[Federal Register Volume 62, Number 184 (Tuesday, September 23, 1997)]
[Rules and Regulations]
[Pages 49881-49883]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-24731]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Chapter I
[Docket No. 96N-0094]
Uniform Compliance Date for Food Regulations
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; response to comments.
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SUMMARY: The Food and Drug Administration (FDA) is responding to
comments that were submitted in response to a final rule establishing
January 1, 2000, as the uniform compliance date for food labeling
regulations that the agency issues between January 1, 1997, and
December 31, 1998. FDA received three comments in response to that
final rule. The agency is not making any changes in the final rule in
response to these comments. January 1, 2000, remains the uniform
compliance date for food labeling regulations that are issued between
January 1, 1997, and December 31, 1998.
EFFECTIVE DATE: December 27, 1996.
FOR FURTHER INFORMATION CONTACT: Gerad L. McCowin, Center for Food
Safety and Applied Nutrition (HFS-150), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-4561.
SUPPLEMENTARY INFORMATION:
I. Background
FDA has periodically announced uniform compliance dates for new
food labeling requirements to minimize the economic impact of label
changes. In 1992, FDA suspended this practice pending the issuance of
regulations implementing the Nutrition Labeling and Education Act of
1990 (the 1990 amendments). In the Federal Register of December 24,
1996 (61 FR 67710), FDA issued a final rule (hereinafter referred to as
the December 24, 1996, final rule) establishing January 1, 1998, as its
new uniform compliance date for all food labeling regulations that are
issued after its publication and before January 1, 1997. FDA announced
that it was reinstating its previous practice of periodically
announcing, as final rules, uniform compliance dates for food labeling
regulations. In the Federal Register of December 27, 1996 (61 FR 68145)
(hereinafter referred to as the December 27, 1996, final rule), FDA
established January 1, 2000, as the uniform compliance date for food
labeling regulations that are issued between January 1, 1997, and
December 31, 1998. Because FDA had already provided notice and
opportunity for comment on the practice of establishing uniform
compliance dates by issuance of a final rule announcing the date (see
61 FR 67710, December 24, 1996), the agency found any further
rulemaking unnecessary. Nonetheless, under 21 CFR 10.40(e)(1), FDA
provided an opportunity until March 13, 1997, for interested persons to
comment on whether the uniform compliance date of January 1, 2000,
should be modified or revoked. In the December 27, 1996, final rule,
FDA advised that it would publish a notice setting out the agency's
conclusions concerning any comments that it received in response to the
final rule or initiate notice and comment rulemaking to modify or
revoke the uniform compliance date that the final rule established.
FDA received three letters, each containing one or more comments,
from trade associations in response to the December 27, 1996, final
rule. A summary of these comments and the
[[Page 49882]]
agency's responses are provided as follows:
II. Comments
A. Dietary Supplements
One of the comments asked the agency to confirm that the final rule
for a uniform compliance date of January 1, 2000, will apply to the
proposed regulations for dietary supplement labels that FDA published
in the Federal Register of December 28, 1995 (60 FR 67176 and 67194).
The comment noted that the December 28, 1995, proposals specified a
compliance date of December 31, 1996, and that obviously that date had
come and gone and the final regulations had yet to be issued. The
comment agreed with FDA's statements concerning the use of a uniform
compliance date and stated that the uniform compliance date of January
1, 2000, should be applied to the final rule issued in response to the
December 28, 1995, proposed regulations concerning dietary supplements.
The comment explained that the dietary supplement labeling regulations
will have a massive impact on the entire industry. It stated that every
single dietary supplement label will need to be revised, and that many
products that do not currently bear nutrition labeling will be required
to do so. The comment concluded that, based on the passage of time and
the need for the industry to have adequate time to reprint and replace
label stock, the uniform compliance date of January 1, 2000, is the
appropriate effective date for the final labeling regulations for
dietary supplements.
As stated in the December 27, 1996, final rule, ``The new uniform
compliance date will apply only to final FDA food labeling regulations
that require changes in the labeling of food products and that publish
after January 1, 1997, and before January 1, 1999'' (61 FR 68145). The
Dietary Supplement Health and Education Act of 1994 (DSHEA) amended the
Federal Food, Drug, and Cosmetic Act (the act) to establish a new
definition for ``dietary supplement'' in section 201(ff) of the act (21
U.S.C. 321(ff)). The last sentence of section 201(ff) of the act
states, ``Except for purposes of section 201(g), a dietary supplement
shall be deemed to be a food within the meaning of this Act.''
Therefore, the agency confirms that the uniform compliance date will
generally apply to regulations that establish requirements for the
labeling of dietary supplements.
In the December 27, 1996, final rule (61 FR 68145 at 68146),
however, FDA advised that if any food labeling regulation, including
one concerning dietary supplements, involves special circumstances that
justify a compliance date other than January 1, 2000, the agency will
determine for that regulation an appropriate compliance date and will
specify that compliance date in the final rule that resolves the
proceeding. Elsewhere in this issue of the Federal Register, FDA is
publishing final rules in response to proposals on dietary supplements
that it published in the Federal Register of December 28, 1995. As
discussed in those final rules, FDA has concluded that a compliance
date of March 23, 1999, is responsive to the directives of DSHEA, and
that extending the compliance date to January 1, 2000, for those final
rules would not be appropriate. Therefore, FDA is adopting March 23,
1999, as the effective date for the final regulations for the labeling
of dietary supplements, rather than January 1, 2000.
B. Bakery Industry
Although two letters from trade associations for the bakery
industry agreed with the concept of a uniform compliance date, these
letters disagreed with establishing January 1, 2000, as the uniform
compliance date for regulations issued between January 1, 1997, and
December 31, 1998. One comment stated that the uniform compliance date
of January 1, 1998, should be extended to January 1, 1999, and that the
uniform compliance date of January 1, 2000, should be extended to
January 1, 2001. The comment stated that this extra year would allow
firms to do laboratory analyses-reformulations, use existing inventory,
and release new products and packaging to consumers. The comment
explained that it is hard to foresee what types of new final
regulations will materialize by December 31, 1998, and that 2 years
would not be sufficient time for all of the changes needed. The comment
suggested that all future uniform compliance dates allow a 3-year
timeframe to make changes. The comment stated that, while some types of
labeling changes may be more swiftly implemented than others, FDA
should consider the more complicated cases like folic acid in
establishing these dates.
The second comment stated that a compliance period of 1 year is not
sufficient for the small and medium, mostly family owned, wholesale
bakers that it represents to implement labeling changes in a manner
that would minimize economic impact. The comment stated that the least
amount of time needed for bakers to efficiently and effectively
implement new labeling regulations would be 24 months. The comment
expressed its concern that the rule would constrict a company's method
of implementing FDA's rules, particularly for slow selling items, where
labels are ordered for an extended length of time.
These two comments raise concerns similar to some that were raised
in response to the uniform compliance date proposal of April 15, 1996
(61 FR 16422), and that were addressed in the December 24, 1996, final
rule. In that proceeding, there were comments that objected to
establishing January 1, 1998, as the uniform compliance date for food
labeling regulations issued between January 1, 1995, and December 31,
1996, on the grounds that it resulted in a ``compliance period'' that
at its shortest possible length would be only 12 months long. FDA
disagreed with those comments, stating that a compliance period that is
18 months or 2 years at its shortest is too long. The agency pointed
out that it must consider the costs and benefits to both the food
producer and the consumer (61 FR 67710). A compliance period of 6
months would increase the benefit to the consumer but would result in
even greater costs to the food producers than are caused by a
compliance period of 12 months. Although a lengthier compliance period
would reduce the costs to food producers, it would delay implementation
of the labeling changes, thus decreasing the value of any benefits to
the consumer.
As the agency pointed out in the December 24, 1996, final rule, the
minimum compliance period of 1 year is the same compliance period that
it has used for all of its uniform effective date final rules dating
back to the 1970's, until it issued the labeling regulations that
implemented the 1990 amendments. The agency is unaware of, nor has
anyone submitted, including in the comments in this proceeding, any
information to demonstrate any problems with respect to bringing labels
into compliance with the various uniform effective dates that it had
established over the period of approximately 20 years during which it
has announced uniform compliance dates. While there have been instances
where the agency has granted extensions beyond the uniform compliance
date, generally firms have come into compliance with little complaint
to the agency. The agency is merely reinstating its former practice.
The agency concludes that the comments on the December 27, 1996,
final rule do not provide a basis on which to initiate rulemaking to
revoke or modify the uniform compliance date
[[Page 49883]]
established therein. Therefore, FDA confirms that January 1, 2000, will
be the uniform compliance date for food labeling regulations issued
between January 1, 1997, and December 31, 1998.
Dated: September 11, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-24731 Filed 9-22-97; 8:45 am]
BILLING CODE 4160-01-F
