad, the company which wishes to use it must be
certified by the NNFA; the actual manufacturer of the product if the
supplier itself does not manufacture that product, must also be
certified. An audit, which is a prerequisite for certification, is
performed by third-party inspectors selected by the NNFA. The audit
results in a Level of Compliance rating which is used to determine
eligibility for certification. The audit consists of a physical
inspection of the premises and an assessment of the applicant's
manufacturing procedures in relationship to the NNFA's GMP standards.
The NNFA briefly describes the applicant's audit in a publication
entitled NNFA GMP Certification Program Overview. See [Tab
3]{.underline}. No testing of raw ingredients or of finished products is
performed by the inspectors. The NNFA certification lasts for a *full
three years.* A certified member could use the GMP seal on every product
label and in every product ad for that period of time, including on any
new products, without any interim inspection or audit by the NNFA or a
third party inspector.

As a consequence of several complaints from JFI during 2000, the NNFA
adopted two disclaimers which are to be used with the NNFA GMP seal.
They are:

[First Disclaimer]{.underline}: "This Seal certifies that the
manufacturer of this product uses quality systems and procedures that
comply with NNFA's Dietary Supplement GMP standards. The quality of
individual ingredients, however, has not been certified."

JFI first requested such a disclaimer from the NNFA in October of 1999
and followed that request with a series of letters in support of such a
disclaimer. This disclaimer was approved by the NNFA Board in April of
2000, announced on June 6,and made effective as of June 1. The NNFA, in
its September 2000 issue of [NNFA Today]{.underline}, discussed the seal
and this disclaimer. See [Tab 4]{.underline}. Among other things, the
NNFA established some disclaimer compliance deadlines. In addition, JFI
pointed out to NNFA that some products bearing the seals on the label
were actually manufactured off-site, at a facility that had not been GMP
audited or certified. NNFA eventually responded with a second
disclaimer.

[Second Disclaimer]{.underline}: "Some products of the company have not
been manufactured at an NNFA certified facility." See para. 8 of [Tab
5]{.underline}.

**NNFA's Weak Disclaimer Is No Cure for Deceptive NNFA GMP Seal**

JFI has vigorously and adamantly insisted from the beginning of this
NNFA GMP program that the program was fatally flawed, and that the seal
was dishonest and constituted false advertising. JFI has argued for many
reforms, short of dismantling the entire program. From the beginning,
July of 1999, JFI has maintained to NNFA, its President, its Board, and
its legal counsel, that *at the very least a clear disclaimer about the
seal's message was essential*. However, it became clear that the
commercial aspects of the NNFA's program were fatally flawed, and that
the association should confine its activity to education and training as
properly befitting its role. See correspondence at [Tab 6]{.underline}.

At first, NNFA's position was that no disclaimer was necessary. After
much resistance, the NNFA finally agreed to require a disclaimer, but
adopted one which is confusing and misleading to consumers, and which
does not disclaim all the misleading implied claims of the seal. Next,
JFI wrote to the NNFA with concerns about enforcement of the disclaimer.
Then, again only after exhaustive, vigorous urging from JFI, NNFA set in
place some enforcement guidelines for monitoring of the required
disclaimer; however, no actual surveillance is part of these guidelines.

By letter dated March 29, 2000, Jarrow L. Rogovin, President of JFI,
proposed the following as an adequate disclaimer, which was never
accepted:

> **Neither the quality of the individual ingredients, the product, its
> safety, nor the accuracy of the label have been certified. This seal
> certifies only manufacturing cleanliness and record keeping
> procedures.**

Instead, the disclaimer finally approved by the NNFA is:

This Seal certifies that the manufacturer of this product uses quality
systems and procedures that comply with NNFA's Dietary Supplement GMP
standards. The quality of individual ingredients, however, has not been
certified.

The NNFA\'s disclaimer which is set out above is misleading because:

1)  The first sentence omits the material statement that not all of the
    company's facilities have been certified. An accurate statement of
    the true circumstances is: ". . . the manufacture of this product
    uses quality systems and procedures . . . at the facilities that
    have been audited."

2)  The second sentence omits the statement that other aspects besides
    the quality of the individual ingredients have also *not* been
    certified.

3)  The second sentence omits the statement that the quality of the
    finished product as a whole has not been certified.

4)  The second sentence omits the statement that the purity of the
    finished product as a whole has not been certified.

5)  The second sentence omits the statement that the safety of the
    finished product as a whole has not been certified.

6)  The second sentence omits the statement that the accuracy of the
    label has not been certified.

7)  The second sentence omits the statement that the effectiveness of
    the product has not been certified.

8)  The second sentence omits the statement that the superiority of the
    certified company's products, as compared to the products of dietary
    supplement companies which do not bear the NNFA GMP seal, has not
    been established or has not been certified.

9)  Consumers and most NNFA retailer members do not have any idea what
    the phrase "NNFA GMP standards" actually means.

JFI is confident that if the FDA and OMB include questions about the
NNFA disclaimer in the consumer survey (please see proposed questions
below), consumer confusion will be evident in the responses.

The paradox of the primary disclaimer is that the number of words which
are needed to inform consumers clearly of the limited nature of the true
claims conveyed by the seal would result in a disclaimer so lengthy that
the average consumer would not read it. For example, a truthful
disclaimer for the NNFA GMP seal would have to read:

> This seal certifies only that the manufacturer complied with NNFA's
> GMP certification program at one point in time. There has been no NNFA
> audit of this particular product, no ongoing review of the
> manufacturer by NNFA or any other organization, and no independent
> verification or validation of any process by an outside laboratory or
> other third party. Further, NNFA has not reviewed the product label,
> including any of the statements, claims or assertions contained
> thereon. Thus, NNFA makes no warranty or guarantee whatsoever as to
> the safety or quality or any other characteristics of the ingredients
> or formulation of the product.

The primary disclaimer which was adopted for use with the seal does not
reasonably inform consumers of the true meaning of the NNFA GMP seal.

In summary, disclaimers were reluctantly adopted by the NNFA following
months of unrelenting pressure by JFI and some other supplier members.
These disclaimers are required to appear in close juxtaposition to the
seal on the actual label, but this requirement is neither monitored nor
enforced.

Claims Made About The NNFA GMP Seal (Logo)---Safety and Quality

The NNFA has distributed a glossy tri-fold brochure promoting its GMP
program. See [Tab 2]{.underline}. The brochure states prominently and in
bold type, "When you see NNFA's Good Manufacturing Practices seal on the
label of a dietary supplement, you can be confident of that product's
safety, quality and purity." The brochure further states, "Consumers
will finally have independent verification that the products they buy
are safe and reliable." and -- also in bold type -- "Assuring the public
of product safety and reliability is a key objective of the National
Nutritional Foods Association." Finally, on the brochure's cover, above
a picture of the GMP seal, there appears, in large bold letters, a
statement that confirms that the seal [is]{.underline} a seal of
approval and a guarantee by the NNFA: "What you see on the label, Is
what you get in the product . . ." \[bold in the original\]. In NNFA's
literature, the GMP Certification Program, an "Overview" of the program
includes the statement: "*This program ensures that all elements of the
manufacturing process are reviewed* to provide assurance that safety and
quality is built into products during manufacture." (Emphasis added.)
See [Tab 3]{.underline}. Furthermore, in a flier advertising the NNFA
seminar on "Preparing for Certification", the NNFA states: "The GMP
Certification Program underscores our members' commitment to quality and
brings that message to consumers through the use of the GMP seal." See
[Tab 7]{.underline}. Further, the "GMP" seal, by its nature, implies
safety. Despite these claims, our client has registered protests with
the NNFA concerning several products containing ingredients in less than
label claim amounts from companies utilizing the GMP logo.

The NNFA's own literature demonstrates that only the manufacturing
*processes* are reviewed; it is not the case that any finished products
are tested by the NNFA or the third party auditors. Thus, any assurances
of product safety and quality, whether direct or implied, are false. The
program merely certifies -- and the seal represents -- that a
manufacturer supposedly has a system in place, at the time of the audit,
which complies with NNFA's manufacturing standards. As Michael Q. Ford,
the former President of NNFA, said in his letter to JFI's President on
August 25, 1999, "The GMP logo certifies that the facility at which a
dietary supplement has been produced has met NNFA's GMP standards for
dietary supplements."

Because of these express and implied representations of safety,
reliability or quality and efficacy, one assumes that the FTC, for
example, would require the manufacturer and NNFA to possess and rely
upon competent and reliable scientific evidence that each product
carrying the GMP seal is safe, reliable, and effective for all purposes
indicated in advertising and on the label. In many instances, such
representations of safety, quality, or reliability and efficacy would be
false and misleading. Similarly, because these same representations are
made as label claims, and because consumers will "read into" the seal
implied claims of quality, safety, and efficiency, the FDA must monitor
and restrict the use of certification seals in some way.

The NNFA does not screen products for categories of ingredient -- or
amounts -- that should not carry the seal.

## False and Misleading Label Claims Through Use of the NNFA GMP Seal Through Ads 

## 

Advertisements containing, describing, and touting the seal define its
meaning for consumers -- a false meaning of quality. Ads reinforce and
bolster label claims; there is a reinforcement of deception here,
especially when products with the seal on the labels are depicted in the
ads. Claims by some certified supplier members of NNFA in some
promotional materials are false and misleading. For example, one such
"certified" company is Consac Industries, Inc., d/b/a Country Life
Vitamins, Inc. This company has advertised aggressively its "NNFA GMP"
status in trade magazine ads, with neck hangers put on thousands of
individual bottles. One such ad, in the March 2000 issue of the [Natural
Foods Merchandiser]{.underline}, starts with a banner headline and goes
on to make several deceptive claims:

MAKE SURE . . . *Your Supplements Are* **GMP Certified!** And with
Country Life you can be sure about what you're getting. That's because
Country Life supplements are manufactured to insure they meet the
highest standards, standards set by the National Nutritional Foods
Association. The *"GMP" Quality Seal* let's \[sic\] you know that
Country Life has met these standards and produces the finest supplements
available. So, "Make sure" your customers look for the *Seal of
Approval* they can trust. **"GMP"**.

(Bold font and quotation marks are in the original.) The claims of this
ad imply that Country Life's dietary supplements are approved by the
NNFA.

JFI has compiled several other examples of deceptive use of the NNFA GMP
seal by certified supplier companies, in print ads and websites. See at
[Tab 8]{.underline}. JFI filed several complaints with the NNFA about a
number of Country Life's products being mislabeled despite claims that
these products were GMP-certified. As a result of these complaints, the
company was compelled to change its labeling and the formulations. JFI
has no reason to believe that other Country Life products bearing the
seal on their labels are not mislabeled. JFI's point in this comment is
that institutional ads such as these reinforce -- in the consumer's mind
-- false meanings of the seal which are then transferred and imprinted
to products bearing that seal on the product labels.

As a result of some certified companies' misuse of the seal, it appears
to consumers that many products *per company* are "approved" by the
NNFA. However, no actual independent testing by the NNFA or its auditors
was ever performed on final products, e.g., a chemical analysis of the
potency of a product or its ingredients, or even a test for the presence
in the container of all ingredients which are declared on the label. As
a further result of the misuse of the seal, products are permitted to
carry the "NNFA GMP" seal that are not true-to-claim. For instance,
although the label could declare that a dietary supplement contains 50
mg of an herb, it might contain only 20 mg of that herb. In such a case,
the NNFA GMP seal conveys to the consumer assurances of product quality
and label accuracy that do not exist.

Indeed, some of the survey questions proposed below seek to clarify
consumers' interpretation of the seal's value. This is in addition to
the underlying problem of a non-profit association attempting to coerce
its own members into co-labeling and diluting their corporate brand
while at the same time this non-profit association illegally confers a
benefit to select members to the detriment of a majority of its
membership.

Other Programs and Seals may have more integrity, but still lead to
consumer confusion. The NNFA GMP Program is in stark contrast to other
certification programs in the dietary supplement industry. The
ConsumerLab.com Product Review, like the NNFA GMP Program, utilizes a
seal that may be used by manufacturers who have met certain criteria,
but is specific to the product only. Unlike the NNFA seal, the seal is
less likely to be generalized to the entire company. Unlike the NNFA
program, ConsumerLab.com Product Review *tests individual products*
pursuant to five *ingredient-related* criteria to determine whether the
tested products are eligible to bear the ConsumerLab.com "Approved
Quality" Seal. These ingredient-related criteria \-- tested in a
laboratory \-- are much more reflective of individual product quality
than are the manufacturer's record-keeping practices, which is the type
of criteria that is audited pursuant to the NNFA GMP Program. The
ConsumerLab.com "Approved Quality" Seal makes clear, on the Seal itself,
exactly what has been certified: for example, if a Ginkgo Biloba
supplement was tested, the seal will bear the words "Ginkgo Biloba" on
the lower portion of the seal; if a multivitamin was tested, the word
"multivitamin" will appear on the lower portion of the seal.

In contrast to NNFA's program, other certification programs use experts
in the field to test individual product quality, and then approve seals
to convey to consumers in a truthful and non-misleading way exactly what
the program is certifying. Unlike this, the NNFA GMP Program misleads
consumers to believe that the products of NNFA GMP-certified companies
are of high quality when, in fact, the quality of those finished
products has never been tested. (See pages taken from the
ConsumerLab.com website, providing specific details of the
ConsumerLab.com Product Review, at [Tab 9]{.underline}.) Apparently,
ConsumerLab.com also maintains surveillance on safety issues such as
serving size Upper Limits ("ULs") when permitting certification. The
NNFA seal has been used even though in some cases, ULs have been
substantially exceeded, e.g., 30 mg of manganese per serving.

However, due to the inferences of quality and superiority which
consumers will inevitably draw when they view certification seals on
dietary supplement products, JFI seriously questions whether *any* seal
or certification program can be implemented in a manner which is
truthful and not misleading.

**Ineffective Enforcement of the NNFA GMP Program and the Disclaimers**

There are several problems with NNFA's 17-paragraph Announcement
entitled "Terms of Use of NNFA GMP Certification Seal." See [Tab
5]{.underline}. *First*, the document is internally inconsistent and
reflects a profound misunderstanding of what the NNFA GMP seal actually
means and conveys to consumers. The first paragraph begins, "The GMP
Seal is a symbol certifying that NNFA's GMP standards, which are
designed to *assure dietary supplement* *product* integrity and
*quality*, have been satisfied at the pertinent facility (or
facilities)." (Emphasis added.) Yet the first disclaimer, quoted in
paragraph 9, includes the statement, "The *quality* *of individual
ingredients*, however, *has not been*." (Emphasis added.) If the seal
does not assure the quality of ingredients, then how can it purport to
assure the quality of the product as a whole? This contradiction
underscores one of the fundamental inaccuracies of the entire GMP
program, which JFI has addressed from the beginning of its
correspondence with the NNFA: The seal means only that the manufacturing
practices and processes have been certified, yet it will be interpreted
by consumers \-- indeed, is misinterpreted by the NNFA itself, even now
\-- to imply certification of finished product quality.

*Next*, this document does not reflect any willingness or ability of the
NNFA to monitor the NNFA GMP program, including institutional
advertising, in any meaningful way. For example, paragraphs 16 and 17
provide that member suppliers and retailers may sell products labeled
with the NNFA GMP Seal provided, among other things, that: "no
verifiable information *comes to NNFA's attention* that the facility
where products labeled, advertised or promoted under the GMP Seal were
manufactured has fallen out of essential compliance with NNFA's GMP
standards." (Emphasis added.) This condition is a type of double
negative structure implying that NNFA will adopt a passive see-no-evil,
hear-no-evil position, rather than a pro-active stance of rigorous and
strict enforcement during the full 3 years of the certification period.
JFI has located several advertisements, by NNFA GMP-certified supplier
members, that either did not contain the required disclaimer at all, or
contained the required disclaimer, not prominently and juxtaposed to the
GMP seal, but in miniscule letters at the very bottom of the ad. See NOW
Foods ad at [Tab 8]{.underline}. Again, the *prominent* presence of a
disclaimer in large institutional ads is essential to qualify and
educate the consumer as to what the seal actually means *and does not
mean* when the seal is present on a product label.

In short, the NNFA's weak enforcement of its seal shows that the
disclaimer has been no deterrent to repeated and egregious deceptive
uses of the seal as a label claim. Because this situation is unlikely to
change, the protection of the consuming public against deceptive label
seals is in the hands of the FDA, as well as the FTC.

**NSF Dietary Supplement Certification Program and Seal**

The joint NNFA-NSF GMP program and seal have grave consequences in
deceptive labeling claims as well as advertising claims. Again, one of
the fundamental problems with these seals is that they constitute
promotions as well as labeling, and promotions that reinforce the
misleading nature of the label claims. Ads can "teach" consumers that a
certification seal means quality, safety, and effectiveness, when that
is not in fact what the seal means.

[Marketing Issues:]{.underline} The improper and inappropriate
partnering of NSF with NNFA in a joint certification effort, results in
a *double* "seal of approval." The front-page article of December's NNFA
Today magazine proclaims as the first benefit of the alliance with NSF a
company's "ability to: gain marketing advantage by demonstrating the
quality of products." This type of commercial promotion is a serious
detriment to the market-makers in the industry. "Me too" products are
being placed on at least a level playing field, if not higher, by virtue
of these unfair and misleading seals, even though these companies will
have done none of the supporting research or marketing. A misleading
double seal will undermine brand recognition and strong trademarks of
many well-respected companies in the industry. Further, JFI's position
is that the scientific focus of the industry is on new information about
dietary supplement products and even new molecules, and this joint GMP
program diverts consumer attention away from product development and
towards the commercial promotion of seals. In addition, this intrusion
into marketing and co-branding undermines the financial health of health
food stores, which make up much of the industry's membership, because
consumers will be in effect told that their loyalty to health food
stores is irrelevant. Further, confused consumers seeking some simple
test are likely to buy the lowest priced product bearing both seals.

[Scientific Issues:]{.underline} Certification programs for dietary
supplements raise numerous complex issues. These same types of issues do
not arise to the same extent when NSF tests and certifies other types of
products according to straightforward standards promulgated by the FDA,
such as NSF's testing and certification of bottled water. Since the NSF
and NNFA certification logos will convey a message of quality to
consumers, the testing of certified products by NSF should incorporate
methods and analyses specifically designed to assure the quality of
finished products. Such testing of dietary supplements, however, is
enormously complex. For example, the testing of probiotics for purity
and potency involves complicated laboratory issues which must take into
account the importance of strain selection or other related production
issues that truly determine quality and effectiveness. The testing of
herbal or other botanical ingredients is likewise complicated, including
identifying the correct species of plant, the plant part used, and
assuring the potency of the active constituents, and should be conducted
by qualified herbalists. From information and documents provided by the
NSF itself, we have learned that the NSF Dietary Supplement
Certification Program does not include this level of testing on
probiotic supplements, and NSF does not employ a single herbalist to
conduct the aforementioned qualitative testing of botanical ingredients.
Furthermore, vitamin and mineral supplements are subject only to
quantitative testing under the NSF program, but are not subject to
qualitative testing. In short, NSF's testing and certification of
dietary supplement quality is more scientifically complex than NSF
realizes and requires the skills of professionals who are not involved
in this process.

[Legal Issues:]{.underline} In addition to scientific and marketing
concerns, JFI has the following legal concerns about a dual NSF NNFA
seal -- especially the use of such seals with no disclaimer.[^2] In this
context, it is significant to note that the cover article about the
strategic alliance in the December issue of [NNFA Today]{.underline}
magazine repeatedly states that the NNFA GMP seal indicates product
quality. Yet NNFA's disclaimer, which was required to be placed in
juxtaposition to the GMP seal\--after JFI's repeated urging that a
disclaimer was necessary\--explicitly discloses that the GMP seal
certifies procedures only and not quality of ingredients or of the
finished product. That disclaimer, which is nowhere printed or even
mentioned in the December 2001 article, reads as follows:

**This Seal certifies that the manufacturer of this product uses quality
systems and procedures that comply with NNFA's Dietary Supplement GMP
standards. The quality of individual ingredients, however, has not been
certified.**

Furthermore, in the attached print advertisement, taken from the October
2001 issue of [Natural Foods Merchandiser]{.underline}, the NNFA seal is
invoked as an assurance of quality, despite the disclaimer above. See
[Tab 10]{.underline}. As we have shown above, this type of
claim---whether on the actual label or in a print ad\--results in a
false label claim and thus deception of consumers. NSF is now partnering
with NNFA, and is associating itself with misleading promotional
practices. Thus, one program and seal is aiding and abetting another
program and seal, and is compounding the confusion for the consumer of
dietary supplements. The false equation of both the NNFA seal and the
NSF seal with "Quality" is demonstrated by literature distributed before
and during the recent trade show, Natural Products Expo West, earlier
this month in Anaheim, California. See [Tab 11]{.underline}.

For all of the reasons presented above, JFI believes that the following
proposed questions, or some form of them, should be included in the
FDA's consumer survey as to the interpretation of label claims.

**PROPOSED QUESTIONS FOR CONSUMER SURVEY ON LABEL CLAIMS**

(All of these questions pertain to the labels and labeling---catalogs,
package inserts, flyers---primarily of a dietary supplement product, and
primarily to the label affixed to the container.)

1.  Do you read most of a label before you buy a product? Circle one:

all the time most of the time often sometimes rarely never

2.  Do you read the entire label before you buy a product? Circle one:

all the time most of the time often sometimes rarely never

3.  Are there any brand names or company names that are so familiar to
    you that you do not feel you need to read the entire label? Circle
    one: Yes No Sometimes\
    \
    Please explain your answer, or give 1 or 2 examples:
    \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

4.  Are there any herbal ingredients that are so familiar to you, or
    that you know you want to buy, such that you do not feel you need to
    read the entire label?\
    Circle one: Yes No Sometimes\
    \
    Please explain your answer, or give 1 or 2 examples:
    \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

5.  Do you read the fine print on the label? Circle one:

all the time most of the time often sometimes rarely never

6.  When you are shopping for dietary supplements, how often do you look
    on the label for a seal or a logo? Circle one:

all the time most of the time often sometimes rarely never

7.  If you are comparing two otherwise similar dietary supplement
    products---e.g., both contain only St. John's Wort---and one label
    bears a logo or seal and one does not, what percentage of the time
    do you decide to buy the one with the seal or logo for that reason?
    Circle one:

all the time most of the time often sometimes rarely never

8.  On average, how much more money per container of a dietary
    supplement (of 30 servings) would you spend for a product labeled
    with a logo or seal as opposed to one not labeled with a logo or
    seal? Circle one:\
    \
    \$15 \$12 \$10 \$7 \$5 \$3 \$2 \$1 0

9.  If a brand of dietary supplement product you traditionally bought
    did not bear a seal or a logo, would you switch to the different
    brand whose label did contain the seal or logo? Circle one:

all the time most of the time often sometimes rarely never

10. Do you pay special attention to print on the label that is in bold
    type? Circle one:

all the time most of the time often sometimes rarely never

11. Do you pay special attention to print placed inside of a box? Circle
    one:

all the time most of the time often sometimes rarely never

12. When you see something that looks like a "disclaimer," how often do
    you read it before you buy the product? Circle one:

all the time most of the time often sometimes rarely never

13. Do you read the entire label [after]{.underline} you buy the
    product? Circle one:

all the time most of the time often sometimes rarely never

14. When you see a seal or a logo of some sort, what ideas does that
    seal or logo convey to you, regardless of what the printing says?
    Please write 3 words that immediately come to mind:
    \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
    \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
    \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

15. What do the letters NNFA mean to
    you?\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

16. What do the letters GMP mean to
    you?\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

17. What do the letters NSF mean to
    you?\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

18. What do the letters USP mean to
    you?\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

19. What does a circle with "ConsumerLab" written inside mean to you?

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

20. Have you seen any of the logos before? Yes No Which ones?

\[Insert NNFA GMP, USP, NSF and ConsumerLab.com logos\]

21. When a circle or seal contains the word "Lab" in it, what does that
    convey to you?

22. What's your interpretation of this symbol?

\[Insert the NNFA GMP circle here, actual size\]

23. When you see a seal or a logo of some sort, are you more likely to
    buy that product? Circle one:

all the time most of the time often sometimes rarely never

24. If your answer was one of the first four choices, why are you more
    likely to buy that product? Please write 1 or 2 sentences:\
    \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

25. When you see a seal or a logo of some sort, does that seal or logo
    convey the idea of purity to you? Circle one: Yes No Sometimes\
    Something similar? What? \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

26. When you see a seal or a logo of some sort, does that seal or logo
    convey the idea of "all natural" to you? Circle one: Yes No
    Sometimes\
    Something similar? What? \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

27. When you see a seal or a logo of some sort, does that seal or logo
    convey confirmation that the structure/function claims being made
    for the product, that is claims that the product has a beneficial
    effect on the structure or function of the body (e.g. promotes a
    healthy heart) are being certified?

28. When you see a seal or a logo of some sort, does that seal or logo
    convey confirmation that the structure/function claims are true and
    accurate? Circle one: Yes No Sometimes\
    Something similar? What? \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

29. When you see a seal or a logo, does that make you more likely to
    read structure/function claims,? Circle one: Yes No Sometimes\
    Something similar? What? \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

30. When you see a seal or a logo of some sort, does that seal or logo
    convey the idea of quality to you? Circle one: Yes No Sometimes\
    Something similar? What? \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

31. When you see a seal or a logo of some sort, does that seal or logo
    convey the idea of effectiveness to you? Circle one: Yes No
    Sometimes\
    Something similar? What? \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

32. When you see a seal or a logo of some sort, does that seal or logo
    convey the idea of safety to you? Circle one: Yes No Sometimes

Something similar? What? \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

33. When you see a seal or a logo of some sort, does that seal or logo
    convey the idea to you that the Supplement Facts box is especially
    accurate and reliable?\
    Circle one: Yes No Sometimes

34. When you see a seal or a logo of some sort, does that seal or logo
    convey the idea to you that the ingredient amounts given in the
    Supplement Facts box are 100% percent exact ?\
    Circle one: Yes No Sometimes

35. When you see a seal and some sort of disclaimer next to it, do you
    read them both together? What effect does the disclaimer have on the
    seal and vice versa. Please write two sentences explaining in your
    own words.

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

36. What is your interpretation of these sentences?

**This Seal certifies that the manufacturer of this product uses quality
systems and procedures that comply with NNFA's Dietary Supplement GMP
standards. The quality of individual ingredients, however, has not been
certified.**

Please rewrite them in your own words and state what they mean to you:

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

37\. When you read those sentences, what do you think they are telling
you about the quality of the finished product?

38\. After reading and interpreting the seal and the words together, a
product with this seal \[NNFA GMP seal\] and these sentences:\
**This Seal certifies that the manufacturer of this product uses quality
systems and procedures that comply with NNFA's Dietary Supplement GMP
standards. The quality of individual ingredients, however, has not been
certified.**\
\
I believe that [the quality]{.underline} of this product is: (Circle
one)

-   Higher than products without the seal and sentences

-   Lower than products without the seal and sentences

-   The same as products without the seal and sentences

-   Don't know

-   It's confusing

39\. After reading and interpreting the seal and the words together, a
product with this seal \[NNFA GMP seal\] and these sentences:

**This Seal certifies that the manufacturer of this product uses quality
systems and procedures that comply with NNFA's Dietary Supplement GMP
standards. The quality of individual ingredients, however, has not been
certified.**

I believe that [the safety]{.underline} of this product is: (Circle one)

-   Higher than products without the seal and sentences

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-   Lower than products without the seal and sentences

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-   The same as products without the seal and sentences

-   Don't know

-   It's confusing

40\. After reading and interpreting the seal and the words together, a
product with this seal \[NNFA GMP seal\] and these sentences:

**This Seal certifies that the manufacturer of this product uses quality
systems and procedures that comply with NNFA's Dietary Supplement GMP
standards. The quality of individual ingredients, however, has not been
certified.**\
\
I believe that [the safety]{.underline} of this product is: (Circle one)

-   Higher than products without the seal and sentences

-   Lower than products without the seal and sentences

-   The same as products without the seal and sentences

-   Don't know

-   It's confusing

41\. Chose any one of your answers above that you want to give further
explanation about---like: "My answer depends on other things!" Depends
on what?

> Please give the number of that answer and whatever further explanation
> you want to provide:
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Again, JFI applauds the FDA's efforts to learn more about how label
claims are interpreted [in practice]{.underline} by surveying consumers
themselves, and we hope that our input proves useful in this endeavor.
JFI also requests a copy of the final survey, to be sent to me at the
address above. Please contact me if you have any questions about this
letter or about JFI's position.

> Sincerely,

Susan D. Brienza

on behalf of Jarrow Formulas, Inc.

and Jarrow L. Rogovin, its President

SDB:pah

Enclosures

cc: Jarrow L. Rogovin, President, JFI

David Seckman, Executive Director, NNFA

Kathleen Pompliano,

Business Development Manager, Dietary Supplements Program, NSF

Michael McGuffin, President, AHPA

Michelle Rusk, Bureau of Consumer Protection, FTC

bcc P. Scott Polisky, Esq.

Neal T. Wiener, Esq.

[^1]: Examples include vitamin E, lycopene, and S-adenosyl-methionine.

[^2]: We believe that the NNFA has embarked on a course of violating a
    number of FTC and IRS regulations. It seems logical to conclude that
    this partnering would involve the NSF in these barred activities,
    including deceptive advertising. These are the subjects of letters
    to those respective entities. .