[Federal Register Volume 62, Number 184 (Tuesday, September 23, 1997)]
[Rules and Regulations]
[Pages 49886-49892]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-24737]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 190
[Docket No. 96N-0232]
Premarket Notification for a New Dietary Ingredient
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is establishing the
procedure by which a manufacturer or distributor of dietary supplements
or of a new dietary ingredient is to submit under the Federal Food,
Drug, and Cosmetic Act (the act) the information on which it has
concluded that a dietary supplement containing a new dietary ingredient
will reasonably be expected to be safe. FDA is issuing this regulation
to enable industry to comply with the requirements of the Dietary
Supplement Health and Education Act of 1994 (the DSHEA).
EFFECTIVE DATE: October 23, 1997.
FOR FURTHER INFORMATION CONTACT: Carolyn W. Miles, Center for Food
Safety and Applied Nutrition (HFS-456), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-401-9858.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of September 27, 1996 (61 FR 50774), FDA
published
[[Page 49887]]
a proposed rule, entitled ``Premarket Notification for a New Dietary
Ingredient'' (hereinafter referred to as ``the September 1996
proposal''). FDA issued this proposal in response to section 8 of the
DSHEA (Pub. L. 103-417). This section of the DSHEA amended the act by
adding, among other provisions, section 201(ff) (21 U.S.C. 321(ff)),
which defines a dietary supplement, and by adding section 413(a) (21
U.S.C. 350b(a)), which provides, among other things, for the
notification of the Secretary of Health and Human Services (the
Secretary) (and by delegation FDA) at least 75 days before the
introduction or delivery for introduction into interstate commerce of a
dietary supplement that contains a new dietary ingredient. Section
413(a) of the act states that a dietary supplement that contains a new
dietary ingredient shall be deemed adulterated unless it meets one of
two requirements. One requirement is that ``the dietary supplement
contains only dietary ingredients which have been present in the food
supply as an article used for food in a form in which the food has not
been chemically altered.'' The alternative requirement is that:
[T]here is a history of use or other evidence of safety
establishing that the dietary ingredient when used under the
conditions recommended or suggested in the labeling of the dietary
supplement will reasonably be expected to be safe and, at least 75
days before being introduced or delivered for introduction into
interstate commerce, the manufacturer or distributor of the dietary
ingredient or dietary supplement provides the Secretary with
information, including any citation to published articles, which is
the basis on which the manufacturer or distributor has concluded
that a dietary supplement containing such dietary ingredient will
reasonably be expected to be safe.
FDA published the September 1996 proposal to establish a procedure
that would enable industry to comply with this notification requirement
in an efficient manner. Adoption of this procedure will help to
facilitate compliance with the notification required by section
413(a)(2) of the act. Interested persons were given until December 26,
1996, to comment on the proposal.
FDA received four letters each containing one or more comments from
consumer groups, a trade association, and industry in response to the
proposal. All of the comments generally supported the proposal. Several
comments suggested modifications or revisions of various aspects of the
proposal. A summary of the comments and the agency's responses follows.
II. New Dietary Ingredients Subject to Notification Requirements
1. Several comments expressed concern that proposed Sec. 190(a),
published in the September 1996 proposal, implied that any ``new
dietary ingredient'' is subject to the notification requirements. The
comments argued that the statutory requirement for notification under
section 413(a)(2) of the act does not apply to those new dietary
ingredients that have been present in the food supply as an article
used for food in a form in which the food has not been chemically
altered, as described in section 413(a)(1) of the act.
FDA agrees with the comments that the notification requirements of
this regulation apply only to new dietary ingredients described in
section 413(a)(2) of the act. Section 413(a)(1) of the act applies to
dietary supplements that contain only dietary ingredients that have
been present in the food supply as an article used for food in a form
in which the food has not been chemically altered, and the statute does
not require that FDA be notified before these products are marketed. To
make clear which new dietary ingredients are subject to the
notification requirement in section 413(a)(2) of the act, FDA is
modifying proposed Sec. 190.6(a) by incorporating the phrase ``that has
not been present in the food supply as an article used for food in a
form in which the food has not been chemically altered'' to define
which new dietary ingredients are subject to the notification
requirement.
III. The Notification
2. One comment opposed the requirement in proposed
Sec. 190.6(b)(3)(i) that the notification include the level of the new
dietary ingredient in the dietary supplement. The comment claimed that
notices may be submitted by vendors who will not know the level of the
new ingredient in the supplement and argued that these vendors should
not be barred from the sale of these ingredients.
FDA does not agree that it would be appropriate to remove the
requirement that the notification include the level of the new dietary
ingredient in the dietary supplement. First, Sec. 190.6(b)(3)(i)
responds to section 413(a)(2) of the act that states that the
manufacturer or the distributor is to provide the information on a
dietary supplement that contains a new dietary ingredient. Both of
these parties would have access to information on the level of the new
dietary ingredient. If a vendor wants to stand in the position of a
manufacturer or distributor, it needs to be able to provide the
information that they can provide.
Second, section 413(a) of the act also states that a dietary
supplement that contains a new dietary ingredient is adulterated unless
there is a history of use or other evidence of safety establishing that
the dietary ingredient, when used under the conditions recommended or
suggested in the labeling of the dietary supplement, will reasonably be
expected to be safe, and that the notification must include the
information on which the manufacturer or distributor has determined
that the dietary supplement containing the dietary ingredient will meet
this standard. It is not possible to have a reasonable expectation of
safety without knowledge of the level of the new dietary ingredient in
the supplement. The dietary ingredient may be safe under certain
conditions of use, but it may be unsafe under other conditions of use.
For example, the essential trace mineral selenium is safe when consumed
in amounts necessary to meet a person's nutrient requirements, but it
is toxic when consumed at high levels. Some dietary ingredients contain
constituents that have potent pharmacologic actions that could cause
the dietary ingredient to present a significant or unreasonable risk of
injury or illness under the labeled conditions of use. The bark of
Pausinystalia yohimbe (K. Schumann) (commonly called yohimbe) contains
the indolalkylamine alkaloid yohimbine, which is a potent alpha-2-
adrenergic antagonist that may be toxic when ingested in high doses.
Thus, if the notification does not contain the level of the dietary
ingredient in the product, the notification would not contain a piece
of information that is necessary if the manufacturer or distributor is
to conclude that the dietary supplement will reasonably be expected to
be safe under the conditions of use recommended or suggested in its
labeling. Without this information, the dietary supplement would be
adulterated under section 402(f)(1)(B) of the act (21 U.S.C.
342(f)(1)(B)). Therefore, FDA is not persuaded to remove or revise
proposed Sec. 190.6(b)(3)(i). This provision is necessary to ensure
that a manufacturer has considered information that directly bears on
the safety of the new dietary ingredient of interest.
3. One comment stated that FDA's proposed rule on the notification
for a new dietary ingredient is a procedural regulation when what is
needed is a substantive regulation that provides adequate guidance to
the manufacturer
[[Page 49888]]
as to the quality and quantity of the information necessary to meet the
requirements of section 413(a)(2) of the act. The comment disagreed
with FDA's assertion that the manufacturer is only required to provide
the basis on which it has concluded that the dietary supplement will
reasonably to expected to be safe and that the manufacturer or
distributor is not required to do a complete search of all available
sources of information on the new dietary ingredient. The comment
maintained that under the proposed regulation, manufacturers could
knowingly market products with documented deleterious effects as long
as they provide FDA with articles citing only a product's benefits.
The comment requested that FDA examine how the DSHEA amended
section 402 of the act as well as section 413 of the act. Section
402(f)(1)(B) of the act states that a ``food shall be deemed to be
adulterated if it is a dietary supplement or contains a dietary
ingredient that is a new dietary ingredient for which there is
inadequate information to provide reasonable assurance that such
ingredient does not present a significant or unreasonable risk of
illness or injury.'' The comment argued that without a minimal safety
data requirement, FDA risks that its interpretation of the DSHEA could
cause a manufacturer to challenge the validity of the DSHEA on the
grounds that the statute is void for vagueness because it does not
provide fair warning to the manufacturer of what is expected. The
comment requested that FDA issue regulations that elaborate on
omissions in the statute by Congress.
The comment further suggested that FDA should require that a new
dietary ingredient, when used under the conditions recommended or
suggested in the labeling of the dietary supplement, be generally
recognized as safe (GRAS); that is, that FDA apply to a new dietary
ingredient the standard that there is general recognition that a
dietary supplement containing the new dietary ingredient ``will
reasonably be expected to be safe.'' The comment further suggested that
FDA should provide industry with examples of publications that are
acceptable as evidence of safety and a list of sources to search for
evidence of adverse effects associated with a new dietary ingredient.
Further, the comment maintained that manufacturers should be required
to provide FDA with a summary of studies and scientific data, including
known adverse effects. The comment stated that, in the absence of an
appropriate scientific standard of evidence, manufacturers would be
free to submit articles from questionable publications or unpublished
materials to establish the safety of the new dietary ingredient. The
comment argued that reliance on a GRAS standard would not be contrary
to the statute or to congressional intent because it would still permit
the marketing of dietary supplements without prior approval.
FDA disagrees with the comment that a substantive, rather than a
procedural, regulation is necessary to respond to section 413(a)(2) of
the act. The comment appears to be opposed to proposed
Sec. 190.6(b)(4), which sets out the substantive information that the
notification must include. Significantly, Sec. 190.6(b)(4) simply
tracks the language of section 413(a)(2) of the act. It is appropriate
that the regulation do so because, contrary to what the comment
asserts, the manufacturer or distributor is not required to do a
complete literature search. It is required only to provide ``the basis
on which [it] has concluded that a dietary supplement containing such
dietary ingredient will reasonably be expected to be safe'' (section
413(a)(2) of the act). That is all that the regulation requires.
FDA agrees with the comment that sections 402(f)(1)(B) and 413 of
the act are related in that they both relate to new dietary
ingredients. FDA also acknowledges that Congress has provided in
section 413(a) of the act that a failure to provide the information
under section 413(a) of the act would render the dietary supplement
adulterated under section 402(f) of the act. The agency, however, in
deciding what information needs to be provided, is bound by the
standard in the act. It is not free to rewrite the law, as the comment
appears to suggest.
The fact that Congress did not create a minimal safety data
requirement in section 413(a)(2) of the act does not render the DSHEA
void for vagueness. The manufacturer's or distributor's obligation
under section 413(a)(2) of the act is clear. It must make a showing as
to why it considers that consumption of a new dietary ingredient will
be safe.
FDA also does not agree that the GRAS concept has relevance here.
The concept of GRAS was adopted by Congress in 1958, as a limitation on
the scope of the ``food additive'' definition (section 201(s) of the
act). Congress excluded from the definition of ``food additive''
substances that are generally recognized, among experts qualified by
scientific training and experience to evaluate their safety, as having
been adequately shown through scientific procedures (or, in the case of
a substance used in food prior to January 1, 1958, through experience
based on common use in food) to be safe under the conditions of their
intended use. However, dietary ingredients, which are used in dietary
supplements, are not food additives. Congress excluded them from the
definition of a ``food additive'' in the DSHEA (section 201(s)(6) of
the act, which was added by section 3(b) of the DSHEA). Thus, the
concept of GRAS is not relevant to how dietary ingredients are
regulated.
Furthermore, there is a fundamental difference between who is to
make at least the initial judgment as to the safety of an ingredient
under section 413(a)(2) of the act and whose judgment is relevant to a
determination that an ingredient is GRAS. Whether an ingredient is GRAS
is based on the judgment of ``experts qualified by scientific training
and experience to evaluate'' the ingredient's safety. In contrast, the
requirement in section 413(a)(2) of the act that a notification be made
for a new dietary ingredient provides that the manufacturer or
distributor is to determine whether a dietary supplement containing
such dietary ingredient will reasonably be expected to be safe. While
this determination is subject to review by FDA, section 413(a) of the
act does not specify that the manufacturer or distributor must rely on
any specified third party in making its judgment. For these reasons,
FDA is not requiring in Sec. 190.6(b)(4) that the notification for a
new dietary ingredient include information establishing that the new
dietary ingredient is GRAS or the subject of any other type of general
recognition.
Furthermore, FDA is not persuaded that it is necessary for the
agency to provide examples of scientific publications that are adequate
to provide the information that can be the basis on which the
manufacturer or distributor has concluded that a dietary supplement
containing the new dietary ingredient will reasonably be expected to be
safe. The agency also is not persuaded that the act requires that a
manufacturer or distributor provide to FDA information on all known
adverse effects attributable to the new dietary ingredient that is the
subject of the submission. Section 413(a)(2) of the act requires only
that the notification provide information ``which is the basis on which
the manufacturer or distributor has concluded that a dietary supplement
containing such dietary ingredient will reasonably be expected to be
safe when used under the conditions recommended or suggested in the
labeling.'' Thus, the statute does not specify or limit what evidence a
manufacturer or distributor may rely on in determining whether the use
of the
[[Page 49889]]
ingredient will reasonably be expected to be safe. Nonetheless, FDA
expects that, in making a determination that a new dietary ingredient
is reasonably expected to be safe and does not present a significant or
unreasonable risk of illness or injury, a manufacturer or distributor
will consider the evidence of safety that is available in the
scientific literature and from examination of reports of adverse
effects associated with the use of a new dietary ingredient.
FDA does not find that the statute requires that the agency
determine the relative merit of different types of evidence of safety,
and therefore, the agency is not modifying Sec. 190.6 to specify
specific safety requirements for new dietary ingredients or to
establish standards that the evidence of safety must meet.
4. One comment opposed the proposed requirement in Sec. 190.6(b)(4)
that the premarket notification for a ``new dietary ingredient''
contain reprints or photostatic copies, including, if necessary,
English translations of all references to published information offered
in support of the notification. The comment stated that with FDA's
diminished resources the handling, cataloging, and storage of such
copies could place a substantial burden on the agency and that this
requirement for submission of copies of cited articles would be
expensive and cumbersome for the manufacturer. The comment suggested
that the requirement for submission of copies of references should not
become a part of the final rule on new dietary ingredient notifications
because of the availability of scientific data through electronic data
bases.
FDA is not persuaded to delete proposed Sec. 190.6(b)(4). FDA finds
that it would take significantly more agency resources to find and
obtain copies of references than would be expended to managing them as
a part of each notification. Furthermore, FDA has found in reviewing
the notifications that have been received since the passage of the
DSHEA that many of the references cited in the notifications are not
readily available in the United States or are not easily obtained
electronically. In some cases, English translations are not available
unless provided by the party making the notification. On the other
hand, the manufacturer or distributor, who has reviewed the published
information in concluding that there is a reasonable expectation of
safety, will have ready access to the articles and thus would be in a
position to supply them to FDA.
Thus, FDA is not persuaded that the requirement that the new
ingredient notification include copies of all references used to
support the notification will impose an excessive or unnecessary burden
on FDA or on manufacturers or distributors who make a notification.
Consequently, it is not revising Sec. 190.6(b)(4).
5. Several comments opposed the proposed Sec. 190.6(b)(5)
requirement that the premarket notification of the marketing of a new
dietary ingredient include the signature of an authorized official of
the manufacturer or distributor of the dietary supplement that contains
the new dietary ingredient.
One comment asked that the regulation be changed to require the
signature of the person who is directly responsible for assimilating
and submitting the premarket notification. The comment stated that in
its company, an ``authorized official'' usually means an officer of the
company, but that the assimilation and submission of documents such as
premarket notifications to FDA is the responsibility of someone who is
not an officer of the company.
Another comment stated that it had no objection to the requirement
in proposed Sec. 190.6(b)(5) that the notification be signed by an
authorized official of the manufacturer or distributor. The comment did
state, however, that such a signature does not constitute a
certification of the accuracy or completeness of the data set out in
the notification. The comment argued that section 8 of the DSHEA is
entirely silent with respect to the signature or certification of
notices, and that the agency's proposal creates an administrative
amendment to DSHEA and is, therefore, inappropriate.
In the preamble to the September 1996 proposal, FDA stated that it
was ``including this provision to ensure that the individual that is
responsible for the accuracy, completeness, and understandability of
the notification is identified'' (61 FR 50774 at 50775). Section 8 of
the DSHEA does not designate a specific employee or representative of a
manufacturer or distributor who is to submit the notice on behalf of a
manufacturer or distributor. FDA did not intend by its use of the word
``authorized'' to designate a particular person that the firm must
assign the responsibility of preparing the notification required under
section 413(a)(2) of the act. Instead, the agency only intended that
Sec. 190.6(b)(5) provide that the person who signs the notification be
familiar with the information contained in it and be available to
answer questions or provide additional information to FDA if questions
about a notification arise. Therefore, FDA is modifying
Sec. 190.6(b)(5) by replacing the term ``authorized official'' with the
word ``person.'' This change will make clear that a manufacturer or
distributor may assign responsibility for the notification to a person
without concern about that person's official capacity within the
management structure of the firm.
The September 1996 proposal did not represent that the signature of
the individual that is responsible for the accuracy, completeness, and
understandability of the notification constitutes a ``certification.''
However, the person signing the notice, and the company on whose behalf
he or she signs it, should recognize that there are significant
consequences to their action, including potential liability under 18
U.S.C. 1001. The intent of section 413(a)(2) of the act is for the firm
to provide to FDA the information that is the basis on which the
manufacturer or distributor has concluded that a dietary supplement
containing such dietary ingredient will reasonably be expected to be
safe. A firm must have such information, or the dietary supplement may
well be adulterated under section 402(f)(1)(B) of the act. The
notification is intended to be the mechanism by which that information
is made available to FDA, so that the agency is aware of the basis that
a manufacturer or distributor has for concluding that there is
reasonable assurance that a new dietary ingredient is safe.
Consequently, the information in the notification must be a fair and
accurate representation of the information that a firm used in
developing its conclusion that a new dietary ingredient is safe. A
notification that intentionally omitted information that would indicate
that a new dietary ingredient presents a significant or unreasonable
risk of illness or injury or that contained false or misleading
information would be a knowing and willful submission of false
information to the Federal Government and could subject the parties
involved to criminal sanctions under 18 U.S.C. 1001.
However, the person who signs the notification need not certify the
information in the notification. The signature is intended to identify
the person to whom FDA may address questions to concerning the
notification. However, such persons should be cognizant of their
responsibility in providing this notification and of the consequences
of submitting of false or misleading information to the Federal
Government.
[[Page 49890]]
IV. Administrative Procedures
6. One comment requested that proposed Sec. 190.6(c) be revised to
state that FDA will send an acknowledgment of the receipt of the
premarket notification of the marketing of a new dietary ingredient
noting the filing date, so that manufacturers will know when the 75-day
notice period expires.
FDA is persuaded to make this revision. However, the agency
cautions that the acknowledgment of the receipt of the premarket
notification of the marketing of a new dietary ingredient does not
constitute a finding by FDA that the new dietary ingredient, or the
dietary supplement that contains the new dietary ingredient, is safe,
or that it is not adulterated under section 402 of the act. Therefore,
FDA has required Sec. 190.6(c) by adding the sentence: ``FDA will
acknowledge the receipt of the notification made pursuant to section
412(a) of the act and will notify the submitter of the date of receipt
of such a notification.''
7. One comment asked that proposed Sec. 190.6(c) be revised by
removing the last sentence which states: ``For 75 days after the filing
date, the manufacturer or distributor of a dietary supplement that
contains a new dietary ingredient shall not introduce or deliver for
introduction, into interstate commerce the dietary supplement that
contains the new dietary ingredient.'' The comment stated that this
language is not found in the act, and that the language is
unnecessarily restrictive. The comment argued that if the agency
completes its review and decides there is no concern, the manufacturer
should not be prohibited from marketing the dietary supplement when
such a determination by FDA is made prior to the 75th day after the
notification was filed.
FDA does not agree that this sentence should be removed from the
regulation. While the comment is correct that the language in the
regulation is not stated in the law, section 413(a)(2) of the act
states, as stated in the previous paragraph, that at least 75 days
before introducing or delivering for introduction, a new dietary
ingredient into interstate commerce, the manufacturer or distributor is
to provide information that the dietary ingredient will reasonably be
expected to be safe. The comment is based on a misunderstanding of the
notification process. Because there is no requirement that the
notification provide a comprehensive safety review of the new dietary
ingredient, it is not likely to provide the agency with a basis to find
that there is no concern. Rather, the process is more likely to
identify those new dietary ingredients that do present a concern. Thus,
it is the people who have provided a notice that raises concerns,
rather than one that does not, who are likely to hear from the agency.
Given this fact, and to ensure that the system runs smoothly, FDA is
codifying its expectation based on the act that manufacturers and
distributors that submit a notification to FDA will not market their
product for 75 days from the date of submission of the notice.
Consequently, FDA has not modified proposed Sec. 190.6(c) as requested
by this comment.
8. One comment asked that proposed Sec. 190.6(d) be changed to
state that:
* * * if additional information is provided in support of the
new ingredient notification, the agency will determine whether the
additional information is a substantive amendment to the submission.
If the agency determines that the new submission is a substantive
amendment, FDA will assign a new filing date. FDA will acknowledge
receipt of the additional information and, when applicable, notify
the manufacturer of the new filing date, which is the date of
receipt by FDA of the information that constitutes the substantive
amendment.
The comment argued that proposed Sec. 190.6(d) would require that any
additional information, regardless of how significant (for example, a
single response to an inquiry from the agency about a submission),
would reset the 75-day period. Furthermore, the comment stated that its
suggested language would provide flexibility for submitting additional
information without unnecessarily prolonging the 75-day period.
FDA agrees with the substance of this comment that the agency
should be flexible in its handling of the submission of additional
materials. Therefore, FDA has revised Sec. 190.6(d) to reflect that if
it receives additional information, the agency will review all
submissions pertaining to the notification in question, including
responses made to inquires from the agency, to determine whether they
are significant and whether they require that the 75-day period be
reset.
V. Environmental Impact
The agency had determined under 21 CFR 25.24(a)(8) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
VI. Analysis of Impacts
A. Benefit-Cost Analysis
FDA has examined the economic implications of this final rule as
required by Executive Order 12866. Executive Order 12866 directs
agencies to assess all costs and benefits of available regulatory
alternatives and, when regulation is necessary, to select regulatory
approaches that maximize net benefits (including potential economic,
environmental, public health, safety, distributive, and equity
effects). Executive Order 12866 classifies a rule as significant if it
meets any one of a number of specified conditions, including: Having an
annual effect on the economy of $100 million, adversely affecting some
sector of the economy in a material way, adversely affecting jobs or
competition, or raising novel legal or policy issues.
In the economic analysis of the proposed rule, FDA estimated the
number of new ingredients to be 0 to 12 per year and the cost per
notification to be $410, for an annual cost range of $0 to $4,920 per
year. In the most recent year, the industry introduced six new
ingredients for an estimated cost of $2,460. FDA received no comments
on these estimates and consequently concludes that the actual costs of
this rule will not be significant.
FDA finds that this final rule does not constitute a significant
rule as defined by Executive Order 12866. Furthermore, it has been
determined that this rule is not a major rule for the purpose of
Congressional Review (Public Law 104-121).
B. Small Business Analysis
FDA has examined the economic implications of this final rule as
required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a
rule has a significant economic impact on a substantial number of small
entities, the Regulatory Flexibility Act requires agencies to analyze
regulatory options that would lessen the economic effect of the rule on
small entities.
FDA received no comments on the regulatory flexibility analysis of
the proposed rule. As the agency stated in the analysis of the proposed
rule, the dietary supplement industry does not have its own standard
industrial classification code. The industry's products come closest to
the industry groups Food Preparations (not elsewhere classified)
(Standard Industrial Classification code 2099) and Medicinal Chemicals
and Botanical Products (Standard Industrial Classification code 2833).
The Small Business Administrations' (SBA) size standards for ``small''
are 500 or fewer employees for food preparations and 750 or fewer
employees for medicinal and botanical products. The use of this size
standard will cause the majority of
[[Page 49891]]
firms in the dietary supplement industry to be classified as small
businesses.
Without further information on the identity of the businesses
introducing new ingredients, FDA concludes that the total number of
businesses affected by the proposed rule will be no more than the
number of new ingredients (estimated to be 0 to 12 per year). Before
the event, FDA cannot determine the sizes of firms that introduce new
dietary ingredients. Small businesses could introduce all new
ingredients or none. The annual number of small businesses potentially
affected by the proposed rule will therefore be the same as the annual
number of new ingredients, 0 to 12.
Whether the cost of notification, approximately $410 per
submission, will be a substantial burden depends partly on the revenues
of the smallest businesses in the dietary supplement industry. For the
smallest businesses in the industry, the cost of notification
considered alone could be a significant burden. This cost, however,
cannot be considered in isolation from the total cost of introducing a
new dietary ingredient. A dietary supplement firm introducing a new
ingredient must first determine that the ingredient can reasonably be
expected to be safe. Technical, legal, and marketing costs of
introducing a new dietary ingredient and ensuring its safety will be
much larger than the cost of providing the information required under
this rule. The costs of notification are therefore not likely to be a
substantial part of the total cost of introducing a new dietary
ingredient. Small businesses capable of bearing the cost of introducing
new ingredients, then, would be highly unlikely to find the additional
cost imposed by the 75-day premarket notification procedure to be an
economically significant burden.
FDA finds that this final rule will not have a significant economic
impact on a substantial number of small entities. Accordingly, under
the Regulatory Flexibility Act (5 U.S.C. 605(b)), the Secretary
certifies that this final rule will not have a significant impact on a
substantial number of small entities.
VII. Paperwork Reduction Act of 1995
This final rule contains information collection requirements that
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
following title, description, and respondent description of the
information collection provisions are shown with an estimate of the
annual reporting and recordkeeping burden. Included in the estimate is
the time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing
each collection of information.
Title: Dietary supplements; dietary ingredients; premarket
notification.
Description: FDA is requiring, by regulation, the submission to the
agency of information that is the basis on which a manufacturer or
distributor of a new dietary ingredient or a dietary supplement
containing a new dietary ingredient has concluded that the dietary
supplement containing such dietary ingredient will reasonably be
expected to be safe. This information must be submitted to the agency
at least 75 days prior to the first commercial distribution of a
dietary supplement containing a new dietary ingredient. FDA will review
the submitted information to determine whether the submission meets the
requirements of section 413 of the act. The agency is establishing
Sec. 190.6 as the procedural regulation for this program. This
regulation provides details of the administrative procedures associated
with the submission and identifies the information that must be
included in the submission in order to meet the requirements of section
413 of the act and to show the basis on which a manufacturer or
distributor of a new dietary ingredient or a dietary supplement
containing a new dietary ingredient has concluded that the dietary
supplement containing such dietary ingredient will reasonably be
expected to be safe.
Description of Respondents: Businesses or other for-profit
organizations.
Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
----------------------------------------------------------------------------------------------------------------
190.6 6 1 6 20 120
Total 120
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There are no capital or operating and maintenance costs associated with this collection of information.
Individuals and organizations may submit comments on these burden
estimates or on any other aspect of these information collection
provisions, including suggestions for reducing the burden, and should
direct them to the Office of Special Nutritionals (HFS-450), Center for
Food Safety and Applied Nutrition, Food and Drug Administration, 200 C
St. SW., Washington, DC 20204.
The information collection provisions in this final rule have been
approved under OMB control number 0910-0330. This approval expires
October 31, 1999. An agency may not conduct or sponsor, and a person is
not required to respond to a collection of information unless it
displays a currently valid OMB control number.
List of Subjects in 21 CFR Part 190
Food ingredients, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, title 21 CFR
chapter I is amended by adding new part 190 to read as follows:
PART 190--DIETARY SUPPLEMENTS
Subpart A--[Reserved]
Subpart B--New Dietary Ingredient Notification
Sec.
190.6 Requirement for premarket notification.
Authority: Secs. 201(ff), 301, 402, 413, 701 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321(ff), 331, 342, 350b,
371).
[[Page 49892]]
Subpart A--[Reserved]
Subpart B--New Dietary Ingredient Notification
Sec. 190.6 Requirement for premarket notification.
(a) At least 75 days before introducing or delivering for
introduction into interstate commerce a dietary supplement that
contains a new dietary ingredient that has not been present in the food
supply as an article used for food in a form in which the food has not
been chemically altered, the manufacturer or distributor of that
supplement, or of the new dietary ingredient, shall submit to the
Office of Special Nutritionals (HFS-450), Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 200 C St. SW.,
Washington, DC 20204, information including any citation to published
articles that is the basis on which the manufacturer or distributor has
concluded that a dietary supplement containing such dietary ingredient
will reasonably be expected to be safe. An original and two copies of
this notification shall be submitted.
(b) The notification required by paragraph (a) of this section
shall include:
(1) The name and complete address of the manufacturer or
distributor of the dietary supplement that contains a new dietary
ingredient, or of the new dietary ingredient;
(2) The name of the new dietary ingredient that is the subject of
the premarket notification, including the Latin binomial name
(including the author) of any herb or other botanical;
(3) A description of the dietary supplement or dietary supplements
that contain the new dietary ingredient including:
(i) The level of the new dietary ingredient in the dietary
supplement; and
(ii) The conditions of use recommended or suggested in the labeling
of the dietary supplement, or if no conditions of use are recommended
or suggested in the labeling of the dietary supplement, the ordinary
conditions of use of the supplement;
(4) The history of use or other evidence of safety establishing
that the dietary ingredient, when used under the conditions recommended
or suggested in the labeling of the dietary supplement, will reasonably
be expected to be safe, including any citation to published articles or
other evidence that is the basis on which the distributor or
manufacturer of the dietary supplement that contains the new dietary
ingredient has concluded that the new dietary supplement will
reasonably be expected to be safe. Any reference to published
information offered in support of the notification shall be accompanied
by reprints or photostatic copies of such references. If any part of
the material submitted is in a foreign language, it shall be
accompanied by an accurate and complete English translation; and
(5) The signature of the person designated by the manufacturer or
distributor of the dietary supplement that contains a new dietary
ingredient.
(c) FDA will acknowledge its receipt of a notification made under
section 413 of the Federal Food, Drug, and Cosmetic Act (the act) and
will notify the submitter of the date of receipt of such a
notification. The date that the agency receives the notification
submitted under paragraph (a) of this section is the filing date for
the notification. For 75 days after the filing date, the manufacturer
or distributor of a dietary supplement that contains a new dietary
ingredient shall not introduce, or deliver for introduction, into
interstate commerce the dietary supplement that contains the new
dietary ingredient.
(d) If the manufacturer or distributor of a dietary supplement that
contains a new dietary ingredient, or of the new dietary ingredient,
provides additional information in support of the new dietary
ingredient notification, the agency will review all submissions
pertaining to that notification, including responses made to inquiries
from the agency, to determine whether they are substantive and whether
they require that the 75-day period be reset. If the agency determines
that the new submission is a substantive amendment, FDA will assign a
new filing date. FDA will acknowledge receipt of the additional
information and, when applicable, notify the manufacturer of the new
filing date, which is the date of receipt by FDA of the information
that constitutes the substantive amendment.
(e) FDA will not disclose the existence of, or the information
contained in, the new dietary ingredient notification for 90 days after
the filing date of the notification. After the 90th day, all
information in the notification will be placed on public display,
except for any information that is trade secret or otherwise
confidential commercial information.
(f) Failure of the agency to respond to a notification does not
constitute a finding by the agency that the new dietary ingredient or
the dietary supplement that contains the new dietary ingredient is safe
or is not adulterated under section 402 of the act.
Dated: August 22, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-24737 Filed 9-22-97; 8:45 am]
BILLING CODE 4160-01-F