(b) No proceeding may be commenced by a State under paragraph (a) of this section:

(1) Before 30 days after the State has given notice to the Food and Drug Administration (FDA) that the State intends to bring such proceeding.

(2) Before 90 days after the State has given notice to FDA of such intent if FDA has, within such 30 days, commenced an informal or formal enforcement action pertaining to the food which would be the subject of such proceeding.

(3) If FDA is diligently prosecuting a proceeding in court pertaining to such food, has settled such proceeding, or has settled the informal or formal enforcement action pertaining to such food.

(c) A State may intervene as a matter of right, in any court proceeding described in paragraph (b)(3) of this section.

(d) The notification that a State submits in accordance with paragraph (b) of this section should include the following information and be submitted in the following recommended format:

(Date)

Name of State agency

Post office address

Street address

City, State, and ZIP code

Name of product(s) covered by the notification

Reporting official, title, and telephone no. FAX NO.

Agency contact (if different from reporting official), title, and telephone no. Director,

Division of Enforcement (HFS-605),

Center for Food Safety and Applied Nutrition,

Food and Drug Administration, 200 C St. SW.,

Washington, DC 20204.

To Whom It May Concern:
The undersigned,

submits this letter of notification pursuant to section 307(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 337(b)(1)) with respect to (name of products covered by the notification and the enforcement action that is to be initiated)

Attached hereto, and constituting a part of this letter of notification are the following: A. The name of the product.

B. The type and size of each product container.

C. Copy of the label and labeling of the product.

D. Manufacturing code (if applicable).

E. Name and address of firm believed to be responsible for violations.

F. Name and address of parent firm (if known).

G. Reason for the anticipated State enforcement action (list specific violations, including sections of the law violated).

H. Name of firm against which action is anticipated (if applicable).

I. Type of enforcement action.
Yours very truly,
Reporting Agency
By

(Indicate authority)

(e) The letter of notification should be signed by a State official authorized by the State to institute the contemplated enforcement actions.

(f) The letter of notification should be sent to the Division of Enforcement (HFS-605), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 200 C St. SW., Washington, DC 20204, FAX number 202-205-4642.

(g) FDA will notify the State of the date in which its letter of notification was received by FDA, Center for Food Safety and Applied Nutrition, Division of Enforcement (HFS-605) (within 2 working days after date of receipt). This date will be the date of notification for the purposes of paragraph (b) of this section.

(h) The Director, Division of Enforcement, Office of Field Programs, Center for Food Safety and Applied Nutrition, FDA, will respond to the State's notification within 30 days of the date of notification by advising:

(1) Whether FDA has commenced an informal or formal enforcement action pertaining to the food that is the subject of the notification; or

(2) Whether FDA is prosecuting a proceeding in court pertaining to such food, has settled such proceeding, or has settled informal or formal enforcement action pertaining to such food.

(i) Information contained in State notification letters shall be exempt from public disclosure to the same extent to which such information would be so exempt pursuant to §§ 20.61, 20.64, and 20.88 of this chapter.

(j) Definitions. (1) Informal enforcement actions include warning letters, recalls, detentions, or other administrative en

forcement actions that pertain to the food in question.

(2) Formal enforcement actions include seizures, injunctions, or other civil judicial enforcement actions that pertain to the food in question. (Information collection requirements in this section were approved by the Office of Management and Budget (OMB) and assigned OMB control number 0910-0275.)

[58 FR 2460, Jan. 6, 1993; 58 FR 17097, Apr. 1, 1993]

Subparts B-E (Reserved)

Subpart F-Misbranding for
Reasons Other Than Labeling

§ 100.100 Misleading containers.

In accordance with section 403(d) of the act, a food shall be deemed to be misbranded if its container is so made, formed, or filled as to be misleading.

(a) A container that does not allow the consumer to fully view its contents shall be considered to be filled as to be misleading if it contains nonfunctional slack-fill. Slack-fill is the difference between the actual capacity of a container and the volume of product contained therein. Nonfunctional slack-fill is the empty space in a package that is filled to less than its capacity for reasons other than:

(1) Protection of the contents of the package;

(2) The requirements of the machines used for enclosing the contents in such package;

(3) Unavoidable product settling during shipping and handling;

(4) The need for the package to perform a specific function (e.g., where packaging plays a role in the preparation or consumption of a food), where such function is inherent to the nature of the food and is clearly communicated to consumers;

(5) The fact that the product consists of a food packaged in a reusable container where the container is part of the presentation of the food and has value which is both significant in proportion to the value of the product and independent of its function to hold the food, e.g., a gift product consisting of a food or foods combined with a container that is intended for further use

after the food is consumed; or durable commemorative or promotional packages; or

(6) Inability to increase level of fill or to further reduce the size of the package (e.g., where some minimum package size is necessary to accommodate required food labeling (excluding any vignettes or other nonmandatory designs or label information), discourage pilfering, facilitate handling, or accommodate tamper-resistant devices). (b) [Reserved] [59 FR 537, Jan. 5, 1994]

Subpart G-Specific Administrative Rulings and Decisions

§ 100.120 Artificially red-dyed yellow varieties of sweet potatoes.

(a) It has been the practice of some growers, packers, and distributors of yellow varieties of sweet potatoes to artificially color the skins of such potatoes with a red dye. Surveys made by the Food and Drug Administration and letters received by the Administration from consumers reveal that this practice can deceive those persons who prefer the naturally red varieties of sweet potatoes. Also, representatives of the red sweet potato industry have alleged that some consumers refuse to purchase any red sweet potatoes since they cannot distinguish between the naturally red ones and those artificially colored with red dye.

(b) The Food and Drug Administration concludes, therefore, that yellow varieties of sweet potatoes artificially colored with a red dye are adulterated within the meaning of section 402(b) of the Federal Food, Drug, and Cosmetic Act.

(c) The Food and Drug Administration will consider appropriate regulatory action regarding such adulterated sweet potatoes shipped in interstate commerce if the act of adulterating the potatoes occurs after 90 days following the date of publication of this statement of policy in the FEDERAL REGISTER.

§ 100.130 Combinations of nutritive and nonnutritive sweeteners in "diet beverages."

As a result of the removal of cyclamic acid and its salts from the

list of substances generally recognized as safe (part 182 of this chapter) by an order published in the FEDERAL REGISTER of October 21, 1969 (34 FR 17063), the Commissioner of Food and Drugs has received inquiries as to the proper composition and labeling, from the standpoint of application of the Federal Food, Drug, and Cosmetic Act, of so-called "diet beverages" that will be made from mixtures of nutritive sweeteners and saccharin or its salts. The Commissioner concludes that:

(a) Any "diet beverage" or diet beverage base made with combinations of nutritive and nonnutritive sweeteners must be so formulated that each ingredient is one which is generally recognized as safe and is not a food additive as defined in section 201(s) or a color additive as defined in section 201(t) of the act, or if it is a food additive or a color additive as so defined, is used in accordance with a regulation established pursuant to section 409 or 721 of the act.

(b) The product is to be so formulated that its caloric value is at least 50 percent less than the caloric value of the comparable product made without artificial sweeteners. In no case shall the beverage provide more than 6 calories per fluid ounce.

(c) If it is to be marketed under a name heretofore used on a product represented to have no, or only a few, calories per serving, the name shall be modified by the word "new" for at least 1 year following the time such product is introduced in a given market.

(d) (1) The label must bear a complete statement of ingredients except that spices, flavorings, and colorings may be designated as such without naming each.

(2) The label must bear a statement of the caloric content per fluid ounce, the carbohydrate content per fluid ounce, a statement of the percentage of saccharin or saccharin salt used, and the statement "Contains mg saccharin (or saccharin salt, as the case may be) per ounce, a nonnutritive artificial sweetener."

(3) To further avoid injury through inadvertent use by diabetics in the belief that the product does not contain carbohydrates, the label of a beverage

containing sugar(s) must bear the statement "Contains sugar(s); not for use by diabetics without advice of a physician."

(4) To avoid confusion by diabetics, the label of a beverage containing sorbitol, mannitol, or other hexitol, must bear the statement "Contains carbohydrates, not for use by diabetics without advice of a physician". To further avoid confusion of these beverages with those sweetened solely with nonnutritive artificial sweeteners which have been marketed in containers bearing prominent statements such as "sugar free", "sugarless", or "no sugar", the labels of beverages containing hexitols must not bear these or similar statements.

(e) Bottlers of diet drinks have on hand large stocks of returnable lithographed bottles bearing statements indicating that the beverages contain cyclamates and/or declarations such as "sugar free", "less than 1 calorie per bottle", or "less than 2 calories per bottle" which bottles were formerly used for artificially sweetened beverages containing cyclamates. The Food and Drug Administration will not object to continued use of these bottles under the following conditions:

(1) The bottles when filled with beverages made with combinations of nutritive and nonnutritive sweeteners may be marketed only:

(i) In multiunit cartons labeled prominently on each principal display panel with the information set forth in paragraphs (c) and (d) of this section and with a prominent, forthright notice that any information on bottles which is contrary to that on the cartons should be disregarded because it is incorrect. To assure adequate prominence and conspicuousness, the following statements should stand out in marked contrast with other labeling: The statement of caloric content and carbohydrate content per fluid ounce, the statement required by paragraph (d) (3) or (4) of this section as applicable, and the notice to disregard any information on bottles which is contrary to that on the cartons. These statements may be made to stand out by means such as setting them forth in boxes, printing in bold capitals on lines

separated from other printed labeling, using colors that contrast with those used for other label statements, or other similar means.

(ii) In vending machines bearing durable labeling which includes all of the information required to appear on cartons set forth with the same degree of prominence.

(2) In addition, the bottles must bear caps labeled prominently with the words "Contains Sugar" or "Contains Carbohydrates", and accurate statements of the caloric content and carbohydrate content per fluid ounce.

$100.135 Disposition of incubator reject eggs.

(a) Investigations by the Food and Drug Administration and a number of State regulatory agencies have revealed that incubator reject eggs, removed as infertile or otherwise unhatchable during hatching operations, are being diverted for human food use. Such eggs are regarded as adulterated within the meaning of section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(3)) because they are unfit for food.

(b) The introduction or delivery for introduction into interstate commerce of adulterated eggs is prohibited under section 301(a) of the aforesaid act (21 U.S.C. 331(a)) unless they have been broken, crushed, or smashed and then denatured with kerosene, creolin, or other suitable denaturant to preclude their diversion to human food channels.

§ 100.140 Label declaration of salt in frozen vegetables.

(a) In a number of diseases or disease conditions it is important to restrict the intake of sodium. Sodium occurs in all natural foods, but added salt makes the most important contribution to the total sodium intake in the diet. Most fresh vegetables are of low sodium content and consumers generally regard frozen vegetables as being free of added salt and suitable for use in low-sodium diets. While salt may not be added directly as a seasoning ingredient during the processing of frozen vegetables, the use of salt brine in quality separation of such vegetables as peas and lima

beans preparatory to freezing may contribute substantial amounts of salt to the finished article. The failure of the labels of frozen vegetables to declare the presence of salt has been the basis of complaints to the Food and Drug Administration.

(b) Section 403(1)(2) of the Federal Food, Drug, and Cosmetic Act requires the label of a fabricated food to bear the common or usual name of each ingredient present. The Department of Health and Human Services regards any frozen vegetable containing salt, added directly or indirectly, as misbranded in violation of section 403(i)(2) of the Federal Food, Drug, and Cosmetic Act unless its label names salt as an ingredient.

(a) It has long been known that tomato rot may be caused by one or more of the following: Fungus diseases, bacterial diseases, virus diseases, and certain nonparasitic diseases. Only the fungus rots are characterized by the presence of mold filaments. Mold counts on comminuted tomato products are not increased by incorporating within the product tomato rot caused by bacteria, virus, or nonparasitic factors. Although high mold counts on these products reveal that large amounts of rotten material are present, low mold counts do not necessarily demonstrate absence of the type of rot caused by the tomato diseases that are not characterized by mold filaments.

(b) Inspections of canneries engaged in the packing of comminuted tomato products show that most packers effectively trim, sort out, and discard rotten tomatoes from the raw stock. Some packers, however, do not properly eliminate rotten tomato material, and a few packers deliberately use rotten tomatoes in these foods, provided the mold count remains low. Some packers, on occasion, have mixed tomato products having a high mold count with tomato products containing little or no mold, so as to produce a blend with a low mold count.

(c) Packers of comminuted tomato products who rely upon the mold count as the sole or primary control proce

dure, to the neglect of adequate sorting and trimming, may produce products with low mold counts which contain substantial amounts of rot.

(d) It is the purpose of this announcement to advise all canners of tomato products that:

(1) Although high mold count is conclusive evidence of inclusion of substantial amounts of rot, mold count is not the only way of establishing that comminuted tomato products contain decomposed tomato material.

(2) Where factory observations or other evidence reveals that comminuted tomato products contain rot not caused by mold, such rot, as well as that caused by mold, will be taken into account in applying the provisions of the Federal Food, Drug, and Cosmetic Act against adulteration.

(3) The blending of tomato products adulterated with tomato rot, of whatever kind, with tomato products made from sound tomatoes, or with other sound food, renders the blend adulterated.

§ 100.150 Notice to packers and shippers of shelled peanuts.

(a) Investigations by the Food and Drug Administration have shown that a number of interstate shipments of shelled peanuts in bags holding from approximately 100 to 125 pounds each have failed to bear labeling as required by the terms of the Federal Food, Drug, and Cosmetic Act.

(b) Shelled peanuts in sacks, whether or not shipped in carload lots, should bear the following information required by the law on food in package form:

(1) The name of the product.

(2) An accurate statement of net weight.

(3) The name and place of business of the packer or distributor.

(c) The information required by paragraph (b) of this section should be conspicuously set forth. It may be printed or stenciled on each bag or, if desired, placed on tags which are securely attached to each bag.

(d) The net weight marked on the bags must be the correct net weight of the peanuts at the time they are delivered to the carrier for interstate shipment. The tare weight of the bag

should not be included in the weight declaration.

$100.155 Salt and iodized salt.

(a) For the purposes of this section, the term "iodized salt" or "iodized table salt" is designated as the name of salt for human food use to which iodide has been added in the form of cuprous iodide or potassium iodide permitted by §§184.1265 and 184.1634 of this chapter. In the labeling of such products, all words in the name shall be equal in prominence and type size. The statement "This salt supplies iodide, a necessary nutrient" shall appear on the label immediately following the name and shall be in letters which are not less in height than those required for the declaration of the net quantity of contents as specified in § 101.105 of this chapter.

(b) Salt or table salt for human food use to which iodide has not been added shall bear the statement, "This salt does not supply iodide, a necessary nutrient. This statement shall appear immediately following the name of the food and shall be in letters which are not less in height than those required for the declaration of the net quantity of contents as specified in §101.105 of this chapter.

(c) Salt, table salt, iodized salt, or iodized table salt to which anticaking agents have been added may bear in addition to the ingredient statement designating the anticaking agent(s), a label statement describing the characteristics imparted by such agent(s) (for example, "free flowing"), providing such statement does not appear with greater prominence or in type size larger than the statements which immediately follow the name of the food as required by paragraphs (a) and (b) of this section.

(d) Individual serving-sized packages containing less than 1⁄2 ounce and packages containing more than 21⁄2 pounds of a food described in this section shall be exempt from declaration of the statements which paragraphs (a) and (b) of this section require immediately following the name of the food. Such exemption shall not apply to the outer container or wrapper of a multiunit retail package.