Federal Register
                                Vol. 59, No. 2
                           Tuesday, January 4, 1994
                            Rules and Regulations

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration 21 CFR Part 101

[Docket No. 93NÄ0478]

RIN O905ÄADO8 and O905ÄAB68

Dietary Supplements; Establishment of Date of Application

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug Administration (FDA) is publishing this final rule
to establish July 1, 1995, as the date on which it will apply the mandatory
nutrition labeling and nutrient content claims provisions of the Federal Food,
Drug, and Cosmetic Act (the act) to dietary supplements of vitamins, minerals,
herbs, and other similar nutritional substances (hereinafter referred to as
dietary supplements). This action is in accordance with the Dietary Supplement
Act of 1992 (the DS act) and the Nutrition Labeling and Education Act of 1990
(the 1990 amendments), which allows the Secretary of Health and Human Services
(the Secretary) (and, by delegation, FDA) to delay, for up to 1 year, the date
on which FDA applies those provisions to foods (including dietary supplements)
if the agency finds that compliance with them would cause "undue economic
hardship.''

EFFECTIVE DATE: July 1, 1995.

FOR FURTHER INFORMATION CONTACT: Laina M. Bush, Center for Food Safety and
Applied Nutrition (HFSÄ726), Food and Drug Administration, 200 C St. SW.,
Washington, DC 20204, 202Ä205Ä5271.

SUPPLEMENTARY INFORMATION:

I. Background

On November 8, 1990, President Bush signed into law the 1990 amendments (Pub.
L. 101Ä535). This statute adds to the Federal Food, Drug, and Cosmetic Act
(the act) among other sections, section 403(q) (21 U.S.C. 343(q)), which makes
nutrition labeling mandatory for most foods, and section 403(r)(2) (21 U.S.C.
343(r)(2)), which gives FDA authority to define nutrient content claims.

In accordance with the 1990 amendments, FDA published proposed rules on
November 27, 1991 (56 FR 60366 et seq.), and final rules on January 6, 1993
(58 FR 2066 et seq.) implementing, among other things, the sections of the act
on mandatory nutrition labeling and nutrient content claims, among other
things, for foods in conventional food form. Because of the DS act, the final
regulations did not include provisions on the nutrition labeling of, or
nutrient content claims for, dietary supplements.

The DS act (Pub. L. 102Ä571) was signed into law on October 6, 1992. In
section 202(a)(1), the DS act established a moratorium until December 15,
1993, on the implementation of the 1990 amendments with respect to dietary
supplements that are not in the form of conventional food. Section 202(a)(2)
of the DS act required the Secretary (and, by delegation, FDA) to issue new
proposed regulations that are applicable to dietary supplements no later than
June 15, 1993, and final regulations by December 31, 1993. On June 18, 1993,
FDA issued proposed regulations in response to this provision of the DS act
(58 FR 33700 et seq.). Elsewhere in this issue of the Federal Register, FDA is
issuing the final rules.

Under section 10(a)(1)(A) and (B) of the 1990 amendments (21 U.S.C. 343 note),
section 403(q) and (r)(2) of the act are effective 6 months after the
promulgation of final regulations or after the date that proposed regulations
are considered to be final regulations. Thus, because the final regulations on
the nutrition labeling of, and nutrient content claims for, dietary
supplements are being issued on January 4, 1994, section 403(q) and 403(r)(2)
will be effective with respect to dietary supplements July 5, 1994. However,
section 10(a)(3)(B) of the 1990 amendments provides that if the Secretary and,
by delegation, FDA      " * * * finds that compliance with sections 403(q) and
403(r)(2) of such Act would cause an undue economic hardship, the Secretary
may delay the application of such sections for no more than one year.''

FDA found such "undue economic hardship'' existed for the conventional food
industry in a final rule published on January 6, 1993 (58 FR 2070), entitled
"Food Labeling: Establishment of Date of Application'' (hereinafter called the
date of application final rule). In that document, FDA delayed the application
of section 403(q) and (r)(2) for 1 year, until May 8, 1994.

In the proposed rules on nutrition labeling (58 FR 33715 at 33725) and
nutrient content claims (58 FR 33731 at 33748) for dietary supplements, FDA
asked for comment on whether a similar delay in application of section 403(q)
and (r)(2) would be appropriate for dietary supplements. The agency gave
interested persons until August 17, 1993, to comment on whether the 6-month
proposed compliance date would cause "undue economic hardship.'' FDA received
approximately 2,000 letters of which approximately one-third contain one or
more comments concerning either the date of application or other economic
issues from consumers, consumer advocacy organizations, health care
professionals, professional societies, universities, manufacturers,
distributors, retailers, trade associations, and State governments. A
discussion of the agency's decision, and a summary of the comments, concerning
the delay of the date of application and other economic issues and the agency
responses follow.

II. Undue Economic Hardship

A. Comments

Several comments requested that FDA extend the date that the nutrition
labeling and nutrient content claim provisions of the act will be applied to
dietary supplements. Most comments requested an additional year, for a total
compliance period of 18 months. One comment proposed a delay of at least 9
months. The comments reported many examples of the difficulties in meeting a
6-month compliance period. Several comments stated that the amount of time
needed to redesign labels would far exceed the resources available. One
comment reported that the insufficient time allowed to revise labels would
result in some products being removed from the market temporarily while new
labels are being prepared. An additional comment requested the extension
because of the difficulties in the logistics of revising existing labels,
printing, packaging, and exhausting existing label supplies with a short
compliance period.

Other comments that requested a delay cited the savings that could be gained
with insignificant loss of benefits. One comment reported that inventory
disposal could be reduced by 85 percent with an 18-month compliance period.
Another comment stated that FDA's cost estimate of $20 million represents 1
percent of industry sales but a much larger percentage of industry profits.
The comment explained that extending the compliance period would reduce the
costs of compliance and, therefore, minimize any reduction in profits.

One comment requested a delay because there will be additional costs for
compliance with the upcoming United States Pharmacopoeia (USP) standards. The
comment stated that resources could be better spent if these compliance
efforts were completed concurrently rather than consecutively.

One comment requested a delay because of the overlap with the final months of
the extended period that was allowed for foods in conventional food form. The
comment reported that many conventional food manufacturers and their label
suppliers are rushing to produce final labels for such foods. The comment said
that supplement manufacturers will not be able to secure revised labels for
their products from label manufacturers in time to meet a 6-month deadline
because of the competition for label manufacturers' resources.

The agency agrees that it will be difficult for dietary supplement
manufacturers to comply within 6 months, especially in light of the fact that
label suppliers are currently stressed with label orders from manufacturers of
food in conventional food form who are attempting to meet the May 1994
deadline for complying with the 1990 amendments. The agency also agrees that
an extension of the date of application would result in significant savings
for the industry. Administrative costs, printing costs, and label inventory
disposal costs are all dependent on the length of the compliance period. The
agency has determined that the costs of the regulations could be reduced with
an extension.

The agency made a determination in the date of application final rule that the
1990 amendments will result in an undue economic hardship on manufacturers of
food products in conventional food form (58 FR 2070 at 2075). The agency notes
that the costs of compliance for manufacturers of foods in conventional food
form represent less than 1 percent of sales. The costs of compliance with a
6-month compliance period for dietary supplements is approximately 2 percent
of sales. Therefore, if the agency does not extend the date of application for
dietary supplement manufacturers, that segment of the food industry will be
asked to bear higher relative costs than the agency determined were reasonable
for foods in conventional food form.

For all these reasons, the agency determines that the congressionally mandated
date of application will result in an undue economic hardship for dietary
supplement manufacturers.

B. The Agency's Determination of a Date of Application of Section 403(q) and
(r)(2) of the Act as Applied to Dietary Supplements

The agency has determined that undue economic hardship will result if the
dietary supplement industry is required to comply with section 403(q) and (r)
of the act within 6 months. As will be shown in the following discussion on
the economic impact, a 6-month delay (total of 12 months to comply) in the
application of section 403(q) and (r)(2) to dietary supplements would result
in over 40 percent savings of compliance cost, and a 12-month delay (total of
18 months to comply) would result in over 50 percent savings. Given the large
disparity in costs of compliance for manufacturers of dietary supplements if
they are required to comply in 6 months, as compared to those that are being
borne by manufacturers of food in conventional form, FDA finds that it should
tailor the delay to reduce the costs for dietary supplement manufacturers and
thus to minimize the disparity. Therefore, the agency concludes that it is
appropriate to delay the application date for dietary supplements for 12
months, as it did for foods in conventional food form. Thus, the agency
intends to apply section 403(q) and (r)(2) to foods labeled after July 1,
1995. The agency fully expects that some dietary supplement firms will be able
to comply before this date once the pressure on printing labels for foods in
conventional food form is eased after May 8, 1994. Therefore, consumers can
expect to begin enjoying the health benefits of the label changes prior to
July 1, 1995.

III. Economic Impact

Some comments agreed with the agency's estimates of the costs of relabeling.
Many comments were directed at issues covered by the advance notice of
proposed rulemaking (ANPRM), which addressed the safe use of dietary
supplements (58 FR 33690, June 18, 1993). Several comments stated that the
three proposals that the agency issued (there was a proposed rule on health
claims (58 FR 33700 in addition to the proposals on nutrition labeling and
nutrient content claims)) and the ANPRM should be considered one proposal.
These comments stated that the economic impact of the four documents would
exceed $100 million and would be considered a major rule under Executive Order
12291.

The agency disagrees. Executive Order 12291 did not apply to advance notices.
Therefore, no analysis of that document was required by that Executive Order.
(FDA has not taken any action with respect to the ANPRM that would make it
subject to Executive Order 12866). The three proposals are concerned with the
labeling of dietary supplements, while the ANPRM is concerned with other
issues. Thus, the costs and benefits associated with regulatory alternatives
described in the ANPRM can be separated from those resulting from the three
proposals on labeling actions. The agency has evaluated the labeling actions
together, however, because it is not possible to separate the impacts of the
various labeling actions. Finally, FDA is taking no further action with
respect to the ANPRM at this time.

A. Scope

1. Several comments objected to the agency's estimate of the number of
products that will be affected by the nutrition labeling and nutrient content
claims rulemakings. Two comments stated that there are 25,000 products that
are potentially affected by the rules, rather than the agency's estimate of
5,000 products. Another comment stated that there are approximately 25,000
herbal products alone that would be required to be tested and relabeled.
Another comment objected to the agency's estimate because the agency failed to
include amino acids, herbal products, and other dietary supplements that have
no recognizable food function.

In its analysis of the proposals, FDA stated that there could be as many as
25,000 products that could be considered to be dietary supplements. The agency
reduced that number to 5,000, an estimate of the number of vitamin and mineral
supplement products, because: (1) Many products that contain herbs or other
similar nutritional substances would not be subject to the nutrition label
requirements because they do not contain the nutrients that must be declared,
and (2) some products marketed as dietary supplements would be unaffected by
the 1990 amendments because they bear drug claims that make them subject to
the drug provisions of the act. For these reasons, it is clear that not all
25,000 products would be required to be tested or relabeled in response to the
regulations implementing the 1990 amendments.

However, FDA is convinced by the comments that some herbal products and other
dietary supplements might need to be tested and relabeled as a result of these
regulations. FDA is unable to determine exactly how many of those products
would be covered by the food provisions of the act rather than by the drug
provisions. Therefore, the agency's final analysis of the rules is based on a
range of products between 5,000 and 25,000.

2. Several comments objected to the agency's estimate that approximately 150
firms will be affected by the regulations. Some comments stated that
approximately 500 firms would be affected by the proposed rules if made final.
Another comment stated that 250 herb manufacturers and 150 manufacturers of
dietary supplements of vitamins and minerals would be affected. Another
comment objected to the agency's source for the number of firms. The comment
explained that Dunn and Bradstreet's Electronic Yellow Pages is primarily a
listing for public companies, and the majority of supplement manufacturers are
privately-held corporations. The comment suggested that conservative estimates
suggest that there are a minimum of 150 herb companies alone.

The agency has confirmed that the Electronic Yellow Pages covers both public
and private organizations of all types and sizes. The agency admits that the
Electronic Yellow Pages is not a perfect source for the number of firms, but
FDA believes that it is not entirely inadequate. The major difference between
the agency's estimate and those of the comments is the inclusion or exclusion
of manufacturers herbal products and products containing other similar
nutritional substances. As stated in the response to the previous comment, the
agency has determined that at least some of these types of dietary supplement
products may be subject to the nutrition labeling provisions. However, because
many of these products do not contain significant amounts of nutrients, many
manufacturers will not be faced with the necessity of relabeling their
products. For these reasons, the agency believes that its estimate of the
number of firms may be low, but that to include all herbal products
manufacturers and manufacturers of other similar nutritional substances would
inflate the estimate. However, the agency has no basis on which to arrive at
the actual number of firms. Therefore, in its final analysis, the agency is
estimating the total number of firms affected to be between 150 and 300.

B. Costs

3. Several comments disagreed with the agency's estimate of administrative
costs. The comments stated that actual administrative expenses would be at
least $1,000 per label. Administrative expenses, according to the comments,
are associated with the creation or redesign, proofreading, legal review,
pricing, bid review, and retraining of customer service and sales staff. One
comment estimates that administrative costs to one firm would be 80 to 120
hours of executive time, or approximately $2,500 to $3,750.

FDA recognizes that the factors that determine administrative costs are very
complicated. The agency's estimates of administrative costs are based on a
compliance cost model for food labeling created for FDA by Research Triangle
Institute (RTI) (Ref. 1). According to RTI, many firms estimate that
administrative effort would be twice as high for a 6-month compliance period
as for a 12-month compliance period. In the dietary supplement proposals, FDA
estimated that for a 6-month compliance period, manufacturers of dietary
supplements will incur administrative costs of $850 per firm. The range of
administrative cost estimates submitted in the comments was broad and there
were no identifiable patterns to the estimates given. Although FDA
acknowledges that its assumptions may have resulted in underestimates, the
comments did not provide enough detailed information to permit FDA to evaluate
the administrative cost estimates that they submitted. Therefore, the agency
is not altering its original estimates based on these comments.

The agency has determined that total administrative costs for a 6-month
compliance period are between $130,000 and $250,000, depending on the exact
number of firms affected by the regulations. As determined by the contractor's
study (Ref. 1), administrative costs are lower with longer compliance periods.
A 1-year compliance period results in administrative costs of between $65,000
and $125,000. An 18-month compliance period results in administrative costs of
between $50,000 and $94,000.

4. One comment stated that the requirement that herbal dietary supplements be
required to bear nutrition labeling would mandate that all herbal products be
assayed for their nutrient content. The comment further explained that testing
for 12 nutrients would cost $588 per product for a total of $15 million for
25,000 products.

The agency agrees that to the extent that herbal product manufacturers will
provide nutrition labeling, herbal products will need to be assayed for their
nutrient content. The agency notes, however, that many herbs do not contain
significant amounts of the nutrients that must be listed in the nutrition
label, and that this fact is determinable from reference works without
testing. Thus, these herbs will not need to be tested. Many comments admitted
that, in general, herbal products do not contain significant amounts of
nutrients and are not consumed for their nutrient content. However, some
herbal products and combination products will require nutrient testing.

In the proposals, the agency assumed that dietary supplements of vitamins and
minerals will not undergo any additional testing as a result of the nutrition
labeling requirements. Comments did not object to this assumption. Therefore,
in its final analysis, the agency is estimating that as many as 20,000
products may undergo testing once every 5 years for a total discounted
analytical cost over the next 20 years of $33 million (7 percent discount
rate).

5. One comment agreed, and several comments disagreed, with the agency's
estimate of label printing and redesign costs. The comments that disagreed
stated that printing and redesign costs would be at least $800 to $1,200 per
label. One comment stated that the cost of redesigning and printing each label
would be 2 hours of desktop redesign, $20 for linotronic service, and $600 for
new plates, for a total of $750 per label.

One comment objected to FDA's assumption that label revisions for supplements
are less comprehensive than revisions for foods in conventional food form. The
comment states that incorporating the "Nutrition Facts'' section plus the
ingredient list will necessitate complete redistribution of information on
many labels.

In the analysis of the proposed rules, the agency estimated that, for a
6-month compliance period, printing and redesign costs would be approximately
$1,000 per label. The comments do not suggest that the agency's estimate is
incorrect. Therefore, the agency's final analysis of printing costs is based
on a per label cost of $1,000 for each of between 15,000 and 75,000 labels, or
between $15 million and $75 million. According to the RTI study, the length of
the compliance period determines a firm's ability to combine planned label
changes with mandated changes. Therefore, incremental labeling and redesign
activities are less costly with lengthier compliance periods. If the agency
extended the compliance period by only 6 months, printing and redesign costs
would be between $7.5 million and $37.5 million. The 1-year extension that the
agency is providing will reduce printing and redesign costs to between $6
million and $28 million.

6. Several comments provided data on label inventories that would be subject
to disposal. These comments stated that a 4- to 6-month supply of product
labels is common, resulting in $3.4 million to $5.1 million of label inventory
that will be discarded. Another comment suggested that its dietary supplement
label and box inventory disposal costs would be $325,000 with a 6-month
compliance period, $200,000 with a 1-year compliance period, and $50,000 with
an 18-month compliance period. One comment estimated the cost of discarding
noncompliant labels would be approximately $30,000 for one firm.

The estimates provided by the comments are in line with the agency's
preliminary estimate of label inventory disposal costs. Therefore, the agency
is not changing its estimate based on the comments. The cost of label
inventory disposal for a 6-month compliance period is between $5 million and
$25 million, depending on the number of products affected. According to the
RTI study and comments, lengthier compliance periods allow firms to use up
more existing label supplies, thus reducing inventory disposal costs.
According to data submitted in response to the Regulatory Impact Analysis
document that was published in the Federal Register of November 27, 1991 (56
FR 60366), and adjusted to reflect the range of products affected, if the
agency had extended the compliance period for an additional 6 months,
inventory disposal costs would be between $3 million and $13 million. The
18-month compliance period that the agency is providing will result in costs
of between $2 million and $9 million.

7. Several comments disagreed with the agency's estimate of the cost of
inventory disposal. The comments argued that firms would dispose of finished
product in addition to labels. The comments stated that typical product costs
for dietary supplements would result in an inventory value for the disposal of
5,000 products of between $48 million and $73 million. One firm estimated its
own cost of discarding noncompliant inventory would be approximately 30
percent of finished goods inventory, or about $45,000.

Because these proposals cover only the labeling of dietary supplements, the
agency does not agree that there would be any reason for firms to dispose of
any product inventory. Nor did the comments provide an explanation as to why
it would be necessary to do so. Moreover, any product packaged and labeled in
accordance with law before the date that FDA begins to apply the section
403(q) and (r) of the act will not need to be relabeled. Therefore, the agency
is not changing its estimate based on this comment.

8. Several comments argued that the agency failed to consider the cost of
discarding and redesigning catalogs, product literature, and advertising. The
comments suggested that these costs would be at least $40,000 per firm, or $20
million for all firms.

The comments did not provide an explanation as to why it would be necessary to
discard and redesign catalogs and product literature. The agency does agree
that, to the extent that these materials are labeling, they must comply with
the nutrient content and health claims provisions of the act.

However, the agency believes that many of the claims made in these types of
materials are drug claims or structure-function claims, not health claims, and
therefore are not subject to these rules. The comments did not present
evidence to support a different finding. Consequently, the agency has no basis
on which to conclude that extensive catalog and product literature redesign
will be required by these final rules. Therefore, the agency is not changing
its estimate based on these comments.

9. Several comments argued that the agency failed to consider the cost of
relabeling of product returned from the retailer. The comments stated that it
is common practice in the supplement industry to accept returns from retailers
in the event of a label change. Industry firms would be faced with a number of
products returned from retailers unwilling to carry products with older
labels. The comments estimated the cost of processing returns, disposing of
product, and applying for full credit at $48 million.

Any product labeled before the applicability date will not need to comply with
the new nutrition labeling and nutrient content claim provisions. Therefore,
no product that is labeled in accordance with law before July 1, 1995, need be
returned, relabeled, or destroyed as a result of these new provisions.
However, FDA agrees that to the extent that product is returned, the cost of
disposing of product returned from retailers because of "old'' labeling should
be considered a cost of these regulations. However, the agency is unpersuaded
of the magnitude of the cost and is unsure of the extent to which "old''
product will be returned. The comments provided insufficient information with
which the agency could estimate these costs. Therefore, the agency is not
changing its estimates based on this comment.

10. Several comments expressed concern that the rules may cause the loss of
many thousands of jobs, the closing of many firms, and the loss of products
from the marketplace. According to one comment, the proposed rules would cause
the loss of more than $10 million in sales and as many as 100 jobs in one
company. Another comment stated a belief that 2 million Americans will lose
their jobs as a result of the regulations. The comments did not provide any
specific information as to how the regulations would cause the loss of jobs
and products.

The agency agrees that the inability to make certain nutrient content or
health claims may reduce the marketability of certain products and perhaps
lead to a company's decision to remove a product from the marketplace.
However, these rules affect only labeling; they do not require any supplement
to be removed from the market. Moreover, the agency does not believe that many
products are currently making health claims, as distinguished from drug claims
or structure-function claims. Therefore, the agency has no basis to find that
these regulations will cause the problems described in these comments. The
agency believes that there is every reason to expect that the continued
marketing of the vast majority of dietary supplement products will be
unaffected by these regulations.

11. In the analysis of the proposed rules, the agency recognized that the
rules could have an adverse impact on small businesses. Most of the costs
associated with labeling regulations are fixed costs, which are typically more
burdensome for small firms than for large firms because of the smaller sales
base on which to spread costs.

One comment stated that the small business exemption was inadequate because
small firms would not be able to avoid complying with the regulations because
of competitive pressure. Another comment stated that the proposals would be
catastrophic to small business owners and workers.

FDA notes that the Nutrition Labeling and Education Act Amendments of 1993,
which were enacted on August 13, 1993, provide relief for small businesses
from the requirements of section 403(q) of the act. The agency believes that
the new exemption for small businesses will significantly mitigate any
negative impact on small firms.

12. One comment stated that the proposed rule regarding health claims will
cause pain, suffering, and death that would not occur were labeling and
advertising allowed to include health claims. The comment was unspecific as to
why these results would occur.

If the absence of health claims causes pain, suffering, or death, these
regulations provide any party with a vehicle for submitting data to support a
particular health claim for agency review. Therefore, the agency does not
agree with this comment.

C. Benefits

13. One comment stated that the regulations will provide benefits by
preventing consumers from wasting money on unnecessary and ineffective dietary
supplements. Another comment stated that if someone wanted to waste a little
money taking too many vitamins or supplements in the hope of avoiding serious
illness and the need for harsh drugs, they should be allowed to do so.

Because there are sources other than labeling that provide information about
the potential uses of dietary supplements, the agency believes that limiting
the use of claims on labels or labeling will be of limited effect in
preventing consumers from purchasing supplements that they erroneously believe
will prevent serious illness. However, these regulations will ensure that the
labels of dietary supplements will provide full nutrition labeling to help
consumers to maintain healthy dietary practices, and they will help to ensure
that any nutrient content or health claims made in the labeling of these
products are scientifically valid, truthful, and not misleading. For these
reasons, these regulations will provide a significant benefit.

14. Some comments stated that the cost of providing nutrition information on
the labels of dietary supplements of herbs would greatly outweigh any clear
public benefit. The comments explained that herbs do not contain significant
amounts of the core nutrients and are not normally consumed for their
nutritional value. Therefore, the value to consumers of including nutrition
labeling on herb products is insignificant.

The agency agrees with this comment. However, the agency notes that those
products that do not contain significant amounts of the 14 mandatory nutrients
will generally not be required to bear nutrition labeling. Therefore, although
there will be no clear public benefit, there will also be no cost.

D. Summary of the Economic Impact

FDA has examined the economic implications of the final rules amending on
nutrition labeling, nutrient content claims, and health claims for dietary
supplements as required by Executive Order 12866 and the Regulatory
Flexibility Act (Pub. L. 96Ä354). 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 effects; distributive impacts; and equity). The Regulatory Flexibility
Act requires analyzing options for regulatory relief for small businesses. FDA
finds that these final rules on dietary supplements, taken together, are not
significant as defined by Executive Order 12866. In accordance with the
Regulatory Flexibility Act, the agency certifies that the final rules will not
have a significant impact on a substantial number of small businesses.

The agency has reviewed the comments and has determined that the costs of
compliance associated with the 18Ämonth compliance period provided by the
agency include administrative costs of between $50,000 and $100,000,
analytical costs of between $0 and $33 million, printing and redesign costs of
between $6 and $28 million, and label inventory disposal costs of between $2
and $9 million. Total discounted costs of the final regulations, taken
together are between $8 and $60 million (7 percent discount rate). If the
agency did not extend the application of the rules, total discounted costs
would be between $20 and $133 million for a 6-month compliance period, or
between $11 and $84 million for a 1-year compliance period.

IV. Environmental Impact

The agency has determined under 21 CFR 25.24 (a)(11) that this action is of a
type that does not individually or cumulatively have a significant impact on
the human environment. Therefore, neither an environmental impact statement is
required.

V. Reference

The following reference has been placed on display in the Dockets Management
Branch (address above) and may be seen by interested persons between 9 a.m.
and 4 p.m., Monday through Friday.

1. RTI, "Compliance Costs of Food Labeling Regulations,'' FDA Contract No.
223Ä87Ä2097, Project Officer Richard A. Williams, Jr., Research Triangle Park,
NC, December 1990.

VI. Conclusion

For the reasons stated above, FDA hereby establishes July 1, 1995, as the date
on which it will apply the mandatory nutrition labeling and nutrient content
claims provisions of the act to dietary supplements.

Dated: December 23, 1993.

David A. Kessler,

Commissioner of Food and Drugs.

Donna E. Shalala,

Secretary of Health and Human Services.

[FR Doc. 93Ä31812 Filed 12Ä29Ä93; 8:45 am]

BILLING CODE 4160Ä01ÄF