Law Library


Federal Register: September 23, 1997 (Volume 62, Number 184)

Rules and Regulations

Page 49883-49886


 

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

Food and Drug Administration

 

21 CFR Part 101

 

Docket No. 96N-0240

 

 

Food Labeling; Notification Procedures for Statements on Dietary

Supplements

 

AGENCY: Food and Drug Administration, HHS.

 

ACTION: Final rule.

 

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SUMMARY: The Food and Drug Administration (FDA) is amending its

regulations to establish the notification procedures for manufacturers,

packers, or distributors of dietary supplements who are marketing

dietary supplement products that bear statements under a provision of

the Federal Food, Drug, and Cosmetic Act (the act). The agency is

adopting this procedure to ensure that notification is accomplished

efficiently. FDA instituted this proceeding to help the industry comply

with the Dietary Supplement Health and Education Act of 1994 (the

DSHEA).

 

EFFECTIVE DATE: October 23, 1997.

 

FOR FURTHER INFORMATION CONTACT: Robert J. Moore, Center for Food

Safety and Applied Nutrition (HFS-456), Food and Drug Administration,

200 C St. SW., Washington, DC 20204, 202-205-4605.

 

SUPPLEMENTARY INFORMATION:

 

I. Background

 

    In the Federal Register of September 27, 1996 (61 FR 50771), FDA

published a proposed rule entitled ``Food Labeling; Dietary Supplement;

Nutritional Support Statement; Notification Procedure'' (hereinafter

referred to as ``the September 1996 proposal''). FDA issued this

proposal in response to section 6 of the DSHEA (Pub. L. 103-417). This

section of the DSHEA amended the act by adding section 403(r)(6) (21

U.S.C. 343(r)(6)). This section of the act allows for statements to be

made on the label or in the labeling of a dietary supplement that does

the following:

    (1) Claims a benefit related to a classical nutrient deficiency

disease and discloses the prevalence of such disease in the United

States,

    (2) describes the role of a nutrient or dietary ingredient intended

to affect the structure or function in humans,

    (3) characterizes the documented mechanism by which a nutrient or

dietary ingredient acts to maintain such structure or function, or

    (4) describes general well-being from consumption of a nutrient or

dietary ingredient if the statements are made in accordance with

certain requirements.

The manufacturer of the dietary supplement must:

    (1) Substantiate that the statement is truthful and not misleading;

    (2) Include, prominently displayed and in boldface type, the

following: ``This statement has not been evaluated by the Food and Drug

Administration. This product is not intended to diagnose, treat, cure,

or prevent any disease;'' and

    (3) Notify the Secretary of Health and Human Services (the

Secretary) (and by delegation FDA) no later than 30 days after the

first marketing of a dietary supplement bearing such a statement that

the statement is being made.

The statement may not claim to diagnose, mitigate, treat, cure, or

prevent a disease or class of diseases.

    In the September 1996 proposal, FDA outlined the procedure by which

manufacturers would comply with the requirements that they notify the

Secretary when they make a claim under section 403(r)(6) of the act.

FDA received eight responses to the proposal. Each response contained

one or more comments. Some comments supported the proposal generally or

supported aspects of the proposal. Other comments addressed issues

outside the scope of the proposal (e.g., guidelines differentiating

health claims from structure/function claims, health information to

consumers, types of claims that can be made, the form and amount of

substantiation FDA will require, when the disclaimer should or should

not be required, and the use of classical nutrient deficiency claims)

and will not be addressed in this document. Several comments suggested

modifications or revisions of various aspects of the proposal. A

summary of the comments and the agency's responses to the comments

follow.

 

II. Notification of ``Products'' or ``Brands''

 

    1. One comment objected to proposed Sec. 101.93(b)(4) (redesignated

as Sec. 101.93(a)(2)(iv)) requiring that the brand name of the product

be included in the notification. The comment argued that providing this

information would be unnecessarily burdensome, and that the DSHEA did

not require this information. The comment cited the fact that a dietary

supplement product, such as vitamin C 500 milligrams (mg), may be

marketed under a variety of brand names, but that the product (i.e.,

the dietary supplement) could be the same from brand ABC to brand XYZ.

The comment argued that if a notification has been made for a claim on

one brand of this dietary supplement, it should not be necessary for

every manufacturer of this type of supplement to file a notification.

    FDA is not persuaded to modify the regulation in response to this

comment. If a manufacturer makes a type of dietary supplement, such as

a vitamin C supplement, under a number of different brand names, under

Sec. 101.93(a)(2)(iv), a manufacturer may list all of the brands on

which the claim is to appear, and thus for which it is providing

notification, in a single submission. The regulation does not require

that a separate notice be submitted for each individual product or

brand.

    FDA finds that the brand name of a dietary supplement is a

necessary part of the notification that a statement of nutritional

support is being made on the label or in the labeling of the dietary

supplement. Including the brand is necessary to efficiently enforce the

act. If the notification does not include the relevant brand name, FDA

will not know which products are in compliance with the notification

requirement of section 403(r)(6) of the act. This is particularly

important because there is no requirement that a manufacturer submit to

FDA its substantiation that establishes that its claim is truthful and

not misleading (section 403(r)(6)(B) of the act). Thus, it cannot be

assumed that the first submission for a claim under section 403(r)(6)

of the act establishes that adequate substantiation exists to support

that claim for all products that may contain that substance. Each

manufacturer must have its own substantiation that any statement it

makes in the labeling of a dietary supplement product under section

403(r)(6) of the act is truthful and not misleading, and the

manufacturer must submit a notice to FDA that attests to this fact.

 

III. Signature of Person Who Can Certify that Firm has

Substantiation

 

    2. Several comments objected to proposed Sec. 101.93(c)

(redesignated as

 

Page 49884

 

Sec. 101.93(a)(3)), which requires that the notice be signed by a

responsible individual or by the person authorized to certify that the

information presented and contained in the notice is accurate. Other

comments objected to proposed Sec. 101.93(c) (redesignated as

Sec. 101.93(a)(3)) which requires that the individual certify that the

information contained in the notice is complete and accurate, and that

the notifying firm has substantiation that the statement is truthful

and not misleading. These comments argued that the DSHEA does not

require that the notification be signed by anyone, and that it does not

require that an individual certify that the information contained in

the notice is complete and accurate, or that the notifying firm have

substantiation that the statement is truthful and not misleading.

    One comment agreed that the company must have substantiation that

statements made in accordance with section 403(r)(6)(B) of the act are

truthful and not misleading. However, this comment maintained that

section 403(r)(6)(B) of the act does not require, or provide any basis

for requiring, signature and certification as part of the notification.

Another comment stated that the DSHEA's requirement that manufacturers

of dietary supplements have substantiation that such statements are

truthful and not misleading is independent of the notification

requirement.

    Several comments also disagreed with FDA's explanation that the

requirement for a signature will ensure that the statutory requirements

have been met, and that the certification is necessary to provide

assurance that a notifying firm has fully complied with the requirement

of section 403(r)(6) of the act.

    Several comments contended that neither the courts nor FDA have

established procedures, guidelines, or standards for identifying the

type and amount of evidence needed to support substantiation, and

therefore, the manufacturer who is giving notification cannot know

whether the evidence it has meets FDA's expectations and has no basis

to provide certification. One comment stated that general dictionary

definitions for ``substantiation'' are of no help because, in the

relevant legal context, the question requires detailed legal analysis,

which at best can only identify possible interpretations and does not

even begin to predict what the agency's ultimate interpretation of

``substantiation'' might be. One comment stated that ``substantiation''

under the DSHEA might be interpreted by regulated supplement companies

to mean a number of different things (e.g., near scientific certainty,

significant scientific agreement, or reasonable basis). The comment

requested that FDA acknowledge that it will not attempt to set a

substantiation standard under the DSHEA comparable to new drug or

health claims requirements, and that it will not adopt the Federal

Trade Commission's ``reasonable basis'' standard that is currently

applied in dietary supplement advertising cases.

    Several comments maintained that the requirement that manufacturers

certify that the notifying firm has substantiation that the statement

is truthful and not misleading goes beyond the authority of the act

because it imposes potential liability under the False Statements Act

(18 U.S.C. 1001) if FDA does not agree that the substantiation relied

upon by the person making the notification meets the requirements of

the act. Another comment contended that the objective of

Sec. 101.93(a)(3) is accomplished by existing Federal statutes (i.e.,

18 U.S.C. 1001) that prohibit the knowing and willful false

representation of any statement to a Government agency. Another comment

objected to the agency subjecting both a manufacturer and the person

representing the company to potential criminal sanctions for making

false statements, and this comment argued that, in doing so, FDA would

be acting in a manner that is inconsistent with the intent of Congress.

    FDA disagrees with these comments and finds that they are without

merit. First, FDA does not agree that the requirement that

manufacturers have substantiation that statements made in accordance

with section 403(r)(6) of the act are truthful and not misleading is

independent of the notification requirement. The last sentence of

section 403(r)(6) of the act states that if a manufacturer of a dietary

supplement proposes to make a ``statement described in the first

sentence of this subparagraph,'' it is to notify the Secretary (that

is, FDA). A ``statement described in the first sentence of section

403(r)(6)'' is one for which (among other things) ``the manufacturer

of the dietary supplement has substantiation that such statement is

truthful and not misleading.'' In section 403(r)(6) of the act, thus,

contrary to the assertion in the comment, there is a direct connection

between the substantiation requirement and the notification requirement

in section 403(r)(6) of the act.

    Second, FDA also finds no merit to the argument made with respect

to 18 U.S.C. 1001. Because the act on its face connects the

notification requirement to the substantiation requirement, a

manufacturer who submits a notification under section 402(r)(6) of the

act without being in possession of substantiation that the claim that

it intends to make, or is making, is truthful and not misleading is

making a false statement to the Government, in violation of 18 U.S.C.

1001. This is true without regard to whether a responsible individual

has signed a certification or not.

    FDA is requiring that the notification be signed by a responsible

individual, and that individual certify the accuracy of the information

presented in the notice, for efficient enforcement of the act under

sections 403(r)(6) and 701(a) of the act (21 U.S.C. 371(a)). The person

signing the notice, and the company on whose behalf he or she signs it,

must recognize that there are significant consequences to their action,

including potential liability under 18 U.S.C. 1001. Signing a

certification that the information in the notice is accurate will

likely cause the person who is doing so to check the information in the

notice. Such a check should minimize any problems under this section of

the act and thus will contribute to its efficient enforcement.

    Third, FDA finds no merit to the comments that claim that firms

have no basis to determine what level of substantiation is necessary.

In this regard, the act is clear on its face: The manufacturer must

have substantiation that the statement is truthful and not misleading.

If the manufacturer has any doubts as to whether it has substantiation

to meet this standard, it should not make the statement in question on

its label or in its labeling. Claims that manufacturers are unable to

interpret this standard are belied by the fact that since the passage

of the DSHEA, FDA has received literally hundreds of notices under

section 403(r)(6) of the act. FDA assumes that these notifications have

been made in good faith, and the submitters were confident that they

were in possession of adequate substantiation. Thus, FDA finds no need

for it to elaborate on the substantiation standard that appears in the

act.

 

IV. Recommended Compliance With the Proposed Rule

 

    3. One comment stated that FDA indicated in the preamble to the

September 1996 proposal that it ``recommends'' that manufacturers

follow the proposed regulation immediately. The comment requested that

FDA make clear that failure to follow ``recommendations'' that are not

final rules carries no penalty or sanction and generates no prejudice.

 

Page 49885

 

    FDA made this recommendation in the September 1996 proposal because

of the many requests from manufacturers to FDA asking for guidance on

how to make a statement of nutritional support notification. However,

the comment is correct that no penalty or sanction applies to

manufacturers who do not make their notification according to these

rules until the effective date of this regulation. It should, however,

be noted that dietary supplement manufacturers do not have the option

of not notifying FDA if they are making statements of nutritional

support on the label or in the labeling of their products. The

requirement to make the notification to FDA no later than 30 days after

the first marketing of the dietary supplement that bears such a

statement became effective with the signing into law of the DSHEA on

October 25, 1994.

 

V. 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.

 

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 and safety, and other advantages;

distributive impacts; and equity). 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 stated that the

costs of this regulation consisted of the costs of preparing and

submitting notification to FDA regarding statements of nutritional

support. FDA concluded that because the information should already have

been gathered in order to prepare the nutritional support statement

itself, the additional cost incurred for notification would be small

and in many instances negligible. One comment said that the costs of

notification could be burdensome for a manufacturer producing many

different brands and products. FDA is not persuaded that this

additional burden would be large, for the same reasons as stated in the

economic analysis of the proposed rule--the notification cost will be

negligible to manufacturers who have borne the labeling costs

associated with nutritional support statements for several different

brands or products. This final rule is procedural and implements the

statutory notification requirement at minimal cost. Other requirements

associated with nutritional support statements will be dealt with by

other rules.

    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 (Pub. L. 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.

    For purposes of defining industry size standards, the Small

Business Administration (SBA) classifies industries according to four-

digit Standard Industrial Classification (SIC) codes. SBA does not

define ``small'' for the dietary supplement industry, because no SIC

code corresponds to the industry--dietary supplements encompass a wide

range of products. The industry's products come closest to the industry

groups Food Preparations N.E.C. (SIC code 2099) and Medicinal Chemicals

and Botanical Products (SIC code 2833). The SBA size standards for

small businesses are 500 or fewer employees for food preparations and

750 or fewer employees for medicinal and botanical products. Under

either employee-based size standard, virtually all firms in the dietary

supplement industry could be classified as small, including some firms

that are among the leaders in sales revenues.

    For the dietary supplement industry, FDA is basing size

classifications on sales revenue rather than employees. According to

the Nutrition Business Journal, of the 850 firms manufacturing dietary

supplements, 11 firms have total revenues over $100 million, accounting

for 53 percent of total sales; 30 firms have sales revenues between $20

and $100 million, accounting for 28 percent of total sales; and 809

firms have sales under $20 million, accounting for 19 percent of total

sales. The 809 firms in the under $20 million category have an average

sales revenue of $800,000 and will be considered small businesses by

FDA. Because the total includes some firms making functional foods that

are not dietary supplements and other products, such as sports

nutrition products, that are not considered dietary supplements, the

estimate may overstate the number of small firms affected by this final

rule.

    The number of small businesses affected by this final rule could

include all small businesses in the dietary supplement industry, if

they choose to use nutritional support statements. As FDA concluded in

the benefit-cost analysis, the additional costs imposed by the

notification provisions will be negligible to small firms once the

labeling provisions have been carried out. This final rule requires

only that the manufacturer notify FDA within 30 days of marketing a

supplement that bears a nutritional support statement on its label. The

information required in the notification is either on the label itself

(e.g., the text of the statement) or readily available (e.g., the name

of the ingredient that is the subject of the statement).

    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 agency certifies

that this final rule will not have a significant impact on a

substantial number of small entities.

 

VII. The 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

title, description, and respondent description of the information

collection provisions are shown below 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: Food Labeling; Notification Procedures for Statements on

Dietary Supplements.

    Description: FDA is, by regulation, requiring manufacturers,

packers, and distributors of dietary supplements to

 

Page 49886

 

notify FDA that they are marketing a dietary supplement product that

bears on its label or in its labeling a statement provided for in

section 403(r)(6) of the act. Section 403(r)(6) of the act requires

that the agency be notified, with a submission about such statements,

no later than 30 days after the first marketing of the dietary

supplement. Information that is required in the submission includes:

(1) The name and address of the manufacturer, packer, or distributor of

the dietary supplement product; (2) the text of the statement that is

being made; (3) the name of the dietary ingredient or supplement that

is the subject of the statement; (4) the name of the dietary supplement

(including the brand name); and (5) a signature of a responsible

individual who can certify the accuracy of the information presented.

    In Sec. 101.93, the agency is establishing procedures for

submitting required information. Section Sec. 101.93 provides details

of the procedures associated with the submission and identifies the

information that must be included in the submission in order to meet

the requirements of section 403 of the act.

    Description of Respondents: Businesses or other for-profit

organizations.

 

   Table 1.--Estimated Annual Reporting Burden

 

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             No. of       Annual Frequency    Total Annual

  Hours per

    21 CFR Section         Respondents      per Response        Responses

  Response         Total Hours

--------------------------------------------------------------------------------

--------------------------------

101.93        420 1               420

      0.5-1       210-420

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--------------------------------

 

(Through inadvertent error, the agency misreported the number of

respondents and the annual frequency per response and omitted the total

annual response in the proposal. Hours per response and total hours

were reported correctly. In this final rule, FDA is correcting the

inadvertent errors that it made in the proposal).

    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 0910-0331. This approval expires on

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 101

 

    Food labeling, Nutrition, Reporting and recordkeeping requirements.

 

PART 101--FOOD LABELING

 

    1. The authority citation for 21 CFR part 101 continues to read as

follows:

 

    Authority: Secs. 4, 5, 6 of the Fair Packaging and Labeling Act

(15 U.S.C. 1453, 1454, 1455); secs. 201, 301, 402, 403, 409, 701 of

the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 342,

343, 348, 371).

 

    2. Section 101.93 is added to subpart F to read as follows:

 

Sec. 101.93  Notification procedures for certain types of statements on

dietary supplements.

 

    (a)(1) No later than 30 days after the first marketing of a dietary

supplement that bears one of the statements listed in section 403(r)(6)

or the Federal Food, Drug, and Cosmetic Act, the manufacturer, packer,

or distributor of the dietary supplement shall notify 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, that it has included such a statement on the label or in the

labeling of its product. An original and two copies of this

notification shall be submitted.

    (2) The notification shall include the following:

    (i) The name and address of the manufacturer, packer, or

distributor of the dietary supplement that bears the statement;

    (ii) The text of the statement that is being made;

    (iii) The name of the dietary ingredient or supplement that is the

subject of the statement, if not provided in the text of the statement;

and

    (iv) The name of the dietary supplement (including brand name), if

not provided in response to paragraph (a)(2)(iii) on whose label, or in

whose labeling, the statement appears.

    (3) The notice shall be signed by a responsible individual or the

person who can certify the accuracy of the information presented and

contained in the notice. The individual shall certify that the

information contained in the notice is complete and accurate, and that

the notifying firm has substantiation that the statement is truthful

and not misleading.

    (b) through (e) Reserved

 

    Dated: August 20, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

FR Doc. 97-24738 Filed 9-22-97; 8:45 am

BILLING CODE 4160-01-F