January 15, 2008

Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane, rm. 1061

Rockville, MD 20852.

To Whom It May Concern:

Shining Ocean, Inc. would like to add its support to the recently taken
decision by the Food and Drug Administration (FDA) to prohibit the use
of "excellent source" and "good source" advertising claims based on the
Institute of Medicine's Adequate Intake (AI) standard of 160 mg per
serving of DHA/EPA. We strongly agree with the FDA that to allow food
producers to use the AI standard would be confusing and potentially
misleading to consumers. We also agree that the state of the science
does not warrant the use of the claim for "excellent source" for as
little as 32 mg, or the 20 % of 160 mg that would be required to use
that claim. Based on the scientific data and the scientists that we have
consulted on this matter, we feel that the FDA had no choice but to take
this action.

Shining Ocean began making Omega 3 fortified surimi seafood products
over five years ago in response to customer and consumer demand about
the growing health concerns over the American diet. Since the discovery
of Omega 3s in the 1970s, research has demonstrated that long chain
fatty acids rich in EPA and DHA have been positively correlated with
numerous health benefits, including but not limited to

-   reduced risk of coronary heart disease

-   lower triglyceride levels

-   brain development in infants

-   prevention and treatment of Alzheimer's

New studies, like the soon to be published study on the benefits of
Omega 3s for Parkinson's disease, demonstrate that the full impact of
Omega 3s on health has not yet been discovered.

For this reason, it is our opinion that the FDA should do whatever it
can to promote greater Omega 3 consumption by American consumers, in
particular the long-chain polyunsaturated fatty acids (PUFA) derived
from a seafood source that bring the most heart healthy benefits. The
first step would be the setting of a daily value for such PUFAs. The
problem, of course, is that recommendations from health advocacy groups
and the scientific community seem to vary. For example:

-   The American Heart Association recommends two fatty fish servings
    per week for healthy individuals and 900mg EPA/DHA daily for
    individuals with coronary heart disease.

-   The British Nutrition Foundation recommends a daily intake of 0.5%
    of total energy intake, or 1.25 grams per day of EPA/DHA.

-   The International Society for the Study of Fatty Acids and Lipids
    (ISSFAL) has recommended a minimum of 650 mg EPA/DHA combined.

Based on these suggestions, it is clear that current intake levels for
DHA/EPA are generally inadequate, somewhere in the 130-150 mg/day range
per day. Thus, for heart health, it appears that there is a "nutrition
gap" of anywhere from 150 -- 750 mg of combined EPA/DHA per day, based
on the data from leading health authorities. Since the science is not
settled, we understand why the FDA has been unwilling to set a daily
value. Research will be ongoing for quite some time, but there is no
longer any doubt that Americans need more Omega 3s in their diet. We
urge the FDA to do what it can to promote their consumption.

As pioneers of the development of Omega-fortified foods, we believe that
nutraceutically-enhanced foods are generally a positive development for
the food industry. However, this general trend does open up questions
about standards. As the public becomes more aware of the health benefits
of Omega 3s, there is a great potential for misunderstanding. The
current labeling practice of "excellent source" claims based on Adequate
Intake levels is one such example.

We support the FDA's decision on three grounds.

-   Excellent source/good source claims all need to be made on the same
    basis to avoid seriously misleading or confusing the consumer.
    Adequate Intake is not the standard that has been used for other
    food products.

-   The common sense notion of an excellent source should match the
    current state of scientific knowledge. There is no scientific
    evidence supporting the health benefits of 160mg of EPA/DHA per day.
    On the contrary, the science supports much higher levels. To allow
    this use of "excellent source" claims to stand runs the risk of
    losing consumer confidence in package claims.

-   Consumers who use Omega-fortified products have the right to expect
    that a heart symbol and an "excellent source" claim on the package
    means that the product will help them reduce their risk of coronary
    heart disease. This may not be the case for products that use AI as
    the basis for determination. In that case the packaging information
    may lead them into a false sense of security with potentially
    harmful consequences.

Based on all these factors we believe that the FDA had no choice but to
disallow the excellent source/good source claims based on Adequate
Intake. We applaud their decision. It is in the best interest of the
consumer and the food industry.

David Burgess, Ph.D.

Director of Research

Shining Ocean, Inc.