Dietary Supplements; Establishment of Date of Application

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 (HFS-726), Food and Drug Administration, 200 C

St. SW., Washington, DC 20204, 202-205-5271.

SUPPLEMENTARY INFORMATION:

I. Background

On November 8, 1990, President Bush signed into law the 1990

amendments (Pub. L. 101-535). 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. 102-571) 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. 96-354). 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 18-month 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. 223-87-2097, 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. 93-31812 Filed 12-29-93; 8:45 am]

BILLING CODE 4160-01-F