Labeling of Drug Products for Over-the-Counter Human Use

DEPARTMENT OF HEALTH AND HUMAN SERVICES

21 CFR Part 330

[Docket No. 92N-0454]

RIN 0905-AA06

Labeling of Drug Products for Over-the-Counter Human Use

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

labeling policy for over-the-counter (OTC) drug products to allow for

the interchangeable use of certain words in labeling required by an OTC

drug monograph. Examples of these words include: ``doctor'' and

``physician,'' ``consult'' and ``ask,'' and ``indications'' and

``uses.'' This final rule provides alternate terminology in the

labeling of OTC drug products for words that have the same meaning.

EFFECTIVE DATE: February 28, 1994.

FOR FURTHER INFORMATION CONTACT: William E. Gilbertson, Center for Drug

Evaluation and Research (HFD-810), Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857, 301-594-5000.

SUPPLEMENTARY INFORMATION: In the Federal Register of April 5, 1993 (58

FR 17553), the agency proposed to amend its general labeling policy for

over-the-counter (OTC) drug products to allow for the interchangeable

use of certain words in the labeling required by an OTC drug monograph.

The agency had previously proposed in a number of tentative final

monographs and included in a number of final monographs a provision

that the words ``doctor'' and ``physician'' may be used interchangeably

in the labeling of OTC drug products. (See, e.g., Secs. 333.150(e),

333.350(e), and 336.50(e) (21 CFR 333.150(e), 333.350(e), and

336.50(e)).) Instead of including this provision in each OTC drug

monograph, the agency proposed to include such a provision in

Sec. 330.1 (21 CFR 330.1) as part of the general conditions under which

an OTC drug is generally recognized as safe, effective, and not

misbranded. The agency also proposed that, at manufacturers'

discretion, the word ``ask'' could be substituted for the word

``consult,'' which appears in the directions for many OTC drug

monograph ingredients. (See, e.g., Secs. 333.150(c)(1), 333.350(c)(2),

and 340.50(c)(2) (21 CFR 340.50(c)(2)).) Thus, the agency proposed that

the phrases ``consult a physician,'' ``consult a doctor,'' ``ask a

physician,'' and ``ask a doctor'' could be used interchangeably. The

agency invited comments and suggestions as to such other terms that

could be used interchangeably, i.e., terms general in nature that

appear in more than one OTC drug monograph.

One trade association, representing OTC drug manufacturers, and one

drug manufacturer submitted comments in response to the agency's

proposal. Copies of the comments are on display in the Dockets

Management Branch (HFA-305), Food and Drug Administration, rm. 1-23,

12420 Parklawn Dr., Rockville, MD 20857, and may be seen by interested

persons between 9 a.m. and 4 p.m., Monday through Friday.

I. Summary of the Comments Received

The comment from the trade association agreed with the agency's

proposal to allow for the interchangeable use of the words ``doctor''

and ``physician,'' and the words ``consult'' and ``ask.'' The comment

suggested the following additional sets of alternative terms and gave

the following citations, showing inclusion in several OTC drug

monographs, as support: (1) ``Clean'' or ``cleanse'' (Secs. 333.150(d),

333.350(d)(1), and 346.50(d)(1) (21 CFR 346.50(d)(1))); (2) ``persist''

or ``continue'' (Secs. 341.76(c)(5)(ii), 346.50(c)(7)(iii),

357.150(c)(1), and 357.850(c)(1)(i) (21 CFR 341.76(c)(5)(ii),

346.50(c)(7)(iii), 357.150(c)(1), and 357.850(c)(1)(i))); (3)

``chronic'' or ``persistent'' (Secs. 336.50(c)(1), 338.50(c)(3),

341.74(c)(2), (c)(3), and (c)(4)(ii) through (c)(4)(iv), and

341.78(c)(1) (21 CFR 338.50(c)(3), 341.74(c)(2), (c)(3), and (c)(4)(ii)

through (c)(4)(iv), and 341.78(c)(1))); (4) ``assistance'' or ``help''

(Secs. 331.30(g), 332.30(c), 341.74(f), and 342.76(c)(5)(i) and

(c)(6)(ii) (21 CFR 331.30(g), 332.30(c), 341.74(f), and 342.76(c)(5)(i)

and (c)(6)(ii))); and (5) ``pulmonary'' or ``lung'' (Secs. 336.50(c)(1)

and 338.50(c)(3)). The comment stated that, in some instances, the

paired terms already appear in the cited regulations and, in other

cases, the alternative terms may be better understood by consumers. The

comment mentioned the following examples: ``Lung'' disease may be

better understood than the more technical ``pulmonary'' disease, and

``persistent'' may be better understood than ``chronic.'' The comment

stated its understanding that the rule is intended only to provide a

glossary of comparable terms that may be used interchangeably, not to

make substantive changes in the underlying required label statements.

For example, the comment mentioned that the rule would not permit the

term ``health professional'' as an alternative to the terms ``doctor''

or ``physician,'' because a ``health professional'' may include

pharmacists, nurses, midwives, and others who are not licensed to

practice medicine. The comment requested that the agency clarify that

this rule applies only to OTC drug monograph language otherwise

required to be declared verbatim in OTC drug product labeling. The

comment added that the rule would not apply to or otherwise affect the

use of truthful and nonmisleading alternative terms that can be used

for monograph indications.

The other comment also proposed that the terms ``assistance'' and

``help'' be allowed interchangeably in the general overdose warning,

which states: ``In case of accidental ingestion, seek professional

assistance or contact a Poison Control Center immediately.''

II. The Agency's Final Conclusions

The agency has carefully evaluated the comments' proposals for the

interchangeable use of certain terms and concludes that the

interchangeable terms suggested by the comments (``clean'' or

``cleanse,'' ``persist(s)'' or ``continue(s),'' ``assistance'' or

``help,'' and ``pulmonary'' or ``lung'') are acceptable and will help

promote better label readability.

In addition, the agency has determined that the terms

``indication(s)'' or ``use(s)'' should be allowed to be used

interchangeably. The agency considers the term ``use(s)'' to be simpler

and better understood by consumers than the term ``indication(s).'' The

agency is including this option in Sec. 330.1(i).

The agency disagrees with the interchangeable use of the words

``chronic'' and ``persistent.'' ``Chronic,'' by definition, is of long

duration, or may be subject to habit or disease for a lengthy period

(Ref. 1). On the other hand, ``persistent,'' by definition, is refusing

to let go, insistently repetitive or continuous, or enduring (Ref. 2).

While ``chronic'' is also ``persistent,'' ``persistent'' is not

necessarily ``chronic.'' For instance, a chronic cough denotes one that

has gone on for a lengthy period of time, while a persistent cough

could be one of recent onset that does not respond to treatment. Thus,

a chronic cough and a persistent cough may be the same, or they could

be two separate entities. Therefore, interchangeable use of the terms

``chronic'' and ``persistent'' is not included in the final rule.

References

(1) ``Webster's II New Riverside University Dictionary,''

Houghton Mifflin Co., Boston, 1984, s.v. ``chronic.''

(2) ``Webster's II New Riverside University Dictionary,''

Houghton Mifflin Co., Boston, 1984, s.v. ``persistent.''

This final rule does not make substantive changes in the language

required in OTC drug monographs. The rule allows for alternative

terminology for certain terms that are sufficiently comparable to be

used interchangeably. The rule does not affect the use of truthful and

nonmisleading terminology as an alternative to monograph indications in

accord with Sec. 330.1(c)(2)(ii) and (c)(2)(iii).

The agency has examined the economic consequences of this final

rule and determined that it does not require either a regulatory impact

analysis, as specified in Executive Order 12866, or a regulatory

flexibility analysis, as defined in the Regulatory Flexibility Act

(Pub. L. 96-354). This final rule provides alternative labeling options

that can be implemented at very little cost by manufacturers at the

next printing of labels, for those products for which the manufacturer

chooses to make a change. Thus, the rule will have no significant

economic impact. The agency concludes that the final rule is not a

major rule as defined in Executive Order 12866. Further, the agency

certifies that the rule will not have a significant economic impact on

a substantial number of small entities as defined in the Regulatory

Flexibility Act.

The agency has determined under 21 CFR 25.24(c)(6) 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.

List of Subjects in 21 CFR Part 330

Over-the-counter drugs.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under

authority delegated to the Commissioner of Food and Drugs, 21 CFR part

330 is amended as follows:

PART 330--OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY

RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED

1. The authority citation for 21 CFR part 330 continues to read as

follows:

Authority: Secs. 201, 501, 502, 503, 505, 510, 701 of the

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352, 353,

355, 360, 371).

2. Section 330.1 is amended by adding new paragraph (i) to read as

follows:

Sec. 330.1 General conditions for general recognition as safe,

effective and not misbranded.

* * * * *

(i) The following terms may be used interchangeably in any of the

labeling established in parts 331 through 358 of this chapter:

(1) ``Ask'' or ``consult''.

(2) ``Assistance'' or ``help''.

(3) ``Clean'' or ``cleanse''.

(4) ``Continue'' or ``persist''.

(5) ``Continues'' or ``persists''.

(6) ``Doctor'' or ``physician''.

(7) ``Indication'' or ``use''.

(8) ``Indications'' or ``uses''.

(9) ``Lung'' or ``pulmonary''.

* * * * *

Dated: October 15, 1993.

Michael R. Taylor,

Deputy Commissioner for Policy.

[FR Doc. 94-1791 Filed 1-27-94; 8:45 am]

BILLING CODE 4160-01-F