[Federal Register Volume 63, Number 108 (Friday, June 5, 1998)]
[Rules and Regulations]
[Pages 30615-30620]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-14915]



[[Page 30615]]

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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.

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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 Sec. 101.36 (21 CFR 101.36). Specifically, the 
requirements for liquid and dried extracts are in section 
Sec. 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 Sec. 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 Sec. 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 Sec. 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

[[Page 30616]]

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 Sec. 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 Sec. 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 
Sec. 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 Sec. 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 Sec. 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

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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 Sec. 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 Sec. 101.36(b)(3)(ii)) and that the name of any solvent 
used appear in the ingredient statement (proposed Sec. 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 
Sec. 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 Sec. 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 Sec. 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 
Sec. 101.36(b)(3)(ii)(B) that ratio information be stated. However, in

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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 Sec. 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 Sec. 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 Sec. 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 Sec. 101.36. The agency 
inadvertently did not repeat in Sec. 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 Sec. 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 Sec. 101.36(b)(3)(i), not just to constituents of liquid 
ingredients. Therefore, rather than revising Sec. 101.36(b)(3)(ii)(B) 
as requested, the agency is modifying Sec. 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 
Sec. 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 Sec. 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

[[Page 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                                  
----------------------------------------------------------------------------------------------------------------
                                  No. of                                                        Total Operating 
   21 CFR         No. of       Responses per   Total Annual      Hours per     Total Annual     and Maintenance 
   Section      Respondents     Respondent       Responses       Response          Hours             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

[[Page 30620]]

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 Sec. 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:


Sec. 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 
Sec. 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