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  1. Inspection References

Important NLEA Dates

Important NLEA Dates

ATTACHMENT 27

IMPORTANT NLEA DATES

February 5, 1993:

Effective date for:

* FDA regulations on state petitions requesting exemption from federal preemption

* FDA regulations on state enforcement notification provisions

* FDA's determination on federal preemptive effect of labeling covered by section 403 (b), (f), (h), (I)(1), and (k) of the act

Comment period ends for:

* Technical comments on FDA's final rules

Period for filing objections and requests for hearing ends for:

* Label statement on food for special dietary use

* Ingredient labeling for dairy products and maple syrup (Filling of objections automatically stays effective date for either of these last two regulations).

March 8, 1993:

Comment period ends for:

* Nonfunctional slack-fill proposal

* Ingredient labeling for protein hydrolysates and vegetable broth in canned tuna; "and/or" labeling for soft drinks.

* FDA "Healthy" proposal (March 18 for USDA proposal)

* Removal/amendment of standards for ice milk and ice cream

May 8, 1993:

Effective date for:

* Health claims - general requirements and related rules

* Total percentage juice labeling

* Ingredient labeling of standardized foods and certified colors

* Ingredient labeling for dairy products and maple syrup (Requirements of State or political subdivisions regarding maple syrup are not preempted until Sept. 1, 1994)

* Federal preemption of labeling covered by sections 403(d) and (r) (1) (B) and (3) of the Act

* Report to Congress on compliance with voluntary nutrition labeling program for raw fruits, vegetables, and fish. Proposed rules to revise voluntary program to be published.

* Proposal on "Misleading Containers; Nonfunctional Slack-Fill" became a final rule by action of law, effective May 10, 1994

January 5, 1994

Effective date for:

* New regulation for "Misleading Containers; Nonfunctional Slack-Fill" that revoked the regulation that became final by action of law that responded to the comments to the proposal of January 6, 1993

A

February 14, 1994:

Effective date for:

* Metric amendments to Fair Packing and Labeling Act

May 8, 1994:

Effective date for:

* Mandatory nutrition labeling, format, RDI/DRV, and serving size

* Nutrient content claims

* Use of nutrient content claims for butter

* Standardized foods named using a nutrient content claim

* Declaration of ingredients (except standardized foods and certified colors, see May 8, 1993)

* Health claim regulations as they apply to restaurant firms consisting of 10 or less establishments

* Federal preemption of labeling covered by sections 403(q) and (r) (1) (A) and (2)

* Label statement on foods for special dietary use (unless stayed by objections, see Feb. 5, 1993)

July 1, 1994:

Effective date for:

* Health claims for dietary supplements

July 6, 1994:

Effective date for:

* USDA nutrition labeling of meat and poultry products

August 8, 1994:

Effective date for:

* Nutrition labeling and nutrient content claims for firms that file a notice with the Office of Food Labeling prior to June 15, 1994.

September 1, 1994:

Effective date for:

* Provisions for ingredient labeling of maple syrup become preemptive for any requirement of a State or political subdivision which is not identical intent

May 8, 1995:

Effective date for:

* Nutrient content claim regulations as they apply to restaurant firms consisting of 10 or less establishments

July 1, 1995:

Effective date for:

* Mandatory nutrition labeling of dietary supplements

* Nutrient content claims on dietary supplements

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ATTACHMENT 28
CONTACT PERSON FOR FOOD LABELING QUESTIONS
(October 20, 2004: this contact list is currently under revision.)

ATTACHMENT 29

FOOD LABELING AND PACKAGING REGULATIONS

INFORMATION SHEET

The Food and Drug Administration (FDA) has developed a series of regulations to implement of Nutrition Labeling and Education Act of 1990 (the 1990 amendments). This information sheet summarizes one of those regulations.

Subject: Misleading Containers; Nonfunctional Slack-fill - Final Rule

Brief Summary: The 1990 amendments provide, among other things, for the Federal preemption of certain State and local food standards and labeling requirements. Section 6 of the 1990 amendments, entitled "National Uniform Nutrition Labeling," adds new section 403A to the Act which prohibits States from establishing food labeling or packaging requirements of the type required by sections 403(b), 403(d), 403(f), 403(h), 403(I) (1) or 403(k) of the Act that are not identical to the requirements of such section. However, the above provisions dealing with misbranding do not become preemptive

until FDA determines that each is being adequately implemented by Federal regulations.

FDA determined that, of the above provisions, all but section 403(d) are being adequately implemented (58 FR 2470; January 6, 1993). Section 403(d) states that a food is misbranded "if is container is so made, formed, or filled as to be misleading."

On January 6, 1993 (58 FR 2957), FDA proposed to amend its regulations to define the circumstances in which the empty space or slack-fill within a container is nonfunctional and, therefore, misleading. The agency provided 60 days for comment on the proposal (hereinafter referred to as the "misleading container proposal").

Section 6(b) (3) (D) (ii) of the 1990 amendments provides that, if the final rule to implement section 403(d) is not promulgated within 30 months of the date of passage of the 1990 amendments (November 8, 1990), the regulation proposed to

implement 403(d) becomes final by operation of law. Section 6 also provides that State shall be preempted with respect to section 403(d) at that time. Final regulations implementing State enforcement provisions of section 4 of the 1990

amendments are set forth in 21 CFR 100.2 (58 FR 2457; January 6, 1993)).

On May 12, 1993, (58 FR 27932), FDA published a notice announcing that, in accordance with section 6 of the 1990 amendments, the January 6, 1993, misleading container proposal became the final regulation by operation of law on May 10, 1993.

the agency noted that the May 12, 1993, document was separate from the January 6 rule making which was ongoing at that time. FDA advised that if intended to issue a regulation in the near future what would supersede the regulation that was

considered final by operation of law.

On December 6, 1993 (58 FR 64123), FDA published a final rule to implement section 403(d) that took into account comments received in response to the January 6, 1993, misleading container proposal. Elsewhere in that same issue of the FEDERAL REGISTER (58 FR 64208), FDA proposed to revoke the regulation that became final by operation of law and to replace

it with the December 6, 1993, final regulation. FDA tentatively found that the December 6, 1993, final regulation is better able toensure adequate implementation of section 403(d) of the Act then the May 10, 1993.

regulation and, because it is a clearer regulation, will facilitate compliance. FDA provided a 10 day period for comment on its decision to supersede the May 10 regulation with the December 6, 1993, A

final rule. On January 5, 1994, (59 FR 536) FDA published a final rule revoking the May 10

regulation and replacing it with the December 6 final rule, effective January 5, 1994.

According to the December 6, 1993, final regulation, a food shall be deemed to be misbranded if its container is made, formed, or filled as to be misleading. FDA concluded that the terms "made" and "formed" are straightforward and thus do not need further elaboration. FDA defined "misleading fill" as nonfunctional slack-fill in a container that does not allow consumers to fully view its contents. the final regulation recognized that some slack-fill my be necessary to perform an appropriate function such as protecting the contents of the container. Slack-fill in excess of that required to

perform an appropriate function is nonfunctional slack-fill and, therefore, misleading fill. The final regulation also provides for slack-fill that is necessary for, or results from: unavoidable product setting, an inability to increase level of fill or further reduce package size, and the packaging of certain convenience foods and foods in reusable containers.

FDA finds that the final regulations will ensure adequate implements of section 403(d) and provide additional consumer protection against misleading fill. This regulation will also provide FDA and State agencies with a uniform means of taking action against misleading containers. Consequently, manufactures can expect that packing will be treated uniformly throughout the State with respect to misleading containers.

Contact Person: Michelle A. Smith, Center for Food and Safety and Applied Nutrition (HFS-158), Food and Drug Administration, 200 C Street SW., Washington, DC 20204, 204-205-5099 Prepared by: MASmith: HFS-158:mas:1/17/94:NFSF_.NFO

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ATTACHMENT 30

FOOD LABELING

APPLICABLE LAWS AND REGULATIONS

(Including Federal Register Notices Pertaining to NLEA)

LAWS REGULATIONS

The Federal Food, Drug, And Cosmetic Act Section 403

Fair Packaging and Labeling Act

Fair Packaging and Labeling Act

Technical Amendments of Labeling Placement, Form and Contents of Statement of Quantity (Public Law 102-329)

Nutrition Labeling and Education Act of 1990 (Publication 101-535)

Exemption Law (Public Law 103-80)

Dietary Supplements Act of 1992 (Public Law 102-571)

Title 21 Code of Federal Regulations Parts 101 Food Labeling

 

Federal Register, January 6, 1993 (58 FR 2066-2964)

Federal Register, January 6, 1993 (58 FR 2066-2964)

Federal Register, April 1&2, 1993 (editorial corrections) (58 FR 17085-17345)

Federal Register, May 21, 1993 (Metric Labeling Proposal) (58 FR 29716-29726)

Federal Register, June 15, 1993 (Restaurant Foods Nutrition Label Proposal) (58 FR 33055-33060)

Federal Register, June 18, 1993 (Dietary Supplements) (58 FR 33690-33751)

Federal Register, August 18, 1993 (Technical Amendments) (58 FR 44020-44096)

Federal Register, November 27, 1991 (Retail Placard Label, Fruits, Vegetables and Fish) (56 FR 60880-60891)

Federal Register, December 21, 1993 (Metric Labeling) (58 FR 67444-67464)

Federal Register, January 4, 1994 (Dietary Supplements (59 FR 350-437)

Federal Register, March 14, 1994 (Small Business Proposal) (59 FR 11872-11883)

Federal Register, May 10, 1994 (Healthy, Final Rule) (59 FR 24232-24250)

Federal Register, July 18, 1994 (Proposal for Labeling Raw Fruits, Vegetables, and Fish) Correction published July 21, 1994 (59 FR 37190)

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ATTACHMENT 31

FDA PRIME CONNECTION

Two pages - Description - Form

ATTACHMENT 32

MODEL SMALL BUSINESS FOOD

LABELING EXEMPTION NOTICE

Instructions for Completion

(Send to: Office of Food Labeling (HFS-150)

Center for Food Safety and Applied Nutrition

Food and Drug Administration

200 C St. SW., Washington, DC 20204)

  1. Name of Firm: Enter recognized legal name of firm.
  2. Firm address: Enter mailing address for principal place of business.
  3. Name of the food product for which exemption is claimed. Enter the name of each food product for which an exemption is claimed. Continuation sheets may be used if necessary.
  4. Name and address of manufacturer: Provide the names and addresses of the manufacturers of the food products for which an exemption is being claimed if they are different than the firm that is submitting the claim for exemption.
  5. Number of full-time equivalent employees: Enter the approximate average number of person employed by the firm for the year preceding the year for which an exemption is claimed. The average number should include all person employed by the firm and its affiliates. The average number of employees may be calculated by using the following formula:
    Total number of employee/hours paid divided by 2080 hours a year = average number of full-time equivalent employees. Employee hours should include overtime paid to employees.
  6. Approximate total number of units sold in the United States between May 8, 1993, and May 7 1994: Enter the total number of units sold in the United States between May 8, 1993, and May 7 1994, for each product listed under item 3 for which a small business exemption is being claimed. Continuation sheets may be used if necessary. A food product is a food in any sized package which is manufactured by a single manufacturer, or which bears the same brand name; which bears the same statement of identity; and which has similar preparation methods. The approximate total number of units is the summation of all units of the various package sizes of the food product in the form in which the food product is sold to consumers.
  7. Certification. The form is to be signed by a responsible individual for the firm that can certify the authenticity of the information presented on the form. The individual signing the form will commit to notify the Office of Food Labeling when the numbers of full-time equivalent employees or total numbers of units of products sold in the United States exceed the applicable numbers for exemption.

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ATTACHMENT 33

PRE NLEA NUTRITIONAL LABELING CHARTS

Standard Format

Declaration of sodium content, optional declaration of potassium.

Optional treatment of nutrients present at less than 2% U.S.

R.D.A.

NUTRITION INFORMATION (PER SERVING)

SERVING SIZE = 1 OZ

SERVING PER CONTAINER = 16

CALORIES 130
PROTEIN 3 Grams
CARBOHYDRATE 18 Grams
FAT 5 Grams
SODIUM  
POTASSIUM 125 Milligrams

PERCENTAGE OF U.S. RECOMMENDED DAILY ALLOWANCES (U.S. RDA)(*)

PROTEIN 4
THIAMINE 4
RIBOFLAVIN 2

CONTAINS LESS THAN 2 PERCENT OF U.S. RDA FOR VITAMIN A, VITAMIN C, NIACIN, CALCIUM, and IRON.

Standard Format

Dual declaration of nutrients.

  1. from product alone.
  2. as consumed.

Optional treatment of nutrients present at less than 2% of U.S. RDA.

NUTRITION INFORMATION

(PER SERVING)

Serving size = 1 oz.

Servings per container = 18

  Dry Dry with 4 oz. vit. D milk
Calories 130 200
Protein 3 7
Carbohydrate, g 18 30
Fat, g 5 9
Sodium 10 75
Potassium 125 310

Percentage of U.S. Recommended Daily Allowance (U.S. RDA)

  Dry Dry with 4 oz. vit. D milk
Protein 4 10
Vitamin A * 2
Vitamin C * *
Thiamine 4 8
Riboflavin 2 15
Niacin * 2
Calcium 2 15
Iron 4 4
Vitamin D * 10

Contains less than 2% of U.S. RDA for these nutrients.

U.S. RECOMMENDED DAILY ALLOWANCE (U.S. RDA) (for use in nutrition labeling of foods, including foods that also are vitamin and mineral supplements for specific age groups or conditions)

  Adults and Children Over 4 yrs. Children under 4 yrs. Infants 12 months and under Pregnant or lactating Women
Protein 85 g[sup]a 28 g[sup]a 25 g[sup]a 65 g[sup]a
Vitamin A 5,000 IU 2,500 IU 1,500 IU 8,000 IU
Vitamin C 60 mg 40 mg 35 mg 60 mg
Thiamine 1.5 mg 0.7 mg 0.5 mg 1.7 mg
Riboflavin 1.7 g 0.8 mg 0.6 mg 2.0 mg
Niacin 20 mg 9.0 mg 8.0 mg 20 mg
Calcium 1.0 g 0.8 g 0.6 g 1.3 g
Iron 18 mg 10 mg 15 mg 18 mg
Vitamin D 400 IU 400 IU 400 IU 400 IU
Vitamin E 30 IU 10 IU 5 IU 30 IU
Vitamin B[sub]6 2.0 mg 0.7 mg 0.4 mg 2.5 mg
Folic Acid 0.4 mg 0.2 mg 0.1 mg 0.8 mg
Vitamin B[sub]12 6 mcg 3 mcg 2 mcg 8 mcg
Phosphorus 1.0 g 0.8 g 0.5 g 1.3 g
Iodine 150 mcg 70 mcg 45 mcg 150 mcg
Magnesium 400 mg 200 mg 70 mg 450 mg
Zinc 15 mg 8 mg 5 mg 15 mg
Copper 2 mg 1 mg 0.6 mg 2 mg
Biotin 0.3 mg 0.15 mg 0.05 mg 0.3 mg
Pantothenic acid 10 mg 5 mg 3 mg 10 mg

If protein efficiency of protein is equal than that of casein, U.S. RDA is 45 g for adults and pregnant or lactating women, 20 g for children under 4 years of age and 18 g for infants.

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Standard Format

Declaration of Sodium, fatty acid composition (optional) and Cholesterol (optional).

NUTRITION INFORMATION (Per Serving)

Serving Size = 2 Tbsp (32 g)
Servings per container = 35
Calories 180 Percent of calories from fat(*) 72
Protein 8 g Polyunsatured 5 g
Carbohydrate 6 g Saturated 2 g
Fat 10 g Cholesterol 0 g
Sodium 150 mg    
PERCENTAGE OF U.S. RECOMMENDED DAILY ALLOWANCE (U.S. RDA)
Protein 15 Riboflavin 2
Vitamin A 2 Niacin 20
Vitamin C 2 Calcium 2
Thiomine 2 Iron 2

Standard Format Dual declaration of nutrients.

  1. from mix alone.
  2. As final prepared product

NUTRITION INFORMATION|
(PER PORTION)
PORTION SIZE = 3 TBSP (MAKES 1 MUFFIN)
SERVINGS PER CONTAINER = 12

  1/2 MIX + « EGG MIX = 2 Tsp MILK
Calories 100 120
Protein, grams 1 2
Carbohydrate, gram 17 18
Fat, grams 3 4
Sodium, mg 140 150
PERCENTAGE OF U.S. RECOMMENDED DAILY ALLOWANCE (U.S. RDA)
Protein 2 4
Vitamin A 0 0
Vitamin C 0 0
Thiamine 4 4
Riboflavin 2 4
Niacin 2 2
Calcium 2 4
Iron 2 2

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