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
49884 Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations

§ 101.93(a)(3)), which requires that the

notice be signed by a responsible

individual or by the person authorized

to certify that the information presented

and contained in the notice is accurate.

Other comments objected to proposed

§ 101.93(c) (redesignated as

§ 101.93(a)(3)) which requires that the

individual certify that the information

contained in the notice is complete and

accurate, and that the notifying firm has

substantiation that the statement is

truthful and not misleading. These

comments argued that the DSHEA does

not require that the notification be

signed by anyone, and that it does not

require that an individual certify that

the information contained in the notice

is complete and accurate, or that the

notifying firm have substantiation that

the statement is truthful and not

misleading.

One comment agreed that the

company must have substantiation that

statements made in accordance with

section 403(r)(6)(B) of the act are

truthful and not misleading. However,

this comment maintained that section

403(r)(6)(B) of the act does not require,

or provide any basis for requiring,

signature and certification as part of the

notification. Another comment stated

that the DSHEA’s requirement that

manufacturers of dietary supplements

have substantiation that such statements

are truthful and not misleading is

independent of the notification

requirement.

Several comments also disagreed with

FDA’s explanation that the requirement

for a signature will ensure that the

statutory requirements have been met,

and that the certification is necessary to

provide assurance that a notifying firm

has fully complied with the requirement

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

Several comments contended that

neither the courts nor FDA have

established procedures, guidelines, or

standards for identifying the type and

amount of evidence needed to support

substantiation, and therefore, the

manufacturer who is giving notification

cannot know whether the evidence it

has meets FDA’s expectations and has

no basis to provide certification. One

comment stated that general dictionary

definitions for ‘‘substantiation’’ are of

no help because, in the relevant legal

context, the question requires detailed

legal analysis, which at best can only

identify possible interpretations and

does not even begin to predict what the

agency’s ultimate interpretation of

‘‘substantiation’’ might be. One

comment stated that ‘‘substantiation’’

under the DSHEA might be interpreted

by regulated supplement companies to

mean a number of different things (e.g.,

near scientific certainty, significant

scientific agreement, or reasonable

basis). The comment requested that FDA

acknowledge that it will not attempt to

set a substantiation standard under the

DSHEA comparable to new drug or

health claims requirements, and that it

will not adopt the Federal Trade

Commission’s ‘‘reasonable basis’’

standard that is currently applied in

dietary supplement advertising cases.

Several comments maintained that the

requirement that manufacturers certify

that the notifying firm has

substantiation that the statement is

truthful and not misleading goes beyond

the authority of the act because it

imposes potential liability under the

False Statements Act (18 U.S.C. 1001) if

FDA does not agree that the

substantiation relied upon by the person

making the notification meets the

requirements of the act. Another

comment contended that the objective

of § 101.93(a)(3) is accomplished by

existing Federal statutes (i.e., 18 U.S.C.

1001) that prohibit the knowing and

willful false representation of any

statement to a Government agency.

Another comment objected to the

agency subjecting both a manufacturer

and the person representing the

company to potential criminal sanctions

for making false statements, and this

comment argued that, in doing so, FDA

would be acting in a manner that is

inconsistent with the intent of Congress.

FDA disagrees with these comments

and finds that they are without merit.

First, FDA does not agree that the

requirement that manufacturers have

substantiation that statements made in

accordance with section 403(r)(6) of the

act are truthful and not misleading is

independent of the notification

requirement. The last sentence of

section 403(r)(6) of the act states that if

a manufacturer of a dietary supplement

proposes to make a ‘‘statement

described in the first sentence of this

subparagraph,’’ it is to notify the

Secretary (that is, FDA). A ‘‘statement

described in the first sentence of

[section 403(r)(6)]’’ is one for which

(among other things) ‘‘the manufacturer

of the dietary supplement has

substantiation that such statement is

truthful and not misleading.’’ In section

403(r)(6) of the act, thus, contrary to the

assertion in the comment, there is a

direct connection between the

substantiation requirement and the

notification requirement in section

403(r)(6) of the act.

Second, FDA also finds no merit to

the argument made with respect to 18

U.S.C. 1001. Because the act on its face

connects the notification requirement to

the substantiation requirement, a

manufacturer who submits a

notification under section 402(r)(6) of

the act without being in possession of

substantiation that the claim that it

intends to make, or is making, is

truthful and not misleading is making a

false statement to the Government, in

violation of 18 U.S.C. 1001. This is true

without regard to whether a responsible

individual has signed a certification or

not.

FDA is requiring that the notification

be signed by a responsible individual,

and that individual certify the accuracy

of the information presented in the

notice, for efficient enforcement of the

act under sections 403(r)(6) and 701(a)

of the act (21 U.S.C. 371(a)). The person

signing the notice, and the company on

whose behalf he or she signs it, must

recognize that there are significant

consequences to their action, including

potential liability under 18 U.S.C. 1001.

Signing a certification that the

information in the notice is accurate

will likely cause the person who is

doing so to check the information in the

notice. Such a check should minimize

any problems under this section of the

act and thus will contribute to its

efficient enforcement.

Third, FDA finds no merit to the

comments that claim that firms have no

basis to determine what level of

substantiation is necessary. In this

regard, the act is clear on its face: The

manufacturer must have substantiation

that the statement is truthful and not

misleading. If the manufacturer has any

doubts as to whether it has

substantiation to meet this standard, it

should not make the statement in

question on its label or in its labeling.

Claims that manufacturers are unable to

interpret this standard are belied by the

fact that since the passage of the

DSHEA, FDA has received literally

hundreds of notices under section

403(r)(6) of the act. FDA assumes that

these notifications have been made in

good faith, and the submitters were

confident that they were in possession

of adequate substantiation. Thus, FDA

finds no need for it to elaborate on the

substantiation standard that appears in

the act.

IV. Recommended Compliance With the

Proposed Rule

3. One comment stated that FDA

indicated in the preamble to the

September 1996 proposal that it

‘‘recommends’’ that manufacturers

follow the proposed regulation

immediately. The comment requested

that FDA make clear that failure to

follow ‘‘recommendations’’ that are not

final rules carries no penalty or sanction

and generates no prejudice.
Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations 49885

FDA made this recommendation in

the September 1996 proposal because of

the many requests from manufacturers

to FDA asking for guidance on how to

make a statement of nutritional support

notification. However, the comment is

correct that no penalty or sanction

applies to manufacturers who do not

make their notification according to

these rules until the effective date of

this regulation. It should, however, be

noted that dietary supplement

manufacturers do not have the option of

not notifying FDA if they are making

statements of nutritional support on the

label or in the labeling of their products.

The requirement to make the

notification to FDA no later than 30

days after the first marketing of the

dietary supplement that bears such a

statement became effective with the

signing into law of the DSHEA on

October 25, 1994.

V. Environmental Impact

The agency has determined under 21

CFR 25.24(a)(8) that this action is of a

type that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

VI. Analysis of Impacts

A. Benefit-Cost Analysis

FDA has examined the economic

implications of this final rule as

required by Executive Order 12866.

Executive Order 12866 directs agencies

to assess all costs and benefits of

available regulatory alternatives and,

when regulation is necessary, to select

regulatory approaches that maximize

net benefits (including potential

economic, environmental, public health

and safety, and other advantages;

distributive impacts; and equity).

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; adversely

affecting some sector of the economy in

a material way; adversely affecting jobs

or competition; or raising novel legal or

policy issues.

In the economic analysis of the

proposed rule, FDA stated that the costs

of this regulation consisted of the costs

of preparing and submitting notification

to FDA regarding statements of

nutritional support. FDA concluded that

because the information should already

have been gathered in order to prepare

the nutritional support statement itself,

the additional cost incurred for

notification would be small and in

many instances negligible. One

comment said that the costs of

notification could be burdensome for a

manufacturer producing many different

brands and products. FDA is not

persuaded that this additional burden

would be large, for the same reasons as

stated in the economic analysis of the

proposed rule—the notification cost will

be negligible to manufacturers who have

borne the labeling costs associated with

nutritional support statements for

several different brands or products.

This final rule is procedural and

implements the statutory notification

requirement at minimal cost. Other

requirements associated with nutritional

support statements will be dealt with by

other rules.

FDA finds that this final rule does not

constitute a significant rule as defined

by Executive Order 12866. Furthermore,

it has been determined that this rule is

not a major rule for the purpose of

congressional review (Pub. L. 104–121).

B. Small Business Analysis

FDA has examined the economic

implications of this final rule as

required by the Regulatory Flexibility

Act (5 U.S.C. 601–612). If a rule has a

significant economic impact on a

substantial number of small entities, the

Regulatory Flexibility Act requires

agencies to analyze regulatory options

that would lessen the economic effect of

the rule on small entities.

For purposes of defining industry size

standards, the Small Business

Administration (SBA) classifies

industries according to four-digit

Standard Industrial Classification (SIC)

codes. SBA does not define ‘‘small’’ for

the dietary supplement industry,

because no SIC code corresponds to the

industry—dietary supplements

encompass a wide range of products.

The industry’s products come closest to

the industry groups Food Preparations

N.E.C. (SIC code 2099) and Medicinal

Chemicals and Botanical Products (SIC

code 2833). The SBA size standards for

small businesses are 500 or fewer

employees for food preparations and

750 or fewer employees for medicinal

and botanical products. Under either

employee-based size standard, virtually

all firms in the dietary supplement

industry could be classified as small,

including some firms that are among the

leaders in sales revenues.

For the dietary supplement industry,

FDA is basing size classifications on

sales revenue rather than employees.

According to the Nutrition Business

Journal, of the 850 firms manufacturing

dietary supplements, 11 firms have total

revenues over $100 million, accounting

for 53 percent of total sales; 30 firms

have sales revenues between $20 and

$100 million, accounting for 28 percent

of total sales; and 809 firms have sales

under $20 million, accounting for 19

percent of total sales. The 809 firms in

the under $20 million category have an

average sales revenue of $800,000 and

will be considered small businesses by

FDA. Because the total includes some

firms making functional foods that are

not dietary supplements and other

products, such as sports nutrition

products, that are not considered dietary

supplements, the estimate may overstate

the number of small firms affected by

this final rule.

The number of small businesses

affected by this final rule could include

all small businesses in the dietary

supplement industry, if they choose to

use nutritional support statements. As

FDA concluded in the benefit-cost

analysis, the additional costs imposed

by the notification provisions will be

negligible to small firms once the

labeling provisions have been carried

out. This final rule requires only that

the manufacturer notify FDA within 30

days of marketing a supplement that

bears a nutritional support statement on

its label. The information required in

the notification is either on the label

itself (e.g., the text of the statement) or

readily available (e.g., the name of the

ingredient that is the subject of the

statement).

FDA finds that this final rule will not

have a significant economic impact on

a substantial number of small entities.

Accordingly, under the Regulatory

Flexibility Act (5 U.S.C. 605(b)), the

agency certifies that this final rule will

not have a significant impact on a

substantial number of small entities.

VII. The Paperwork Reduction Act of

1995

This final rule contains information

collection requirements that are subject

to review by the Office of Management

and Budget (OMB) under the Paperwork

Reduction Act of 1995 (44 U.S.C. 3501–

3520). The title, description, and

respondent description of the

information collection provisions are

shown below with an estimate of the

annual reporting and recordkeeping

burden. Included in the estimate is the

time for reviewing instructions,

searching existing data sources,

gathering and maintaining the data

needed, and completing and reviewing

each collection of information.

Title: Food Labeling; Notification

Procedures for Statements on Dietary

Supplements.

Description: FDA is, by regulation,

requiring manufacturers, packers, and

distributors of dietary supplements to
49886 Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Rules and Regulations

notify FDA that they are marketing a

dietary supplement product that bears

on its label or in its labeling a statement

provided for in section 403(r)(6) of the

act. Section 403(r)(6) of the act requires

that the agency be notified, with a

submission about such statements, no

later than 30 days after the first

marketing of the dietary supplement.

Information that is required in the

submission includes: (1) The name and

address of the manufacturer, packer, or

distributor of the dietary supplement

product; (2) the text of the statement

that is being made; (3) the name of the

dietary ingredient or supplement that is

the subject of the statement; (4) the

name of the dietary supplement

(including the brand name); and (5) a

signature of a responsible individual

who can certify the accuracy of the

information presented.

In § 101.93, the agency is establishing

procedures for submitting required

information. Section § 101.93 provides

details of the procedures associated

with the submission and identifies the

information that must be included in

the submission in order to meet the

requirements of section 403 of the act.

Description of Respondents:

Businesses or other for-profit

organizations.

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN

21 CFR Section No. of

Respondents

Annual Frequency

per Response

Total Annual ResponsesHours per

Response Total Hours

101.93 420 1 420 0.5–1 210–420

(Through inadvertent error, the agency

misreported the number of respondents

and the annual frequency per response

and omitted the total annual response in

the proposal. Hours per response and

total hours were reported correctly. In

this final rule, FDA is correcting the

inadvertent errors that it made in the

proposal).

Individuals and organizations may

submit comments on these burden

estimates or on any other aspect of these

information collection provisions,

including suggestions for reducing the

burden, and should direct them to the

Office of Special Nutritionals (HFS–

450), Center for Food Safety and

Applied Nutrition, Food and Drug

Administration, 200 C St. SW.,

Washington, DC 20204.

The information collection provisions

in this final rule have been approved

under OMB control number 0910–0331.

This approval expires on October 31,

1999. An agency may not conduct or

sponsor, and a person is not required, to

respond to a collection of information

unless it displays a currently valid OMB

control number.

List of Subjects in 21 CFR Part 101

Food labeling, Nutrition, Reporting

and recordkeeping requirements.

PART 101—FOOD LABELING

1. The authority citation for 21 CFR

part 101 continues to read as follows:

Authority: Secs. 4, 5, 6 of the Fair

Packaging and Labeling Act (15 U.S.C. 1453,

1454, 1455); secs. 201, 301, 402, 403, 409,

701 of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 321, 331, 342, 343, 348, 371).

2. Section 101.93 is added to subpart

F to read as follows:

§ 101.93 Notification procedures for

certain types of statements on dietary

supplements.

(a)(1) No later than 30 days after the

first marketing of a dietary supplement

that bears one of the statements listed in

section 403(r)(6) or the Federal Food,

Drug, and Cosmetic Act, the

manufacturer, packer, or distributor of

the dietary supplement shall notify the

Office of Special Nutritionals (HFS–

450), Center for Food Safety and

Applied Nutrition, Food and Drug

Administration, 200 C St. SW.,

Washington, DC 20204, that it has

included such a statement on the label

or in the labeling of its product. An

original and two copies of this

notification shall be submitted.

(2) The notification shall include the

following:

(i) The name and address of the

manufacturer, packer, or distributor of

the dietary supplement that bears the

statement;

(ii) The text of the statement that is

being made;

(iii) The name of the dietary

ingredient or supplement that is the

subject of the statement, if not provided

in the text of the statement; and

(iv) The name of the dietary

supplement (including brand name), if

not provided in response to paragraph

(a)(2)(iii) on whose label, or in whose

labeling, the statement appears.

(3) The notice shall be signed by a

responsible individual or the person

who can certify the accuracy of the

information presented and contained in

the notice. The individual shall certify

that the information contained in the

notice is complete and accurate, and

that the notifying firm has

substantiation that the statement is

truthful and not misleading.

(b) through (e) [Reserved]

Dated: August 20, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–24738 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 190

[Docket No. 96N–0232]

Premarket Notification for a New

Dietary Ingredient

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is establishing the

procedure by which a manufacturer or

distributor of dietary supplements or of

a new dietary ingredient is to submit

under the Federal Food, Drug, and

Cosmetic Act (the act) the information

on which it has concluded that a dietary

supplement containing a new dietary

ingredient will reasonably be expected

to be safe. FDA is issuing this regulation

to enable industry to comply with the

requirements of the Dietary Supplement

Health and Education Act of 1994 (the

DSHEA).

EFFECTIVE DATE: October 23, 1997.

FOR FURTHER INFORMATION CONTACT:

Carolyn W. Miles, Center for Food

Safety and Applied Nutrition (HFS–

456), Food and Drug Administration,

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

202–401–9858.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of September

27, 1996 (61 FR 50774), FDA published