[Federal Register Volume 66, Number 62 (Friday, March 30, 2001)]
[Rules and Regulations]
[Pages 17356-17359]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-7980]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 101, 102, 106, 107, 130, 146, 165, and 190

[Docket No. 01N-0134]


Foods, Infant Formulas, and Dietary Supplements; Technical 
Amendments

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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SUMMARY: The Food and Drug Administration (FDA) is making technical 
amendments to its regulations that address food labeling, common or 
usual names for nonstandardized foods, infant formulas, food standards, 
and dietary supplements. The purpose of the amendments is to update the 
names, addresses, and phone numbers for FDA offices and professional 
organizations, to correct minor errors and inadvertent omissions in the 
Code of Federal Regulations (CFR), and to delete obsolete information. 
The technical amendments made by this final rule are editorial in 
nature and are intended to provide accuracy and clarity to the agency's 
regulations.

DATES: This rule is effective March 30, 2001.

FOR FURTHER INFORMATION CONTACT:  Rhonda Rhoda Kane, Office of 
Nutritional Products, Labeling and Dietary Supplements (HFS-821), Food 
and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-
4168.

SUPPLEMENTARY INFORMATION: FDA is making technical amendments in its 
regulations under parts 101, 102, 106, 107, 130, 146, 165, and 190 (21 
CFR parts 101, 102, 106, 107, 130, 146, 165, and 190). Specifically, as 
a result of an FDA reorganization in 2000, the Office of Special 
Nutritionals and the Office of Food Labeling were combined to form the 
Office of Nutritional Products, Labeling and Dietary Supplements. 
Therefore, this rule updates the name and mail codes for this new 
office in FDA regulations on food labeling (part 101), common or usual 
name for nonstandardized foods (part 102), infant formula quality 
control procedures (part 106), infant formula (part 107), food 
standards (part 130), and new dietary ingredient notification 
requirements for dietary supplements (part 190). In parts 106 and 107, 
pertaining to infant formulas, this rule also corrects FDA emergency 
phone numbers and a regulation section citation for FDA district 
offices. Similarly, this rule updates the names, addresses, and other 
contact information for several professional organizations cited in FDA 
regulations on food labeling (part 101) and requirements for 
standardized foods (part 146). In addition, FDA discovered that minor 
errors and omissions were inadvertently published in the CFR affecting 
its regulations on food labeling (part 101), infant formulas (parts 106 
and 107), and requirements for standardized foods (part 165). This rule 
makes the needed corrections. Finally, due to the passage of time, 
certain food labeling provisions for juices (Sec.  101.17) are now 
obsolete and are removed from FDA regulations by this rule.
    This final regulation makes the noted technical amendments. The 
final rule contains no collection of information. Therefore, clearance 
by the Office of Management and Budget under the Paperwork Reduction 
Act of 1995 is not required. The changes addressed in this final rule 
are as follows:
    1. FDA's recent reorganization resulted in changes in the names of 
several of its offices, mail codes, phone numbers, and staff contacts 
cited in its regulations. This rule amends parts 101, 102, 106, 107, 
130, and 190 to incorporate all of these types of changes and other 
minor corrections as noted below:
     Throughout part 101, pertaining to food labeling, the 
Office of Food Labeling (HFS-150) or the Center for Food Safety and 
Applied Nutrition (HFS-150) is cited as the FDA office responsible for 
this part's provisions. The new name and mail code for the Office of 
Food Labeling are the Office of Nutritional Products, Labeling and 
Dietary Supplements (HFS-800). The new mail code for the Center for 
Food Safety and Applied Nutrition pertaining to part 101 is (HFS-800). 
The new FDA office name and mail code are substituted for the old ones 
wherever they appear in part 101.
     In Sec. 101.93(a)(1), dietary supplement manufacturers, 
packers or distributors are required to notify FDA no later than 30 
days post marketing about any structure or function claims made on the 
labeling of their dietary supplements. The name and mail code of the 
FDA office to contact for this purpose are changed from Office of 
Special Nutritionals (HFS-450) to the Office of Nutritional Products, 
Labeling and Dietary Supplements (HFS-810).
     In Sec. 102.23(c)(5), pertaining to requirements for 
peanut spreads, the FDA mail code for the Center for Food Safety and 
Applied Nutrition is changed from (HFS-150) to (HFS-800).
     In Sec. 106.120(a), pertaining to notification 
requirements for new formulations and reformulations of infant 
formulas, the FDA mail code for the Center for Food Safety and Applied 
Nutrition is changed from (HFS-450) to (HFS-830).
     In Sec. 106.20(b), the FDA emergency phone number for 
manufacturers to call to report adulterated or misbranded infant 
formulas is changed from 202-737-0448 to 301-443-1240. Also in 
Sec. 106.120(b), the regulatory section citation for a list of FDA 
district offices for manufacturers to contact to report this infant 
formula problem is currently erroneously stated in two places as 
Sec. 5.115 and is corrected to read Sec. 5.215.
     In Sec. 107.50(e)(1), pertaining to notification 
requirements for exempt infant formulas, the FDA mail code for the 
Center for Food Safety and Applied Nutrition is changed from (HFS-450) 
to (HFS-830).
     In Sec. 107.50(e)(2), the FDA emergency phone number for 
manufacturers to call to report adulterated or misbranded exempt infant 
formulas is changed from 202-737-0448 to 301-443-1240. Also in 
Sec. 107.50(e)(2), the regulatory section citation for a list of FDA 
district offices for manufacturers to contact to report this problem is 
currently erroneously

[[Page 17357]]

stated in two places as Sec. 5.115 and is corrected to read Sec.  
5.215.
     In Secs.  107.230(e), 170.240(b), and 107.250, pertaining 
to infant formula recalls, notification requirements for violative 
infant formulas, and the termination of an infant formula recall, 
respectively, the regulatory section citation for a list of FDA 
district offices for manufacturers to contact to report these 
situations is currently erroneously stated one or more times as Sec.  
5.115 and is corrected to read Sec.  5.215. Also, in Sec.  107.240(b), 
the FDA emergency phone number for manufacturers to call to report 
violative infant formula is changed from 202-857-8400 to 301-443-1240.
     In Sec.  130.17(c), the regulations currently state the 
Chief, Food Standards Branch, Office of Food Labeling, Center for Food 
Safety and Applied Nutrition (HFS-158) as the FDA contact to whom a 
request for a temporary permit must be filed. This temporary permit is 
for interstate shipment of experimental packs of food varying from the 
requirements of definitions and standards of identity. The new FDA 
contact for filing such a permit is the Team Leader, Conventional Foods 
Team, Division of Standards and Labeling Regulations, Office of 
Nutritional Products, Labeling and Dietary Supplements, Center for Food 
Safety and Applied Nutrition (HFS-822).
     In 190.6(a), the FDA name and mail code for manufacturers 
or distributors to submit a premarket notification for a dietary 
supplement containing a new dietary ingredient are changed from the 
Office of Special Nutritionals (HFS-450) to the Office of Nutritional 
Products, Labeling and Dietary Supplements (HFS-820).
    2. A final rule, published in the Federal Register on September 23, 
1997 (62 FR 49825), amended FDA's food labeling regulations to 
establish requirements for the identification of dietary supplements 
and for their nutrition labeling and ingredient labeling in Sec.  
101.4. Section 101.4(h) requires that the product label for dietary 
supplements that contain dietary ingredients that are botanicals to 
state the common or usual names of these ingredients. Current 
regulations also require that the common or usual names stated on the 
label for these ingredients be consistent with the names standardized 
in Herbs of Commerce, 1992 edition, which was incorporated by 
reference. The address for the American Herbal Products Association, 
the publisher and source of copies of the Herbs of Commerce, has 
changed from 4733 Bethesda Ave., suite 345, Bethesda, MD 20814 to 8484 
Georgia Ave., suite 370, Silver Spring, MD 20910. This rule amends the 
address cited in Sec.  101.4(h) for the American Herbal Products 
Association and includes the following phone and facsimile numbers and 
electronic mail address as additional ways to contact the association: 
phone: 301-588-1171, FAX: 301-588-1174, and e-mail: [email protected].
    3. A final rule, published in the Federal Register on September 23, 
1997 (62 FR 49859), revised FDA's regulations on nutrient content 
claims and health claims for conventional foods and dietary 
supplements. FDA discovered two inadvertent errors from that rulemaking 
that affect Secs.  101.14 and 101.54. Old Sec.  101.14(a)(4) was 
removed and old Sec.  101.14(a)(5) was redesignated as the new Sec.  
101.14(a)(4). At that time, FDA did not realize that Sec.  101.14(e)(3) 
referenced the original Sec.  101.14(a)(5), which is now paragraph 
(a)(4). Therefore, this rule amends Sec.  101.14(e)(3) by referring to 
Sec.  101.14(a)(4) and not (a)(5). In addition, when Sec.  101.54(e)(1) 
was revised, FDA inadvertently omitted the terms ``extra'' and ``plus'' 
as synonyms for the nutrient content claim ``more.'' Consequently, this 
rule reinserts the additional terms for ``more'' in Sec.  101.54(e)(1).
    4. In an amendment to Sec. 101.17 published in the Federal Register 
on July 8, 1998 (63 FR 37030), FDA allowed, for a specified period of 
time, the warning statements required in the labeling of juices to be 
displayed on signs and placards located near products sold in stores as 
an alternative to having this information included on the product 
labels themselves. Section 101.17(g)(4)(i) and (g)(4)(ii), 
respectively, stated that the dates for this labeling flexibility were 
September 8, 1999, for apple juice or apple cider and November 5, 1999, 
for all other juices. Since these dates have passed, these sections of 
the regulations are no longer needed. This rule deletes these two 
paragraphs as well as the words ``except that'' from that end of the 
sentence in the introductory Sec.  101.17(g)(4) directly preceding 
Sec.  101.17(g)(4)(i) and (g)(4)(ii).
    5. A final rule, published in the Federal Register on March 24, 
1998 (63 FR 14035), amended FDA's regulations to reflect a change in 
the name and address for the association of Official Analytical 
Chemists. The association's old address was P.O. Box 540, Benjamin 
Franklin Station, Washington, DC 20044. The association's new name and 
address are AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, 
Gaithersburg, MD 20877-2504. FDA discovered that there are two 
instances in parts 101 and 146 where this change was inadvertently 
overlooked. Therefore, this rule amends Sec.  101.100(a)(4), pertaining 
to exemptions from food labeling requirements, and Sec.  146.132(a)(1), 
pertaining to food standard requirements for canned grapefruit juice, 
to reflect the current name and address for AOAC INTERNATIONAL.
    6. In Sec.  165.110(b)(2) and (b)(4)(i)(C), pertaining to the 
microbiological and chemical quality testing of bottled water, the 
regulations currently state the address for the American Public Health 
Association as 1015 15th (or Fifteenth) St. NW., Washington, DC 20005. 
The American Public Health Association is the source of copies of a 
resource incorporated by reference for analyzing the quality of water. 
The new address for the American Public Health Association is 800 I St. 
NW., Washington, DC 20001. This rule amends part 165 to reflect the new 
address of the American Public Health Association.
    7. In Sec.  165.110(b)(4)(iii)(E), (b)(4)(iii)(E)(1)(ii), and 
(b)(4)(iii)(E)(11)(i), pertaining to the requirements for bottled 
water, current regulations mistakenly state the address for the 
National Technical Information Service (NTIS), U.S. Department of 
Commerce as 5825 Port Royal Rd., Springfield, VA 22161. NTIS is the 
source of copies of a resource incorporated by reference for analyzing 
trace minerals in water. The correct street address is 5285 Port Royal 
Rd., Springfield, VA 22161. In addition, these paragraphs 
inconsistently refer to the National Technical Information Service by 
either including or excluding the acronym (NTIS) with the name or by 
using the acronym without the name spelled out. This rule amends part 
165 to consistently and correctly cite the name and address for the 
National Technical Information Service (NTIS).
    Publication of this document constitutes final action of these 
changes under the Administrative Procedure Act (5 U.S.C. 553). FDA has 
determined that notice and public comment are unnecessary because these 
amendments are merely correcting nonsubstantive errors.

List of Subjects

21 CFR Part 101

    Food labeling, Nutrition, Reporting and recordkeeping requirements.



[[Page 17358]]

21 CFR Part 102

    Beverages, Food grades and standards, Food labeling, Frozen foods, 
Oils and fats, Onions, Potatoes, Seafood.

21 CFR Part 106

    Food grades and standards, Infants and children, Nutrition, 
Reporting and recordkeeping requirements.

21 CFR Part 107

    Food labeling, Infants and children, Nutrition, Reporting and 
recordkeeping requirements, Signs and symbols.

21 CFR Part 130

    Food additives, Food grades and standards.

21 CFR Part 146

    Food grades and standards, Fruit juices.

21 CFR Part 165

    Beverages, Bottled water, Food grades and standards.

21 CFR Part 190

    Food additives, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
101, 102, 106, 107, 130, 146, 165, and 190 are amended as follows:

PART 101--FOOD LABELING

    1. The authority citation for 21 CFR part 101 continues to read as 
follows:

    Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 
343, 348, 371; 42 U.S.C. 243, 264, 271.


Part 101  [Amended]

    2. Part 101 is amended by removing the words ``Office of Food 
Labeling (HFS-150)'' wherever they appear and by adding in their place 
``Office of Nutritional Products, Labeling and Dietary Supplements 
(HFS-800)'', and by removing the old mail code ``(HFS-150)'' after the 
Center for Food Safety and Applied Nutrition wherever it appears and by 
adding in its place the new mail code ``(HFS-800)''.


Sec. 101.4  [Amended]

    3. Section 101.4 Food; designation of ingredients is amended in 
paragraph (h) by removing the address for American Herbal Products 
Association ``4733 Bethesda Ave., suite 345, Bethesda, MD 20814'' and 
by adding in its place ``8484 Georgia Ave., suite 370, Silver Spring, 
MD 20910, 301-588-1171, FAX 301-588-1174, e-mail: [email protected]''.


Sec. 101.14  [Amended]

    4. Section 101.14 Health claims: general requirements is amended in 
paragraph (e)(3) by removing the words ``paragraph (a)(5)'' and by 
adding in their place ``paragraph (a)(4)''.


Sec. 101.17  [Amended]

    5. Section 101.17 Food labeling warning and notice statements is 
amended in paragraph (g)(4) by removing the words ``, except that:'' 
from the end of the sentence in the introductory paragraph, and by 
adding in their place a period after the word ``container'', and by 
removing paragraphs (g)(4)(i) and (g)(4)(ii).


Sec.  101.54  [Amended]

    6. Section 101.54 Nutrient content claims for ``good source,'' 
``high,'' ``more,'' and ``high potency'' is amended in paragraph (e)(1) 
by removing the words `and ``added'' ' and by adding, in their place 
the words ` ``added,'' ``extra,'' and ``plus'' '.


Sec.  101.93  [Amended]

    7. Section 101.93 Certain types of statements for dietary 
supplements is amended in paragraph (a)(1) by removing the words 
``Office of Special Nutritionals (HFS-450)'' and by adding in their 
place ``Office of Nutritional Products, Labeling and Dietary 
Supplements (HFS-810)''.


Sec.  101.100  [Amended]

    8. Section 101.100 Food; exemptions from labeling is amended in 
paragraph (a)(4) by removing the words ``Association of Official 
Analytical Chemists, P.O. Box 540, Benjamin Franklin Station, 
Washington, DC 20044'' and by adding in their place ``AOAC 
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 
20877-2504''.

PART 102--COMMON OR USUAL NAME FOR NONSTANDARDIZED FOODS

    9. The authority citation for 21 CFR part 102 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 343, 371.


Sec.  102.23  [Amended]

    10. Section 102.23 Peanut spreads is amended in paragraph (c)(5) by 
removing the mail code ``(HFS-150)'' after the words ``Center for Food 
Safety and Applied Nutrition'' and by adding in its place ``(HFS-
800)''.

PART 106--INFANT FORMULA QUALITY CONTROL PROCEDURES

    11. The authority citation for 21 CFR part 106 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 350a, 371.
    12. Section 106.120 is amended in paragraph (a) by removing the 
mail code ``(HFS-450)'' after the words ``Center for Food Safety and 
Applied Nutrition'' and by adding in its place the new mail code 
``(HFS-830)'', and in paragraph (b) by revising the second and third 
sentences to read as follows:


Sec.  106.120  New formulations and reformulations.

* * * * *
    (b)   *  *  *  This notification shall be made, by telephone, to 
the Director of the appropriate Food and Drug Administration district 
office specified in Sec.  5.215 of this chapter. After normal business 
hours (8 a.m. to 4:30 p.m.) the FDA emergency number, 301-443-1240, 
shall be used. The manufacturer shall send a followup written 
confirmation to the Center for Food Safety and Applied Nutrition (HFS-
605), Food and Drug Administration, 200 C St. SW., Washington, DC 
20204, and to the appropriate Food and Drug Administration district 
office specified in Sec. 5.215.

PART 107--INFANT FORMULA

    13. The authority citation for 21 CFR part 107 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 343, 350a, 371.
    14. Section 107.50 is amended in paragraph (e)(1) by removing the 
mail code ``(HFS-450)'' after the words ``Center for Food Safety and 
Applied Nutrition'' and by adding in its place the new mail code 
``(HFS-830)'', and in paragraph (e)(2) by revising the second and third 
sentences to read as follows:


Sec. 107.50  Terms and conditions.

* * * * *
    (e)  *  *  *    
    (2)  *  *  *  This notification shall be made, by telephone, to the 
Director of the appropriate FDA district office specified in Sec.  
5.215 of this chapter. After normal business hours (8 a.m. to 4:30 
p.m.), the FDA emergency number, 301-443-1240, shall be used. The 
manufacturer shall send a followup written confirmation to the Center 
for Food Safety and Applied Nutrition (HFS-605), Food and Drug 
Administration, 200 C St. SW., Washington, DC 20204, and to the 
appropriate FDA district office specified in Sec.  5.215.


Sec.  107.230  [Amended]

    15. Section 107.230 Elements of an infant formula recall is amended 
in paragraph (e) by removing the reference to ``Sec.  5.115'' and by 
adding in its place ``Sec.  5.215''.

[[Page 17359]]

    16. Section 107.240 Notification requirements is amended in 
paragraph (b) by removing the reference to ``Sec. 5.115'' and by adding 
in its place ``Sec.  5.215'', and by removing the old emergency phone 
number ``202-857-8400'' and by adding in its place the new emergency 
phone number ``301-443-1240''.


Sec.  107.250  [Amended]

    17. Section 107.250 Termination of an infant formula recall is 
amended in the introductory paragraph by removing the reference to 
``Sec.  5.115'' and by adding in its place ``Sec. 5.215''.

PART 130--FOOD STANDARDS: GENERAL

    18. The authority citation for 21 CFR part 130 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 336, 341, 343, 371.


Sec.  130.17  [Amended]

    19. Section 130.17 Temporary permits for interstate shipment of 
experimental packs of food varying from the requirements of definitions 
and standards of identity is amended in paragraph (c) by removing the 
words ``Chief, Food Standards Branch, Office of Food Labeling, Center 
for Food Safety and Applied Nutrition (HFS-158)'' and by adding in 
their place ``Team Leader, Conventional Foods Team, Division of 
Standards and Labeling Regulations, Office of Nutritional Products, 
Labeling and Dietary Supplements, Center for Food Safety and Applied 
Nutrition (HFS-822)''.

PART 146--CANNED FRUIT JUICES

    20. The authority citation for 21 CFR part 146 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.


Sec.  146.132  [Amended]

    21. Section 146.132 Grapefruit juice is amended in paragraph (a)(1) 
by removing the words ``Association of Official Analytical Chemists 
International, 1111 N. 19th St., Suite 210, Arlington, VA 22209'' and 
by adding in their place ``AOAC INTERNATIONAL, 481 North Frederick 
Ave., suite 500, Gaithersburg, MD 20877-2504''.

PART 165--BEVERAGES

    22. The authority citation for 21 CFR part 165 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 341, 343, 343-1, 348, 349, 371, 379e.


Sec.  165.110  [Amended]

    23. Section 165.110 Bottled water is amended as follows:
    a. In paragraph (b)(2) by removing the words ``American Public 
Health Association, 1015 15th St. NW., Washington, DC 20005'' and by 
adding in their place ``American Public Health Association, 800 I St. 
NW., Washington, DC 20001'';
    b. In paragraph (b)(4)(i)(C) by removing the words ``American 
Public Health Association, 1015 Fifteenth St. NW., Washington, DC 
20005'' and by adding in their place ``American Public Health 
Association, 800 I St. NW., Washington, DC 20001'';
    c. In paragraph (b)(4)(iii)(E) by removing the words ``National 
Technical Information Service (NTIS), U.S. Department of Commerce, 5825 
Port Royal Rd., Springfield, VA 22161'' and by adding in their place 
``National Technical Information Service (NTIS), U.S. Department of 
Commerce, 5285 Port Royal Rd., Springfield, VA 22161'';
    d. In paragraph (b)(4)(iii)(E)(1)(ii) by removing the words 
``National Technical Information Service, U.S. Department of Commerce, 
5825 Port Royal Rd., Springfield, VA 22161'' and by adding in their 
place ``National Technical Information Service (NTIS), U.S. Department 
of Commerce, 5285 Port Royal Rd., Springfield, VA 22161''; and
    e. In paragraph (b)(4)(iii)(E)(11)(i) by removing the words ``NTIS, 
U.S. Department of Commerce, 5825 Port Royal Rd., Springfield, VA 
22161'' and by adding in their place ``National Technical Information 
Service (NTIS), U.S. Department of Commerce, 5285 Port Royal Rd., 
Springfield, VA 22161''.

PART 190--DIETARY SUPPLEMENTS

    24. The authority citation for 21 CFR part 190 continues to read as 
follows:

    Authority: Secs. 201(ff), 301, 402, 413, 701 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321(ff), 331, 342, 350b, 
371).


Sec.  190.6  [Amended]

    25. Section 190.6 Requirement for premarket notification is amended 
in paragraph (a) by removing the words ``Office of Special Nutritionals 
(HFS-450)'' and by adding in their place ``Office of Nutritional 
Products, Labeling and Dietary Supplements (HFS-820)''.

    Dated: March 27, 2001.
Ann M. Witt,
Acting Associate Commissioner for Policy.
[FR Doc. 01-7980 Filed 3-29-01; 8:45 am]
BILLING CODE 4160-01-S