## R·D·I·A

### Research-based Dietary Ingredient Association

1722 Eye Street N.W.

Washington, DC 20006

May 4, 2000

Dockets Management Branch (HFA-305)

Food and Drug Administration

Room 1061

5630 Fishers Lane

Rockville, MD 20852

Submitted via e-mail: FDADockets@oc.fda.gov

RE: Food Labeling: Dietary Supplement Health Claims; Public Meeting
Concerning Implementation of Pearson Court Decision and Whether Claims
of Effects on Existing Diseases May be Made as Health Claims

Docket No. 00N-0598

65 Fed Reg 14219 (March 16, 2000)

Dear Sir or Madam:

The Research-based Dietary Ingredient Association (RDIA) is an
organization of companies representing food, food ingredient, medical
food, and dietary supplement industry segments.

Our members came together in recognition of the fact that manufacturers
of different types of products are increasingly developing functional
foods, dietary supplements and dietary ingredients with health-related
beneficial properties*.* Consumers are also demanding new products that
promote health and protect against disease. To assure that this new
field of consumer health maintenance develops responsibly, our members
recognize the need to establish standards for scientific research and
appropriate use of such research for substantiating product claims and
safety. Research-based organizations must lead the way in setting
base-line standards to ensure that products are safe and efficacious.
These comments are submitted in response to the request in the Federal
Register reference listed above.

**Summary**

A\) The Pearson decision has placed the FDA in a position where it must
take action reconsidering the Pearson health claims petitions that were
the basis of the decision, and clarify the meaning of "significant
scientific agreement" (SSA). Further the court suggested that the FDA's
approach for determining SSA raised the bar inappropriately high and
that perhaps some health claims could be granted with appropriate
disclaimers. Since the Court did require that the claims be truthful and
non-misleading, the claim with any such disclaimer must meet this
criterion. Considering the complexity of scientific data - in vitro vs
in vivo, cohort studies vs epidemiological studies, interventions,
questions of appropriate biomarkers for the disease under discussion;
etc. - the likelihood is high that claims describing inconclusive
results will be presented in a way that may be misleading to the lay
public -- but even in those cases, the public should be allowed to see
such claims.

B\) FDA has been making considerable effort to regulate dietary
supplements and functional foods using criteria that are consistent for
both categories. We have commented that we agree with this approach in
our filings at stakeholder meetings in 1999 in regard to
structure/function claims. We believe this is the proper approach in the
health claims arena as well. DSHEA notwithstanding -- dietary
supplements and 'functional foods' have the same aim -- to provide
options to the public to help them manage their own health. They need to
be treated similarly under Pearson.

C\) We believe that a third party review, for claims, would be a
mechanism that would help achieve a consistent, thorough, expeditious,
and impartial review of claims for products. RDIA has talked to the Life
Science Research Office (LSRO) and others about conducting such reviews.
The FDA could then exercise its right under FDAMA and turn such review
into an "authoritative" statement.

D\) 403(r)(1)(B) of the FD&C Act related to health claims authorizes a
claim in labeling of a food that "characterizes the relationship of any
nutrient...to a disease..." This wording would not seem to limit health
claims solely to 'prevention' but rather allow them for whenever this
definition is met. If one considers areas where claims exist today, one
can imagine cases where the distinction between 'prevention' and
'treatment' would be indistinguishable (even if prevention was a driving
force of the NLEA).

**Q&A**

FDA must move to implement the Pearson decision as quickly as possible,
but not by sacrificing its role as a key regulatory agency. It must move
by exercising its key regulatory role -- this will not mean a blanket
authorization of huge numbers of health claims with baffling
disclaimers, but rather only such claims as meet the criteria of the
Pearson decision. This is not a trivial assignment. In the notice cited
above, the FDA asked for comments on certain questions.

Q. 1. What is the best regulatory approach for protecting and promoting
the public health?

And

Q. 2. Can qualifying language (including disclaimers) be effective in
preventing consumers from being misled by health claims based on
preliminary or conflicting evidence?

A. The regulatory action of the FDA must result in making available
**safe** products. Because of the complexity of biology, and the fact
that health claims are statements about materials that ***may*** protect
consumers from some disease conditions, further disclaimers are
difficult to make. Under the Pearson decision the FDA must also help the
public manage their health concerns by regulating how companies tell
consumers about the level of certainty in the scientific data. Doing
this so that the result of the communication is truthful and does not
mislead the consumer will be difficult, even with the use of
disclaimers, but probably can be done in some limited number of cases.

In any case, no disclaimer can make a claim that is inherently
misleading, non-misleading. Disclaimers in this context have a place
only when they clear up uncertainty, not broaden it.

Q. 3. Is there a way to preserve the existing regulatory framework for
health claims consistent with the First Amendment?

A. Yes, as described above, but it will be difficult to do. We suggest
that a third party review of claims would help a great deal -- in the
evaluation of the science and determination of the level of uncertainty
of the conclusion.

There are two routes today by which health claims may be authorized 1)
by FDA study of information brought to it and 2) by governmental
scientific agencies and NAS (as specified under FDAMA). The utilization
of a third party scientific review system (with subsequent authorization
of the health claim by FDA exercising their role as a governmental
scientific agency under FDAMA) could constitute another route to the
creation of health claims. The availability of a third party review
process, paid for by those seeking the review, would enable the FDA to
leverage the considerable scientific resources available in academic
institutions. FDA's participation in setting up such a process would
give FDA the assurance that the process would meet their needs of
scientific rigor. Given the enormous amount of research being done for
health benefits of foods and supplements, the number of companies
producing such products, and the interest of the public in taking a more
active role in the management of their own health, the need for this
will only grow.

Q. 4. If health claims are permitted based on a standard less rigorous
than significant scientific agreement, what is the best way to
distinguish among claims supported by different levels of evidence so
that consumers are not misled? Does the word \`\`may\'\' in existing
health claims accurately communicate the strength of the evidence
supporting claims that meet the significant scientific agreement
standard, or should other language be used?

A. We do not believe that the use of the word "may" as it is currently
used is enough to communicate the message and that determination of the
best route of communication will be determined after analyses of some
number of examples where the data does not yet meet the SSA standard,
but looks like a health claim is appropriate. Better than "may" as a
disclaimer is an accurate statement of what is known, e,g, "A limited
number (2) of studies have shown that X may be beneficial for Y and
these are the only existing studies that have been done (or, one other
study showed no significant benefit)."

We want to make clear that the quality of the science employed must not
be diminished. The nature of the claim's substantiation has to match the
nature of the claim being made; the level of science for
structure/function claims (while not relevant to this enquiry) should be
as high.

Q. 5. If health claims are permitted based on a less rigorous standard,
what actions can be taken to provide incentives to manufacturers to
conduct further research on emerging substance-disease relationships?

A. We do not believe health claims should be submitted on a less
rigorous standard. Some incentives are already available when the
material is covered by patents, but as one looks to traditional foods
and supplements, there is limited patenting room available. We do not
claim to know all of the possible solutions to this difficult and
important question. Manufacturers will be more likely to conduct
research on whether and how a product might work on a health-related
condition if they can benefit directly from the results of the research.
They will be less likely to conduct research if the results can
automatically be used by their competitors and at no incremental cost.
This is likely to be the case where the product or ingredient is in
widespread use or available widely for future use. One potential
incentive would be granting for a defined period of time, exclusive
rights to practice the claim to the party who pays for and conducts the
research. .

Q. 6. The Pearson opinion mentions circumstances in which FDA might be
justified in banning certain health claims outright (e.g., where the
evidence in support of the claim is outweighed by evidence against the
claim, or where the evidence supporting it is qualitatively weaker than
the evidence against it) (Pearson, 164 F.3d at 659 and n.10).

a\. How should FDA determine when evidence supporting a health claim is
outweighed by evidence against the claim?

b\. How should FDA determine when evidence supporting a health claim is
qualitatively weaker than the evidence against the claim?

A. This will have to be done in a case by case manner as proposed claims
are worked through. We have made comments on this topic on
structure/function claims and FDAMA for the May 11, 1999; June 8, 1999;
and August 4, 1999.

c\. Are there other circumstances in which health claims are inevitably
misleading and cannot be made nondeceptive by qualifying language?

A. Yes, the particular cases will emerge as examples are worked through.

Q. 7. What safety information is necessary to prevent a health claim
from being misleading? For example, such information might include side
effects, drug and food interactions, and segments of the population who
should not use the product or should consult a physician before doing
so. When a product may have adverse effects unrelated to the subject of
a scientifically valid health claim, is the claim misleading? Under what
circumstances, if any, should the product be allowed to bear the claim?

A. The answer to this will depend on the material. We see this as being
a safety issue rather than a claim issue. A product that has harmful
side effects (or contains material with such effects) or drug or food
interactions has them regardless of whether a claim is being made.

Q. 8. What actions should the agency take to ensure that consumers
receive all relevant information about the safety of products that bear
health claims and about research on product safety?

A. Once it is decided what information is relevant, FDA has the
capability to decide how it is conveyed to the consumer public. Such
concerns, of course, have to take into account the intended use pattern
of the product.

We encourage FDA to enact Pearson carefully and speedily. Consumer
response will eventually determine the usefulness of the claims -- both
for selling product and for aiding their personal health maintenance.

Sincerely,

Stephen D. McCurry, Ph.D.

# Research-based Dietary Ingredient Association 

**Butler, Jennie C**

**From:** McCurry, Steve /mtka \[Steve McCurry /mtka\]

**Sent:** Thursday, May 04, 2000 7:47 PM

**To:** FDADockets@oc.fda.gov

**Cc:** Steve_McCurry@cargill.com

**Subject:** COMMENTS on Pearson, Docket 00N-0598

**Importance:** High

These comments are from the Research-based Dietary Ingredients

Association (RDIA)