RE-EVALUATION OF LOW FAT CRITERION FOR HEART DISEASE HEALTH CLAIMS

I. BACKGROUND

Coronary heart disease risk is the subject of five health claims
authorized by FDA regulations. Four out of five require the foods
eligible for the heart disease risk claims be "low fat" foods. FDA's
justification for imposing the "low fat" eligibility criterion at the
time of authorizing these claims is explained below.

[Saturated Fat and Cholesterol/CHD Health Claim]{.underline} 21 CFR
101.75

The first coronary heart disease (CHD) risk health claim authorized by
FDA is a claim that related diets low in saturated fat and cholesterol
to reduced risk of CHD (101.75). In authorizing this health claim in
1993, FDA concluded that the scientific evidence linking diets low in
saturated fat and cholesterol to reduced risk of CHD is strong. The
eligibility criteria for a food to use this claim are that the food be
"low saturated fat," "low cholesterol," and also "low total fat." FDA
noted that, while total fat is not as strongly or directly linked to
increased risk of CHD as is saturated fat and cholesterol, it may have
significant indirect effects. FDA justified the low fat eligibility
criterion in that: 1) low fat foods generally help individuals in
reducing their intake of saturated fat and cholesterol, and 2) excess
calories, of which fat contributes more per g than the other energy
nutrients, is associated with two health-related conditions (obesity and
diabetes) that are risk factors for heart disease. In this health claim
regulation FDA made a distinction between the direct causal effect of
dietary saturated fat and cholesterol on CHD risk, and the strong but
indirect relationship of dietary total fat and CHD risk. As such, the
subject of the claim is "dietary saturated fat and cholesterol" and
dietary total fat is addressed as an additional criterion that must be
met by a food before it may used the "dietary saturated fat and
cholesterol" health claim.

Meats, fish, and poultry play an important role in the U.S. dietary
pattern, serving as entrees as well as rich sources of protein,
bioavailable sources of many minerals, and rich sources of several
vitamins. When eaten in moderation and prepared with little or no added
fat, lean meats, fish, and poultry can play an important role in helping
consumers to meet dietary guidelines. However, applying the saturated
fat and cholesterol/CHD health claim's low fat criterion virtually
prohibits this category of foods from bearing the health claim and as a
result, may inadvertently interfere with the dietary guidance goals of
encouraging consumption of a variety of foods and of increased use of
lean meats, fish, and poultry instead of higher fat cuts. To remedy this
situation FDA created an exemption to the low fat criterion and instead
provided for saturated fat and cholesterol/CHD claims on game meats and
fish that meet the "extra lean" requirements for saturated fat,
cholesterol and total fat, although these requirements are not as
stringent as the definitions for "low saturated fat," "low cholesterol,"
and "low total fat."

[Fruits, Vegetable and Grain Products that contain Fiber/CHD Health
Claim]{.underline} 21 CFR 101.77

In 1993 FDA also authorized the use of a health claim relating diets
rich in fruits, vegetables, and grain products that contain some types
of dietary fiber, particularly soluble fiber, and reduced risk of CHD
(101.77). Consistent with the requirements for the saturated fat and
cholesterol/CHD health claim, eligibility criteria for this health claim
include that foods bearing the health claim be "low saturated fat," "low
cholesterol," and "low total fat." The "low total fat" criterion was
included because low total fat is one of the characterizing features of
diets rich in fiber-containing fruits, vegetables, and grain products.
Because the effects of saturated fat and cholesterol are not readily
separated from the effects of other nutritive components of fruits,
vegetables, and grain products, and because the scientific evidence
linking diets low in saturated fat and cholesterol to reduced risk of
heart disease is strong, saturated fat and cholesterol are specified as
qualifying nutrients. Total fat is also specified as a qualifying
nutrient because a low content of total fat is characteristic of dietary
patterns which relate to lower heart disease risk, and because it
facilitates the ability of consumers to achieve diets low in saturated
fat and cholesterol.

[Soluble Fiber from Certain Foods/CHD Health Claim]{.underline} 21 CFR
101.81

In 1997 FDA authorized a new health claim relating soluble fiber of
whole oat foods and CHD risk (101.81). This health claim regulation was
subsequently amended to add psyllium husk and oatrim as an additional
sources of soluble fiber eligible for the claim. Again, FDA followed
suit with the saturated fat and cholesterol/CHD health claim and
required as eligibility criteria that foods using the soluble fiber/CHD
health claim be "low saturated fat," "low cholesterol," and "low total
fat." As before, FDA noted that while total fat is not directly linked
to increased risk of CHD, it may have significant indirect effects.

[Soy Protein/CHD Health Claim]{.underline} 21 CFR 101.82

In 1999 FDA authorized a new health claim relating soy protein and CHD
risk (101.82). Again, FDA followed suit with the saturated fat and
cholesterol/CHD health claim and required as eligibility criteria that
foods using the soy protein/CHD health claim be "low saturated fat,"
"low cholesterol," and "low total fat." However, for the soy protein/CHD
health claim the agency waived the "low fat" criterion for food products
consisting of or derived from whole soybeans, as long as those products
contained no additional fat not derived from the soybeans. FDA noted
that products derived from whole soybeans are useful sources of soy
protein that, like fish and game meats that are "extra lean," can be
appropriately incorporated in a diet that is low in fat, saturated fat,
and cholesterol.

[Plant Sterol and Stanol Esters/CHD Health Claim]{.underline} 21 CFR
101.83

In 2000 FDA authorized its fifth health claim regulation pertaining to
CHD. 21CFR 101.83 authorizes the use of a health claim relating
consumption of plant sterol and stanol esters with CHD risk. As in the
previous CHD health claims eligibility criteria for foods bearing this
CHD health claim include "low saturated fat" and "low cholesterol."
However, in a break with past practice, the plant sterol/stanol
ester/CHD health claim does not require eligible foods to be low in
total fat.

The Dietary Guidelines for Americans, 2000, modify the previous
guideline for total fat intake. The new guideline states, "*Choose a
diet that is low in saturated fat and cholesterol and moderate in total
fat*." This new guideline also states, "*Some kinds of fat, especially
saturated fats, increase the risk for coronary heart disease by raising
the blood cholesterol. In contrast, unsaturated fats (found mainly in
vegetable oils) do not increase blood cholesterol*." This modification
in the dietary guidelines, from the recommendation to choose a diet low
in total fat in the 4th edition of the U.S. Dietary Guidelines to the
recommendation to choose a diet moderate in total fat in the Dietary
Guidelines for Americans, 2000, is based on current scientific evidence
of the role of diet in CHD, which does not support assigning first
priority to a diet low in total fat. The agency\'s reliance on dietary
guidelines in the plant sterol/stanol ester/ and CHD health claim and in
previous health claim regulations is based on provisions of the 1990
amendments that direct FDA to issue health claim regulations that take
into account the role of the nutrients in food in a way that will
enhance the chances of consumers maintaining healthy dietary practices
(see section 403(r)(3)(A) and (r)(3)(B) of the FFD&C Act), along with
legislative history that mentions the role of health claims in
encouraging Americans to eat balanced, healthful diets that meet federal
government recommendations.

The agency concluded that not imposing a "low fat" requirement for the
sterol/stanol ester and CHD health claim is consistent with the emphasis
in the Dietary Guidelines for Americans, 2000, on diets moderate in
total fat. Inasmuch as fats were the only technically feasible carriers
of plant sterol/stanol esters at the time, requiring foods bearing the
health claim to be "low fat" would have greatly limited the number of
foods that could use this health claim. Such a requirement would lessen
the public health benefits of the rule. On the other hand, there were a
number of foods, such as margarines and salad dressings, that could be
formulated to contain plant stanol or sterol esters while still
qualifying as "low saturated fat" and "low cholesterol." Given the
strength of the evidence supporting the cholesterol-lowering effects of
plant sterol/ stanol esters, FDA required that foods bearing this health
claim be "low saturated fat" and "low cholesterol," but not "lowfat."

Hypertext links to health claim regulations referenced:

§ 101.75 --
http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/cfr_2003/aprqtr/pdf/21cfr101.75.pdf

§ 101.77 --
http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/cfr_2003/aprqtr/pdf/21cfr101.77.pdf

§ 101.81 --
http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/cfr_2003/aprqtr/pdf/21cfr101.81.pdf

§ 101.82 --
http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/cfr_2003/aprqtr/pdf/21cfr101.82.pdf

§ 101.83
--http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/cfr_2003/aprqtr/pdf/21cfr101.83.pdf