Uniform Compliance Date for Food Regulations

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