Federal Register / Vol. 63, No. 108 / Friday, June 5, 1998 /Rules and Regulations 30615

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket Nos. 95N–0245 and 94P–0110]

RIN 0910–AA59

Food Labeling; Statement of Identity,

Nutrition Labeling and Ingredient

Labeling of Dietary Supplements;

Compliance Policy Guide, Revocation

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; action on petitions

for reconsideration.

SUMMARY: The Food and Drug

Administration (FDA) is revising its

nutrition labeling requirements for

dietary supplements that contain liquid

extracts to allow the quantity of an

extract to be listed on the basis of

volume, solvents present to be listed in

the ingredient statement, and the

optional listing in the nutrition label of

the ratio of starting material to the final

volume of solvent, and to clarify that the

quantity of any constituents of dietary

ingredients be listed in the nutrition

label in terms of quantitative amount by

weight on a ‘‘per serving’’ basis. FDA is

also eliminating the requirement that a

description of a dried extract include

the name of the solvent used. This

action is in response to four petitions for

reconsideration.

EFFECTIVE DATE: These revisions are

effective March 23, 1999.

FOR FURTHER INFORMATION CONTACT:

Susan Thompson, Center for Food

Safety and Applied Nutrition (HFS–

165), Food and Drug Administration,

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

202–205–5587.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of September

23, 1997 (62 FR 49826), FDA published

a final rule entitled ‘‘Food Labeling;

Statement of Identity, Nutrition and

Ingredient Labeling of Dietary

Supplements; Compliance Policy Guide,

Revocation’’ (hereinafter identified as

‘‘the September 1997 final rule’’). In the

September 1997 final rule, FDA

amended its food labeling regulations to

establish requirements for the

identification of dietary supplements

and for their nutrition labeling and

ingredient labeling in response to the

Dietary Supplement Health and

Education Act of 1994 (the DSHEA).

The September 1997 final rule is to

become effective March 23, 1999.

The requirements for the nutrition

labeling of dietary supplements are

found in § 101.36 (21 CFR 101.36).

Specifically, the requirements for liquid

and dried extracts are in section

§ 101.36(b)(3)(ii)(B) and (b)(3)(ii)(C),

respectively. Section 101.36(b)(3)(ii)(B)

states:

For any dietary ingredient that is a liquid

extract from which the solvent has not been

removed, the quantity listed shall be the

weight of the total extract with information

on the concentration of the dietary

ingredient, the solvent used, and the

condition of the starting material (i.e.,

whether it is fresh or dried), e.g., ‘‘fresh

dandelion root extract, x mg (y:z) in 70%

ethanol,’’ where x is the number of mg of the

entire extract, y is the weight of the starting

material and z is the volume (milliliters) of

solvent. Where the solvent has been partially

removed (not to dryness), the final

concentration shall be stated (e.g., if the

original extract was 1:5 and 50 percent of the

solvent was removed, then the final

concentration shall be stated as 1:2.5).

Section 101.36(b)(3)(ii)(C) states:

For a dietary ingredient that is an extract

from which the solvent has been removed,

the weight of the ingredient shall be the

weight of the dried extract. The dried extract

shall be described by an appropriately

descriptive term that identifies the solvent

used, e.g., ‘‘dried hexane extract of

—————’’ or ‘‘—————, dried hexane

extract.’’

II. Petitions for Reconsideration

FDA received four petitions for

reconsideration under § 10.33 (21 CFR

10.33) relating to the requirements for

the labeling of extracts. A petition for

reconsideration from the American

Herbal Products Association (AHPA),

the Utah Natural Products Alliance, and

the National Nutritional Foods

Association (Docket Nos. 95N–0245/

PRC 4 and 94P–0110/PRC 4) (hereinafter

referred to as the ‘‘joint petition’’),

requested that FDA reconsider the

provision on liquid extracts in

§ 101.36(b)(3)(ii)(B), stay its effective

date, and adopt the petition’s proposed

restatement of this provision. The

petitioners stated that, with respect to

extracts, FDA had proposed ‘‘For any

dietary ingredients that are liquid

extracts, the weight shall not include

the weight of solvents’’ (60 FR 67194 at

67216, December 28, 1995). The

petitioners stated that interested parties

could not reasonably have anticipated

that the final rule would require

specifying the solvent used, the ratio,

and the condition of the starting

material. Thus, they contended that the

final rule violated the rulemaking

provisions of the Administrative

Procedure Act (5 U.S.C. 553), because of

inadequate provision of notice and

opportunity for comment.

The petitioners recommended the

adoption of the following technical

amendments to this provision: (1) The

quantity of a dietary supplement that is

a liquid extract be stated in volume, not

weight measurements; (2) solvents that

have not been removed from a liquid

extract be included in the ingredient

list; (3) information on the

concentration of a liquid extract in the

form y:z be optional; and (4)

constituents of a liquid extract be stated

by weight on a ‘‘per serving’’ basis.

Specifically, the petition requested

that § 101.36(b)(3)(ii)(B) be amended to

read:

For any dietary ingredient that is a liquid

extract from which the solvent has not been

removed, the quantity listed shall not be the

weight but shall instead be the volume of the

total extract. If information is included on the

concentration of the dietary ingredient in the

form y:z, it shall be expressed as a ratio of

the weight (in grams) of the starting material

to the volume (in milliliters) of solvent.

Additionally, the condition of the starting

material shall be stated if the starting

material is in fresh condition (e.g., ‘‘fresh

dandelion root extract (y:z)’’), and may be

stated if the starting material is in dried

condition. If a product contains a dietary

ingredient that is a liquid extract from which

the solvent has not been removed and is

labeled in any manner which quantifies or

claims to contain one or more specific

contained constituents of a botanical, the

constituent shall be quantified on the label

by weight on a ‘‘per serving’’ basis, in

accordance with paragraph (b)(3)(iii) of this

section.

The petitioners stated that with these

technical amendments the provision

would be consistent with the original

proposal. The petitioners also stated

that they are developing guidelines for

manufacturing extracts that they plan to

publish in a volume tentatively entitled

‘‘AHPA Extracts Manufacturers

Guidelines.’’

Another petition for reconsideration,

from Wakunaga of America Co., Ltd.

(Docket Nos. 95N–0245/PRC 1 and 94P–

0110/PRC 1) (hereinafter referred to as

the ‘‘Wakunaga petition’’), requested

that FDA reconsider and revoke the

provisions on extracts or revise those

provisions to eliminate the requirement

to identify the solvent used and the ratio

of the botanical to the solvent. The

petitioner stated that FDA apparently

adopted a suggestion in a comment to

describe extracts by the ratio of weight

to volume of solvent without any

opportunity for other parties to

comment on this requirement in

violation of the Administrative

Procedure Act. The petitioner

contended that the disclosure of

proprietary information was never

addressed by FDA in the proposed or

final regulations and that the potential
30616 Federal Register / Vol. 63, No. 108 / Friday, June 5, 1998 /Rules and Regulations

damages of such disclosure are

sufficient grounds to revoke the

requirement for such disclosures. The

petitioner emphasized that if FDA did

not accept either of their requests, it

should at least propose the requirements

in the final rule to allow opportunity for

comment.

Two other petitions for

reconsideration were received, one from

AHPA (Docket Nos. 95N–0245/PRC 2

and 94P–0110/PRC 2) (hereinafter

referred to the ‘‘AHPA petition’’), and

another from the Council for

Responsible Nutrition and Nutrilite

Division of Amway Corporation (Docket

Nos. 95N–0245/PRC 3 and 94P–0110/

PRC 3) (hereinafter referred to as the

‘‘CRN/Amway petition’’). Both

petitioners requested that FDA

reconsider the provision on dried

extracts in § 101.36(b)(3)(ii)(B), stay the

effective date of the second sentence of

this provision, and revoke the sentence.

In addition, AHPA further requested

that FDA should confer with AHPA and

other interested parties regarding the

need for, and alternatives to, the

revoked requirement.

AHPA included a number of reasons

in the statement of grounds for their

petition. The petitioners stated that

interested parties were deprived of

adequate notice and opportunity for

comment on solvent identification in

violation of the Administrative

Procedure Act’s rulemaking provisions.

AHPA also contended that identifying

solvents used in the manufacture of

dried extracts is arbitrary. The

petitioners stated that the solvent used

in the preparation of an extract is only

one factor of many factors that are

important in the manufacturing process.

Moreover, they stated that ‘‘solvents

used in food, food additives, and

substances generally recognized as safe

are not required to be disclosed on

labels.’’

Furthermore, the petitioners argued

that identifying solvents used in the

manufacture of dried extracts is

potentially misleading. They expressed

concern that consumers may assume

that solvents remain in the products

when, in fact, they do not. Also, they

observed that such disclosure may cause

some manufacturers to switch to

solvents that are less effective because

of the fear that consumers may be

misled by chemical solvent names.

The CRN/Amway petition contained

some of the same reasons as the AHPA

petition for revoking the second

sentence of the provision on dried

extracts. The petitioners stated that

interested parties were not given notice

and opportunity to comment on this

sentence. They stated that this provision

should be made the subject of a new

notice of proposed rulemaking if FDA

wishes to include it in the final

regulations.

The CRN/Amway petition also took

issue with FDA’s statement in the

preamble of the September 1997 final

rule (62 FR 49826 at 49834) that

‘‘solvent information is needed in the

nutrition label of dietary supplements to

appropriately describe extracts because

dietary ingredients do not have

individual regulations, like the

regulations for food additives, that

specify how they are to be made, and,

when needed for identity or safety

reasons, what solvent can be used in the

processing.’’ The petitioners stated that

the example that FDA used of a food

additive regulation that specifies what

solvent can be used (i.e., 21 CFR

172.580(b)) is atypical and, like AHPA,

charged that requiring solvent

information in the nutrition label of

dietary supplements imposes labeling

requirements that are inconsistent with

conventional foods.

FDA received a comment in support

of the AHPA, Wakunaga, and CRN/

Amway petitions that stated that it

agreed with these petitions.

FDA also received a submission on

December 24, 1997, identified by the

submitter as comments on the joint

petition, a petition for reconsideration,

a petition for stay of action, and a

petition to amend parts of

§ 101.36(b)(3)(ii). For the reasons

discussed in the following paragraphs,

the agency has handled this submission

only as a comment on the joint petition.

As a comment on the joint petition, it

stated general support for the proposed

technical amendments to

§ 101.36(b)(3)(ii)(B) recommended by

the joint petition and stated the belief

that these amendments could be made

administratively, without the need for

notice and comment.

Under § 10.33, a petition for

reconsideration is to be submitted

within 30 days from the date of the

decision involved (this can be waived

for good cause) and shall contain no

new information or views. Because the

December 24, 1997, submission was not

timely and contains new information

and views, FDA has not filed it as a

petition for reconsideration.

Likewise, FDA is not handling this

submission as a petition for stay of

action because, under 21 CFR 10.35, this

type of petition must specify the

provision for which a stay is requested

and be submitted no later that 30 days

after the date of the decision involved.

FDA finds no mention of a stay in the

submission.

Further, the December 24, 1997,

submission has not been filed as a

petition to amend parts of

§ 101.36(b)(3)(ii). This submission

pointed out specific areas of confusion

and expressed the hope that it would

stimulate discussion about how best to

standardize labeling practices. In

addition, the submission suggested

adding a new section to define the terms

‘‘extract,’’ ‘‘botanical extract,’’ and

‘‘native extract.’’ The submission also

proposed a scheme that would allow for

the identification in the nutrition label

of the type of solvent used, rather than

the specific name of the solvent.

Additionally, the submission stated that

procedures should be established for

expressing the ratio of dried extracts

that would clarify whether or not fillers

have been taken into consideration.

These issues are beyond the scope of

reconsideration of the September 1997

final rule, and are therefore not

addressed in this final rule. The agency

urges industry to consider them in the

development of guidelines on extracts,

however.

III. Response to Petitions

FDA has fully evaluated the petitions

for reconsideration and reviewed the

administrative record of the September

1997 final rule to determine if, in light

of the arguments raised in the petitions,

the agency would have reached a

different decision regarding the

nutrition labeling of dry and liquid

extracts in dietary supplements.

As explained in the following

paragraphs, the agency has determined

that, based on the administrative record

at the time of the publication of the

September 1997 final rule, the agency

did not make the correct decision.

The joint petition, AHPA petition,

and CRN/Amway petition requested

that FDA stay the effective date of the

provisions of the final regulations

pertaining to extracts. The agency is not

issuing a stay because the agency

believes that a stay is unnecessary. This

final rule resolves the issues well

enough in advance of March 23, 1999,

the effective date for this rule and the

September 1997 final rule, to allow

firms to meet that effective date.

A. Liquid Extracts

In the agency’s December 28, 1995 (60

FR 67194), proposed rule (the December

1995 proposal) on nutrition labeling of

dietary supplements entitled ‘‘Food

Labeling; Statement of Identity,

Nutrition Labeling and Ingredient

Labeling of Dietary Supplements,’’ the

agency proposed that for dietary

ingredients for which the Reference

Daily Intakes (RDI’s) and the Daily
Federal Register / Vol. 63, No. 108 / Friday, June 5, 1998 /Rules and Regulations 30617

Reference Values (DRV’s) have not been

established, the supplement facts

should include the quantitative amount

by weight per serving of the dietary

ingredient listed, and not the weight of

any component, or the source of, that

dietary ingredient. For dietary

ingredients that are liquid extracts, the

agency proposed that the weight would

not include the weight of the solvents.

The comments on the December 1995

proposal convinced the agency that this

latter proposal with respect to liquid

extracts was unfeasible. The petitions

for reconsideration do not question that

decision, and the agency stands by it. In

the December 1995 proposal’s stead, the

agency required that the quantity of the

entire extract be listed. The petitions for

reconsideration have not questioned

this provision of the September 1997

final rule.

They do, however, question several

other aspects of the final provision on

liquid extracts, some of which follow

directly from the quantification of the

entire extract and others that arise less

directly from that decision. The former

include whether the volume or the

weight should be used to quantify a

liquid extract and whether the solvent

in the extract should be listed in the

nutrition information or in the

ingredient list. The latter include

whether the ratio of the starting material

to the final product should be required.

The agency has, therefore, reexamined

the administrative record of the

September 1997 final rule, in light of the

arguments in the petitions for

reconsideration, to determine how the

agency should have finalized the

provision regarding how to quantify

liquid extracts.

1. Quantity Listed on the Basis of

Volume

The joint petition proposed that the

quantity of dietary ingredients in liquid

extract form be listed by volume and not

by weight. None of the comments of the

December 1995 proposal directly

requested that the quantity of a liquid

extract be listed in terms of its volume

rather than its weight. A couple of

comments, however, clearly assumed

that liquid extracts should be listed by

volume and not by weight. For example,

one comment suggested that the relative

strength of an extract be expressed in a

volume to weight ratio that would

reflect what volume of liquid extract

was equivalent to what weight of herb.

For such a ratio to be useful, the

quantity of liquid extract would have to

be listed by volume. A second comment,

portrayed in the September 1997 final

rule as agreeing to the listing of the

weight of the entire extract (62 FR 49826

at 49833), actually provided several

examples using volumes of entire

extracts. The agency therefore concludes

that the administrative record for the

September 1997 final rule supports the

use of volume as a means of listing the

quantity of a liquid extract.

The joint petition forcefully argues

that only volume should be used to list

the quantity of a liquid extract.

However, the agency received one

comment that recommended that liquid

extracts should be listed by weight. The

agency concludes that it is appropriate

for manufacturers to have the option of

listing quantity by weight. The agency

is, therefore, modifying

§ 101.36(b)(3)(ii)(B) to require that

liquid extracts be quantified either by

volume or by weight.

2. Solvent Listed in the Ingredient

Statement

In the December 1995 proposal (60 FR

67194 at 67216), FDA proposed that the

dry weight of a liquid extract be

declared in the nutrition label (proposed

§ 101.36(b)(3)(ii)) and that the name of

any solvent used appear in the

ingredient statement (proposed

§ 101.4(g)) (60 FR 67194 at 67214). In

the September 1997 final rule, FDA

required that the weight of the total

extract be listed in the nutrition label,

and that the name of the solvent be

included in the description of the liquid

extract in the nutrition information. The

joint petition requested that solvents

that have not been removed from a

liquid extract be included in the

ingredient list. The Wakunaga petition

requested that FDA revoke the

provisions on extracts in

§ 101.36(b)(3)(ii)(B) and (b)(3)(ii)(C) or

revise those provisions to eliminate the

requirement to identify the solvent

used.

FDA has reconsidered this issue.

Under section 403(i) of the Federal

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 343(i)), the solvent present in

liquid extracts must be identified. The

comments on the December 1995

proposal do not directly address the

issue of where the solvent should be

listed, although it is raised by their

suggestion that the quantity of the total

extract be listed. On the one hand, FDA

continues to believe, as in the

September 1997 final rule, that it is

appropriate for the name of the solvent

to appear in the nutrition label as a part

of the description of a liquid extract

because the solvent is present in the

extract, the entire extract is listed as a

dietary ingredient, and the solvent is

included in the quantity listed for the

extract. Labeling in this manner is

truthful and nonmisleading. Those

wishing to label solvents in this manner

should, therefore, have this option.

On the other hand, the agency is

persuaded that it is reasonable to allow

manufacturers to list solvents either in

the nutrition label or the ingredient list.

This approach is consistent with the

December 1995 proposal. Moreover,

allowing flexibility is consistent with

section 403(q)(5)(F) of the act, which

allows sources of dietary ingredients to

be listed in either the nutrition label or

the ingredient list. Therefore, FDA is

revising § 101.36(b)(3)(ii)(B) to allow the

identity of the solvent in liquid extracts

to be listed in either the nutrition label

or the ingredient list. The agency points

out that if the name of the solvent is not

included in the nutrition label, it must

be included in the ingredient list in

accordance with § 101.4(g), as had been

proposed in the December 1995

proposal.

3. Ratio Information Optional

The December 1995 proposal would

have required, for dietary ingredients

that are liquid extracts, that the weight

listed for the dietary ingredient not

include the weight of the solvent. The

comments pointed out that listing the

weight of an extract was not an

indication of the concentration or

strength of an extract. Some of the

comments suggested that a truthful and

nonmisleading description of the

content of the extract, such as a weight

to volume ratio, should be permitted.

One of these comments stated that

nonstandardized extracts typically are

marketed on the basis of a dry botanical

to solvent ratio. Other comments

suggested that the ratio approach may

be useful, but pointed out that the

weight of the botanical at the beginning

of the extraction process is only one of

several factors that affect the

concentration of the extract.

As a result of these comments, the

agency required in the September 1997

final rule that liquid extracts should be

described by a ratio of the weight of the

starting material to the volume of the

solvent or a description of these values.

The petitions for reconsideration have

convinced the agency, however, that it

did not adequately consider the

comments. In fact, none of the

comments requested that ratio

information be required, only that it be

permitted. Considering this fact, the

agency is convinced that, at the time of

the September 1997 final rule, it

incorrectly required that this

information be included in the labeling

of dietary supplements. Therefore, FDA

is removing the requirement in

§ 101.36(b)(3)(ii)(B) that ratio

information be stated. However, in
30618 Federal Register / Vol. 63, No. 108 / Friday, June 5, 1998 /Rules and Regulations

recognition of the comment on the

December 1995 proposal suggesting that

the use of ratio information may provide

truthful and nonmisleading information,

the agency is not opposed to the

optional inclusion of ratio information.

Section 101.36(b)(3)(ii)(B) is, therefore,

revised accordingly.

In the September 1997 final rule, the

agency required that, when listing

ratios, the condition of the starting

material should be specified, i.e.,

whether it is fresh or dried. The joint

petition stated that the condition should

be required only when the starting

material is fresh. FDA notes that one of

the comments stated that typically the

starting material is dried. Additionally,

when dried material is used, the amount

declared would not include the weight

of any water, so consumers would not

be misled. Thus, FDA concludes that it

unnecessarily required that the

condition of dried material be declared.

Therefore, FDA is revising

§ 101.36(b)(3)(ii)(B) to require that the

condition of the starting material be

required only when it is fresh and may

be stated optionally when it is dried.

Having reconsidered the issue of the

use of ratios and how they should be

stated, when declared, the agency

believes that other approaches (such as

individual product monographs, good

manufacturing practices, or industry

guidelines) may provide for better

product standardization in the future.

These other approaches necessitate

further investigation and cooperative

research between the agency and the

dietary supplement industry. Until such

activities can be accomplished, FDA

believes that the most appropriate

course of action, and the one most

useful to consumers, is to proceed to

implement the DSHEA by moving ahead

with mandatory nutrition labeling in the

most truthful, nonmisleading, and

flexible manner understood at this time.

As experience in this area is gained by

all parties, FDA anticipates that the

flexibility in this final rule may

minimize the need for amendments.

4. Quantification of Constituents of a

Liquid Extract Should Be Listed on a

‘‘Per Serving’’ Basis.

The agency’s December 1995 proposal

requested comments on whether

constituents of dietary ingredients

should be permitted to be listed. The

comments favored such listing. The

September 1997 final rule, therefore,

provided that constituents of a dietary

ingredient described in § 101.36(b)(3)(i),

which would include constituents of

extracts, may be listed, followed by their

quantitative amounts by weight.

The joint petition requested

clarification that constituents of liquid

extracts, when declared, should be

listed on a ‘‘per serving’’ basis. This

petition requested that

§ 101.36(b)(3)(ii)(B) pertaining to liquid

extracts be amended to include the

sentence:

If a product contains a dietary ingredient

that is a liquid extract from which the solvent

has not been removed and is labeled in any

manner which quantifies or claims to contain

one or more specific contained constituents

of a botanical, the constituent shall be

quantified on the label by weight on a ‘per

serving’ basis, in accordance with paragraph

(b)(3)(iii) of this section.

The agency points out that the

DSHEA specified that quantities in the

nutrition label should be listed on a

‘‘per serving’’ basis (see section

403(q)(5)(F)(ii) of the act) and FDA

implemented this basis for the listing of

dietary ingredients in § 101.36. The

agency inadvertently did not repeat in

§ 101.36(b)(3)(iii) that when the

quantitative amounts by weight of

constituents are listed, they should be

reported on a ‘‘per serving’’ basis. The

agency believes that revising

§ 101.36(b)(3)(iii) to add the words ‘‘per

serving’’ is the most direct way of

clarifying this issue and points out that

this paragraph applies to constituents of

all dietary ingredients described in

§ 101.36(b)(3)(i), not just to constituents

of liquid ingredients. Therefore, rather

than revising § 101.36(b)(3)(ii)(B) as

requested, the agency is modifying

§ 101.36(b)(3)(iii) to require that the

quantitative amount of constituents be

declared on a ‘‘per serving’’ basis.

B. Dry Extracts

As requested in the AHPA, CRN/

Amway, and Wakunaga petitions, FDA

has reconsidered the provision on dried

extracts in § 101.36(b)(3)(ii)(C). The

AHPA petition requested that this

provision be reconsidered, revoked, or

revised to eliminate the requirement for

identification of the solvent. The other

petitions requested that FDA reconsider

and stay the second sentence of this

provision, then revoke it. The second

sentence reads ‘‘The dried extract shall

be described by an appropriately

descriptive term that identifies the

solvent used, e.g., ‘dried hexane extract

of —————’ or ‘—————, dried

hexane extract.’ ’’

The September 1997 final rule

required that the solvent used to

produce a dried extract be identified

because the agency had concluded that

the solvent used determines the

composition of an extract (62 FR 49834).

Reconsidering the comments to the

December 1995 proposal (which were

generally about liquid extracts but

which the agency believes apply to dry

extracts also), the agency concludes

that, although the identity of the solvent

contributes significantly to the

composition of an extract, other factors

also contribute to the composition of an

extract. Because these other factors are

not currently accounted for in an

adequate way by any labeling or other

requirements, the agency believes that,

at the time of the September 1997 final

rule, it was inappropriate to require the

identification of the solvent used to

produce a dry extract. Therefore, having

reconsidered the administrative record

of the September 1997 final rule in light

of the arguments raised in the petitions

for reconsideration, FDA is removing

the second sentence in

§ 101.36(b)(3)(ii)(C) as requested by the

petitions.

The agency believes that, given

adequate compendial standards or good

manufacturing practices, the factors

relevant to the concentration and

composition of dietary ingredients that

are extracts may be accounted for so as

to enable the agency, at some future

date, to require further information

about extracts in the labeling of dietary

supplements.

IV. Economic Analysis

A. Benefit/Cost Analysis

FDA has examined the impacts of this

final rule under Executive Order 12866.

Executive Order 12866 directs agencies

to assess the 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 effects; distributive impacts;

and equity). According to Executive

Order 12866, a regulatory action is

‘‘economically 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. A regulation is considered

‘‘significant’’ under Executive Order

12866 if it raises novel legal or policy

issues. FDA finds that this final rule is

neither an economically significant nor

a significant regulatory action as defined

by Executive Order 12866.

In addition, FDA has determined that

this rule does not constitute a

significant rule under the Unfunded

Mandates Reform Act of 1995 (UMRA)

requiring cost-benefit and other

analyses. A significant rule is defined in

section 1531(a) of UMRA as ‘‘a Federal

mandate that may result in the

expenditure by State, local, and tribal
Federal Register / Vol. 63, No. 108 / Friday, June 5, 1998 /Rules and Regulations 30619

governments in the aggregate, or by the

private sector, of $100,000,000 (adjusted

annually for inflation) in any 1 year.’’

Finally, in accordance with the Small

Business Regulatory Enforcement

Fairness Act of 1996, the administrator

of the Office of Information and

Regulatory Affairs of the Office of

Management and Budget has

determined that this final rule is not a

major rule for the purpose of

congressional review.

FDA is publishing these revisions in

response to four petitions for

reconsideration of the requirements for

the labeling of extracts, which are

effective March 23, 1999. FDA is making

compliance easier by making the

requirements for the labeling of extracts

more flexible. These revisions will not

result in any additional costs.

B. Small Entity Analysis

FDA has examined the impacts of this

final rule as required by the Regulatory

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

rule has a significant impact on a

substantial number of small entities, the

Regulatory Flexibility Act requires

agencies to analyze options that would

minimize the economic impact of that

rule on small entities. 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.

These revisions will provide

additional flexibility for complying with

the requirements for the labeling of

extracts. This rule will not cause any

additional labels to be changed but will

make it easier for small firms to comply

with existing requirements by making

those requirements more flexible. FDA

further notes that small products from

certain small firms are exempt from the

requirements provided no claims are

made.

V. Environmental Impact

The agency has determined under 21

CFR 25.30(k) 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. Paperwork Reduction Act of 1995

This final rule contains information

collection provisions that are subject to

review by the Office of Management and

Budget (OMB) under the Paperwork

Reduction Act of 1995 (the PRA) (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 burden. Included in

the estimate is the time required for

reviewing instructions, searching

existing data sources, gathering and

maintaining any data needed, and

completing and reviewing each

collection of information.

Title: Requirements for Statement of

Identity, Nutrition, and Ingredient

Labeling of Dietary Supplements.

Description: This final rule revises the

requirements for the declaration of

information concerning extracts used in

dietary supplements that were

established by the September 1997 final

rule. In response to four petitions for

reconsideration of the September 1997

final rule, FDA is revising the

regulations that establish labeling

requirements for dietary supplements

that contain extracts. This final rule

revises the labeling requirements for

dietary supplements that contain liquid

extracts to allow: (1) The quantity of an

extract to be listed on the basis of

volume or weight, (2) solvents present

to be listed in the ingredient statement

or the nutrition label, and (3) the

optional listing in the nutrition label of

the ratio of starting material to the

volume of solvent. FDA is also

eliminating the requirement that a

description of a dried extract include

the name of the solvent used. This final

rule does not revise any of the other

information collection provisions in the

September 1997 final rule, such as the

requirements for nutrition labeling of

dietary supplements.

As required by section 3506(c)(2)(B)

of the PRA (44 U.S.C. 3506(c)(2)(B)),

FDA provided an opportunity for public

comment under the PRA when the

proposed rule was published in

December 1995. The information

collection provisions of the September

1997 final rule were discussed in that

final rule and submitted to OMB for its

review and approval (62 FR 49826 at

49845). OMB subsequently approved

the information collection provisions of

the September 1997 final rule under

OMB control number 0910–0351 (see 62

FR 66635, December 19, 1997).

The revisions in this final rule will

reduce the information collection

burden to producers of dietary

supplements that contain extracts. FDA

had previously estimated, and OMB had

approved, the total annual hour burden

for the information collection

requirements of the September 1997

final rule at 136,040 hours. FDA now

estimates that the total annual hour

burden for the information collection

requirements of the September 1997

final rule, as revised by this final rule,

will be 134,890 hours.

Description of Respondents: Persons

and businesses, including small

businesses.

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN

21 CFR Section No. of

Respondents

No. of

Responses per

Respondent

Total Annual

Responses

Hours per

Response

Total Annual

Hours

Total Operating and

Maintenance Costs

101.36(b)(2) and (b)(3) (except paragraphs

(b)(3)(ii)(B) and

(b)(3)(ii)(C)) (disclosure) 850 40 34,000 3.9 132,600 $40,000,000

101.36(b)(3)(ii)(B) and

(b)(3)(ii)(C) (disclosure) 250 30 7,500 0.3 2,250

101.36(f)(2) (reporting) 20 1 20 2 40

Totals 134,890 $40,000,000

FDA estimated in the September 1997

final rule that there were a maximum of

850 suppliers of dietary supplements

and that each supplier had 40 products

whose labels required revision. FDA

also estimated that there were at least

250 of these firms that produce herbal

or botanical products. These are the

firms whose products are most likely to

contain extracts as ingredients. Based on

the agency’s knowledge of the dietary

supplement marketplace, FDA estimates

that approximately 25 percent of these

firms’ products contain dry extracts.

FDA estimates that with elimination of
30620 Federal Register / Vol. 63, No. 108 / Friday, June 5, 1998 /Rules and Regulations

the requirement for identifying the

solvent used for dry extracts, no firms

will provide information concerning the

identity of the solvent. FDA estimates

that firms will provide the ratio of the

starting materials to the volume of the

solvents used in the production of

liquid extracts only when it is in their

best interest and that this will occur no

more than 10 percent of the time. The

other revisions to the regulations should

also help reduce the amount of time that

a firm must spend to provide the

required information. All of the

information required by this final rule to

be disclosed on the label of dietary

supplements that contain liquid extracts

is information that a firm would be

expected to have in the normal course

of its business of producing dietary

supplements. Firms should know or

have readily available to them

information on the amount of the extract

by volume or weight that is present in

the dietary supplement and the identity

of the solvent. The hour burden

estimates in Table 1 of this document

are for the information collection

provisions established by regulation and

do not include those that stem solely

from the act or the DSHEA.

Although the statement of identity,

nutrition, and ingredient labeling

regulations for dietary supplements in

§ 101.36 were approved following

publication of the September 1997 final

rule (OMB control number 0910–0351),

FDA has resubmitted them to OMB for

approval of the revised requirements for

label disclosure of extract ingredients in

this final rule. Prior to the effective date

of the regulations, FDA will publish a

notice in the Federal Register

announcing OMB’s decision to approve,

modify, or disapprove the revised

requirements. 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.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 101 is

amended as follows:

PART 101—FOOD LABELING

1. The authority citation for 21 CFR

part 101 continues to read as follows:

Authority: 15 U.S.C. 1453, 1454, 1455; 21

U.S.C. 321, 331, 342, 343, 348, 371.

2. Section 101.36 is amended by

revising paragraphs (b)(3)(ii)(B),

(b)(3)(ii)(C), and (b)(3)(iii) to read as

follows:

§ 101.36 Nutrition labeling of dietary

supplements.

* * * * *

(b) * * *

(3) * * *

(ii) * * *

(B) For any dietary ingredient that is

a liquid extract from which the solvent

has not been removed, the quantity

listed shall be the volume or weight of

the total extract. Information on the

condition of the starting material shall

be indicated when it is fresh and may

be indicated when it is dried.

Information may be included on the

concentration of the dietary ingredient

and the solvent used, e.g., ‘‘fresh

dandelion root extract, x (y:z) in 70%

ethanol,’’ where x is the number of

milliliters (mL) or mg of the entire

extract, y is the weight of the starting

material and z is the volume (mL) of

solvent. Where the solvent has been

partially removed (not to dryness), the

final concentration, when indicated,

shall be stated (e.g., if the original

extract was 1:5 and 50 percent of the

solvent was removed, then the final

concentration shall be stated as 1:2.5).

Where the name of the solvent used is

not included in the nutrition label, it is

required to be listed in the ingredient

statement in accordance with § 101.4(g).

(C) For a dietary ingredient that is an

extract from which the solvent has been

removed, the weight of the ingredient

shall be the weight of the dried extract.

(iii) The constituents of a dietary

ingredient described in paragraph

(b)(3)(i) of this section may be listed

indented under the dietary ingredient

and followed by their quantitative

amounts by weight per serving, except

that dietary ingredients described in

paragraph (b)(2) of this section shall be

listed in accordance with that section.

When the constituents of a dietary

ingredient described in paragraph

(b)(3)(i) of this section are listed, all

other dietary ingredients shall be

declared in a column; however, the

constituents themselves may be

declared in a column or in a linear

display.

* * * * *

Dated: May 29, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–14915 Filed 6–4–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 165

[Docket No. 98N–0294]

Beverages: Bottled Water; Correction

AGENCY: Food and Drug Administration,

HHS.

ACTION: Direct final rule; correction.

SUMMARY: The Food and Drug

Administration (FDA) is correcting a

final rule that appeared in the Federal

Register of May 11, 1998 (63 FR 25764).

The document lifted the stay of the

effective date for the allowable levels in

the bottled water quality standard for

nine chemical contaminants, i.e.,

antimony, beryllium, cyanide, nickel,

thallium, diquat, endothall, glyphosate,

and 2,3,7,8–TCDD (dioxin), that was

imposed in a final rule published on

March 26, 1996. The document was

published with some errors under the

‘‘DATES’’ section. This document

corrects those errors.

DATES: The regulation published at 63

FR 25764 is effective February 2, 1999.

Submit written comments by July 27,

1998. If no timely significant adverse

comments are received, the agency will

publish a document in the Federal

Register no later than August 6, 1998,

confirming the effective date of the

direct final rule. If timely significant

adverse comments are received, the

agency will publish a document of

significant adverse comment in the

Federal Register withdrawing this

direct final rule no later than August 6,

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:

Henry Kim, Center for Food Safety and

Applied Nutrition (HFS–306), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–260–0631.

SUPPLEMENTARY INFORMATION: FDA

published a direct final rule in the

Federal Register of May 11, 1998 (63 FR

25764), lifting the stay of the effective

date for the allowable levels in the

bottled water standard for nine chemical

contaminants. As published, the dates

section is incorrect.

In FR Doc. 98–12381, beginning on

page 25764 in the Federal Register of

Monday, May 11, 1998, the following

correction is made:

1. On page 25764, beginning in the

second column, the ‘‘DATES’’ section is