[Federal Register Volume 59, Number 62 (Thursday, March 31, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-7632]
[[Page Unknown]]
[Federal Register: March 31, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 5, 101, 105, and 130
[Docket No. 94N-0103]
RIN 0905-AD08 and 0905-AB68
Food Labeling; Date of Application
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is clarifying matters
regarding the interpretation of the ``date of applicability'' for the
regulations governing mandatory nutrition labeling of food products.
The agency reaffirms that a product labeled after May 8, 1994, that
does not comply with the mandatory nutrition labeling and nutrient
content claims provisions of the Federal Food, Drug, and Cosmetic Act
(the act), which were added by the Nutrition Labeling and Education Act
of 1990 (the 1990 amendments), is misbranded. Also, the agency states
that no further extension to the date of applicability is possible
under the act.
DATES: FDA will apply section 403(q) and 403(r)(2) of the act (21
U.S.C. 343(q) and 343(r)(2)) and the regulations that implement this
section of the act (21 CFR 101.9 implements section 403(q) except
403(q)(4) of the act; 21 CFR 101.13, subpart D of 21 CFR part 101, and
21 CFR 130.10 implement section 403(r)(2) of the act) on May 8, 1994,
for all products labeled on or after that date.
FOR FURTHER INFORMATION CONTACT: F. Edward Scarbrough, Center for Food
Safety and Nutrition (HFS-150), Food and Drug Administration, 200 C St.
SW., Washington, DC 20204, 202-205-4561.
SUPPLEMENTARY INFORMATION: FDA is announcing that May 8, 1994, is the
date of application for the regulations governing the mandatory status
of nutrition labeling and nutrient content claims. In the Federal
Register of August 18, 1993 (58 FR 44033), the agency stated that, ``*
* * the date, May 8, 1994, * * * will apply to all food products
labeled on or after May 8, 1994, rather than to all food products
initially introduced into interstate commerce on or after that date.''
The Nutrition Labeling and Education Act of 1990 (the 1990 amendments),
the amendments to the act that provided the explicit authority for
these regulations, does not permit the agency to establish a later date
of application. In fact, the May 8, 1994, date already represents
agency exercise of the maximum flexibility provided to it by Congress
in the 1990 amendments. Without an explicit FDA finding that undue
economic hardships would result, the date of application of the
regulations would have been May 8, 1993 (58 FR 2070). Therefore,
nonexempt products labeled on or after May 8, 1994, and not bearing
required nutrition labeling will be out of compliance with the act.
Recently, two issues have been brought to the agency's attention:
1. In the Federal Register of August 18, 1993 (58 FR 44033 at
44035), the agency stated ``The term `labeled' means the date that the
label is affixed to the product or product container.'' It has been
reported that there are some in the food industry who are interpreting
this sentence as permitting the manufacture of food product containers
bearing labels in conformance with existing regulations and then
warehousing the finished containers to be filled with food products
after the May 8, 1994, date of application. Under this scenario, a
manufacturer could stockpile huge quantities of empty containers and
avoid changing labels for weeks or even months.
This view is a complete misreading of the August 18, 1993,
document. FDA included the term ``or product container'' in the
sentence in question to ensure that the sentence covered situations in
which food is labeled by affixing a label to the container in which it
is enclosed, as well as those in which the label is affixed to the
food. The sentence was not included to provide a means of avoiding the
May 8, 1994, applicability date.
The agency expects that all products coming off a manufacturer's
production line on May 8, 1994, after 12:01 a.m. will bear the required
nutrition labeling, whether the food is directly labeled or put into
containers. FDA inspectors will be instructed to examine the product as
it leaves the production line. Any manufacturer who is filling
improperly labeled containers will not be in compliance with the act.
2. Recently, the agency has received a number of requests from a
variety of manufacturers asking for extensions of time to comply with,
or even for exemptions from, the nutrition labeling regulations. Many
of these requests cite potentially significant monetary losses because
large quantities of label inventory must be destroyed. Others state
that they will be unable to comply with the regulations because they
have been unable to obtain necessary nutrient values, or because
printing facilities have become saturated.
As stated previously in the document, FDA has no authority to grant
exemptions from nutrition labeling beyond those in the act and provided
for in the agency's regulations. Also, FDA cannot further delay the
date of applicability beyond May 8, 1994, regardless of the economic
hardships on the specific manufacturer. The agency further points out
that the labeling in question is required nutrition information that
both Congress and FDA consider important to the public health. The food
industry has known since November 8, 1990, that such labeling would be
required and, thus, has had over 3 years to plan for this transition.
Additionally, even if FDA were able to grant extensions, the agency
would question the fairness to the large segment of the food industry
that has already invested the time and expense of converting its food
labels in order to meet the May 8, 1994, date of applicability.
FDA recognizes that there may be a very small number of firms that
will be unable to come into compliance despite all good faith efforts
to do so. While FDA is not unwilling to consider the extraordinary
circumstances presented by these few firms, the agency advises
generally that a nonexempt product failing to bear nutrition labeling
or bearing nutrition information inconsistent with the regulations of
January 6, 1993, as modified on August 18, 1993, will be out of
compliance if labeled on or after May 8, 1994.
FDA has received reports of firms that have a significant supply of
containers or labels that will not be used up by the May 8, 1994,
applicability date. The agency points out that such firms need not
dispose of such containers or labels but can use them if they can be
brought into compliance through the use of stickers that comply with
the new regulations placed on the noncomplying container or label. In
no case, however, can FDA grant an exemption in these circumstances.
Thus, FDA will not be issuing letters of exemption or extensions to
the mandatory nutrition labeling regulations beyond those confirming
exemptions or extensions formally recognized under the act or provided
for under 21 CFR 101.9(g)(9) because compliance is technologically
infeasible or impracticable.
The agency reaffirms that a product labeled after May 8, 1994, that
does not comply with section 403(q) and 403(r)(2) of the the act is
misbranded. Also, the agency states that no further extension to the
date of applicability is possible under the act.
Dated: March 25, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-7632 Filed 3-28-94; 1:49 pm]
BILLING CODE 4160-01-F