July 5, 2002

Dockets Management Branch

5630 Fishers Lane

Room 1061- HFA-305,\
Rockville, MD, 20852

RE: Over-the-Counter Drugs: Labeling Requirements; Partial Delay of
Compliance \[Dockets No. 98N-0337, 96N-0420, 95N-0259, and 90P-0201\]

To Whom It May Concern:

These comments are submitted by the Consumer Healthcare Products
Association (CHPA) in response to FDA's April 5, 2002, *Federal
Register* publication establishing a partial delay in compliance for
certain products which are subject to FDA's final rule that established
standardized format and content requirements for the labeling of all OTC
drug products (Drug Facts Rule). These products are designated in the
partial delay of compliance as "convenience-size" over-the-counter (OTC)
drug products.

CHPA is the 121-year-old trade organization representing the
manufacturers and distributors of nonprescription, or OTC, medicines and
dietary supplements. CHPA has been a principal industry voice during the
evolution of the Drug Facts Rule, and many of the final provisions of
the rule are similar to those proposed by CHPA. Our association has also
discussed with the agency the matter of convenience sizes, as noted in
the published partial delay in compliance.

CHPA supports FDA's conclusion that "some accommodation for convenience
size packages is appropriate," and concurs with the agency's course of
action to establish a partial delay of compliance, thereby creating an
opportunity for all interested parties to comment on the "viability,
desirability, and impact" of a proposed rule for convenience size OTC
drug products. Furthermore, as part of this process, CHPA urges FDA to
consider the broadest range of issues related to this matter, both in
the context of the partial delay of compliance as well as in the
questions the agency plans to pose for public comment in the proposed
rule.

**[CHPA Supports FDA's Course of Action to Seek Public
Comment.]{.underline}**

On May 13, 2002, FDA received comments from a third party representing
Mechanical Servants, Inc. (MSI) opposing a Citizen Petition submitted by
Lil' Drug Store Products, Inc. (LDSP) on May 27, 2001. LDSP's comments
were the basis for FDA's publication of a partial delay of compliance.
The issues raised by MSI are complicated, requiring due consideration
and public comment. Hence, CHPA urges that FDA stay the course it has
undertaken and proceed with the development of a public review and
comment rulemaking to resolve the various important issues surrounding
establishment of a safe harbor for OTC convenience size packages.

FDA Should Cast a Wide Net in Seeking Comments on a Proposed Rule on
Convenience Sizes.

The matter of establishing a clear definitional line for OTC convenience
sizes is a complicated undertaking, and the potential ramifications of
various proposals should be carefully thought out. Therefore, FDA should
cast a wide net in seeking comments to its proposed rule. For example:

-   Further consideration of the "1 to 2 dose"[^1] criterion set forth
    in the partial delay of compliance needs to be undertaken, and
    indeed might even be undertaken as part of the delay of compliance
    in the context of the following rationale. The "1 to 2 dose" rule is
    inconsistent, and does not fairly treat all OTC products.\
    \
    For example under the rule for a solid oral dosage form, a roll of
    antacids might not be considered a convenience size, yet its use by
    consumers is typically *prn*, "on-the-go." Convenience and
    portability are key to this product category. An antacid roll
    typically contains a day's dosage (e.g., 3 or 4 tablets per maximum
    dose, not more than 3 doses per 24 hours). Where the inconsistency
    in the "1-2 dose" rule comes into play is in the consideration of
    the antacid example in relation to an oral 12-hour timed release
    dosage form, where two doses represent a day's treatment. FDA should
    attempt to bring consistency and fairness to its interim "1-2 dose"
    rule, and at least consider specific exemptions to its interim rule,
    both during the delay and in the final resolution of this issue.
    Other examples might also exist where reasonable exceptions to the
    "1-2 dose" rule should be considered, and these would undoubtedly be
    identified in the review and comment period to the proposed rule.
    For instance, consideration should also be given to products with no
    dosage limitations (e.g., sunscreens, antiperspirants, etc.).

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-   Manufacturers of products which meet the convenience size definition
    may still elect to follow some of the provisions of the Drug Facts
    rule to keep a reasonable degree of consistency in the presentation
    of information across all retail sizes of the same product. FDA
    should seek comments as to how this might be done, including such
    approaches as utilizing a decreased type size, allowing wrapping of
    bulleted statements (i.e., a paragraph format) and removing
    hairlines and bar lines between sections of information, provided
    the content of the labeling conforms with the appropriate final
    monographs. This could be accomplished by FDA making a definitive
    statement to this effect and waiving compliance action.

-   There may be clear opportunities for truncation and abbreviation and
    possibly deletion of some label elements that would not adversely
    affect the proper self-selection and subsequent safe and effective
    use of a particular OTC product. Drawing an inflexible line, as
    proposed by MSI, that would preclude truncation and abbreviation
    based on the type of information needed for appropriate
    self-selection is simply unreasonable. "Other information," toll
    free numbers, storage conditions, and potentially other information
    should be considered as suitable areas for truncation, since they
    would have little bearing on appropriate self-selection.

These are a few of the various issues that FDA should consider in
implementing the partial delay of compliance and preparing a proposed
rule on OTC convenience sizes. CHPA believes that FDA has taken the
right course of action and should proceed to a public review and comment
process.

![](media/image1.wmf){width="2.45in"
height="0.7111111111111111in"}Sincerely yours,

R. William Soller, Ph.D.

Senior Vice President and

Director of Science & Technology

WS/OTClabeling/Convenience Sizes/ConvSiz Com to Delay\[2\]

[^1]: FDA's partial delay of compliance for "convenience size" OTC
    products extends to all OTC drug products that: (1) contain no more
    than two doses of an OTC drug; and (2) because of their limited
    available labeling space, would require more than 60 percent of the
    total surface area available to bear labeling to meet the
    requirements set for in 201.66(d)(1) to (d)(9) and therefore qualify
    for labeling modifications currently set forth in 201.66(d)(10). FDA
    defined "dose" for this purpose as the maximum single serving
    \[i.e., dose\] for an adult (or a child for products marketed only
    for children) as specified in the product's directions for use.