[Federal Register: November 29, 2004 (Volume 69, Number 228)]
[Rules and Regulations]
[Page 69278-69280]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29no04-4]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 201
[Docket No. 1990N-0309]
RIN 0910-AF50
Drug Labeling; Sodium Labeling for Over-the-Counter Drugs
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule
amending the regulations for sodium labeling for over-the-counter (OTC)
drug products by extending the sodium content labeling requirement to
[[Page 69279]]
rectal drug products containing sodium phosphate/sodium biphosphate
(sodium phosphates). FDA is taking this action because people with
certain medical conditions are at risk for an electrolyte imbalance to
occur when using rectal sodium phosphates products. Serious adverse
events and deaths have occurred because of the high level of sodium
present in these products. This final rule is part of FDA's ongoing
review of OTC drug products.
DATES: This rule is effective November 29, 2005.
FOR FURTHER INFORMATION CONTACT: Neel Patel, Center for Drug Evaluation
and Research (HFD-560), Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301-827-2222.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of March 24, 2004 (69 FR 13765), FDA issued
a proposed rule to amend the regulations for sodium labeling for OTC
drug products to require sodium content labeling for rectal drug
products containing sodium phosphates. FDA considers it important that
consumers be aware of the sodium content of OTC rectal drug products
containing sodium phosphates and that this information appear in
product labeling so that it will be readily available to consumers,
physicians, and other health professionals. Some OTC laxative drug
products intended for rectal administration can contain very high
levels of sodium from both active and inactive ingredients. Significant
amounts of some of these products may be absorbed causing an
electrolyte imbalance.
Section 201.64 (21 CFR 201.64) requires orally ingested sodium
phosphates products to bear sodium content information. FDA proposed to
add paragraph (k) to Sec. 201.64 to require sodium content information
to appear in the labeling of rectal drug products containing dibasic
sodium phosphate and/or monobasic sodium phosphate.
II. Final Rule Amending Sodium Labeling Regulations
FDA did not receive any comments to its proposed new labeling
requirements, its discussion of the statutory authority to require this
labeling, or its discussion of this labeling requirement being
constitutionally permissible under the first amendment. Accordingly,
FDA is not repeating those discussions in this final rule, but is
incorporating the discussions regarding statutory authority and the
first amendment by reference (see 69 FR 13766 to 13767). FDA is
finalizing its proposal by requiring sodium content information to
appear in the labeling of OTC rectal drug products containing dibasic
sodium phosphate and/or monobasic sodium phosphate.
III. Analysis of Impacts
FDA has examined the impacts of this final rule under Executive
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the
Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1501 et seq.). 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). Under the Regulatory
Flexibility Act, if a rule has a significant economic impact on a
substantial number of small entities, an agency must analyze regulatory
options that would minimize any significant impact of the rule on small
entities. Section 202(a) of the Unfunded Mandates Reform Act of 1995
requires that agencies prepare a written statement of anticipated costs
and benefits before proposing any rule that may result in an
expenditure in any one year by State, local, and tribal governments, in
the aggregate, or by the private sector, of $100 million (adjusted
annually for inflation).
FDA concludes that this final rule is consistent with the
principles set out in Executive Order 12866 and in these two statutes.
As discussed in this section of the document, the final rule will not
be economically significant as defined by the Executive order. With
respect to the Regulatory Flexibility Act, FDA concludes that the rule
would not have a significant economic impact on a substantial number of
small entities. The Unfunded Mandates Reform Act of 1995 does not
require FDA to prepare a statement of costs and benefits for the final
rule, because the final rule is not expected to result in any 1-year
expenditure that would exceed $100 million adjusted for inflation. The
current inflation adjusted statutory threshold is about $110 million.
The purpose of this final rule is to extend the requirement for
sodium content labeling to OTC rectal drug products that contain sodium
phosphates so that the information is available to: (1) Health
professionals and (2) individuals who need to limit their sodium
intake. The final rule would require minor relabeling of OTC rectal
drug products containing sodium phosphates. There are fewer than five
major manufacturers of these products in the OTC drug marketplace. One
company manufactures a nationally branded product with the others
producing private label products. One large manufacturer produces about
one-half to two-thirds of the products covered by this final rule.
Three small manufacturers account for the remainder of the market.
There may be other manufacturers/marketers not identified in sources
FDA reviewed, but FDA believes there are a limited number and they
would be small manufacturers. FDA concludes that this final rule would
not have a significant economic impact on small entities, using the
U.S. Small Business Administration designations for this industry (750
employees). Together, fewer than 300 stockkeeping units (SKUs) are
marketed. The manufacturer of the nationally branded product and some
private label manufacturers of these products already include sodium
content information in the labeling of their products. Any necessary
relabeling (addition of sodium content labeling) will impose direct
one-time costs on some manufacturers. FDA has been informed that the
cost to relabel these products ranges from $500 to $3,500 per SKU.
Using $3,500 per SKU, and assuming all SKUs would need to be relabeled,
the total one-time cost to relabel these products would be $1,050,000.
Actual costs will be lower because most of these products already
include the sodium content information in their labeling.
Manufacturers that have not voluntarily included sodium content
information may also incur one-time costs to test their products to
determine the sodium content. The cost to test for one cation (e.g.,
sodium) is about $150 for private label manufacturers. Assuming they
repeat the testing, the total one-time costs for an estimated 10
products would be $3,000.
FDA considered but rejected several labeling alternatives: (1) A
longer implementation period and (2) an exemption from coverage for
small entities. A longer time period would unnecessarily delay the
benefit of the new labeling to consumers who self-medicate with these
products. FDA rejected an exemption for small entities because the
labeling is also needed by consumers who purchase products marketed by
those entities.
For the reasons stated previously and under the Regulatory
Flexibility Act (5 U.S.C. 605(b)), FDA certifies that this final rule
will not have a significant economic impact on a substantial number of
small entities.
[[Page 69280]]
IV. Paperwork Reduction Act of 1995
FDA concludes that the labeling requirement in this document is not
subject to review by the Office of Management and Budget because it
does not constitute a ``collection of information'' under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Rather, the labeling
statements are a ``public disclosure of information originally supplied
by the Federal government to the recipient for the purpose of
disclosure to the public'' (5 CFR 1320.3(c)(2)).
V. Environmental Impact
FDA has determined under 21 CFR 25.31(a) 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. Federalism
FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, the agency has concluded
that the rule does not contain policies that have federalism
implications as defined in the Executive order and, consequently, a
federalism summary impact statement is not required.
List of Subjects in 21 CFR Part 201
Drugs, Labeling, Reporting and recordkeeping requirements.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
201 is amended as follows:
PART 201--LABELING
0
1. The authority citation for 21 CFR part 201 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 358, 360,
360b, 360gg-360ss, 371, 374, 379e; 42 U.S.C. 216, 241, 262, 264.
0
2. Section 201.64 is amended by adding paragraph (k) to read as
follows:
Sec. 201.64 Sodium labeling.
* * * * *
(k) The labeling of OTC drug products intended for rectal
administration containing dibasic sodium phosphate and/or monobasic
sodium phosphate shall contain the sodium content per delivered dose if
the sodium content is 5 milligrams or more. The sodium content shall be
expressed in milligrams or grams. If less than 1 gram, milligrams
should be used. The sodium content shall be rounded-off to the nearest
whole number if expressed in milligrams (or nearest tenth of a gram if
expressed in grams). The sodium content per delivered dose shall follow
the heading ``Other information'' as stated in Sec. 201.66(c)(7). Any
product subject to this paragraph that contains dibasic sodium
phosphate and/or monobasic sodium phosphate as an active ingredient
intended for rectal administration and that is not labeled as required
by this paragraph and that is initially introduced or initially
delivered for introduction into interstate commerce after November 29,
2005, is misbranded under sections 201(n) and 502(a) and (f) of the
act.
Dated: November 18, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-26269 Filed 11-26-04; 8:45 am]
BILLING CODE 4160-01-S