## R·D·I·A

### Research-based Dietary Ingredient Association

1722 Eye Street N.W.

Washington, DC 20006

November 13, 2023

Dockets Management Branch HFA-305),

Food and Drug Administration

5630 Fishers Lane, rm. 1061

Rockville, MD 20852

RE: Docket No. 99N-0554

How to Use Health Claims and Nutrient Content Claims in Food

Labeling; Public Meeting

Federal Register 14178 (March 24, 1999)

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. The members include
Cargill, Galagen, General Nutrition, Monsanto, and Novartis.

Our companies came together because we feel that for the growing field
of consumer health maintenance to develop responsibly, industry needs to
help establish standards for scientific research and appropriate use of
such research for substantiating product claims and safety. RDIA is
committed to helping develop and promote these standards of scientific
research and substantiation. We will work with appropriate scientific
bodies to carry out this work.

We have made comments pursuant to the federal register request:

1e: *How does the significant scientific agreement standard apply to
health claims based on authoritative statements?*

RDIA believes that foods and dietary supplements whose benefits to
health have been demonstrated via sound scientific research, to a
reasonable certainty, should be able to describe these benefits on
labeling and via other types of communications. We see no scientific
rationale for differing standards of substantiation for labeling claims
on either foods or dietary supplements made under FDAMA, NLEA or DSHEA.
We believe all types of claims, whether they are structure/function
claims, NLEA health claims, or FDAMA health claims, should meet the same
standard of "reasonable certainty" that the claim is true. The nature of
the science needed to support a claim likely will vary depending on the
type of claim made, but the same standard of "reasonable certainty" that
the claim is truthful and not misleading should be required. We
encourage FDA to apply this standard evenly to all types of claims on
both foods and dietary supplements. We believe this standard is
consistent with the standards for advertising claims substantiation
applied by the FTC.

We also believe there should be mechanisms in place to assure that
claims made on foods and dietary supplements do in fact, meet a standard
of reasonable certainty and that they can be used by manufacturers
within a timely manner after their data evaluation is complete. The FDA
Modernization Act essentially provides for this by allowing the use of
labeling health claims based on appropriate authoritative statements
under a timely notification process.

At the same time, the food and dietary supplement industries are
developing products with claims based on new data at a pace that exceeds
the abilities of the FDA, with its current limited resources, to review
them expeditiously. RDIA believes it could help FDA with this issue. For
example, we believe a process similar to that used for private GRAS
assessments could be applied to claims evaluation. A company could seek
the evaluation of an independent body of experts to provide an unbiased
opinion of the adequacy of the data supporting a claim. The Life
Sciences Research Office, for example, or another organization of
similar stature, could be considered to be an independent expert. Claims
determined to be adequately supported could be distinguished on
labeling. This option would take much of the burden of data evaluation
off the FDA. If such a process were done voluntarily by manufacturers,
we would ask FDA to exercise its authority under FDAMA to authorize use
of a health claim at the time its regulation is proposed.

2b: *What requirements of 21 CFR 101.14 should we apply to health claims
based on authoritative statements?*

We believe the field of nutritional science has made enormous strides in
discovering the health benefits of foods and components in foods. We
need to think more expansively about what are acceptable and desirable
components to increase in our diets. Just as in the 1980\'s we realized
that increasing our intake of fiber three-fold could benefit health, we
are now discovering that increasing intake of other components in foods
also may be beneficial. However, section 101.14(b)(3)(i) states that for
a substance to be eligible for a health claim, it must "contribute
taste, aroma, or nutritive value...". We believe other components in
foods should be viewed as providing "nutritive value," once they have
been shown through sound scientific research to have beneficial effects
on human physiological processes, whether or not these processes are
known to be associated with disease. We are encouraged by the Agency's
recent reaction to Lipton's view that phytosterols contribute to the
nutritive value of margarine. We hope this indicates an open perspective
in FDA's consideration of future products.

We also support the requirement under CFR 101.14(b)(3)(ii) that the
substance about which a health claim is made should be demonstrated to
be safe at the level necessary to justify the claim and also lawful
under the applicable food safety provisions of the FDCA. We believe
there is no scientific reason to support different standards of safety
for foods and dietary supplements, even though the approval processes
are different by statute. Consumers have the right to expect that both
these types of products are safe. We encourage FDA to require that foods
and dietary supplements, whether they have FDAMA health claims, any
other type of claim, or no claim at all, meet a [common safety standard
that consumption of these products will not pose a significant or
unreasonable risk to health when used as intended.]{.underline}

3b: *Should we provide by regulation that health claims based on
authoritative statements may be used in the labeling of dietary
supplements?*

RDIA encourages FDA to extend the opportunity to make health claims
based on authoritative statements on the labeling of dietary
supplements. As we have stated today, we believe FDA should adhere to a
policy of uniform treatment for dietary supplements and foods. The
claims should be subject to the same level of science for all products,
but the level of the research needed depends on the nature of the claim.

In other words, the same ingredient, whether it goes into a dietary
supplement or food should meet the same standard of safety and all
claims, whether on foods or dietary supplements, should be required to
meet the same standard of reasonable certainty that the claim is
substantiated.

In summary, RDIA recognizes that FDAMA has provided a new, expeditious
mechanism to allow health claims on products based on authoritative
statements. We urge FDA to implement the provisions of this Act and also
to work to make uniform the requirements for safety and substantiation
for all types of products and claims.

Attached are the verbal comments I plan to make at the open meeting on
May 11, 1999:

Thank you for the opportunity to present our views on FDAMA's provisions
concerning labeling claims made on foods and dietary supplements.

The Research-based Dietary Ingredients Association is a recently-formed
association of companies committed to championing the role of science in
the development of functional food ingredients and related products. We
believe it is essential for science based companies to take the lead in
establishing and abiding by standards for scientific research to assure
a product's safety, to substantiate its claims, and to assure consumer
trust. Our mission is to catalyze a process to develop and obtain
support for these standards.

Our submitted comments are responsive in detail to FDA's request for
input regarding FDAMA; however, we wish to take this opportunity to
provide our perspectives on several closely related matters pertaining
to the broad area of the safety of functional foods and ingredients,
dietary supplements, and the scientific support for their labeling
claims. Such issues cut across product categories and types of claims,
and their application laws and regulations.

Consumers have the right to know that the foods and dietary supplements
they consume are safe and that the claims made about them are truthful
and not misleading. RDIA believes that two fundamental principles should
guide all aspects of research and development of ingredients and the
food and supplement products in which they appear:

First, whether they are conventional foods, dietary supplements, or new
dietary ingredients, these products should meet a [common safety
*standard* that their consumption will not pose a significant or
unreasonable risk to health when used as intended]{.underline}. Meeting
this standard may require a scientific *process* similar to that used to
demonstrate that a product is Generally Recognized As Safe. For example,
if the safety assessment of a New Dietary Ingredient in a dietary
supplement indicates that the safety standard articulated above cannot
be met through experience based on common use, then some form of safety
research will be required.

We believe there is a need for uniformity of understanding in the
industry as to what this safety standard means and what information is
required to be assured this standard is met. While the DSHEA does not
require the GRAS *process* neither does it excuse any company from
providing products that are safe for the target population, at the
specified level of ingestion. RDIA's goal is to help establish within
the industry, uniformity in understanding what information and science
are required to meet the safety *standard* as indicated under the law.

Our second fundamental principle is that [any type of labeling claim
made about foods, ingredients or dietary supplements should be based on
competent and reliable scientific evidence that establishes its
truthfulness to a reasonable certainty.]{.underline}

In addition, RDIA believes that products, whose benefits to health have
been demonstrated via sound scientific research, to a reasonable
certainty, should be able to describe these benefits in labeling and via
other types of communications. We see no rationale for differing
*standards* of substantiation for labeling claims on either foods or
dietary supplements. The nature of the science needed to support a claim
likely will vary depending on the type of claim made, but the same
standard of "reasonable certainty" that the claim is truthful and not
misleading should be required. We further believe that
structure/function claims about the physiological effects of foods and
supplements should be allowed, provided they do not state an ability to
prevent, cure, or treat a disease, regardless of the \"biomarker
status\" of the particular structure or function.

Stephen D. McCurry

Manager of Biochemistry

Cargill Incorporated

P.O. Box 9300, M.S. 110

Minneapolis, MN 55440-9300

Phone 612-742-6462

Fax 612-742-7573

e-mail: <steve_mccurry@cargill.com>

Sincerely,

Stephen D. McCurry