Q: I heard that the amount of sodium lactate allowed in some products has changes but it is not in the 2000 9 CFR. Can you give me this information?

A. According to 9 CFR 424.21(c), sodium lactate can be used as a anti-microbial in various meat & poultry products at a level of 4.8%. This regulation came out earlier this year after the 2000 9 CFR was published.

Q: I am producing a chicken taco meat filling with mostly dark chicken meat. My inspector is questioning why we don’t have to add “dark” to the product name. Can you please clarify?

A. 9 CFR 381.117(c) states that if poultry amount is below 10% of the total product or the poultry is ground, you do not need to indicate light or dark in the product name. The premise is that the light and dark chicken will be indistinguishable in the product.

Q: We are now able to approve standardized products generically in house.  Beef Patties are considered a non-specific product by USDA.  Since it does have a regulation in the CFR, does that make beef patties a standardized product?  Would the Labeling Review Branch approve this if it was given to them? 

 A: Beef patties are a standardized product as it is listed in the 9 CFR 319.15.c. It says that "Beef Patties" shall consist of “fresh and/or frozen beef with or without the addition of beef fat as such and/or seasoning, binders, Mechanically Separated (Species) used in accordance with 9CFR 319.6, and/or partially defatted beef fatty tissue may be used without added water or with added water only in amounts such that the product characteristics are essentially that of a meat patty”.  As long as the product has no claims or nutritional facts panel, it could be approved generically.  The LRB (Labeling Review Branch) could also approve this but it would not be a priority for them.

Q: If I had ingredients that were considered natural but the product was oven baked, could I still state "All Natural" or "All natural ingredients" on my label?

 A:  As long as the ingredients are not specially processed and are considered natural, it does not matter what the cooking method is on the product.  The ingredients must meet the criteria for natural as stated in Policy Memo 055 which states the ingredients are not any kind of “artificial flavor or flavoring, coloring ingredient, or chemical preservative (as defined in 21 CFR 101.22), or any other artificial or synthetic ingredient”.

Q:   I had a label refused for the product name which is Caribbean Style Chicken.  The reviewer stated that Caribbean Style is not defined and the name should be Caribbean Brand Chicken, Made in Chicago.  I am using a purchased Caribbean seasoning blend and thought that would be enough.  What do I need to do get this label approved without “brand” in the name?  

A:  If a purchased seasoning has as part of its name a geographic term, then that term may be incorporated into the product name.  For example, if a seasoning called "Caribbean Seasoning #312" were to be used on  a pork loin, the product name could read, "Pork Loin with Caribbean Seasoning".  To gain USDA approval, a copy of the purchased seasoning label would need to be included in the USDA label documentation.

 Because there is no definition for "Caribbean Style", the product could not be called "Caribbean Style Pork Loin" or "Caribbean Pork Loin", unless it were made in the Caribbean.

Q:  Can we apply the 70/30 rule on mechanically separated chicken and turkey, and use "and" in place of a comma between these ingredients? For example mechanically separated chicken and turkey?

A:  This information is found in the Final Rule for the Use of Two Kinds of Poultry Without Label Change in the Federal Register entry dated March 9, 1998. It states that mechanically separated poultry is considered part of the poultry ingredients. The poultry ingredients must constitute no more than 30% of the poultry and poultry ingredients because the remainder must be the poultry. The poultry ingredients "must be listed separately in the ingredient statement, including the mechanically separated (kind) in accordance with the November 3, 1995, regulatory change in the poultry product inspection regulations (9 CFR 381.117 (e))". Therefore, mechanically separated chicken and mechanically separated turkey must be listed as such in the ingredient statement without the use of "and".

Q:  We manufacture different types of Burritos in Florida. Can we call our product Southwestern Style Burrito even though we are not in the southwest?

A:  Yes, if you have at least 4 of the following ingredients: Bean, Corn, Cilantro, Peppers (Chili or Bell Pepper), Monterey Jack Cheese or Cheddar Cheese. The Southwest standard was just released as a new standard this past spring. It should be published the next time the Food Standards and Labeling Policy Book is updated.

Q:  On my package, I have decided to put my signature line and ingredient statement on the principal display panel of my label and my nutrition facts panel on my information panel. Is this acceptable?

A:  Yes, it is. According to 317.2, the ingredient statement, signature line and the nutrition facts panel can be placed on the information panel. If you choose to put the ingredient statement and the signature line on the PDP, you may. If the ingredient statement, signature line and nutrition facts panel are displayed on the information panel, then they must be contiguous to one another (9 CFR 317.2 (m)(2)(ii). The required information does not need to be duplicated on more than one panel.

Q:  I produce sample product in my plant on a fairly regular basis. What guidelines do I need to follow to label the product?

A:  Sample labels need to follow all of the guidelines that regular product labels follow. All required features are needed for sample labels. The only difference is the sample labels do not need to come into Washington for approval. They do need, however, to be generically approved in your plant (9 CFR 317.5 (b)(8)).

Q:  I have a bacon flavor that has a USDA legend on the label. I would like to put the flavor into my product but do not want my product to be amenable. If I know the percent of bacon in the flavor, can I base the amenability on the percent bacon in the flavor or do I have to base it on the amount of bacon flavor in my product?

A:  The amenability of the product is based on the amount of bacon flavor in the product not the amount of bacon in the bacon flavor. According the the Food Standards and Labeling Policy Book, any food that contains as least 3% raw or 2% cooked meat or poultry falls under USDA jurisdiction. For this product, you could have no more than 2% bacon flavor in your product and still fall under FDA jurisdiction.

Q:  What can you call a product with 70% BBQ Sauce, 20% cooked beef and 10% textured vegetable protein?

A:  Since this product does not meet the BBQ Sauce with Meat standard and the meat to TVP ratio is less than 7:1, the name can be BBQ Sauce, Cooked Beef and Textured Vegetable Protein Product. You must make sure the product is nutritionally equivalent to BBQ Sauce with Meat (the TVP must be fortified).

Q:  Why can't I put binders in my cooked chicken sausage?

A:  Chicken sausage falls under the requirement for "species" sausage. This sausage, per 9 CFR 319.140, is only permitted to have condimental seasonings, 3% water, and no more than 50% fat. Even though you are cooking this sausage, binders are not permitted. Binders are permitted, however, in generic-type cooked sausages at levels of up to 3.5% per 318.7 & 319.180(e), so this product could be called by it's generic sausage name such as wiener, furter, wurst, etc and qualified by "made with chicken."

Q:  I submitted a Pizza Flavored Frank to the Labeling Review Branch and it was refused. Why can't I use pizza flavored to describe my franks (or other products like meatballs etc)?

A:  The problem here is that you are using Pizza, which has a defined standard, in a product name of another product that also has a defined standard. Pizza, according to the USDA (319.600) is a bread based food product with tomato sauce, cheese, and meat topping. The USDA prohibits the use of the term "flavored" to indicate a product that fails to meet the standard. Your frank also has a standard which defines its’ composition, therefore you must describe it as such. You may indicate however that your standardized product is made with pizza seasonings. Another option is to use pizza in a fanciful name followed by a descriptive name or as a nonspecific product followed by the ingredient statement.

Q: I am working on a new product with cooked chicken, vegetables, and breadcrumbs. The percent breakdown is 10% cooked chicken, 16% breadcrumbs, 57% vegetables and 17% sauce. I wanted to call this a chicken stew but the standard for chicken stew requires 12%-cooked chicken. What other options do I have?

A: There 2 options for this product.The percent chicken could be raised to 12% or the product canbe called "Vegetable Stew with Chicken".

Q: When can you use herb in the product name?

A: Herb is not a recognized term at USDA. If the herbs are different spices, they must be listed as spices on the labels. If a non-meat purchased product is used in a meat or poultry product and herb is in the product name, then USDA allows herb on the meat or poultry product label.

Q: What should the correct serving size be for a 12-oz bone in steak? The percent of bone in the steak is 20%.

A: The serving size for any food product should be based on the edible portion of the product. Since there is 20% bone, the edible portion is 9.6 oz. The steak is a discrete unit so the serving size would be 1 steak (269g/9.6 oz). Also, make sure it is stated on the transmittal the approximate amount of bone in the steak and that the nutrition facts panel is base on the edible portion of the steak.

Q: I recently purchased some poultry items off the Internet and noticed they did not have nutrition labeling. Are federally inspected products sold over the Internet considered retail products?

A: USDA considers meat and poultry products sold over the Internet as retail products. The products are manufactured and sold directly to the consumer without going through the grocery store. All required labeling features must be on the label and, if necessary, FSIS approval of the label. If these guidelines are not followed, then FSIS may prohibit sale of your product until they are meet. This also applies to home replacement meals sold over the Internet. FSIS does not consider these products as deli type products because they are packaged and then delivered to the consumer.

Q: Can I make a breakfast sausage with beef or sheep and still call it breakfast sausage (not include the species in the product name)? I have noticed most breakfast sausages are made from pork.

A: In 319.143 it states breakfast sausage is "…prepared with fresh and/or meat; or fresh and/or frozen meat and meat by-products…". In 301.2(rr)(1) meat is defined as the "…part of the muscle of any cattle, sheep, swine or goats which is skeletal…". Since meat is defined as cattle, sheep, swine or goats, any of these meats can be used in breakfast sausage and be named Breakfast Sausage.

Q: I am designing a new package for a brand new line of burritos and would like to have a plate full of burritos (8-10) in the picture on the package. The package only holds 4 burritos. I will say "Serving Suggestion" next to the picture. Can I do this?

A: No. The picture on the package has to be somewhat representative of what's in the package. If you show more burritos on the package than what's in the package, the consumer may believe that is what is really in the package.

Q: We are preparing a label for a product that will be imported into the US. We have the product name on the principal display panel and on the sides of the package. "Product of Canada" is under the product name on the principal display panel (PDP). Do we need to have "Product of Canada" every where the product name is?

A: Yes, you do. In the Standards and Labeling Policy Book it states that the country of origin must be shown immediately after the product name. It does not state that you must put the country of origin after each name but in the SLPB entry it does say that imported products must state the country of origin so they are not misrepresented as American products.

Q: I have a cooked ham that I would like to label as natural. Is this possible?

A: No. In order to call something natural, it must not contain any preservatives and be minimally processed (Policy Memo 055). The sodium nitrite (a preservative) used in curing hams also artificially colors the product so the product is altered from its natural state. On a natural product you must state that the product is minimally processed-no artificial ingredients. Cooking the ham with the sodium nitrite no longer qualifies the product as minimally processed-no artificial ingredients.

Q: Our company just purchased a new product line from another company. We will be moving production to our facility. They have labels they will be transferring to our plant. Do we need to get temporary approval to use these labels in our plant?

A: No, if the only problem with the labels is the establishment number and possibly the signature line, a temporary approval is not required. However, the product would have to be code marked in a manner acceptable to the Inspector-in-Charge. In addition, records would have to be maintained that properly identifies product origin in the event of a product recall. If the labeling is false or misleading (except for the establishment number or signature line), for example, a geographical claim (made in Iowa), the label would have to be corrected and a temporary approval obtained from the Labeling Review Branch (LRB) prior to use of the label. If the label, prior to the transfer, currently has a temporary approval, it can be transferred but temporary approval must be obtained from LRB prior to use of the label. Remember, when requesting temporary approval, always indicate the reason(s) for requesting temporary approval on the application for label approval.

Q: We have a raw chicken injected with a solution and our marketing department would like to use the statement "Enhanced with a 15% solution" instead of "Containing up to 15% solution". Is this possible?

A: Yes. As long as the labeling clearly indicates the addition of a solution took place and you meet all of the conditions of a containing statement (the smallest letter in the containing statement is ž the size of the largest letter in the product name, the containing statement is contiguous to the product name), the term "enhanced" can be used in the solution statement.

Q: I have a marinated beef sirloin steak, which is also rubbed with seasonings. The rub is Cajun style and contains paprika. My label was refused because of the paprika. Can you explain why?

A: Paprika is not allowed in or on raw red meat products per 9 CFR 318.7(d)(I). Paprika misrepresents the freshness and leanness of the meat. However, in accordance with the Food Standards and Labeling Policy Book entry for "Paprika" (#2), paprika can be rubbed on the fat portion of the meat cut but not on muscle tissue as long as the product name is appropriately qualified, e.g. "fat colored with paprika".

Q: Can I call my product "Sicilian Meatballs," if it is made in Oregon using an old family recipe from Sicily?

A: No. Generally, the name of a place may not appear in a product name without further explanation unless the product is made in that place. For example, "Sicilian Meatballs" would have to be made in Sicily.

An important exception to this rule is a regional style defined in the Standards and Labeling Policy Book, such as "Italian Style." If a product meets a defined style with a geographic term in it, the product need not be manufactured in the region cited. For example, "Italian Style" meatloaf could be made in Brooklyn, so long as it meets the standard for "Italian Style."

Unless there is an entry in the Policy Book for a specific regional style, it is generally not permitted to attach the word "style" to the name of that region in a product name. Since there is no "Sicilian Style" defined, you could not call your product "Sicilian Style Meatballs" either.

However, you may use the word "brand" after the name of any geographic area, followed by a "made in..." statement noting the actual place of manufacture. So you could call your product "Sicilian Brand Meatballs, Made in Oregon."

Many processors have petitioned successfully for the use of undefined geographic styles. If you are willing to give it a try, you could petition for the use of "Sicilian Style." You would need to submit documentation -- from cookbooks, menus or other culinary sources -- that confirms that certain ingredients and/or procedures used to make your meatballs are truly characteristic of Sicily.

Q: I have more than forty square inches of available labeling space on my package. I have room for a Nutrition Facts panel in a columnar format on the back of the box, but my graphic artist would rather put it on side panel and use the full tabular format. Is this permissible?

A: No. The full tabular format is a special version of the standard format (all features included, with no abbreviations) that has been rearranged. Unlike the regular tabular format -- which has certain modifications to make it smaller, so that it can be used on packages with less than forty square inches of labeling space -- the full tabular format is intended for use on packages with more than forty square inches of available labeling space. However, it must be proven that the available labeling space is configured in such a way that no matter what you do, a columnar format CANNOT be accommodated; for example, the product is in a shallow tub. Positioning your artwork so that it uses up space where a columnar panel could appear, then saying you haven't got the room for the columnar format, is not a valid reason for using the full tabular format.

The following questions came from participants in the Nutrition Labeling and General Labeling breakout sessions at Prime Label's Tenth Annual Federal Food Regulatory Conference, April 6-8, 1998. 

Q: If there is tenderizer as well as flavoring in the solution added to a product, what is the proper way to declare it on the product label?

A: Two important requirements apply when both tenderizer and flavoring are present in added solution.

The presence of the tenderizer must be noted in a qualifying statement contiguous to the product name. This qualifying statement should read "Tenderized with _________," with the name(s) of the tenderizer(s) inserted (e.g., "Tenderized with Bromelin and Papain").

In addition, the solution pickup level declared on the label should be three percent less than the actual total pickup level. For example, if the total solution pickup of flavoring and tenderizer is 7%, the product should bear a containing statement reading "Contains 4% of a solution of..." Moreover, the name(s) of the tenderizer(s) should not appear in the containing statement. These adjustments are made because 3% of the final pickup is assumed to be from the tenderizer, which is already accounted for in the qualifying statement. The actual level of tenderizer IS NOT taken into consideration in such a case.

Q: In 9 CFR, I read that the metric weight of the serving size on the Nutrition Facts panel should be rounded to the nearest 5 grams. I have gotten many labels approved without rounding to the nearest 5 grams, but was wondering which is correct.

A: With all the different rounding increments cited in 9 CFR for Nutrition Facts panels, it's easy to get them mixed up. However, you should know that there is no entry requiring or recommending that the gram weight of a serving be rounded to the nearest 5 grams. The appropriate citation (9 CFR 317.319(b)(9)(ii)) stipulates that the gram weight of the household measure used to express the serving size should be rounded to the nearest whole number. The only exceptions are for products whose serving gram weight is less than five grams: between 2 and 5 grams, round to the nearest half gram (0.5 gram); below 2 grams, round to the nearest tenth of a gram (0.1 gram). A label reviewer would have no way of knowing that you rounded the serving gram weight to the nearest five grams, so your error was never caught.

Q: What is the correct Reference Amount Commonly Consumed (RACC) for lasagna?

A: Sally Jones at USDA/FSIS' Labeling Review Branch informs us that the original RACC table for meat and poultry products put meat lasagna into the category of "mixed dishes NOT measurable with a cup." This error was corrected: meat lasagna now appears under "mixed dishes measurable with a cup," and the ready-to-serve RACC is 1 cup.

Q: When is it correct to use the term "about" when stating the number of servings per container? What rounding rules apply?

A: In many cases, the number of servings per container is a whole number. But for many products with a constant net weight, the net weight is not an even multiple of the serving size. In such cases, the number of servings per container should be rounded and prefaced by the word "about." Over 5 servings, round to the nearest whole number; between 2 and 5 servings, round to the nearest 0.5 serving. For example, a package with a net weight of 500 grams and a serving size of 108 grams contains 4.63 servings, which would be rounded to "about 4.5."

Q: I have heard that FSIS plans to extend the "70/30 rule" to poultry products? Is this true?

A: Yes; a Federal Register notice on March 9, 1998 announced that the so-called "70/30 rule" for meat labeling now applies to poultry. For those unfamiliar with this rule, it can eliminate the need for a label change on a product where two types of meat (or two varieties of poultry) are present in slightly varying amounts. The "70/30 rule" for meat (see 9CFR 317.2(f)(1)(v)) states that:

• The two types of meat must make up at least 70% of the meat block (i.e., meat plus meat by-products), and neither may constitute less than 30% of the meat block.

• If the above condition is met, the two types of meat may be listed in the ingredients statement linked by the word "and" instead of being separated by a comma. The order of predominance of these two ingredients can change without a need for a label change, so long as they remain within the stated limits.

Example: A product contains beef and pork, which together always represent at least 74% of the meat block. The actual percentage of beef ranges 32-45% of the meat block, and the percentage of pork ranges 36-42% of the meat block. For this reason, there may be more beef than pork, or vice versa. Note that the combination always constitutes at least 70% of the meat block, and neither component ever represents less than 30% of the meat block; therefore, the "70/30 rule" applies. The processor can have a single label for the product stating "beef and pork" or "pork and beef" in the ingredients.

Q: What is the correct serving size for a large, ready-to-serve ham that varies in weight from 7 to 12 pounds? How should the number of servings per container be declared?

A: The ham is a large unit that must be divided before serving. If it were smaller, and its weight were constant, it would be meaningful to express the serving size as a fraction of the whole...but this is not the case. The correct way to express the serving size is find the correct RACC (reference amount customarily consumed) and round it to the nearest number of ounces. For a ready-to-serve entree without sauce, the RACC is 85 grams; the nearest number of ounces is 3 (85/28 = 3). This should be followed by the gram weight of 3 ounces in parentheses, which is 84g. The complete serving size declaration is "3 ounces (84g)."

Since the ham can weigh anywhere from 7 to 12 pounds, the number of 3-ounce servings per container is not constant. The number of servings per container therefore should be declared as "Varied."

Q: I understand that there's a regulation permitting me to list every ingredient present at levels of two percent or lower at the end of my ingredient statement, in no particular order. What is the advantage of doing this? Please provide a citation. 

A: 9 CFR 317.2(f)(vi)(A) and 381.118(a)(2)(i) state that "Product ingredients which are present in individual amounts of 2 percent or less by weight may be listed in the ingredients statement in other than descending order of predominance: Provided, That such ingredients are listed by their common or usual names at the end of the ingredients statement and preceded by a quantifying statement, such as "Contains ____ percent of ______," "Less than ____ percent of ______." The percentage of the ingredient(s) shall be filled in with a threshold level of 2 percent, 1.5 percent, 1.0 percent, or 0.5 percent, as appropriate. No ingredient to which the quantifying statement applies may be present in an amount greater than the stated threshold."

Please note that it is not the SUM of the ingredients that matters; it is the quantity of EACH ingredient in the list that matters.

When is this strategy useful? When a product has more than one ingredient present at a level below two percent, and it is likely that small adjustments will be made to their amounts. These adjustments may not cause major changes in ingredient levels, but could change the order of predominance...which necessitates a generic approval. Using this type of statement can spare you the trouble of reapproval.

Q: When does the USDA Inspector In Charge have to sign my label approval application (Form 7234)?

A: Never. IICs are no longer involved in the label approval process. Even the requirement that the IIC sign when you apply for extension of temporary approval has been eliminated. The only time your IIC would get involved with your label approval records is when a question arises regarding accuracy.

Q: If my product's processing procedures and formulation meet a standard of identity, am I forced to use the standardized name as my true product name? I have a creamed chicken dish that is 18% sliced chicken meat, 12% vegetables, and 70% cream sauce. It meets the "chicken stew" standard, but I don't want to call it that.

A: No, you are not forced to use the standardized name "chicken stew." You have the option of using a truthful and complete descriptive name as your true product name. The descriptive name must list the major components in descending order by weight and include relevant information about processing. It can include a standardized name if certain portions of the product meet standards.

For the product in question, acceptable descriptive names include:

• "Creamed Chicken with Vegetables," since the chicken and sauce portion meet the creamed poultry standard.

• "Cream Sauce, Chicken Meat, and Vegetables," which simply lists the three major components in descending order of predominance by weight.

Q: I have an approved label for a product originally packaged in a fairly large container. I now wish to package the same product in a smaller container, which has less than 40 square inches of available labeling space. My new label will have all the same features as the original label; the only difference is that the new label's Nutrition Facts panel will be in a tabular format, not the standard format as originally approved. Is the new label a generic approval?

A: Assuming that the only change is in the presentation of the Nutrition Facts, the answer is "yes." Modifying the Nutrition Facts panel format in a manner allowed by the regulations does not require reapproval. But if you are making any changes in the nutrition facts themselves — which could happen if the smaller package changes your serving size — the answer is "no."

Q: I have a ready-to-cook product which I believe falls into the "mixed dish not measurable with a cup" category. I consulted the table of Reference Amounts Customarily Consumed (RACCs) for meat and poultry products, and found that there is no RACC listed for a ready-to-cook product in this category; all I saw was a RACC for a ready-to-serve product in this category, which is 140 grams. What value should I be using?

A: If you look at the meat and poultry RACC table, you'll notice that in almost every category, there is no value listed for the ready-to-cook version. Here's the reason: cooking yield varies considerably from product to product.

The correct RACC for a product of this type is the amount of ready-to-cook (as packaged) product that yields the ready-to-serve RACC after cooking. To arrive at this amount, simply divide the ready-to-serve RACC by your percent yield. If your yield is 80%, then the ready-to-cook RACC is 140 grams divided by .80, or 175 grams.

Q: I am manufacturing pre-cooked meat patties that weigh 54 grams apiece. The RACC used to determine the serving size for this type of food is 85 grams. By my calculations, the number of patties that most closely approximates the RACC is two (2 patties = 127% of the RACC, while 1 patty = 64% of the RACC). I take this to mean that the correct serving size is "two patties." However, a competitor makes a similar product and is declaring his serving size as "one patty." Who is right?

A: You're both right. When you have a product that is packaged in discrete units, it is always correct to make the serving size the number of units that most closely approximates the RACC — in this case, two patties. But when the size of a unit falls between 50% and 67% of the RACC, you have the option of making the serving size only one unit — in this case, one patty.

Q: I'm not a food labeling specialist, just a confused consumer who reads her labels carefully. I've been comparing packages of uncooked bacon and have seen labeled serving sizes ranging anywhere from 10 to 60 grams! How can this be? Isn't there a standardized serving for bacon?

A: You just asked a BIG question! There is a reference serving size (called a Reference Amount Commonly Consumed, or RACC) for every product type, which can be found in the Code of Federal Regulations. And labeled serving sizes generally fall within a narrow range of this value. But when it comes to bacon, you're dealing with more than one product type and more than one RACC.

Government food consumption surveys have indicated that a typical serving of cooked bacon is about 15 grams. Meat bacon has only about a 28% cooking yield, so the RACC for uncooked meat bacon is 54 grams — the amount that cooks down to a 15-gram serving. Poultry bacon has a higher yield, so the RACC for uncooked poultry bacon is 28 grams — again, the amount that cooks down to a 15-gram serving. Part of your problem may be that you're comparing raw meat and raw poultry bacon.

Here's yet another catch: Most nutrition information has to be for the food in its packaged form. But bacon undergoes such a great change in nutritional composition during cooking that packers of raw bacon have been given the option of providing nutrition information for the cooked version. Of course, the Nutrition Facts panel must indicate as much, and this fact may have escaped your notice. The RACC for cooked bacon is 15 grams.

Don't despair! The regulations that cover bacon serving sizes are unusually complex. (They actually get more complicated when you start looking at bacon bits and breakfast strips.) For virtually every other product type, there is only one reference serving size.

Q: When requesting a temporary approval, what materials do I need to submit to the Labeling Review Branch?

A: Any application for label approval must include a completed Form 7234. When you are applying for a temporary, be sure to check this as your approval type on Form 7234; also indicate the number of labels on hand and the number of days requested (maximum 180). Clearly state the exact reason for requesting a temporary — most applicants do this below the processing procedures in Block 9. For example, state "water should come before corn syrup in ingredients statement" instead of "order of predominance incorrect on label." Attach a copy of the original approval (both the label and transmittal) to Form 7234. Also attach the actual label (not a copy).

Q: When I submitted labels for sketch approval in the past, and all the required features were not included in the sketch, I was able to write "Used with all required features" in Block 13 of Form 7234. Now I'm told I need to itemize the missing required features on my sketch application, and state exactly how they will be applied. Why the change?

A: In the past, when both sketch and final approvals were issued, reviewers had an opportunity to check that required features missing from the sketch were included in the final label. Now that final approvals have been eliminated, there's no second chance to be sure that every required feature is present...so you need to assure the reviewer examining your sketch application that you are aware of the exact features that are missing and have made provisions for their inclusion.

Q: I recently received a temporary approval for a label where an incorrect ingredients statement is being covered with a sticker. The reviewer wrote "will comply with Policy Memo 115" on the application. What does this mean?

A: Policy Memo 115 mandates that a sticker used to correct a label error must be of the type which destroys the underlying label or package if removed, or is self-destructive. Whenever you apply for a temporary approval where you intend to cover erroneous information with a pressure-sensitive sticker, you should state that it will be in compliance with Policy Memo 115 on your label approval application.

Q: When selecting ingredients from the ingredient database or importing formulations I’ve designed in Genesis, I sometimes get messages about nutrient data that is missing. I then have to decide whether to leave the value as missing or make the value zero. Why is this and how should I decide?

A: In the USDA’s Handbook 8 Release 11 data, the Genesis R&D ingredient data, and most like any other ingredient database available, not every ingredient has been analyzed for everyone of the 37 nutrients involved with nutrition labeling. It makes sense that the people maintaining these databases should only declare a nutrient’s value as zero if they have data from an analysis by some lab that shows the value actually to be zero. This holds true even if it might seem perfectly obvious to you that, for a particular nutrient in a particular ingredient, a value listed as unknown actually must be zero.

So then, what do you do when EZ FormŪ reports a missing value? First, if the nutrient is not important to you, i.e., its not a core nutrient that must appear on the Nutrition Facts Panel (NFP) and its not a nutrient that you optionally wish to declare, then the safest course of action is clearly to leave the value as missing; you won’t be using it anyway. If you must, or optionally wish to, have the nutrient appear on the NFP, then you must use your background in food science to see if you can conclude with confidence that the nutrient’s value is really zero for all intents and purposes. If so, go ahead and tell EZ FormŪ to treat the nutrient’s value as zero. If not, leave the value as missing for the moment. Of course, if a core nutrient’s value is missing, you will not be able to display or print the NFP. This fact will remind you that you must go back to nutrient profile screen for that ingredient in the formulation in question and enter a value for the nutrient that you have subsequently obtained from a supplier or other source.

Q: Why is it that sometimes when I print out a Nutrition Facts Panel, the words appear in a font different from normal and do not fit inside the panel borders?

A: To properly print the Nutrition Facts Panel (NFP), EZ FormŪ must send a special set of fonts to the printer. Problems can occur if the printer does not have enough memory to hold the fonts or if something cause the fonts to be erased after EZ FormŪ sends them. Based on the problem you describe, I expect you are printing the Nutrition Facts Panel (NFP) using a printer on a network. Off a network, this problem would only occur intermittently if you were occasionally turning the printer off and later back on again without also having exited and re-entered EZ FormŪ. However, on a network, there are two reasons that the proper fonts might not be available during NFP printing. First off, if you print an NFP after someone else has sent a print job through, their print job will usually reinitialize the printer and throw out the fonts that EZ FormŪ has sent previously. This is why the latest version of EZ FormŪ asks before each printing of an NFP if you would like to download the fonts again. When printing on a network, it is a good idea to answer ‘yes’ each time to this query. If this doesn’t solve the font problem, then the culprit is undoubtedly the network’s print spooler settings. Normally, a small lag exists between the end of font downloading and the start of NFP data transmission to the printer. If the network spooler is configured with a relatively short ‘time out,’ the print spooler will reinitialize the printer when the actual NFP data starts to transmit. The resulting loss of fonts can be corrected either by having your network administrators lengthen or eliminate the ‘time out’ or by invoking EZ FormŪ by adding the word ‘File’ to the command line. In other words, invoke EZ FormŪ by typing EZFORM FILE and then pressing Enter.

Q: I have a raw product with a containing statement and need to change the pickup level. Does this qualify as a generic label approval?

A: Yes, provided that the change in pickup does not affect either the ingredient order of predominance or the product name. Also, be sure to check that any restricted ingredients in the solution remain within the regulated limits.

Q: Can I call a product "Thai Style?"

A: The term "Thai Style" is acceptable for products that contain at least five of the following ingredients: basil, chilies or chili products, cilantro, coconut or coconut products, coriander, cumin, fish sauce, galangal, garlic, ginger, green onions, jasmine rice, lemon grass, peanuts or peanut products, rice noodles, shallots, and soy sauce.

Q: Does the USDA still grant temporaries for labels that don't declare mechanically separated species?

A: No. However, exceptions are made for labels printed between the date the regulation came out (November 3, 1995) and the date it became effective (November 4, 1996), or for labels printed earlier than November 6, 1996; in such cases, you must provide an inventory of your label stock and proof of the printing date (printer's invoice) when submitting your application.

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