PART 100-GENERAL

Subparts A-F-[Reserved]

Subpart G-Specific Administrative Rulings and Decisions

Sec.

100.120 Artificially red-dyed yellow varieties of sweet potatoes.

100.130 Combinations of nutritive and nonnutritive sweeteners in "diet beverages." 100.135 Disposition of incubator reject eggs.

100.140 Label declaration of salt in frozen vegetables.

100.145 Notice to packers of comminuted tomato products.

100.150 Notice to packers and shippers of shelled peanuts.

100.155 Salt and iodized salt.

100.160 Tolerances for moldy and insect-infected cocoa beans.

AUTHORITY: Sec. 701, 52 Stat. 1055-1056 as amended (21 U.S.C. 371), unless otherwise noted.

SOURCE: 42 FR 14306, Mar. 15, 1977, unless otherwise noted.

Subparts A-F [Reserved]

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

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 706 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 saccharin (or saccharin salt, as the case may be) per ounce, a nonnutritive artificial sweetener."

mg

(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 nu

tritive 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.

(Secs. 201(s), 403, 409(d), 52 Stat. 1047-1048, as amended, 72 Stat. 1784 as amended, 1787 (21 U.S.C. 321(s), 343, 348))

§ 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.

(Secs. 301, 402, 52 Stat. 1042, 1046 (21 U.S.C. 331, 342))

§ 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(i)(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.

§ 100.145 Notice to packers of comminuted tomato products.

(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 procedure, 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.

90-061 0-82--2