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 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 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 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 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 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