[Federal Register Volume 62, Number 249 (Tuesday, December 30, 1997)]
[Proposed Rules]
[Pages 67771-67775]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33921]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket Nos. 91N-384H and 96P-0500]
RIN 0910-AA19


Food Labeling: Nutrient Content Claims, Definition of Term: 
Healthy

AGENCY: Food and Drug Administration, HHS.

ACTION: Advance notice of proposed rulemaking.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that it 
is considering whether to institute rulemaking to reevaluate and 
possibly amend certain provisions of the nutrient content claims 
regulations pertaining to the use of the term ``healthy.'' This action 
is in response to a citizen petition from ConAgra, Inc., to amend the 
definition of this term. The petitioner has raised important issues 
regarding both the technological feasibility of reductions in sodium 
levels in foods that currently meet FDA's definition for the term 
``healthy'' and the safety of at least some of these foods if there are 
reductions in their sodium levels. The agency is requesting that data 
be submitted relative to these issues. In addition, FDA is responding 
to comments that it received in response to a stay of certain 
provisions pertaining to the use of the term ``healthy.''

DATES: Written comments by March 16, 1998.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:  Joyce J. Saltsman, Center for Food 
Safety and Applied Nutrition (HFS-165), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-205-5483.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of May 10, 1994 (59 FR 24232), FDA 
published a final rule to establish a definition of the term 
``healthy'' under section 403(r) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 343(r)). In that final rule, FDA 
stated that the fundamental purpose of a ``healthy'' claim is to 
highlight those foods that, based on their nutrient levels, are 
particularly useful in constructing a diet that conforms to current 
dietary guidelines (59 FR 24232 at 24233). In its consideration of 
comments relative to the proposed qualifying level of sodium to be 
incorporated into the definition of the term ``healthy,'' the agency 
rejected comments that suggested that the food should meet the 
requirements for ``low sodium'' (59 FR 24232 at 24239). The agency 
stated that such a definition was too restrictive, and that many foods 
that would otherwise meet the definition of ``healthy'' would be 
disqualified by a ``low sodium'' requirement. The agency stated that 
for the claim to be useful, foods that are able to bear the term should 
be of a sufficient number and variety to help consumers achieve a total 
diet that is consistent with current dietary recommendations (59 FR 
24232 at 24239).
    The agency explained that sodium plays an important role in 
consumer acceptance of a product, and that many products that qualify 
to bear a claim for ``healthy'' may lose their appeal to consumers 
because of an unacceptable flavor profile if, in addition to being low 
in fat and saturated fat, the foods were low in sodium. FDA stated 
that, if consumers abandon products or add salt to taste at the table, 
foods bearing the term would lose their usefulness in assisting 
consumers to achieve dietary recommendations with respect to sodium 
intake (59 FR 24232 at 24239).
    Based on the comments to the proposed rule for ``healthy'' relative 
to specific sodium levels, the agency adopted qualifying criteria of 
360 milligrams (mg) of sodium per reference amount customarily consumed 
(RACC) in individual foods and 480 mg sodium per RACC in main dish and 
meal products (59 FR 24232 at 24240). In addition, the agency 
established a transition period to allow time for industry to 
reformulate products to meet the new qualifying sodium levels. The 
agency determined that levels of 480 mg of sodium in individual foods, 
single ingredient seafood, and game meat, and of 600 mg of sodium in 
main dishes and meal products, were appropriate levels during the 
transition period, but that after January 1, 1998 (essentially 3-1/2 
years from the date of publication of the final rule), these foods 
would have to meet the lower sodium qualifying levels to bear the claim 
``healthy'' (59 FR 24232 at 24241 and 24245 and see 
Sec. 101.65(d)(2)(ii), (d)(3)(ii), and (d)(4)(ii) (21 CFR 
101.65(d)(2)(ii), (d)(3)(ii), and (d)(4)(ii))).
    On December 13, 1996, FDA received a petition from ConAgra, Inc. 
(the petitioner), 888 17th St. NW., suite 300, Washington, DC 20006, 
requesting that Sec. 101.65(d) be amended to ``eliminate the sliding 
scale sodium requirement for foods labeled `healthy' by eliminating the 
entire second tier levels of 360 mg sodium for individual foods and 480 
mg sodium for meals and main dishes'' (Docket 96P-0500, CP-1, p. 1). 
Alternatively, the petitioner requested that the effective date of 
January 1, 1998, in Sec. 101.65(d)(2) through (d)(4) be delayed until 
such time as food technology catches up with FDA's goals to reduce the 
sodium content of foods, and until there is a better understanding of 
the relationship between sodium and hypertension.
    The agency was persuaded by the petition that it is in the public 
interest to stay the effect of the lower standards for sodium in the 
definition of ``healthy'' in Sec. 101.65 while the agency endeavors to 
resolve the issues raised by the petition. Therefore, in the Federal 
Register of April 1, 1997 (62 FR 15390), FDA published a final rule 
that stayed, until January 1, 2000, the effective date of January 1, 
1998, in Sec. 101.65(d)(2)(ii) and (d)(4)(ii) for when foods must 
achieve the lower sodium levels (the ``second tier levels'') to qualify 
to bear the term ``healthy.'' The agency said that it was issuing the 
stay to allow itself time to reevaluate the standard, and to evaluate 
the data contained in the petition and any additional data that it may 
receive; to conduct any subsequent notice-and-comment rulemaking that 
it finds is necessary; and to allow ample time for implementation of 
the rule or of any changes in the rule that may result from the 
agency's reevaluation.

[[Page 67772]]

 Accordingly, FDA announced that interested persons may submit comments 
regarding the appropriateness of the basis for the stay and the 
feasibility of further lowering the sodium level in foods while 
maintaining consumer acceptability.
    FDA is issuing this advance notice of proposed rulemaking (ANPRM) 
to respond to the comments that it received in response to the stay and 
to solicit comments and additional information on whether it should 
propose to amend the definition of the term ``healthy'' relative to the 
sodium requirements. Those interested persons that believe that the 
agency should amend the ``healthy'' definition should address what the 
amended regulation should require to ensure that the term can appear on 
a significant number of foods but is not so broadly defined as to lose 
its value in highlighting foods that are useful in constructing a diet 
that is consistent with dietary guidelines. Those who believe that the 
current definition is appropriate and should not be changed should 
provide data that demonstrate that the definition, with the sodium 
levels that were scheduled to take effect in January of 1998, is not so 
restrictive as to effectively preclude use of the term.

II. FDA's Response to Comments on the Stay of Certain Provisions in 
the Definition of ``Healthy''

    FDA received eight comments in response to the stay of the sodium 
provisions in Sec. 101.65(d)(2)(ii) and (d)(4)(ii) from industry, trade 
associations, a health care association, and a Federal Government 
agency. Most of the comments agreed with the agency's decision to stay 
these provisions until January 1, 2000, to allow the agency time to 
reevaluate the standard on the basis of available data, including the 
data contained in the petition and any additional data that the agency 
may receive.
    Three comments disagreed with the agency's decision to stay the 
regulations. Two of the comments asserted that to stay the sodium level 
is a disadvantage to those companies that are ready to produce products 
that qualify to bear the term ``healthy'' under the stayed provisions. 
One comment stated that the consumer benefits if companies are prepared 
and allowed to respond to the opportunity to be one of a few or of 
several to offer and label foods as ``healthy.'' The other comment 
stated that many companies have demonstrated their ability and 
willingness to manufacture products that meet the lower second-tier 
sodium levels in Sec. 101.65(d)(2)(ii) and (d)(4)(ii). The comment 
stated that reducing sodium intake is one component of a comprehensive 
nutritional approach to blood pressure lowering that would benefit many 
Americans.
    One comment stated that FDA's decision to stay the lower sodium 
requirements conflicts with the agency's findings in adopting the 
``healthy'' final rule in 1994. The comment noted that, in the final 
``healthy'' regulation, FDA arrived at the final sodium criteria based 
on four key findings: (1) The levels will assist consumers in 
constructing a diet consistent with dietary guidelines; (2) they 
provide for a reasonable amount of sodium that enables a wide variety 
of foods to use the ``healthy'' claim without compromising the appeal 
of the food; (3) the levels are not so restrictive that they are likely 
to disqualify many foods that are recommended to be included in a 
healthy diet; and (4) the level ensures consistency with the U.S. 
Department of Agriculture (USDA). The comment stated that FDA seems 
willing to ignore its stated public health goals out of concern that 
certain foods may not be commercially viable at the levels of sodium 
determined by FDA to be appropriate.
    FDA recognizes that some companies will have reformulated their 
products to meet the second tier sodium levels in Sec. 101.65(d)(2)(ii) 
and (d)(4)(ii) by 1998, but it disagrees with the comments that stated 
that the stay will put these companies at a disadvantage. These 
companies will be able to make comparative claims that highlight their 
achievement (e.g., ``25 percent less sodium than Brand X''). As stated 
in the final rule of April 1, 1997, FDA encourages manufacturers who 
can meet the lower sodium levels for particular foods to do so even as 
the agency reevaluates the issues discussed in the petition (62 FR 
15390 at 15391).
    The agency also disagrees that it is ignoring the basis on which it 
established the sodium criteria out of concern that certain foods may 
not be commercially viable at the second-tier sodium levels. The 
petitioner raised significant questions, based on work that it did 
after publication of the ``healthy'' final rule, relative to the second 
of the four key findings noted previously; namely, whether there will 
be a wide variety of foods that will qualify to use the term 
``healthy'' at the second-tier sodium levels that are also acceptable 
to consumers. Given this fact, but given that the scientific evidence 
indicates further reductions in fat and sodium intakes will result in 
meaningful public health gains (62 FR 15390), the agency is staying the 
second tier levels until it resolves this issue. The agency is 
concerned that if the technology does not yet exist that permits 
manufacturers to produce, by January 1, 1998, certain types of reduced 
sodium foods that are acceptable to consumers, the possibility exits 
that the term ``healthy'' will disappear from the market. FDA will 
evaluate the data that it receives on whether the technological 
barriers to reducing the sodium content to the lower levels required in 
Sec. 101.65(d)(2)(ii) and (d)(4)(ii), and likewise for 
Sec. 101.65(d)(3)(ii), are insurmountable or not. The burden is on 
interested persons to provide convincing evidence to show why the lower 
sodium levels are not attainable. If they fail to do so, the lower 
sodium levels will become effective on January 1, 2000.

III. Petition to Amend the Definition of ``Healthy'' and the Agency 
Response

A. The Petition

    The petitioner cited as grounds to amend the definition of 
``healthy'': (1) A lack of scientific basis supporting the Daily 
Reference Value for sodium and the allowable levels of sodium in 
Sec. 101.65(d); (2) a lack of consumer acceptance of products 
containing low sodium levels; (3) a lack of acceptable sodium 
substitutes and the difficulties in manufacturing whole lines of food 
products at low sodium levels; and (4) FDA's failure to provide notice 
and comment on the second tier sodium levels in the ``healthy'' 
definition, to follow directives of the Nutrition Labeling and 
Education Act of 1990 (the 1990 amendments), and to consider recent 
scientific studies that raise concerns if too little sodium is consumed 
(Docket 96P-0500, CP-1, p. 3).
    Relative to the efforts of industry to lower the sodium level of 
foods, the petitioner stated that the technology does not yet exist to 
manufacture certain low fat products that both contain the levels of 
sodium necessary to satisfy the second tier requirements in the 
``healthy'' definition and are acceptable to consumers (Docket 96P-
0500, CP-1, p. 24). The petitioner argued that there is no adequate 
substitute for sodium chloride as a provider of a salty taste (Docket 
96P-0500, CP-1, p. 36). In addition, the petitioner stated that salt 
enhances or modifies all flavors of food, and that flavors are dulled 
or become harsh when salt is reduced.
    The petitioner submitted the results of a consumer survey that 
examined consumer acceptance of three products (hot dogs, macaroni and 
cheese, and chicken soup) with different sodium

[[Page 67773]]

levels (600 mg, 480 mg, and 360 mg sodium per serving) (Docket 96P-
0500, CP-1, pp. 25 to 28 and exhibit 161). While the results of the 
survey show reductions in consumer acceptance at levels of 480 mg 
sodium, a much greater, i.e., a statistically significant, reduction 
occurred at levels of 360 mg sodium per serving. As stated by the 
petitioner, ``If the sodium is so low in a product as to render the 
product tasteless or even bad tasting, consumers will not eat the 
product or will reach for the table salt. This is counter productive to 
the intent of the 1990 amendments and will not result in the goal 
Congress envisioned; i.e., to improve the eating habits of the American 
public, but instead could result in even more salt intake--not less'' 
(Docket 96P-0500, CP-1, p.28).
    The petitioner also delineated several technological concerns 
associated with lowering the sodium levels in foods related to the 
functional role of salt. For example, the petitioner described the 
effects of such reductions on the microbial stability of perishable 
products, on product texture and water binding capacity, on the flavor 
characteristics of certain ingredients, and on total electrolyte 
levels, which, the petitioner asserted, play a critical role in product 
safety (Docket 96P-0500, CP-1, pp. 28 to 30).
    The petitioner explained that a number of novel, proprietary, and 
known technological approaches to replace or potentiate sodium have 
been evaluated, but that, to date, none have been found to have 
suitable consumer acceptance. The petitioner stated that potassium 
chloride, often cited as capable of increasing salty taste, is also 
known for leaving a bitter aftertaste and has not gained widespread, 
satisfactory consumer acceptance (Docket 96P-0500, CP-1, p. 41). The 
petitioner suggested that to achieve the second-tier sodium levels as 
defined for ``healthy'' will require the ``invention, development, and 
commercialization of ingredients or components that do not exist 
today'' (Docket 96P-0500, CP-1, p. 41).

B. The Agency Response

    FDA finds that some of the issues raised in the petition regarding 
the second tier sodium levels appear to have merit. Others do not.
    The agency does not find merit in the petition's questions 
regarding the lack of scientific basis for the usefulness of lowered 
sodium levels in the diet of the general population. There is 
significant scientific agreement that lower dietary sodium levels 
reduce the risk of hypertension (Refs. 1 to 7). The overwhelming 
majority of experts and of authoritative bodies still favors making 
recommendations for the general public to moderate sodium intake. This 
consensus is reflected in the Dietary Guidelines for Americans (Ref. 
8).
    FDA also finds the petitioner's argument that the agency failed to 
provide notice and comment on the second tier sodium levels in the 
``healthy'' definition to be without merit. The revisions in the sodium 
requirements for individual foods and main dishes and meal products 
that were adopted in the ``healthy'' final rule were a logical 
outgrowth of the proposal (59 FR 24232 at 24241). In the proposal, the 
agency asked for comments for evaluating whether the definition of 
``healthy'' that it had proposed (i.e., foods that do not exceed the 
disclosure level for sodium or cholesterol and are ``low'' in fat and 
saturated fat) was appropriate (58 FR 2944 at 2947). FDA acknowledged 
that its proposed definition of the term ``healthy'' differed from the 
definition for ``healthy'' that was proposed by USDA (i.e., meat or 
poultry that contain less than 10 grams (g) of fat, less than 4 g of 
saturated fat, less than 95 mg of cholesterol, and less than 480 mg of 
sodium per 100 g and per reference amount customarily consumed for 
individual foods, and per 100 g and labeled serving for meal-type 
products) (58 FR 688); and FDA asked for comments on whether it was 
necessary that FDA and USDA provide uniform criteria for use of this 
term, or whether different definitions would be appropriate (58 FR 2944 
at 2948). As stated previously, the agency received comments that 
argued that FDA should adopt levels both lower and higher than those 
that it proposed and those that it adopted (see 59 FR 24232 at 24238 
and 24239). FDA considered the information submitted in the comments in 
arriving at the final levels (see 59 FR 24232 at 24239 to 24241). Thus, 
the agency provided full and adequate notice of its intent to adopt 
sodium levels, and the levels that it adopted were the logical 
outgrowth of the proposal. See Small Refiner Lead Phase-Down Task Force 
v. USEPA, 70S F.2d 506, 548-550 (D.C. Cir. 1983).
    However, the agency does find that the issues relative to 
technological and safety concerns of reduced sodium foods present 
important questions that merit further consideration.
    FDA has defined the term ``healthy'' to serve as a means to help 
consumers to identify food products that will help them meet the 
guidelines for a healthy diet. Consumers understand the significance of 
this term, and thus many make purchasing decisions based on its 
presence on a food label. Because of this fact, manufacturers have an 
incentive to produce foods that qualify to bear this term. If the 
petitioner is correct that the technology does not yet exist that will 
permit manufacturers, by January 1, 1998, to produce certain types of 
low fat foods at the lower levels of sodium required in Sec. 101.65(d) 
that are still acceptable to, and safe for, consumers, then the 
possibility exists that ``healthy'' will disappear from the market for 
such foods. This result would force consumers who are interested in 
foods with restricted fat and sodium levels to choose among foods in 
which an effort has been made to lower the level of one or the other of 
these nutrients but not necessarily both. If this situation comes to 
pass, FDA will have squandered a significant opportunity. Therefore, 
the agency has decided that, before allowing the new sodium levels for 
``healthy'' to go into effect, it needs to explore whether it has 
created an unattainable standard for many types of foods.
    Accordingly, FDA is considering whether to institute rulemaking to 
resolve the issues raised by the petition and to reevaluate the sodium 
provisions of the nutrient content claims regulations pertaining to the 
use of the term ``healthy.'' In this notice, the agency is asking for 
data or evidence on what will happen to the use of the term ``healthy'' 
in the market if the second-tier sodium levels were in effect. How many 
products that bear the term ``healthy'' would be eliminated? Would 
there be other impacts on the number of consumer choices?
    The agency is also asking for: (1) Data regarding the technological 
feasibility of reducing the sodium content of individual foods 
(including single ingredient seafood and game meats) to 360 mg per RACC 
and of reducing the sodium content of meals and main dishes to 480 mg 
sodium per labeled serving, and (2) additional information or views on 
consumer acceptance of foods with such sodium levels.
    With regard to technological feasibility, the agency is asking for 
information about the availability or lack of availability of 
acceptable sodium substitutes, the difficulties in manufacturing 
different lines of food products with lowered sodium levels, and the 
impact of these sodium levels on the shelf-life stability and the 
safety of the food. Are there certain types of foods for which it is 
not possible to reach the second tier levels of sodium? If so, what are 
these foods? Should FDA make special exemptions for them, or should FDA 
exclude them from bearing the term ``healthy?''
     The agency is also asking for comments on other approaches to

[[Page 67774]]

reduce the amount of sodium in foods labeled ``healthy.'' It is 
important that consumers seeking to eat a health-promoting diet have 
food choices available that enable them to reduce the amount of sodium 
in their diet.
    If the comments reveal that agreement exists that there are 
technological hurdles that cannot be overcome at this time for all 
foods, or certain types of food, the agency is interested in exploring 
options for maximizing the public health gains that would come from 
reducing dietary sodium levels. To this end, the agency has identified 
the following four options that seem to represent the available 
alternatives.
    One, the agency may make no changes to the stayed rule, and the 
second tier sodium levels in Sec. 101.65(d)(2)(ii) and (d)(4)(ii) will 
become effective on January 1, 2000. This is the default option should 
the industry fail to provide evidence, data, or arguments that support 
amendment of these sections. Adequate support for these levels existed 
at the time FDA published the May 10, 1994, final rule; and the agency 
will not hesitate to reconfirm them in the event that the industry 
fails to provide evidence to persuade FDA to do otherwise.
    Two, FDA can propose to amend the definition of ``healthy'' in 
Sec. 101.65(d)(2)(ii) and (d)(4)(ii) as requested in the petition, and, 
at the same time, propose to amend Sec. 101.65(d)(3)(ii), to make the 
current sodium levels for individual foods, single ingredient seafood 
and game meats, main dishes, and meal products the qualifying levels 
and to delete Sec. 101.65(d)(2)(ii)(C)(1) and (d)(2)(ii)(C)(2), 
(d)(3)(ii)(C)(1) and (d)(3)(ii)(C)(2), and (d)(4)(ii)(B) in their 
entirety. FDA is likely to propose this option should the evidence 
submitted in response to this ANPRM demonstrate that it is 
technologically impossible to find salt substitutes for use in any type 
of food that would satisfactorily meet the requirements for taste, 
texture, safety, and consumer acceptance. However, persons who support 
this course would have to provide evidence on the efforts that they or 
others have made to comply with the second tier sodium levels, and they 
would have to provide a persuasive explanation as to why these 
reductions in sodium levels are not attainable.
    Three, if data and information submitted in response to this ANPRM 
suggest that technological advancements could be made but would require 
more time than provided in the stay of the effective date for the tier 
two sodium reductions (i.e., January 1, 2000, see 62 FR 15390), the 
agency would consider continuing the stay of the effective date of 
Sec. 101.65(d)(2) and (d)(4) for an appropriate period of time. To 
support this option, FDA would expect to receive information 
demonstrating that progress is being made in the reformulation of 
``healthy'' products, as well as information that provides an estimate 
of how much additional time is needed and that establishes the 
reasonableness of this estimate.
    Four, the agency could reconsider the sodium levels that it has 
established as the second tier of the ``healthy'' definition. For 
example, one possibility might be that an individual food would have to 
contain 360 mg sodium or less per RACC, or at least 25 percent less 
sodium per RACC than a market basket norm, so long as the final sodium 
level does not exceed 480 mg per RACC. For both main dish and meal 
products, the agency might consider the use of a percent reduction from 
the disclosure level for main dishes (720 mg sodium) or a percent 
reduction from the market basket norm. If a 25 percent reduction from 
the disclosure level of 720 mg were applied, the sodium level per 
labeled serving for main dishes and meals would be 540 mg (720 mg times 
0.25 equals 180, and 720 mg minus 180 mg equals 540 mg).
    If the definition is set at the reasonably achievable level of a 25 
percent reduction from the disclosure level or from the market basket 
norm, more foods are likely to be available, and consumers will be able 
to select from more and different foods to meet dietary guidelines. 
Furthermore, market competition may spur some manufacturers to exceed 
this minimal reduction, thereby resulting in foods with even greater 
reductions. On the other hand, the question that must be considered is 
whether a 25 percent reduction from the disclosure level or market 
basket norm is of adequate dietary significance to warrant use of the 
term ``healthy.''
    Based on the foregoing, the agency requests comments on whether it 
should institute rulemaking to reevaluate the sodium provisions of the 
nutrient content claims regulations pertaining to the use of the term 
``healthy'' and on the other issues raised by the petition.

IV. Executive Order 12866 Analysis

    If any rulemaking is proposed as a result of comments received to 
this ANPRM, FDA will examine the economic implications of the proposed 
rule as required by Executive Order 12866, which directs agencies to 
assess all costs and benefits of available regulatory alternatives. 
Executive Order 12866 classifies a rule as significant if it meets any 
one of a number of specified conditions, including having an annual 
effect on the economy of $100 million or adversely affecting in a 
material way a sector of the economy, competition, or jobs, or if it 
raises novel legal or policy issues.
    If FDA institutes rulemaking, the agency will examine the potential 
costs of the proposed rule, including but not limited to label redesign 
costs, product reformulation costs, and potential loss of product or 
product name. FDA will also examine potential benefits including 
improved access to information regarding the health effects of 
particular foods. FDA requests information that would aid the agency in 
responding to the Executive Order.

V. Regulatory Flexibility Analysis

    If a rule has a significant impact on a substantial number of small 
entities, the Regulatory Flexibility Act (5 U.S.C. 601-612) requires 
agencies to analyze options that would minimize the economic impact of 
that rule on small entities. According to the Regulatory Flexibility 
Act, the definition of a small entity is a business independently owned 
and operated and not dominant in its field. The Small Business 
Administration (SBA) has set size standards for most business 
categories through use of four-digit Standard Industrial Classification 
codes. For most processed foods, SBA considers any entity with fewer 
than 500 employees to be small. FDA requests information on the number 
of small entities that use the term ``healthy'' in the labeling of 
their products. FDA also requests information regarding the impact on 
small entities of the four options which FDA has identified and 
described in section III.B of this document. Specifically, FDA is 
interested in how each option may impact on a small entity's viability.

VI. Comments

    Interested persons may, on or before March 16, 1998, submit to the 
Dockets Management Branch (address above) written comments regarding 
this ANPRM. Two copies of any comments are to be submitted, except that 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. 
Received comments may be seen in the office above between 9 a.m. and 4 
p.m., Monday through Friday.

VII. References

    The following references have been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons

[[Page 67775]]

between 9 a.m. and 4 p.m., Monday through Friday.
    1. DHHS, Public Health Service (PHS), ``The Surgeon General's 
Report on Nutrition and Health,'' U.S. Government Printing Office, 
Washington, DC, pp. 139 to 143, 157 to 161, 165, and 167 to 174, 
1988.
    2. FNB/NAS, Diet and Health, National Academy Press, Washington, 
DC, pp. 355 to 356, 549 to 553 and 556 to 561, 1989.
    3. Joint National Committee on Detection, Evaluation, and 
Treatment of High Blood Pressure, ``The Fifth Report of the Joint 
National Committee on Detection, Evaluation, and Treatment of High 
Blood Pressure,'' Archives of Internal Medicine, 153:154 to 183, 
1993.
    4. Nutrition Committee, American Heart Association, ``Dietary 
Guidelines for Healthy American Adults--A Statement for Health 
Professionals from the Nutrition Committee, American Heart 
Association,'' Circulation, 94:1795 to 1800, 1996.
    5. LSRO, ``Evaluation of Publicly Available Scientific Evidence 
Regarding Certain Nutrient-Disease Relationships, 4. Sodium and 
Hypertension,'' Bethesda, MD, December 1991.
    6. FNB, National Research Council, ``Recommended Dietary 
Allowances,'' 10th ed., National Academy Press, Washington, DC, pp. 
247-261, 1989.
    7. USDA, DHHS, ``Report of the Dietary Guidelines Advisory 
Committee on the Dietary Guidelines for Americans,'' USDA, 
Washington, DC, 1995.
    8. USDA, DHHS, ``Nutrition and Your Health: Dietary Guidelines 
for Americans,'' 4th ed., Home and Garden Bulletin No. 232, 1995.

    Dated: December 10, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-33921 Filed 12-29-97; 8:45 am]
BILLING CODE 4160-01-F