[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]]
=======================================================================
-----------------------------------------------------------------------
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 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
[[Page 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 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
[[Page 30618]]
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