[Federal Register Volume 62, Number 74 (Thursday, April 17, 1997)]
[Notices]
[Pages 18774-18775]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-9876]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97D-0086]


Food Labeling: Draft Guidance on Diet Plans

AGENCY: Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY: The Food and Drug Administration (FDA) is providing draft 
guidance to the marketers of food plans that are represented as a total 
diet and that have been formulated so that the dietary intake of 
various nutrients by those who participate in the plan is controlled. 
The agency hopes that this guidance, if finalized, will help to 
minimize any problems that may develop should firms proceed to market 
with these plans.

DATES: Written comments by July 1, 1997.

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: Christine J. Lewis, Center for Food 
Safety and Applied Nutrition (HFS-451), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-205-4168.

SUPPLEMENTARY INFORMATION: FDA is aware that there is interest in the 
food industry in offering a food plan in which most of the food in the 
diet is purchased through the plan. The foods sold in these plans would 
be formulated so that the total diet of those who comply with the plan 
provides controlled levels of such nutrients as fat, saturated fat, 
cholesterol, and sodium.
    FDA applauds innovative efforts to help consumers maintain healthy 
dietary practices. The agency notes that one of the main purposes of 
the Nutrition Labeling and Education Act (the 1990 amendments) was to 
encourage such practices, and, thus, such plans can be seen, at least 
conceptually, as consistent with that statute. The agency also 
recognizes that diets can be structured to be useful in the management 
of certain chronic conditions. The agency has no desire to do anything 
that would discourage efforts to achieve these innovative goals.
    While these plans have the potential to be useful, they also have 
the potential to create a number of significant concerns under the 
Federal Food, Drug, and Cosmetic Act (the act). The purveyors of such 
programs will need to take care to ensure that, in presenting these 
programs to the American consumer, they do not run afoul of any of the 
provisions of the act. Given this need for care, FDA has concluded that 
it would be useful to companies that either have decided, or who may 
decide, to offer such programs, and that it would help to prevent 
regulatory problems, if the agency outlined the statutory concerns that 
it can foresee could be created by these programs. The agency is also 
setting out its thoughts on these concerns. The agency would welcome 
comments on these preliminary views from interested persons. The major 
concerns that FDA has at least preliminarily identified follow.

A. Health Claims

    Under section 403(r)(1)(B) of the act (21 U.S.C. 343(r)(1)(B)) and 
21 CFR 101.14(a)(1), a health claim is:
    * * * any claim made on the label or in labeling of a food, 
including a dietary supplement, that expressly or by implication, 
including ``third party'' references, written statements (e.g., a 
brand name including a term such as ``heart''), symbols (e.g., a 
heart symbol), or vignettes, characterizes the relationship of any 
substance to a disease or health-related condition. Implied health 
claims include those statements, symbols, vignettes, or other forms 
of communication that suggest, within the context in which they are 
presented, that a relationship exists between the presence or level 
of a substance in the food and a disease or health-related 
condition.
    Thus, for a claim to be a health claim, one of the essential 
elements is that it be, expressly or by implication, about a particular 
substance and not about the total diet. The agency points out that, in 
adopting the health claim final rule, it said that:
    * * * phrases on labeling such as ``eat a variety of foods to 
__________,'' ``eat a variety of fresh fruits and vegetables to 
__________,'' or ``follow the food pyramid to __________,'' without 
any reference, either express or implied, to a substance that might 
be in the foods, would not satisfy this element. The latter types of 
claims would not be subject to regulation as health claims.
(58 FR 2478 at 2480, January 6, 1993). The agency thus recognizes that 
claims about the effects of a diet plan, depending on how the claim is 
made, would arguably not be subject to regulation as a health claim.
    FDA advises that it will carefully scrutinize any claims that are 
made for a diet plan to determine whether they are health claims. For 
example, a claim that the diet has been designed to provide high levels 
of vitamin A to reduce the risk of cancer would be a health claim 
because the statement links the two basic components of a health claim, 
a food substance and a disease or health-related condition. Any claims 
that are made that are health claims must be made in accordance with 
FDA's authorizing regulations, or they will misbrand the products under 
section 403(r)(1)(B) of the act.

B. Nutrient Content Claims

    A claim that expressly or by implication characterizes the level of 
a nutrient in a food is a nutrient content

[[Page 18775]]

claim (21 CFR 101.13(b)). Such claims must be made in accordance with 
FDA's regulations defining the claim (section 403(r)(1)(A) of the act). 
FDA cautions that care must be taken in how claims are made about diet 
plans to ensure that the foods in the plan are not represented as 
having lower, or higher, nutrient levels than they actually contain. 
For example, a claim that a plan has been formulated to provide low fat 
foods, as compared to a claim that the plan has been formulated to 
provide a diet that is low in fat, would imply that the foods in the 
plan are low fat. Thus, every food in the plan would have to meet the 
definition for ``low fat'' in 21 CFR 101.62(b)(2) to avoid being 
misbranded.

C. Foods for Special Dietary Use

    Foods that purport or are represented as to be used to supply a 
special dietary need that exists by reason of a physical, 
physiological, pathological, or other condition are foods for special 
dietary use under section 411(c)(3)(A) of the act (21 U.S.C. 
350(c)(3)(A)). There is a substantial possibility that a diet plan may 
be represented in a way that subjects the foods in the plan to 
regulation as foods for special dietary use. For example, a claim that 
the diet plan provides a modified diet, formulated for those who must 
restrict their sodium intake, would present the foods in the plan as 
foods for special dietary use. Under section 403(j) of the act, FDA has 
authority to require, on the label of such foods, information 
concerning their dietary properties that it finds necessary to fully 
inform purchasers about their value for special dietary use.
    FDA advises that, if these diet plans appear on the market, FDA 
will carefully scrutinize the labeling and advertising for such plans 
to see whether it is necessary for the agency to invoke its authority 
under section 403(j) of the act.

D. False or Misleading Claims

    Under section 403(a)(1) of the act, food is deemed to be misbranded 
if its labeling is false or misleading in any particular. FDA would 
expect that any firm that markets a diet plan will have evidence about 
the effects of following the plan, and that that evidence would 
establish that any claims that are made about that plan and the food 
that makes up the plan are truthful and not misleading. FDA also would 
expect that the firm will share that evidence with FDA. For example, if 
there is a claim that a plan has been clinically proven to have a 
certain effect, FDA will expect that at least one properly designed 
clinical study has been done with the particular diet plan, that the 
results of the study or studies fully support the claims that are made, 
and that the results of the studies will be shared with FDA.

E. Drug Claims

    FDA is concerned that claims made about a diet plan could evidence 
an intent that the plan is to be used as a drug. Under section 
201(g)(1)(B) of the act (21 U.S.C. 321(g)(1)(B)), articles intended for 
use in the diagnosis, cure, mitigation, treatment, or prevention of 
disease in humans or other animals are deemed to be drugs. Thus, for 
example, a claim that a diet plan is a ``therapeutic diet'' could 
subject the plan to regulation under the provisions of the act that 
apply to drugs and, in particular, new drugs. FDA therefore cautions 
that manufacturers who decide to market diet plans with claims that 
subject the plans to regulation as drugs must be prepared to satisfy 
the applicable statutory requirements.

F. Meat and Poultry Products

    FDA advises that diet plans that include meat or poultry products 
are also subject to regulation by the Food Safety and Inspection 
Service of the U.S. Department of Agriculture, under the Meat 
Inspection Act and the Poultry Products Inspection Act.

G. Conclusion

    In conclusion, FDA advises that this document's discussion of the 
regulatory requirements that apply to diet plans is not intended to 
discourage such plans. It is intended to ensure that manufacturers who 
decide to go forward with such plans do so with an understanding of the 
act and FDA's regulations. The agency hopes that, by laying out its 
concerns and expectations, it will help to minimize the problems that 
will develop should firms proceed to market with these plans and thus 
to maximize the likelihood that consumers will fully appreciate the 
benefits that they offer.
    This draft guidance represents the agency's current thinking on 
food plans that are marketed as a total diet. It does not create or 
confer any rights for or on any person and does not operate to bind FDA 
or the public. An alternative approach may be used if such approach 
satisfies the requirements of the applicable statute, regulations, or 
both.
    Interested persons may, on or before July 1, 1997 submit to the 
Dockets Management Branch (address above) written comments on this 
draft guidance. 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.

    Dated: April 8, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-9876 Filed 4-16-97; 8:45 am]
BILLING CODE 4160-01-F