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M-I-03-14: Labeling and Standards of Identity Questions and Answers

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HHS:PHS:FDA:CFSAN:OC:DCP:MSB

5100 Paint Branch Parkway
College Park, MD 20740-3835

M-I-03-14

October 3, 2003

TO: All Regional Food and Drug Directors
Attn: Regional Milk Specialists

FROM: Milk Safety Branch (HFS-626)

SUBJECT: Labeling and Standards of Identity Questions and Answers

Following are questions and answers concerning Labeling and Standard of Identity issues raised at recent Regional Milk Seminars and Special Problems in Milk Protection Courses.

Copies of this memorandum are enclosed for distribution to Regional Milk Specialists, State Milk Regulatory Agencies, State Laboratory Evaluation Officers and State Milk Sanitation Rating Officers in your region. This memorandum should be widely distributed to representatives of the dairy industry and other interested parties and also will be available on the FDA Web site at http://www.cfsan.fda.gov at a later date.

If you would like an electronic version of this document prior to it being available on the CFSAN Web Site, please e-mail your request to Robert.Hennes@cfsan.fda.gov.
 

/s/

Norris A. Robertson, Jr.,
Milk Sanitation Officer
Milk Safety Branch

/s/

CAPT Robert F. Hennes, RS, MPH, Chief
Milk Safety Branch
 

LABELING AND STANDARDS OF IDENTITY
QUESTIONS AND ANSWERS

  1. PMO-Sections 1 and 4 and Appendix L.

    Can dimethylpolysiloxane, a defoamer, be added to milk sold as milk?

    No. Dimethylpolysiloxane cannot be added to milk (of any fat level) that is sold as "Milk". (Refer to 21 CFR 173.340)

    Can dimethylpolysiloxane be added to milk used to make standardized lowfat yogurt?

    Yes. Dimethylpolysiloxane may be added as a defoaming agent to milk that is used to make standardized lowfat yogurt, provided it meets the requirements listed under 21 CFR 173.340 and 130.8.

    Section 173.340 allows for the addition of dimethylpolysiloxane in the processing of food, and its use is considered safe if present at a level that results in the food, i.e., yogurt, containing no more than 10 parts per million.

    Section 130.8 allows a food to conform to the standard of identity for that particular food even if it contains an ingredient not provided for in the standard of identity, provided that: 1) the ingredient is introduced in the standardized food as a result of its addition to another ingredient permitted by the standard of identity for that food, and 2) the ingredient qualifies as an incidental additive in non-standardized foods in accordance with 21 CFR 101.100.

    In the case of adding dimethylpolysiloxane to lowfat yogurt, it meets the first requirement stated above, if it is introduced into lowfat yogurt as part of lowfat milk. It also qualifies as an incidental additive under 21 CFR 101.100(a)(3)(ii)(c), if it is added to the food for its technical or functional effect during processing, but does not have a functional or technical effect in the finished food, lowfat yogurt, and is present in insignificant amounts in the finished food.

  2. PMO-Sections 1 and 4 and Appendix L.

    How should a dried blended product of nonfat milk and lactose reduced ultra-filtered (UF) milk be labeled?

    We recommend that the product be labeled as "DRIED BLEND OF NONFAT MILK AND ULTRA-FILTERED, LACTOSE REDUCED, NONFAT MILK". A label such as "High Protein Nonfat Dry Milk Powder" is not acceptable to FDA. This dried blended product does not meet the standard of identity for Nonfat Dry Milk and therefore cannot be labeled as such. (Refer to 21 CFR 131.125) However, the amount of protein contained in the dried blended product could be placed below the product identification, i.e., "?? % Protein".

    Can a dried blended product of nonfat milk and lactose reduced ultra-filtered (UF) milk be labeled Grade "A", and if so, in what Grade "A" products can it be added to as an ingredient?

    If this dried blended product is derived from Grade "A" milk, it can be labeled as Grade "A" and can be IMS Listed. It should be listed as Code 27 in the IMS List. However, very few standards of identity for Grade "A" products allow UF milk to be added. Many standards of identity do not allow for any ingredient except "milk". If the standard of identity only allows for "milk", this dried blended product is not "milk" and cannot be added. There are products that provide for the addition of optional dairy ingredients and other optional ingredients. This dried blended product may be appropriate in these Grade "A" products. However, whenever this dried blended product is used, it must be declared in the ingredient statement of the finished food.

    This product may not be appropriate for other milk products, for example, dry curd cottage cheese and sour cream. The standard of identity for dry curd cottage cheese (21 CFR 133.129) provides for the use of specific dairy ingredients. These dairy ingredients are sweet skim milk, concentrated skim milk and nonfat dry milk. (Refer to 21 CFR 133.129(b)(2)) The dried blended product would not qualify. The standard of identity for sour cream (21 CFR 131.160) permits the use of only pasteurized cream as the basic ingredient. It provides for the optional use of safe and suitable ingredients that improve texture, prevent syneresis, or extend the shelf life of the product. (Refer to 21 CFR 131.160(b)) This dried blended product does not meet these stipulations required for optional ingredients.

  3. PMO-Sections 1 and 4 and Appendix L.

    The Grade "A" dried powder blend, trade name "Culture Mate", ingredient statement lists "hydrolyzed casein". However, the blend sheets indicate that "whey protein hydrolysate" is used. Would this situation be a labeling violation that we should address?

    Yes. Whey protein hydrolysate and hydrolyzed casein are two distinct and separate ingredients, the names of which cannot be used interchangeably. Section 102.22 requires protein hydrolysates to be named using the specific source of the protein. Therefore, if the manufacturer used the ingredient "whey protein hydrolysate" in the "Culture Mate" premix as shown in the blend sheet, then the ingredient statement of this food must declare this ingredient as "whey protein hydrolysate," and not as "hydrolyzed casein" as is currently being identified.

    The Milk Safety Branch (MSB) would recommend that the State Regulatory Agency work with the company to get the label corrected within a reasonable period of time. MSB would also recommend that such violations found on a rating or check rating of the blending plant be indicated as a labeling violation and the appropriate corresponding value be taken from Number 3, Part III of the "Report of Enforcement Methods".

  4. PMO-Sections 1 and 4 and Appendix L.

    Is a milk product labeled "Fat Free Half-and-Half " properly labeled?

    Yes. A milk product can be labeled "Fat Free Half-and-Half" provided it meets the requirements of 21 CFR 131.180, 21 CFR 130.10, and 21 CFR 101.62. This would be a food that uses a standardized name and a nutrient content claim per the provisions in 21 CFR 130.10.

  5. PMO-Section 4

    Is the labeling term "Extra Rich" allowed on a whole milk package where the milk has a milkfat content of 5 percent?

    No. The standard of identity for milk provides for a minimum milk fat content of 3.25 percent. (Refer to 21 CFR 131.110) Therefore, a whole milk product with a milkfat content of 5 percent is still the standardized food "milk".

    The claim "Extra Rich" explicitly and implicitly characterizes the level of nutrients in this food and therefore must comply with the laws and regulations governing nutrient content claims. Nutrient content claims may only be used, if they are authorized. The term "Extra Rich" is not authorized by regulation or by the act and; therefore, cannot be used on a food label in a nutrient context.

    "Extra" is an authorized nutrient content claim. (Refer to 21 CFR 101.54(e)) However, this claim may not be used to describe the level of fat in a food. "Extra" may be used to describe the level of protein, vitamins, minerals, dietary fiber or potassium, provided, in part, that the food contains at least 10 percent more of the Reference Daily Intake (RDI) or Daily Reference Value (DRV) of the specified nutrient per Reference Amount Customarily Consumed (RACC).

    "Rich in" is also an authorized nutrient content claim. (Refer to 21 CFR 101.54(b)) This claim may be used to describe the level of a nutrient with an established RDI or DRV, provided, in part, the food contains 20 percent or more of the RDI or DRV of the specified nutrient per the RACC. (Refer to 21 CFR 101.54(b)) While "Rich in" was not originally intended to cover the nutrient "fat", 21 CFR 101.54(b) does not specifically prohibit a "Rich in Fat" claim. However, in order for a product to claim that it is "Rich in Fat", it would have to contain at least 13 grams of fat per reference amount customarily consumed. The reference amount for milk is 240 mL (1 cup). (Refer to 21 CFR 101.12) Would a whole milk product with a milkfat content of 5 percent require a statement regarding the percentage of milkfat in the product?

    No. However, we recognize that firms may want to distinguish 5 percent fat milk from 3.25 percent fat milk. We would not object to a factual claim, such as, "5% fat" to make this distinction. In addition, we would not object to a fanciful term in conjunction with the declaration of the percentage fat, provided that the fanciful term does not explicitly or implicitly characterize the level of fat in this food. (Refer to 21 CFR 101.3(b))

  6. PMO-Appendix L.

    Is vitamin addition to milk optional or required?

    Vitamin addition to milk is optional. (Refer to 21 CFR 131.110) The standard for "milk" allows for the optional addition of vitamins A and D. However, if vitamins A and D are added, they must be present at levels required in the standard, i.e., 2000 IU for vitamin A and 400 IU for vitamin D per quart. (Refer to 21 CFR 131.110(b))

    Is vitamin addition to lowfat, reduced fat or skim milk optional or required?

    Vitamin addition to lowfat or reduced fat milk is required to replenish any reduction in essential nutrients caused by the removal of the fat. (Refer to 21 CFR 130.10(b)) However, vitamin addition to lowfat, reduced fat or skim milk, beyond replenishing any reduction in essential nutrients caused by the removal of the fat, is also optional.

    Section 130.10 specifies that standardized foods that are modified to make nutrient content claims, i.e. lowfat or reduced fat, must not be nutritionally inferior to the standardized food. Nutritional inferiority means any reduction of an essential nutrient present in a measurable amount, i.e. at least 2% of the Daily Reference Value per Reference Amount Customarily Consumed. In the case of milk, vitamin A, for example, is an essential nutrient that is lost by partially or completely removing the fat portion, and that meets the "measurable amount" requirement. Therefore, vitamin A is required to be added to lowfat, reduced fat and skim milks at a level needed to replace that lost by removing the fat portion of unfortified whole milk. (Refer to 21 CFR 130.10 (b)) If vitamin D is present in a measurable amount in unfortified whole milk (i.e., at least 8 IU per 240 mL), vitamin D must be added back in an amount needed to replace that lost by removing the fat portion to produce lowfat, nonfat, or skim milk. (Refer to 21 CFR 130.10 (b))

    The addition of any nutrients, including vitamins A and D, over and above that needed to restore the levels lost during processing of lowfat, reduced fat or skim milk is optional and depends on the nutrient content claim made on the label. For example, if these milks made relative claims on the labels; such as, "fortified", "enriched", or "added" with respect to vitamin A and/or D content, they would need to meet the requirements of 21 CFR 101.54(e).

  7. PMO-Appendix L.

    Can menhaden oil be used in Grade "A" dairy products?

    Yes. However, the use on menhaden oil in dairy products is determined by section 184.1472 and the standard of identify of the particular standardized food. Menhaden oil is currently allowed in several dairy products, including cheese products and frozen dairy products, at specific maximum levels of use. (Refer to 21 CFR 184.1472 and relevant definitions in 21 CFR 170.3.)

    Specifically, can menhaden oil be used in Yogurt?

    No. "Yogurt" may not contain menhaden oil as the standards for "yogurt", "lowfat yogurt", and "nonfat yogurt" (21 CFR 131.200, 21 CFR 131.203 and 21 CFR 131.206, respectively) do not provide for the addition of menhaden oil. (Refer to 21 CFR 170.10) However, menhaden oil is considered GRAS and is allowed in yogurt-based non-standardized products at a maximum level of use of 4.0%. (Refer to 21 CFR 184.1472)

    Menhaden oil is permitted in yogurt-based non-standardized products, but not in "yogurt" because per 21 CFR 170.10, simply because a food additive/GRAS regulation permits the addition of an ingredient in a food, it does not imply that the ingredient may be used in a standardized food, unless it is recognized as a permitted ingredient in the applicable food standard(s). Therefore, given that the standards for "yogurt", "lowfat yogurt", or "nonfat yogurt" do not provide for the addition of menhaden oil, this ingredient is not permitted in a product that is named "yogurt", "lowfat yogurt", or "nonfat yogurt". However, because this ingredient is a safe and suitable substance for use in the yogurt category of foods, it may be added to non-standardized yogurt products (i.e., a non-standardized yogurt-based beverage) as specified by 21 CFR 184.1472.

    In 2002, FDA proposed to amend 184.1472. (Refer to 67 Federal Register 8744 (February 26, 2002)). Among other things, FDA proposed to allow menhaden oil in "milk products" (a food category defined in 21 CFR 170.3 (n)(31), which encompasses yogurt-based non-standardized products) at a maximum level of use of 5.0%. The proposed rule indicates that the intended use of menhaden oil is as a substitute for other edible fats or oils. However, this is only a proposed rule, and is not currently in effect. Note, as explained above, the current regulation permits the use in this category of foods at a maximum level of use of 4%.