[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