[Federal Register Volume 61, Number 189 (Friday, September 27, 1996)]
[Proposed Rules]
[Pages 50774-50778]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-24752]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 190
[Docket No. 96N-0232]
Premarket Notification for a New Dietary Ingredient
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to
establish 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 setting out those steps that it has tentatively concluded
are necessary to ensure that notification is accomplished efficiently
but with the least burden possible on the industry. FDA is issuing this
proposal in response to the Dietary Supplement Health and Education Act
of 1994 (the DSHEA).
DATES: Written comments by December 26, 1996.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857, 301-245-1064.
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, 202-205-5372.
SUPPLEMENTARY INFORMATION:
[[Page 50775]]
I. Background
On October 25, 1994, the DSHEA (Pub. L. 103-417) was signed into
law. The DSHEA, among other things, amended the act by adding section
201(ff) (21 U.S.C. 321(ff)), which defines a dietary supplement, and by
adding section 413 (21 U.S.C. 350b), which, among other things,
provides 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 contain only dietary ingredients that have been
present in the food supply as articles used for food in a form in which
they have not been chemically altered. Alternatively, the dietary
supplement is not adulterated if there is a history of use or other
evidence of safety establishing that the new dietary ingredient, when
used under the conditions recommended or suggested in the supplement's
labeling, will reasonably be expected to be safe, and at least 75 days
before the supplement is 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, 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.
FDA urges that, pending final action, manufacturers and
distributors who file notices with FDA under section 413(a) of the act
follow the procedures proposed in this document.
II. The Proposal
A. Notification Procedure
Proposed Sec. 190.6(a) provides that at least 75 days before
introducing or delivering for introduction into interstate commerce a
dietary supplement that contains a new dietary ingredient, the
manufacturer or distributor of that supplement, or of the new dietary
ingredient, 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 the dietary
supplement containing the new dietary ingredient will reasonably be
expected to be safe. Proposed Sec. 190.6(a) requires that the
notification be submitted as an original and two copies. FDA
tentatively concludes that the submission of this number of copies is
necessary to ensure that there will be a copy for public display and
copies for any agency employees who will need to review the
notification.
Proposed Sec. 190.6(b)(1) provides that the notification shall
include the name and address of the manufacturer or distributor of the
new dietary ingredient or of the dietary supplement that contains the
new dietary ingredient. This information is necessary to identify the
firm that is responsible for the notification and that intends to
market the new dietary ingredient.
Proposed Sec. 190.6(b)(2) provides that the new dietary ingredient
notification contain 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. FDA
tentatively concludes that this information is necessary so that the
agency will know what ingredient is the subject of the notification and
will be able to determine whether the information submitted is
appropriate for making an evaluation of the safety of the new dietary
ingredient.
Proposed Sec. 190.6(b)(3) requires that the notification contain a
description of the dietary supplement, or dietary supplements, that are
to contain the new dietary ingredient. FDA is proposing that this
description include the level of the new dietary ingredient in the
dietary supplement (Sec. 190.6(b)(3)(i)) and 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 (Sec. 190.6(b)(3)(ii)). This information is necessary to
facilitate the agency's review of the use of the new dietary ingredient
and to determine whether there is any basis for concern about the
safety of its use.
Proposed Sec. 190.6(b)(4) provides that the new dietary ingredient
notification shall also contain 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. Under proposed
Sec. 190.6(b)(4), this history of use or other evidence of safety must
include citation to published articles or other evidence that is the
basis on which the distributor or manufacturer of the dietary
supplement has concluded that a dietary supplement containing such
dietary ingredient will reasonably be expected to be safe. Proposed
Sec. 190.6(b)(4) reflects the requirements in section 413(a)(2) of the
act. FDA is providing in proposed Sec. 190.6(b)(4) that any reference
to published information offered in support of the notification
required by Sec. 190.6(a) be accompanied by reprints or photostatic
copies of such references, and that, if any part of the material
submitted is in a foreign language, it be accompanied by an accurate
and complete English translation. FDA tentatively concludes that
submission of this material is necessary for efficient implementation
of this provision of the act.
Proposed Sec. 190.6(b)(5) provides that the new dietary ingredient
notification contain the signature of an authorized official of the
manufacturer or distributor of the dietary supplement that contains the
new dietary ingredient. FDA is including this provision to ensure that
the individual that is responsible for the accuracy, completeness, and
understandability of the notification is identified.
B. Administrative Procedures
Proposed Sec. 190.6(c) states that the date that the agency
receives the notification submitted under Sec. 190.6(a) is the filing
date for the notification. Consistent with section 413(a)(2) of the
act, proposed Sec. 190.6(c) also provides that the manufacturer or
distributor of the dietary supplement that contains the new dietary
ingredient is not to introduce the dietary supplement, or deliver it
for introduction, into interstate commerce for 75 days after the filing
date. Congress provided for a 75-day notice so that the agency would
have sufficient time to examine all of the material submitted and
decide whether there is any basis for concern about the marketing of a
dietary supplement that contains a new dietary ingredient.
Proposed Sec. 190.6(d) states that if the manufacturer or
distributor of the dietary supplement that contains a new dietary
ingredient, or of a new dietary ingredient, provides additional
information in support of the new dietary ingredient notification, the
date of receipt by FDA of the additional information in support of the
new dietary ingredient notification will constitute the filing date of
the notification. FDA tentatively concludes
[[Page 50776]]
that it is necessary to give a new filing date to the new dietary
ingredient notification when additional information in support of the
notification is received so that the agency has time to examine all of
the material submitted and to determine whether there is any basis for
concern about the marketing of the dietary supplement.
Consistent with section 413(a) of the act, proposed Sec. 190.6(e)
provides that the FDA will not disclose the existence of, or the
information contained in, a new dietary ingredient notification for 90
days after the filing date of the notification. Proposed Sec. 190.6(e)
also provides that 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.
Proposed Sec. 190.6(f) makes clear, however, that 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 that it is not
adulterated under section 402 of the act (21 U.S.C. 342). This
tentative position reflects the fact that the manufacturer or
distributor of a new dietary ingredient or a dietary supplement that
contains a new dietary ingredient is only required to provide the basis
on which it has concluded that the dietary supplement will reasonably
be expected to be safe. Since the manufacturer or distributor is not
required to do a complete search of all available sources of
information on the new dietary ingredient, the agency will not be in a
position to make a determination that the supplement is safe, or that
it is not adulterated under section 402 of the act.
III. Environmental Impact
The agency has determined under 21 CFR 25.24(a)(8) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
IV. Analysis of Impacts
FDA has examined the economic impact of the proposed rule as
required by Executive Order 12866 and the Regulatory Flexibility Act (5
U.S.C. 601-612). 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. 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 impact of the rule on small entities. FDA
finds that the proposed rule does not constitute a significant rule as
defined by Executive Order 12866, and finds that under the Regulatory
Flexibility Act, the proposed rule will not have a significant impact
on a substantial number of small entities.
The rule sets out the information that must be included in a
premarket notification for a new dietary ingredient. The information
must show the basis for the manufacturer's conclusion that the
ingredient is expected to be safe. Because the rule deals only with the
filing of information, the compliance costs are all clerical. Technical
and legal costs of introducing a new dietary ingredient and ensuring
its safety will be borne regardless of the proposed rule.
In the section of the document dealing with the Paperwork Reduction
Act, FDA estimates that the burden to industry will be approximately 20
hours per submission. The costs per hour are estimated to be $20.50 for
labor, benefits, and overhead (mainly computer time and photocopying).
The cost to industry per submission is therefore estimated to be $410.
In the most recent year, six new dietary ingredients appeared, which
would imply an annual cost to industry of $2,460. FDA assumes that the
number of new ingredients will vary, but will not be greatly different
from the past year. The plausible range is estimated to be 0 to 12 new
ingredients per year, for a cost range of 0 to $4,920 per year. Because
industry may take several years to adjust to the DSHEA, FDA expects the
number of new ingredients (and annual costs) to be closer to the high
end of the range in the next few years and closer to the low end after
that.
FDA is not able to quantify the benefits of this rule. The rule
increases the information available to FDA for implementing and
enforcing rules dealing with the new dietary ingredient provisions of
the DSHEA. The benefits are therefore derived from the benefits of FDA
efforts to implement the DSHEA so as to ensure that dietary ingredients
do not present a significant or unreasonable risk of illness or injury.
Under the Regulatory Flexibility Act, FDA must consider the effects
of the proposed rule on small businesses. The Small Business
Administration (SBA) does not define ``small'' for the dietary
supplement industry. The industry's products, for the most part, come
closest to being included in the Commerce Department's industry
categories of Food Preparations N.E.C. (not elsewere classified)
(Standard Industrial Classification code 2099) and Medicinal Chemicals
and Botanical Products (Standard Industrial Classification code 2833).
The SBA size standards for small are 500 or fewer employees for food
preparations and 750 or fewer employees for medicinal and botanical
products. According to either size standard, the majority of firms in
the dietary supplement industry would be classified as small
businesses. The total number of businesses affected by the proposed
rule will be small--no more than the number of new ingredients
(estimated to be 0 to 12 per year). FDA cannot determine, before the
event, the sizes of firm 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. The effect, as shown above, will be small--approximately $410
per submission. FDA concludes that the proposed rule will not have a
significant economic effect on a substantial number of small
businesses.
V. Paperwork Reduction Act
This proposed rule contains information collections that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3507). Therefore, in
accordance with 5 CFR 1320, the title, description, and respondent
description of the proposed collection of information requirements are
shown below with an estimate of the annual collection and information
burden. Included in the estimate is the time for assembling existing
data sources, gathering necessary information, and completing and
submitting the premarket notification.
FDA is interested in receiving comments that: (1) Evaluate whether
the proposed collection of information is necessary for the proper
performance of the function of the agency, including whether the
information will have practical utility; (2) evaluate the accuracy of
the agency's estimate of the
[[Page 50777]]
burden of the proposed collection of information; (3) evaluate the
quality, utility, and clarity of the information to be collected; and
(4) minimize the burden of the collection of information on those who
are to respond, including through the use of automated collection
techniques or other forms of information technology.
Title: Dietary supplements; dietary ingredients; premarket
notification.
Description: FDA is proposing a regulation requiring 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 before 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 proposing to
establish 21 CFR part 190 as the procedural regulations for this
program. This proposal 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 of a
dietary supplement that contains 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
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Annual
21 CFR Section No. of Frequency per Hours per Total Hours
Respondents Response Response
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190.6 6 1 20 120
Total ............... ............... ............... 120
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The agency believes that there will be minimal burden on the
industry to generate data to meet the requirements of the premarket
notification program, because the agency is requesting only that
information that the manufacturer or distributor should already be
developing to satisfy itself that a dietary supplement containing a new
dietary ingredient is in full compliance with the act. However, the
agency estimates that extracting and summarizing the relevant
information from the company's files, and presenting it in a format
that will meet the requirements of section 413 of the act, will require
a burden of approximately 20 hours of work per submission.
The agency has submitted to OMB copies of this proposed rule for
its review of this information collection requirement. Interested
persons are requested to submit comments regarding the collection of
information requirements to FDA's Dockets Management Branch (address
above) and to the Office of Information and Regulatory Affairs, OMB,
New Executive Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC
20503. Attn: FDA Desk Officer.
VI. Comments
Interested persons may, on or before December 26, 1996, submit to
the Dockets Management Branch (HFA-305), Food and Drug Administration,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, written comments
regarding this proposal. Two copies of any comment are to be submitted,
except that individuals may submit one copy. Comments are to be
identified with the docket number found in brackets in the heading of
this document. Received comments may be seen in the office above
between 9 a.m. and 4 p.m., Monday through Friday.
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
the authority delegated to the Commissioner of Food and Drug, it is
proposed that title 21 CFR chapter I be amended by adding new part 190
to read as follows:
PART 190--DIETARY SUPPLEMENTS
Authority: Secs. 201(ff), 301, 402, 413, 701 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321(ff), 331, 342, 371).
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, 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 202004, information, including any citation to published
articles, that is the basis on which the manufacturer or distributor
has concluded that the dietary supplement 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
[[Page 50778]]
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 an authorized official of the manufacturer or
distributor of the dietary supplement that contains the new dietary
ingredient.
(c) 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 date of receipt by FDA of the additional
information in support of the new dietary ingredient notification shall
constitute the filling date.
(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: September 19, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-24752 Filed 9-26-96; 8:45 am]
BILLING CODE 4160-01-F