[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