Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations 49881

other nutrients or dietary ingredients,

the label or labeling shall clearly

identify which vitamin or mineral is

described by the term ‘‘high potency’’

(e.g., ‘‘Botanical ‘X’ with high potency

vitamin E’’).

(2) The term ‘‘high potency’’ may be

used on the label or in the labeling of

a multiingredient food product to

describe the product if the product

contains 100 percent or more of the RDI

for at least two-thirds of the vitamins

and minerals that are listed in

§ 101.9(c)(8)(iv) and that are present in

the product at 2 percent or more of the

RDI (e.g., ‘‘High potency multivitamin,

multimineral dietary supplement

tablets’’).

(3) Where compliance with

paragraphs (f)(1)(i), (f)(1)(ii), or (f)(2) of

this section is based on a nutrient that

has been added to a food (other than a

dietary supplement), that fortification

shall be in accordance with the policy

on fortification of foods in § 104.20 of

this chapter.

(g) Nutrient content claims using the

term ‘‘antioxidant.’’ A nutrient content

claim that characterizes the level of

antioxidant nutrients present in a food

may be used on the label or in the

labeling of that food when:

(1) An RDI has been established for

each of the nutrients;

(2) The nutrients that are the subject

of the claim have recognized

antioxidant activity; that is, when there

exists scientific evidence that, following

absorption from the gastrointestinal

tract, the substance participates in

physiological, biochemical, or cellular

processes that inactivate free radicals or

prevent free radical-initiated chemical

reactions;

(3) The level of each nutrient that is

the subject of the claim is sufficient to

qualify for the § 101.54(b), (c), or (e)

claim (e.g., to bear the claim ‘‘high in

antioxidant vitamin C,’’ the product

must contain 20 percent or more of the

RDI for vitamin C). Beta-carotene may

be a subject of the claim when the level

of vitamin A present as beta-carotene in

the food that bears the claim is

sufficient to qualify for the claim. For

example, for the claim ‘‘good source of

antioxidant beta-carotene,’’ 10 percent

or more of the RDI for vitamin A must

be present as beta-carotene per reference

amount customarily consumed; and

(4) The names of the nutrients that are

the subject of the claim are included as

part of the claim (e.g., ‘‘high in

antioxidant vitamins C and E’’).

Alternatively, when used as part of a

nutrient content claim, the term

‘‘antioxidant’’ or ‘‘antioxidants’’ (as in

‘‘high in antioxidants’’) may be linked

by a symbol (e.g., an asterisk) that refers

to the same symbol that appears

elsewhere on the same panel of a

product label followed by the name or

names of the nutrients with recognized

antioxidant activity. The list of nutrients

shall appear in letters of a type size

height no smaller than the larger of onehalf of the type size of the largest

nutrient content claim or 1/16 inch.

3. Section 101.60 is amended by

revising paragraph (c)(1)(iii)(A) to read

as follows:

§ 101.60 Nutrient content claims for the

calorie content of foods.

* * * * *

(c) * * *

(1) * * *

(iii)(A) It is labeled ‘‘low calorie’’ or

‘‘reduced calorie’’ or bears a relative

claim of special dietary usefulness

labeled in compliance with paragraphs

(b)(2), (b)(3), (b)(4), or (b)(5) of this

section, or, if a dietary supplement, it

meets the definition in paragraph (b)(2)

of this section for ‘‘low calorie’’ but is

prohibited by §§ 101.13(b)(5) and

101.60(a)(4) from bearing the claim; or

* * * * *

Dated: September 11, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–24732 Filed 9–22–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I

[Docket No. 96N–0094]

Uniform Compliance Date for Food

Regulations

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; response to

comments.

SUMMARY: The Food and Drug

Administration (FDA) is responding to

comments that were submitted in

response to a final rule establishing

January 1, 2000, as the uniform

compliance date for food labeling

regulations that the agency issues

between January 1, 1997, and December

31, 1998. FDA received three comments

in response to that final rule. The

agency is not making any changes in the

final rule in response to these

comments. January 1, 2000, remains the

uniform compliance date for food

labeling regulations that are issued

between January 1, 1997, and December

31, 1998.

EFFECTIVE DATE: December 27, 1996.

FOR FURTHER INFORMATION CONTACT:

Gerad L. McCowin, Center for Food

Safety and Applied Nutrition (HFS–

150), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–205–4561.

SUPPLEMENTARY INFORMATION:

I. Background

FDA has periodically announced

uniform compliance dates for new food

labeling requirements to minimize the

economic impact of label changes. In

1992, FDA suspended this practice

pending the issuance of regulations

implementing the Nutrition Labeling

and Education Act of 1990 (the 1990

amendments). In the Federal Register of

December 24, 1996 (61 FR 67710), FDA

issued a final rule (hereinafter referred

to as the December 24, 1996, final rule)

establishing January 1, 1998, as its new

uniform compliance date for all food

labeling regulations that are issued after

its publication and before January 1,

1997. FDA announced that it was

reinstating its previous practice of

periodically announcing, as final rules,

uniform compliance dates for food

labeling regulations. In the Federal

Register of December 27, 1996 (61 FR

68145) (hereinafter referred to as the

December 27, 1996, final rule), FDA

established January 1, 2000, as the

uniform compliance date for food

labeling regulations that are issued

between January 1, 1997, and December

31, 1998. Because FDA had already

provided notice and opportunity for

comment on the practice of establishing

uniform compliance dates by issuance

of a final rule announcing the date (see

61 FR 67710, December 24, 1996), the

agency found any further rulemaking

unnecessary. Nonetheless, under 21

CFR 10.40(e)(1), FDA provided an

opportunity until March 13, 1997, for

interested persons to comment on

whether the uniform compliance date of

January 1, 2000, should be modified or

revoked. In the December 27, 1996, final

rule, FDA advised that it would publish

a notice setting out the agency’s

conclusions concerning any comments

that it received in response to the final

rule or initiate notice and comment

rulemaking to modify or revoke the

uniform compliance date that the final

rule established.

FDA received three letters, each

containing one or more comments, from

trade associations in response to the

December 27, 1996, final rule. A

summary of these comments and the
49882 Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations

agency’s responses are provided as

follows:

II. Comments

A. Dietary Supplements

One of the comments asked the

agency to confirm that the final rule for

a uniform compliance date of January 1,

2000, will apply to the proposed

regulations for dietary supplement

labels that FDA published in the

Federal Register of December 28, 1995

(60 FR 67176 and 67194). The comment

noted that the December 28, 1995,

proposals specified a compliance date of

December 31, 1996, and that obviously

that date had come and gone and the

final regulations had yet to be issued.

The comment agreed with FDA’s

statements concerning the use of a

uniform compliance date and stated that

the uniform compliance date of January

1, 2000, should be applied to the final

rule issued in response to the December

28, 1995, proposed regulations

concerning dietary supplements. The

comment explained that the dietary

supplement labeling regulations will

have a massive impact on the entire

industry. It stated that every single

dietary supplement label will need to be

revised, and that many products that do

not currently bear nutrition labeling will

be required to do so. The comment

concluded that, based on the passage of

time and the need for the industry to

have adequate time to reprint and

replace label stock, the uniform

compliance date of January 1, 2000, is

the appropriate effective date for the

final labeling regulations for dietary

supplements.

As stated in the December 27, 1996,

final rule, ‘‘The new uniform

compliance date will apply only to final

FDA food labeling regulations that

require changes in the labeling of food

products and that publish after January

1, 1997, and before January 1, 1999’’ (61

FR 68145). The Dietary Supplement

Health and Education Act of 1994

(DSHEA) amended the Federal Food,

Drug, and Cosmetic Act (the act) to

establish a new definition for ‘‘dietary

supplement’’ in section 201(ff) of the act

(21 U.S.C. 321(ff)). The last sentence of

section 201(ff) of the act states, ‘‘Except

for purposes of section 201(g), a dietary

supplement shall be deemed to be a

food within the meaning of this Act.’’

Therefore, the agency confirms that the

uniform compliance date will generally

apply to regulations that establish

requirements for the labeling of dietary

supplements.

In the December 27, 1996, final rule

(61 FR 68145 at 68146), however, FDA

advised that if any food labeling

regulation, including one concerning

dietary supplements, involves special

circumstances that justify a compliance

date other than January 1, 2000, the

agency will determine for that

regulation an appropriate compliance

date and will specify that compliance

date in the final rule that resolves the

proceeding. Elsewhere in this issue of

the Federal Register, FDA is publishing

final rules in response to proposals on

dietary supplements that it published in

the Federal Register of December 28,

1995. As discussed in those final rules,

FDA has concluded that a compliance

date of March 23, 1999, is responsive to

the directives of DSHEA, and that

extending the compliance date to

January 1, 2000, for those final rules

would not be appropriate. Therefore,

FDA is adopting March 23, 1999, as the

effective date for the final regulations

for the labeling of dietary supplements,

rather than January 1, 2000.

B. Bakery Industry

Although two letters from trade

associations for the bakery industry

agreed with the concept of a uniform

compliance date, these letters disagreed

with establishing January 1, 2000, as the

uniform compliance date for regulations

issued between January 1, 1997, and

December 31, 1998. One comment

stated that the uniform compliance date

of January 1, 1998, should be extended

to January 1, 1999, and that the uniform

compliance date of January 1, 2000,

should be extended to January 1, 2001.

The comment stated that this extra year

would allow firms to do laboratory

analyses-reformulations, use existing

inventory, and release new products

and packaging to consumers. The

comment explained that it is hard to

foresee what types of new final

regulations will materialize by

December 31, 1998, and that 2 years

would not be sufficient time for all of

the changes needed. The comment

suggested that all future uniform

compliance dates allow a 3-year

timeframe to make changes. The

comment stated that, while some types

of labeling changes may be more swiftly

implemented than others, FDA should

consider the more complicated cases

like folic acid in establishing these

dates.

The second comment stated that a

compliance period of 1 year is not

sufficient for the small and medium,

mostly family owned, wholesale bakers

that it represents to implement labeling

changes in a manner that would

minimize economic impact. The

comment stated that the least amount of

time needed for bakers to efficiently and

effectively implement new labeling

regulations would be 24 months. The

comment expressed its concern that the

rule would constrict a company’s

method of implementing FDA’s rules,

particularly for slow selling items,

where labels are ordered for an

extended length of time.

These two comments raise concerns

similar to some that were raised in

response to the uniform compliance

date proposal of April 15, 1996 (61 FR

16422), and that were addressed in the

December 24, 1996, final rule. In that

proceeding, there were comments that

objected to establishing January 1, 1998,

as the uniform compliance date for food

labeling regulations issued between

January 1, 1995, and December 31, 1996,

on the grounds that it resulted in a

‘‘compliance period’’ that at its shortest

possible length would be only 12

months long. FDA disagreed with those

comments, stating that a compliance

period that is 18 months or 2 years at

its shortest is too long. The agency

pointed out that it must consider the

costs and benefits to both the food

producer and the consumer (61 FR

67710). A compliance period of 6

months would increase the benefit to

the consumer but would result in even

greater costs to the food producers than

are caused by a compliance period of 12

months. Although a lengthier

compliance period would reduce the

costs to food producers, it would delay

implementation of the labeling changes,

thus decreasing the value of any benefits

to the consumer.

As the agency pointed out in the

December 24, 1996, final rule, the

minimum compliance period of 1 year

is the same compliance period that it

has used for all of its uniform effective

date final rules dating back to the

1970’s, until it issued the labeling

regulations that implemented the 1990

amendments. The agency is unaware of,

nor has anyone submitted, including in

the comments in this proceeding, any

information to demonstrate any

problems with respect to bringing labels

into compliance with the various

uniform effective dates that it had

established over the period of

approximately 20 years during which it

has announced uniform compliance

dates. While there have been instances

where the agency has granted

extensions beyond the uniform

compliance date, generally firms have

come into compliance with little

complaint to the agency. The agency is

merely reinstating its former practice.

The agency concludes that the

comments on the December 27, 1996,

final rule do not provide a basis on

which to initiate rulemaking to revoke

or modify the uniform compliance date
Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations 49883

established therein. Therefore, FDA

confirms that January 1, 2000, will be

the uniform compliance date for food

labeling regulations issued between

January 1, 1997, and December 31, 1998.

Dated: September 11, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–24731 Filed 9–22–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 96N–0240]

Food Labeling; Notification

Procedures for Statements on Dietary

Supplements

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending its

regulations to establish the notification

procedures for manufacturers, packers,

or distributors of dietary supplements

who are marketing dietary supplement

products that bear statements under a

provision of the Federal Food, Drug, and

Cosmetic Act (the act). The agency is

adopting this procedure to ensure that

notification is accomplished efficiently.

FDA instituted this proceeding to help

the industry comply with the Dietary

Supplement Health and Education Act

of 1994 (the DSHEA).

EFFECTIVE DATE: October 23, 1997.

FOR FURTHER INFORMATION CONTACT:

Robert J. Moore, Center for Food Safety

and Applied Nutrition (HFS–456), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–205–4605.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of September

27, 1996 (61 FR 50771), FDA published

a proposed rule entitled ‘‘Food Labeling;

Dietary Supplement; Nutritional

Support Statement; Notification

Procedure’’ (hereinafter referred to as

‘‘the September 1996 proposal’’). FDA

issued this proposal in response to

section 6 of the DSHEA (Pub. L. 103–

417). This section of the DSHEA

amended the act by adding section

403(r)(6) (21 U.S.C. 343(r)(6)). This

section of the act allows for statements

to be made on the label or in the

labeling of a dietary supplement that

does the following:

(1) Claims a benefit related to a

classical nutrient deficiency disease and

discloses the prevalence of such disease

in the United States,

(2) describes the role of a nutrient or

dietary ingredient intended to affect the

structure or function in humans,

(3) characterizes the documented

mechanism by which a nutrient or

dietary ingredient acts to maintain such

structure or function, or

(4) describes general well-being from

consumption of a nutrient or dietary

ingredient if the statements are made in

accordance with certain requirements.

The manufacturer of the dietary

supplement must:

(1) Substantiate that the statement is

truthful and not misleading;

(2) Include, prominently displayed

and in boldface type, the following:

‘‘This statement has not been evaluated

by the Food and Drug Administration.

This product is not intended to

diagnose, treat, cure, or prevent any

disease;’’ and

(3) Notify the Secretary of Health and

Human Services (the Secretary) (and by

delegation FDA) no later than 30 days

after the first marketing of a dietary

supplement bearing such a statement

that the statement is being made.

The statement may not claim to

diagnose, mitigate, treat, cure, or

prevent a disease or class of diseases.

In the September 1996 proposal, FDA

outlined the procedure by which

manufacturers would comply with the

requirements that they notify the

Secretary when they make a claim

under section 403(r)(6) of the act. FDA

received eight responses to the proposal.

Each response contained one or more

comments. Some comments supported

the proposal generally or supported

aspects of the proposal. Other comments

addressed issues outside the scope of

the proposal (e.g., guidelines

differentiating health claims from

structure/function claims, health

information to consumers, types of

claims that can be made, the form and

amount of substantiation FDA will

require, when the disclaimer should or

should not be required, and the use of

classical nutrient deficiency claims) and

will not be addressed in this document.

Several comments suggested

modifications or revisions of various

aspects of the proposal. A summary of

the comments and the agency’s

responses to the comments follow.

II. Notification of ‘‘Products’’ or

‘‘Brands’’

1. One comment objected to proposed

§ 101.93(b)(4) (redesignated as

§ 101.93(a)(2)(iv)) requiring that the

brand name of the product be included

in the notification. The comment argued

that providing this information would

be unnecessarily burdensome, and that

the DSHEA did not require this

information. The comment cited the fact

that a dietary supplement product, such

as vitamin C 500 milligrams (mg), may

be marketed under a variety of brand

names, but that the product (i.e., the

dietary supplement) could be the same

from brand ABC to brand XYZ. The

comment argued that if a notification

has been made for a claim on one brand

of this dietary supplement, it should not

be necessary for every manufacturer of

this type of supplement to file a

notification.

FDA is not persuaded to modify the

regulation in response to this comment.

If a manufacturer makes a type of

dietary supplement, such as a vitamin C

supplement, under a number of

different brand names, under

§ 101.93(a)(2)(iv), a manufacturer may

list all of the brands on which the claim

is to appear, and thus for which it is

providing notification, in a single

submission. The regulation does not

require that a separate notice be

submitted for each individual product

or brand.

FDA finds that the brand name of a

dietary supplement is a necessary part

of the notification that a statement of

nutritional support is being made on the

label or in the labeling of the dietary

supplement. Including the brand is

necessary to efficiently enforce the act.

If the notification does not include the

relevant brand name, FDA will not

know which products are in compliance

with the notification requirement of

section 403(r)(6) of the act. This is

particularly important because there is

no requirement that a manufacturer

submit to FDA its substantiation that

establishes that its claim is truthful and

not misleading (section 403(r)(6)(B) of

the act). Thus, it cannot be assumed that

the first submission for a claim under

section 403(r)(6) of the act establishes

that adequate substantiation exists to

support that claim for all products that

may contain that substance. Each

manufacturer must have its own

substantiation that any statement it

makes in the labeling of a dietary

supplement product under section

403(r)(6) of the act is truthful and not

misleading, and the manufacturer must

submit a notice to FDA that attests to

this fact.

III. Signature of Person Who Can

Certify that Firm has Substantiation

2. Several comments objected to

proposed § 101.93(c) (redesignated as