Sub Chapter 500

Additives

Sec. 500.100 Additives - Labeling with Adequate Directions for Many Uses (CPG 7117.01)

BACKGROUND:

Many food additive regulations require that the label or labeling of an additive or a premix containing the additive bear adequate directions for use. Because many additives have multiple uses, it may be impractical to include complete directions on the label.

POLICY:

The labeling requirements for food additives with multiple uses may be met by listing complete directions in a brochure or leaflet and labeling bulk drums as follows:

"Caution: This substance should only be used in or on foods (or food packaging) in accordance with the regulations issued under the Federal Food, Drug, and Cosmetic Act. Specific details furnished in "________" (Insert name of brochure)."

The brochures must be provided to each food customer with each shipment of product.

Issued: 10/1/80

Sec. 500.200 Food Additives - "GRAS" (CPG 7117.12)

BACKGROUND:

Section 409 of the Federal Food, Drug, and Cosmetic Act provides that a substance added to food is unsafe unless the substance conforms to the terms of an exemption for investigational use, or unless the substance is in conformance with a regulation describing the conditions under which the substance may be safely used or unless the substance is generally recognized as safe (GRAS). Although it is impractical to list all substances that are GRAS, FDA has identified numerous substances which, when used for their specified uses and in accordance with good manufacturing practice, are GRAS. See 21 CFR Part 182 *, 184 and 186*. According to 21 CFR 182.1(b), the following good manufacturing practices are applicable to GRAS substances:

- The quantity of the substance added to food must not exceed the amount reasonably required to accomplish the intended technical effect.

- Any substance intended for use in or as food must be of appropriate food grade and must be prepared and handled as a food ingredient.

Routine FDA investigational work and consumer or trade complaints often reveal that industry does not always observe these good manufacturing practices.

POLICY:

Although a regulation may exist authorizing the use of a GRAS substance, the addition of a GRAS substance to a food may cause that food to be adulterated when it can be established that:

- The substance is not of a quality consistent with its use as food for human consumption, or

- The substance is not used in accordance with the principles of good manufacturing practices, i.e. is added in amounts in excess of that which is necessary to accomplish the effect for which the use of the substance is GRAS, or

- *Where there are "specific limitations,"* the substance is not used for the *specified* technical effect *or is used in excess of the "specific limitations"* for which the use of the substance is GRAS.

If one or more of the above can be demonstrated, recommend appropriate regulatory action to CFSAN/Office of Field Programs/Division of Enforcement (HFS-605).

*Material between asterisks is new or revised.*

Issued: 6/1/86
Revised: 3/95, 8/96

Sec. 500.250 Food Additives - Labeling: Directions for Safe Use (CPG 7117.13)

BACKGROUND:

Section 409 of the Federal Food, Drug, and Cosmetic Act authorizes the establishment of conditions for the safe use of food additives. Conditions may include the maximum quantity of such additive which may be used, or permitted to remain, in or on such food, and any directions, or other labeling requirements, deemed necessary to assure the safe use of the additive.

Many substances that have approved food additive uses also have various non-food uses. The label of these substances must have directions necessary to assure safe use in accordance with the applicable food additive regulation.

POLICY:

Food grade chemicals sold as such and recommended or intended to be used in or on foods, must have labeling that includes directions for safe use, and any specific limitation listed in any regulation governing the use of the chemical as a food additive. If there are no such limitations, the labeling must include information concerning the levels of the chemical that may be used in a manner consistent with good manufacturing practices. Products that do not have such labeling may be deemed misbranded under 403(a)(1) and section 201(n) of the FD&C Act.

Issued: 6/1/86
Revised: 3/95, 8/96

Sec. 500.300 "Approved by FDA" - Use of Phrase Objectionable in Marketing or Labeling of a Food Additive (CPG 7117.09)

BACKGROUND:

A firm that had *a regulated* food additive intended for coating paper used as a food wrap wanted to use the phrase "Approved by FDA" in connection with promoting the sale of the chemical to firms making food wrapping materials.

POLICY:

FDA objects strongly to the phrase "Approved by FDA" in connection with the marketing or labeling of a product which has been processed through the food additives regulations.

There is no objection to a firm providing information that it *is selling a regulated* food additive in response to an inquiry received from a customer or other interested party, nor is there any objection to it's issuing guarantees that shipments of the chemical are in *compliance with* of the food additive provisions of the Federal Food, Drug, and Cosmetic Act.

*Material between asterisks is new or revised.*

Issued: 9/23/76
Revised: 10/1/80 Reissued: 6/27/88
Revised: 8/96

Sec. 500.400 Use of Calcium Chloride as a Drying Agent in Such Products as Packaged Potato Chips and Peanuts (CPG 7117.02)

BACKGROUND:

We received a letter discussing a plan to include a cartridge of calcium chloride as a drying agent in packages of such products as potato chips and peanuts.

POLICY:

*We have advised inquirers that we would not object to the use of such cartridges provided the following conditions prevail:*

1. The calcium chloride is enclosed in a container so constructed as to prevent contamination of the food by sifting of the dry substance, or leakage should it become dissolved in moisture taken up from the atmosphere.

2. The container should be made of materials suitable for use in contact with food and should be of sufficient size to ensure that the article will not be accidentally chewed or ingested along with the food.

3. The package containing the food is conspicuously labeled to show the presence of the container with the calcium chloride and that the calcium chloride is not a part of the food in the package.

4. The container is not of such dimensions as to increase the size of the food package so as to mislead purchasers with respect to the quantity of food contained therein.

5. The quantity of contents of the food package is declared in terms of the food therein exclusive of the calcium chloride and its container.

6. The package of calcium chloride should be identified with the nature of the desiccant, *and* the fact that it should not be opened or eaten.

*Material between asterisks is new or revised.*

Issued: 9/14/76
Reissued: 10/1/80, 6/27/88
Revised: 3/95

Sec. 500.425 The Use of Color Additives in Paper and Paperboard Intended for Use With Food (CPG 7117.10)

BACKGROUND:

In response to inquiries about the use of color additives as colorants in paper and paperboard intended for use in contact with food, FDA provides the following advice: (Note this advice is a clarification of advice issued as an advisory opinion by the Associate Commissioner for Regulatory Affairs on September 18, 1979, (Docket Number 79A-0165/AP).

POLICY:

We have no objection to the use of colorants in paper and paperboard intended for food contact if the colorants are color additives regulated for direct addition to food generally and do not have specific restrictions on the levels or kinds of use.* These color additives, which are restricted only by good manufacturing practice, would be among the color additives exempt from certification, which are listed in 21 CFR Part 73, Subpart A; those subject to certification, which are listed in 21 CFR Part 74, Subpart A; and those provisionally listed in 21 CFR 81.1(a) for food use.

These colorants, however, when used in paper and paperboard should not impart a color to the food by migration.

The use of any other color additive as a colorant in paper and paperboard is not authorized by the above policy. Inquiries or requests for such uses should be submitted to *CFSAN/Office of Pre-market Approval (HFS-215)*. *Additionally, 21 CFR 176.170(b) lists specific colorants regulated for use in food contact paper and paperboard. Office of Pre-Market Approval evaluates the use of additional colorants in paper and paperboard on a case-by-case basis*. Actions in this area should be based solely on headquarters initiated assignments. Any questions that might arise concerning the need for sample collections, inspections, or special investigations should be referred to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)* for review and recommendation.

*Material between asterisks is new or revised*

Issued: 5/21/80
Reissued: 10/1/80, 2/26/88
Revised: 3/95

Sec. 500.450 Volatile N-Nitrosamines in Rubber Baby Bottle Nipples (CPG 7117.11)

BACKGROUND:

A German study on the occurrence of volatile N-nitrosamines (nitrosamines) in rubber baby bottle nipples was presented at the meeting of the American Chemical Society in the spring of 1981. FDA's subsequent investigation of the problem revealed the presence of nitrosamines in rubber nipples marketed in the United States and showed that the nitrosamines could migrate into foods, such as milk and infant formula, that contact the nipple during the conventional sterilization process.

FDA expressed concern to the industry over infant exposure to nitrosamines, many of which are carcinogens, and informed manufacturers that appropriate measures must be taken to reduce nitrosamine formation in rubber nipples to the lowest level that is technologically feasible. Manufacturers altered product formulas and manufacturing processes to reduce nitrosamine formation. Available data indicate that nipples containing 10 ppb or less are now possible under existing manufacturing processes.

REGULATORY ACTION GUIDANCE:

Nitrosamines in nipples at levels greater than an established action level are considered avoidable contamination under section 406 of the Federal Food, Drug, and Cosmetic Act.

An action level of 10 ppb for individual nitrosamines applies to both consumer and hospital rubber baby bottle nipples initially introduced or initially delivered for introduction into interstate commerce on or after January 1, 1985.

Samples shall be analyzed according to the method published in Food and Chemical Toxicology, Vol. 20, pp. 939 to 944, 1982 and using the modification described in FDA memorandum dated April 6, 1984, which calls for the addition of 2g Ba(OH)₂ to the solution to be distilled. Confirmation tests should be performed only for nitrosamines that exceed the 10 ppb level.

For shipments of baby bottle nipples, both consumer and hospital nipples, made after January 1, 1985, the following represent criteria for recommending legal action to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)*:

1. The level of any individual volatile N-nitrosamine in each of 3 aliquots from a composite of 12 rubber baby bottle nipples exceeds 10 ppb,

and

2. The identity of the nitrosamine that exceeds the 10 ppb level is confirmed by gas chromatography-mass spectrometry.

*Material between asterisks is new and revised*

Issued: 1/1/84
Revised: 6/6/84, 12/26/84
Reissued: 6/27/88
Revised: 3/95

Sub Chapter 505

Bakery Goods

Sec. 505.100 Bakery Products, Candy - "Catch-All" or "Shotgun" Ingredients Declaration (CPG 7102.01)

BACKGROUND:

The Food and Drug Administration has consistently objected to "catch-all" or "shotgun" ingredient statements in labeling. At the same time it has recognized that there may be instances where this may be a practical technique for labeling assortments or multiple items containing nonuniform ingredients. Therefore, the Food and Drug Administration has not ruled out entirely the possibility of designing labels that are suitable for more than one similar product or for use on packages of assortments. However, it has maintained that any such labeling should not deny the consumer information to which he is entitled, nor should such labeling be misleading.

POLICY:

Regulations 21 CFR^a specify that ingredients shall be listed by common or usual name in order of decreasing predominance by weight. The declaration shall be presented on any appropriate information panel in adequate type size, without obscuring design, vignettes, or crowding. The entire ingredient statement shall appear on a single panel of the label.

Optional ingredients used in standardized food shall also be listed by common name, usually the name by which the ingredient is specified in the standard of identity, in order of decreasing predominance on a single panel of the label except that the standard may require certain words or statements to appear immediately preceding or following the name of the food.

The Food and Drug Administration will not object to "shotgun" ingredients labeling -- labels that are designed for more than one product -- provided other requirements of the Act and regulations are met and such labeling is not false or misleading. It is possible to devise this kind of ingredient labeling for bakery products and candy where:

1. One wrapper is to be used for two or more closely related items in which one or more ingredients are not included in all such items.

2. Assortments in one package and all ingredients are not common to items in the assortments. 21 CFR ^b permits such labeling when "in terms which are as informative as practical and which are not misleading." In cases where such labeling is necessary, those ingredients common to all items should be listed first in the ingredient declaration followed by a listing of ingredients not common to all, including specific indications of which ingredients are actually present in designated articles. Few instances will defy such organization and with the possible exception of candy assortments the statement of identity in conjunction with the ingredient declaration must enable the consumer to tell exactly what is in each article of food.

It is not possible to devise shotgun labeling in instances where a manufacturer wishes to be able to use one or more ingredients interchangeably although it may be possible to devise adequate labeling if the several ingredients are ones that can be designated by a general common or usual name such as leavening or baking powder or in cases where the ingredient is a standardized article. Names that are not accepted common or usual names such as fruit purees, fruits, edible oils, gums, emulsifiers, nut meats, etc., should not be used. Such ingredients should be listed each by specific common or usual names.

^a 21 CFR 101.4*(a) *

^b 21 CFR 101.100(a)(1)

*Material between asterisks is new or revised.*

Issued: 10/1/80
Revised: 8/96

Sec. 505.200 "Butter" Featured in Product Name (CPG 7102.05)

BACKGROUND:

There have been inquiries as to what is required to feature the word "butter" in the labeling of a product as "Butter Cookies," "Butter Shortbread," etc.

POLICY:

The Food and Drug Administration will consider a name "Butter ____________ " or the use of the word butter in conjunction with the name as false and misleading unless all of the shortening ingredient is butter. If the product contains both butter and shortening but a sufficient amount of butter to give a characteristic butter flavor to the product, an appropriate name would be "butter flavored ____________." However, if the product contains any artificial butter flavor it would have to be labeled in compliance with 21 CFR 101.22(i)(2).

Issued: 3/2/77
Revised: 10/1/80
Reissued: 3/8/88

Sec. 505.300 "Butter-Nut" Bread (CPG 7102.04)

BACKGROUND:

Inquiries have been received about the use of the name "Butter-Nut" on the wrapper of white bread. This term has apparently been in general use since as early as World War 1. No action has ever been taken against a product because of this name.

POLICY:

The FDA does not have information that the labeling of bread as "Butter-Nut Bread" is misleading to consumers; therefore, no action will be instituted against a product solely because of the use of this name.

Issued: 1/24/77
Revised: 10/1/80
Reissued: 3/8/88

Sec. 505.350 Honey Bread, Honey Buns (CPG 7102.03)

BACKGROUND:

No standard of identity has been established under the Federal Food, Drug, and Cosmetic Act for "honey bread." Inquiries are sometimes received from bakers concerning the labeling of bread or buns as "honey bread" or "honey buns," or by similar names.

POLICY:

The FDA does not object to use of the word "honey" in the name of nonstandardized bread, buns, or other bakery products if *the products do not purport to be standardized foods and* enough honey is used to give the product a characteristic honey flavor. *FDA believes that at least 8% honey (based on weight of flour) should be used in a bread labeled as honey bread. The use of lesser quantity is not prohibited, but in that case, "honey" should not be featured in the labeling.* Honey must be listed in its order of predominance in the ingredient statement regardless of the *amount* present.

*Material between asterisks is new or revised.*

Issued: 1/19/77
Revised: 10/1/80
Reissued: 3/8/88

Sec. 505.400 Chow Mein Noodles, Chinese Noodles and Other Oriental Noodles; Labeling (CPG 7102.02)

BACKGROUND:

Administration Information Letter No. 84, December 29, 1948, stated:

While we have consistently advised inquirers that Chinese noodles are regarded as the noodles covered by the standard of identity, we have, after a great deal of consideration, decided against any attempt to enforce this policy with respect to the so-called chow mein noodles, either wet or fried. We have not previously made any formal decision regarding the packaged product such as we have here (Chinese Noodles), but there is a substantial argument in favor of taking the same position as with the wet or fried chow mein noodles. In the event of a contest, we would have to admit that this is a product which has for years been marketed with a low egg content or, for that matter, in many cases containing no eggs at all.

In response to numerous inquiries regarding other types of oriental noodles, particularly "Ramen" or "Japanese" noodles, this interpretation is now being applied to oriental noodles other than chow mein noodles and Chinese noodles. These products are not considered to be in violation of the standard of identity for noodles providing that labeling is adequate to prevent misinterpretation by the consumer.

POLICY:

Oriental-style noodles, such as "Japanese," "Ramen," "Chinese," and "chow mein" noodles, are not considered to be the article described by the standards of identity for noodles. Although the composition and appearance of oriental-style noodles may resemble the standardized article, such products are considered not to be in violation of the standard providing they are not represented to be the standardized article.

When such products are labeled "noodles," the descriptor or qualifying term (e.g., "Chinese," "Chow Mein," "Japanese," "Japanese-Style," "Ramen," "Ramen Japanese-Style," "Oriental," "Oriental-Style") should immediately precede "noodles." Both the descriptor and "noodles" should appear in the same type size, style, color, and background contrast.

Issued: 12/3/73
Revised: 10/1/80, 3/8/88, 8/96

Sec. 505.500 Macaroni and Noodle Products - Adulteration Involving Insect Fragments and Rodent Hairs (CPG 7102.06)

BACKGROUND:

The defect action levels established in this guide for macaroni and noodle products are based on an extrapolation of the defect action levels for soft wheat flour. These action levels are necessary as soft wheat flour is permitted to be incorporated into macaroni products, although most macaroni products are manufactured from durum flour and semolina which are excluded from the action levels established for wheat flour (See Sec. 578.450 for CPG 7104.06). A survey of macaroni and noodle products collected from the retail market provided data on the level of unavoidable insect and rodent filth in macaroni products and revealed that the majority of the samples contained filth levels significantly below the levels established in the guide.

REGULATORY ACTION GUIDANCE:

The following represents criteria for recommending direct reference seizure to Division of Compliance Management and Operations (HFC-210) and for direct citation by District Offices:

1. Insect Fragments: Actionable if the average insect fragments in six or more subsamples is greater than or equal to 225 per 225 grams

or

2. Rodent Hairs: Actionable if the average rodent hairs in six or more subsamples is greater than or equal to 4.5 per 225 grams.

*NOTE: Analyze by the method specified in AOAC XV Ed., 969.41.*

SPECIMEN CHARGE:

Article adulterated while held for sale after shipment in interstate commerce, within the meaning of 21 U.S.C. 342(a)(3), in that it consists wholly or in part of a filthy substance by reason of presence therein of insect fragments and rodent hairs.

NOTE: Only use direct citation authority when prosecution is anticipated and evidence to support a prosecution is included with the adulteration charge. Evidence necessary to support a prosecution is specified in existing regulatory procedures issuances.

*Material between asterisks is new or revised.*

Issued: 1/4/82
Revised: 8/96

Sub Chapter 510

Beverages

Sec. 510.100 Beverage Bases (CPG 7101.01) BACKGROUND:

In an issuance identified as TC-215, dated March 21, 1940, we stated:

There would appear to be no objection to designation as a beverage base of a preparation to be mixed with sugar and water to make a beverage, provided the name is accompanied by a conspicuous statement to the effect that the article is to be used with sugar. As you know, there are on the market complete beverage bases, that is, articles to which it is necessary to add only water to make a finished beverage. The purchaser should be able to readily distinguish, by means of the name or accompanying statement, between such articles and those to which sugar must be added by the purchaser before beverages can be made from them.

POLICY:

We consider the designation "beverage base" acceptable as the common or usual name required by section 403(i)(1) of the Federal Food, Drug, and Cosmetic Act and to specify the identity of an article as required by section 4(a)(1) of the Fair Packaging and Labeling Act, provided: the article is one to which only water need be added to make a finished beverage. If ingredients other than water must be added to make the beverage, the name is accompanied by a conspicuous statement concerning the ingredient or ingredients which must be added.

Issued: 12/3/73
Reissued: 10/1/80
Revised: 11/1/88

Sec. 510.200 Brandy Containing Methyl Alcohol - Food Additive (CPG 7119.09)

BACKGROUND:

Domestic brandies rarely exceed 0.1% methyl alcohol and manufacturers of foreign brandies do not usually offer for import into the U.S. brandies exceeding 0.35% methyl alcohol. However, foreign brandies manufactured for consumption within their native countries may contain up to 1% or more. More than 20 years ago the Alcohol and Tobacco Tax Division, Internal Revenue Service and FDA mutually agreed that the maximum permitted level of methyl alcohol in brandy should be informally established at 0.35%.

REGULATORY ACTION GUIDANCE:

Detain if the brandy contains in excess of 0.35% methyl alcohol (Imports only).

Issued: 10/1/80

Sec. 510.300 Unfermented Beverages - Use of Word "Campagne" (CPG 7101.03)

BACKGROUND:

The term "champagne" when used alone and apart from any qualifying or descriptive words has been commonly understood to describe an effervescent or sparkling wine produced in a Province of France, the gas therein being the result of natural fermentation.

In the case of U.S. v. Schraubstadter et al. the Court indicated that a wine having substantially the same qualities as the champagne manufactured in France and produced substantially in the same way, originating in California, should not be held to be misbranded if labeled "California Champagne." (See N.J. No. 1020 and 199 Fed. 568).

The Food and Drug Administration has consistently expressed the opinion that the word "champagne" is false and misleading when used to describe such products as soda water, artificially carbonated grape juice, artificially carbonated sweet cider, etc. A seizure was made in 1921 of an artificially carbonated apple juice with capsicum, labeled "Sparkling White Seal" and so packaged to imply it was champagne. The verdict for the government was appealed and was upheld by the Circuit Court of Appeals (Duffy-Mott Co. v. U.S. 285 Fed. 737).

Even when it is apparent to prospective purchasers that an article is not "champagne," the word carries connotations of superior quality.

POLICY:

The word "champagne" is objectionable when used to describe such products as soda water, artificially carbonated grape juice, artificially carbonated sweet cider, or similar beverages, and may cause such beverages to be misbranded.

Issued: 10/01/80

Sec. 510.400 Dealcoholized Wine and Malt Beverages - Labeling (CPG 7101.04)

BACKGROUND:

Wine is defined in the Federal Alcohol Administration Act (FAA Act) as, among other things, containing not less than 7 and not more than 24 percent alcohol by volume [27 U.S.C. 211(a)(6)]. Bureau of Alcohol, Tobacco and Firearms (BATF) labeling regulations apply only to wines containing alcohol within the specified range. Dealcoholized wines are prepared by removing alcohol from a wine. Because dealcoholized wine products contain less than 7 percent alcohol by volume, they are not covered by the FAA Act and are subject to the labeling provisions of the Federal Food, Drug, and Cosmetic Act.

The term "malt beverage" is defined in the FAA Act as a beverage made by alcoholic fermentation of specific materials [27 U.S.C. 211(a)(7)]. Malt beverages are not characterized by specific alcohol content. All malt beverages meeting the definition of the FAA Act are within the purview of the BATF statute, regardless of alcohol content. Regulations pertaining to the labeling of malt beverages are found in Title 27 of the Code of Federal Regulations, Part 7.

POLICY:

The term "dealcoholized" or "alcohol-removed" should appear in the statement of identity, immediately preceding either the term "wine" or the standard of identity [27 CFR 4.21] designation of the type of wine from which it was derived, such as "burgundy." The qualifying words "dealcoholized" or "alcohol-removed" should appear in letters equal in size to "wine" or to the standardized name on the principal display panel of the label. Where a specific designation is used, such as "dealcoholized claret" or "alcohol-removed burgundy," the product must be true to source type as defined by BATF regulations. To ensure that consumers are not misled as to the alcohol content of the product, the statement of identity should be followed by the declaration, "contains less than 0.5 percent alcohol by volume." FDA considers use of the terms "dealcoholized" and "alcohol-removed" in the statement of identity of a reduced alcohol wine product to be misleading if the alcohol content exceeds 0.5 percent by volume.

We do not object to the presence of the additional label claim "non-alcoholic" on labels of dealcoholized wines. However, the term "non-alcoholic" should not be used in lieu of the term "dealcoholized" or "alcohol-removed" as the sole qualifier in the statement of identity of the wine product.

FDA does not consider the terms "non-alcoholic" and "alcohol-free" to be synonymous. The term "alcohol-free" may be used only when the product contains no detectable alcohol.

Beverages such as soft drinks, fruit juices, and certain other flavored beverages which are traditionally perceived by consumers to be "non-alcoholic" could actually contain traces of alcohol (less than 0.5 percent alcohol by volume) derived from the use of flavoring extracts or from natural fermentation. FDA also considers beverages containing such trace amounts of alcohol to be "non-alcoholic." We, therefore, have no basis for objecting to claims of "non-alcoholic" on labels of dealcoholized wines, even though they are derived from alcoholic beverages. FDA policy and BATF regulations on the labeling of malt beverages (27 CFR 7.26) are consistent on the use of the terms "non-alcoholic" and "alcohol-free."

The labeling of malt beverages that are prepared in accordance with the provisions of 27 CFR Part 7 (including dealcoholized malt beverages) is solely under the jurisdiction of BATF. Inquiries concerning the labeling of malt beverages should be referred to BATF's Product Compliance Branch. If it is unclear whether a product meets the FAA Act definition of malt beverage, contact BATF for guidance. If BATF concludes that a product is not within their jurisdiction, FDA will exercise authority over the label of the beverage. If there are questions concerning the statement of identity of a non-BATF regulated product, contact *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)* for coordination and guidance.

*Material between asterisks is new or revised.*

Issued: 10/01/80
Revised: 9/11/89, 3/95

Sec. 510.450 Labeling - Diluted Wines and Cider with Less Than 7% Alcohol (CPG 7101.05)

BACKGROUND:

FDA has received *inquires* concerning which federal agency has jurisdiction over the labeling of diluted wines and ciders. These questions concern such beverages which contain less than 7% alcohol by volume.

Alcoholic beverages subject to or complying with packaging or labeling requirements imposed by the Federal Alcohol Administration Act, 27 U.S.C. 201 et seq. (FAA Act), administered by the Treasury Department, are exempt from the requirements of the Fair Packaging and Labeling Act (Sec. 10(a)(4)). Wine is defined by the FAA Act as having 7% or more of alcohol by volume. The above mentioned products with less than 7% alcohol are not defined in this Act, or subject to the packaging and labeling requirements of this Act. Thus, their packaging and labeling is subject to requirements of both the FD&C Act and the FP&L Act.

POLICY:

Beverages such as diluted wine and cider, which have an alcohol content of less than 7% by volume and are not defined in the Federal Alcohol Administration Act, are subject to the labeling requirements of the Federal Food, Drug, and Cosmetic Act and Fair Packaging and Labeling Act as expressed in Title 21 of the Code of Federal Regulations.

*Material between asterisks is new or revised.*

Issued: 10/01/80
Revised: 3/95, 8/96

Sec. 510.500 Green Coffee Beans - Adulteration with Insects; Mold (CPG 7101.06)

REGULATORY ACTION GUIDANCE:

The following represents criteria for direct reference seizure to Division of Compliance Management and Operations, (HFC-210), and for direct citation by District Offices:

1. Insects and Mold - an average of 10 percent or more by count of green coffee beans are insect infested, including insect damaged, or moldy;

or

2. Graded green coffee beans are poorer than Grade 8 of the New York Green Coffee Association.

*NOTE: Criteria for direct reference seizure are determined using the method specified in FDA Technical Bulletin Number 5, "Macroanalytical Procedures Manual," Chapter V.1.A - Method for Coffee Beans.*

REMARKS:

If live external infestation is present use the CPG titled "Food Storage and Warehousing - Adulteration - Filth" (See Sec. 580.100 for CPG 7103.01) in accordance with "Interpretation of Insect Filth" (See Sec. 555.600 for CPG 7120.18).

SPECIMEN CHARGE:

*Article (Green Coffee Beans) adulterated (when introduced into and while in interstate commerce) (while held for sale after shipment in interstate commerce), within the meaning of 21 U.S.C. 342(a)(3), in that it consists wholly or in part of a filthy substance by reason of presence therein of (insects), (insect fragments), and (insect damaged green coffee beans); and that is consists in part of a decomposed substance by reason of presence therein of (moldy, decomposed green coffee beans).*

NOTE: Psocids, as well as other non-storage insects not normally associated with green coffee beans, are to be reported separately from live whole insects or equivalent. The presence of such incidental non-storage insects in a lot of green coffee beans does not meet the criteria for direct reference seizure under this guide or the guide for food storage and warehousing. Any regulatory action based on the presence of such incidental non-storage insects must be referred to CFSAN/Office of Field Programs/Division of Enforcement (HFS-605) for coordination and review.

*Material between asterisks is new or revised.*

Issued: 10/01/80
Revised: 3/95, 8/96

Sec. 510.600 Dimethylnitrosamine in Malt Beverages (CPG 7101.07)

BACKGROUND:

In 1978, the United States Brewers Association (USBA) informed the FDA that German researchers had reported finding low levels of dimethylnitrosamine (DMNA) in beer. The FDA and USBA each surveyed beers and other malt beverages available in the United States and reported similar findings. Based on information from the Germans and subsequent investigations by the USBA, it is apparent that DMNA formation occurs principally during the kilning (drying) of sprouted barley used in the production of barley malt. The barley malt is then used in the wort for making beer and other malt beverages.

The level of DMNA formed during kilning varies depending on a number of factors. Studies have shown that higher levels of DMNA are more likely to occur when the malt is kilned by direct fire (open flame) than when indirect fire is used. Various methods for reducing DMNA formation have been investigated, including the introduction of sulfur to the open flame. Although other techniques are under experimentation, the USBA has reported that sulfur is being used during kilning for most barley malt currently produced in the U.S., resulting in substantially lowered levels of DMNA. Consequently, the level of DMNA in beverages produced from those malts also should be substantially reduced.

DMNA has been shown to cause cancer in laboratory animals and a level of safety cannot be established. The agency has determined that it is necessary to minimize human exposure to the lowest practical level. This level was determined to be 5 ppb DMNA, based on the analytical limit and the extent to which DMNA can be reduced in malt beverages by good manufacturing practices. Beverages containing more than 5 ppb DMNA may be considered to be adulterated under section 402 of the Act.

REGULATORY ACTION GUIDANCE:

The following represents criteria for recommending legal action to CFSAN/Office of Field Programs/Division of Enforcement (HFS-605):

Each of four subsamples contains greater than 5 ppb DMNA and the presence of DMNA is confirmed by mass spectectometry.

NOTE: Refer to Sec. 578.500 (CPG 7104.07) for DMNA in barley malt.

Issued: 8/24/70
Revised: 10/1/80
Reissued: 11/1/88
Revised: 3/95, 8/96

Sec. 510.700 Fortification of Standardized Juices (CPG 7101.08)

BACKGROUND:

In response to an inquiry submitted by the State of Florida, Department of Citrus, concerning whether orange or grapefruit juices, which otherwise comply with applicable standards of identity, can be fortified or enriched in any manner provided they are appropriately labeled, the Associate Commissioner for Regulatory Affairs issued an advisory opinion (Docket Number 87A-0237). The relevant policy expressed in the advisory opinion is quoted under the POLICY heading of this guide.

POLICY:

The agency believes that it will be necessary to consider each product, its fortification, use, and labeling, on its own merits. Generally, FDA believes that fortification of a standardized product would violate the standard of identity if the resultant fortified product purports to be or is represented as the standardized product. Specific foods that are subject to a standard may, however, be fortified, and the resultant products marketed as a non-standardized product under certain conditions.

In 1980, FDA adopted a fortification policy (21 CFR 104.20) ... that identifies the basis for food fortification that FDA considers reasonable (45 FR 6316). The agency stated: "Indiscriminate fortification of foods could lead to confusion about the necessity or propriety of food fortification. It could mislead consumers about the overall nutritional value of various kinds of foods and could lead to potentially serious health problems" (45 FR 6322).

It is therefore FDA's position that fortification of a food in a manner that is not consistent with FDA's fortification policy may be misleading. If the act of fortification is misleading, it follows that a common or usual name that reflects that act is also misleading. In addition, the agency is concerned that the declaration of the fortification may be accompanied by deceptive or misleading claims for the fortified food that lead the consumer to believe that there is some special benefit from eating the food, which may not be the case. To the contrary, consumption of a food that has been fortified in a manner not consistent with 21 CFR 104.20 may lead to excessive intake of a nutrient, which can have harmful consequences.

Therefore, while it may be possible to make a fortified orange juice or grapefruit juice product, such a product cannot be made in any manner that a manufacturer may choose. The orange or grapefruit juice to which the nutrients are to be added must meet the definition and standard of identity for the unfortified juice.

In addition, the product must be labeled as required by the Food, Drug, and Cosmetic Act and the regulations promulgated under 21 CFR Part 101. In particular, the labeling of the fortified product must bear, among other things, a common or usual name or descriptive term which includes the name of the added nutrient, e.g., "orange juice product with added _____." The purpose of this requirement is to assure that the fortified juice product is easily distinguishable from the non-fortified standardized juice.

Finally, the fortification *should* be consistent with 21 CFR 104.20. Nutrients may appropriately be added to a food to correct a dietary insufficiency recognized by the scientific community. FDA urges manufacturers who may be contemplating making a fortified juice product to present to the agency, before implementing a fortification plan, information that, among other things, demonstrates that a dietary insufficiency exists; identifies the affected population groups; and shows that the nutrient is stable in the food, is physiologically available from the food, is present in the food at a level that will not result in excess consumption of the nutrient, and is suitable for its intended purpose.

If the guidelines as set forth in 21 CFR 104.20 are not followed in the fortification of food products, such as juices in question, the fortification products and their labeling may be misleading and subject to regulatory action.

*Material between asterisks is new or revised.*

Issued: 5/13/88
Revised: 8/96