Tag Archives: food labeling

Rounding Errors That Make Nutrition Facts Panels Non-Compliant, and How Small Producers Catch Them Before Print

By Waqar Anwar
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Most Nutrition Facts problems that surface in a retailer audit don’t start in the lab. The analysis or database calculation is usually sound. The error creeps in at the last step, when raw numbers are converted into the values printed on the panel.

FDA’s rounding rules in 21 CFR 101.9(c) are short, but each nutrient has its own increments, and those increments change at specific thresholds. That is where small and mid-size producers most often slip. A sodium value printed as 145 mg instead of 140 mg will not stop a product from shipping. It does tell a retailer’s label reviewer, a state inspector or FDA that the label was not built against the regulation, and it invites a closer look at everything else.

The rounding ladders in plain language

Each nutrient follows a ladder: below a floor, declare zero or “less than”; in a middle band, round to a fine increment; above a threshold, switch to a coarser one. The ladders QA teams use most:

Nutrient Declare as zero Middle band Above threshold
Calories Under 5 5–50: nearest 5 Over 50: nearest 10
Total, saturated and trans fat Under 0.5 g 0.5 g to under 5 g: nearest 0.5 g 5 g and over: nearest 1 g
Cholesterol Under 2 mg 2–5 mg: “less than 5 mg” Over 5 mg: nearest 5 mg
Sodium, potassium Under 5 mg 5–140 mg: nearest 5 mg Over 140 mg: nearest 10 mg
Total carbohydrate, fiber, total sugars, added sugars, protein Under 0.5 g (may be 0) Under 1 g: “less than 1 g” 1 g and over: nearest 1 g
%DV, macronutrients — — Nearest 1%
%DV, vitamins and minerals Under 2% (may be 0) 2–10%: nearest 2%; 10–50%: nearest 5% Over 50%: nearest 10%

FDA’s Food Labeling Guide collects these rules in a single table (Appendix H). It belongs on the desk of anyone who signs off on label artwork.

Five error patterns, with corrections

  1. The wrong increment above a threshold. A snack with 53 calories per serving is printed as 55. Above 50 calories the increment is 10, so the correct declaration is 50. Sodium of 143 mg is often printed as 145 mg; above 140 mg it rounds to the nearest 10, so 140 mg. These errors usually come from a spreadsheet that applies one rounding formula across the whole range.
  2. Decimals where the rule calls for zero or “less than.” Trans fat of 0.3 g printed as “0.3 g” should read 0 g. Cholesterol of 3 mg printed as “3 mg” should read “less than 5 mg.” Protein of 0.7 g printed as “0.7 g” should read “less than 1 g.” Decimals below the floor look precise, but the regulation provides no such format.
  3. Rounding twice. Producers round per-serving values, then multiply them to fill a per-container column, or round per-100 g data before scaling to the serving. Each step compounds the error. Take a product with 138 mg sodium per serving and three servings per container. The correct per-container figure starts from 414 mg and rounds to 410 mg. Multiplying the rounded 140 mg by three gives 420 mg, which is wrong. Every column and every scaled value should be calculated from unrounded data.
  4. %DV built on outdated Daily Values. The 2016 Nutrition Facts final rule changed several Daily Values: sodium from 2,400 to 2,300 mg, total fat from 65 to 78 g, total carbohydrate from 300 to 275 g and dietary fiber from 25 to 28 g. Templates built before the update are still in circulation. For 3 g of fiber, the current DV gives 11%; the old one gives 12%.

A related point is often misread. Under 21 CFR 101.9(d)(7)(ii), %DV may be calculated from either the declared (rounded) amount or the actual (unrounded) amount. A panel showing 0 g saturated fat beside 2% DV can therefore be correct: 0.4 g divided by the 20 g DV is 2%. The real risk is mixing methods across nutrients or SKUs. Choose one method, document it and apply it consistently, so any reviewer can reproduce every number on the panel.

  1. An incomplete added sugars declaration. The “Includes X g Added Sugars” line is mandatory and carries its own %DV, based on a 50 g Daily Value. Common gaps are a missing %DV, or a %DV calculated against total sugars. A product with 12 g of added sugars should show 24% DV on that line.

Rounding is not accuracy

Correct rounding does not make a value compliant on its own. Under 21 CFR 101.9(g), FDA compares laboratory results against the declared value. Added or fortified nutrients must be present at 100% or more of the declared amount. Naturally occurring vitamins, minerals, protein and fiber must reach at least 80%. Calories, sugars, total and saturated fat, cholesterol and sodium must not exceed 120% of the declared value. A value rounded down near a band edge leaves less headroom, so QA teams should check results that sit close to those limits.

For exporters: the same problem, different ladders

Canada’s Food and Drug Regulations set their own rounding table (in the table to section B.01.401). It looks similar to FDA’s for calories and sodium, but differs at low levels, for example in how small amounts of fat are expressed. Canada also has no added sugars line; its sugars %DV is based on total sugars, with a 100 g Daily Value.

The EU format under Regulation (EU) No 1169/2011 works per 100 g or 100 ml and declares energy in both kJ and kcal. It declares salt rather than sodium. The European Commission’s 2012 guidance on tolerances sets the rounding: for example, fat, carbohydrate, sugars, protein and fiber at 10 g or more round to the nearest 1 g, and between 0.5 g and 10 g to the nearest 0.1 g.

The most common export error is converting a finished U.S. panel by hand. Salt is sodium multiplied by 2.5, and that conversion must start from unrounded sodium, not from the value printed on the U.S. label. Each market’s panel should be rebuilt from the original data.

A pre-print checklist for QA teams

A second reviewer can work through this list in under 15 minutes per SKU, before artwork is released:

  1. Start from unrounded per-serving values, and keep them in the label file alongside the artwork.
  2. Apply each nutrient’s own ladder. Recheck any value near a threshold: 50 calories, 140 mg sodium, 5 g fat, 0.5 g and 1 g.
  3. Confirm every zero and “less than” declaration against the floor for that nutrient.
  4. Calculate per-container, dual-column and alternate-unit values from unrounded data, never from printed values.
  5. Check every Daily Value against the current table in 21 CFR 101.9, and record which %DV method you used.
  6. Confirm the added sugars line and its %DV are present and calculated against 50 g.
  7. Compare declared values with lab results for 101.9(g) headroom, especially values near the 80% and 120% limits.
  8. For export SKUs, rebuild each market’s panel from the original data under that market’s rules.

Rounding errors are cheap to prevent and expensive to find later. A short, written verification step before print is the most reliable way to keep them off the shelf.

References

  • 21 CFR 101.9, Nutrition labeling of food, paragraphs (c), (d) and (g)
  • FDA, Guidance for Industry: A Food Labeling Guide, Appendix H (Rounding the Values According to FDA Rounding Rules)
  • FDA, Food Labeling: Revision of the Nutrition and Supplement Facts Labels, final rule, 81 FR 33742 (May 27, 2016)
  • Health Canada, Food and Drug Regulations, section B.01.401 and its table
  • Regulation (EU) No 1169/2011 on the provision of food information to consumers
  • European Commission, Guidance document for competent authorities for the control of compliance of EU legislation with regard to the setting of tolerances for nutrient values declared on a label (December 2012)
Jennifer Allen

Consumers: A New Food Labeling Authority

By Jennifer Allen
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Jennifer Allen

Pop quiz. Who regulates food? You’re probably going through an alphabet soup of agencies in your head right now, and you wouldn’t be wrong. FDA, USDA, FTC, state and local agencies, all play a role in regulating the food we eat. But how many of you thought of the consumer? In recent years, consumers have increasingly become a de facto regulatory agency by harnessing the power of the courts. Statements on your labels that may pass muster with FDA and other agencies are falling afoul of consumer expectations, and consumers are seeking, and sometimes obtaining, redress in the courts. Although there have been some more promising rulings lately suggesting that some courts at least are beginning to rein in these types of claims, food manufacturers should nevertheless be vigilant.

Take, for example, the case of Mantikas v. Kellogg Company. There, a group of consumers sued the manufacturer of Cheez-It crackers. The crackers were available in a version that contained the language “Whole Grain” in large font in the middle of the principal display panel, with smaller language stating “Made with 8G of whole grain per serving” in the corner. But the ingredients panel showed that enriched white flour was the primary ingredient. The Second Circuit Court of Appeals held that the consumers had stated a claim under their states’ consumer protection laws. Even though the product did in fact contain 8 grams of whole grains, and even though the consumer could look to the ingredient panel to learn that the primary ingredient was white flour, the court explained that the purpose of the back and side panels is to offer more detailed information than that on the front panel, not to correct a misconception caused by a misleading representation on the front panel. The “whole grain” representation was clearly intended to mislead the consumer into believing that the product was made predominantly or entirely with whole grains when that was not in fact true. The fact that the consumer could figure that out by reading the ingredients panel was not enough to satisfy the court.

Consumers are also on the attack against terms like “real,” “natural,” “good for you,” “pure,” and “wholesome,” terms that are not explicitly regulated by FDA. What each of these terms has in common is that they are vague and hard to prove or disprove. What does “real” even mean? Under one definition, all food is real unless it’s the plastic food in a child’s toy box. Cyanide is natural, and may even be pure, but we wouldn’t want to eat it. And almost everything we eat could be good for us in the sense that it helps stave off starvation. You see where I’m going with this. These terms are wildly open to interpretation, and the chances of you and your consumer interpreting them the same way are slim. Better to stick to narrower terms that you can substantiate. For example, you might say that your popsicles are flavored with the juice of real fruit, though, like Cheez-Its, beware of making that claim if the majority of the flavor is not from real fruit juice.

And consumer suits go way beyond the content of the product. Take, for example, the case of Broomfield v. Craft Brew Alliance, Inc. In that case, a group of consumers sued over labeling that deceived them into believing that Craft Brew’s beer was made in Hawaii. While the defendant did manufacture beer in Hawaii, the beer it sold on the mainland was made on the mainland. The court sided with the consumers. While pictures of surf boards and the phrase “Liquid Aloha” weren’t enough to make the case, Craft Brew went far beyond that, with a map of Hawaii depicting the location of its brewery, a Hawaiian address, and an invitation to visit the brewery when in Hawaii.

So what’s a manufacturer to do? When coming up with that enticing label, first, think like a consumer. What might that consumer believe or, at least, what might they be able to convince a court that they believed? Second, conduct a risk/benefit analysis. Is that “all natural” label expected to generate enough extra sales to justify the risk of a consumer lawsuit. Finally, ask your attorney to check on the existing legal landscape. Has another manufacturer run into legal problems using the very same language you want to use? If so, did the court suggest ways in which the manufacturer could have cured the problem? If in doubt, use specific, verifiable statements over vague pronouncements of “healthiness.” And above all, don’t play games with the consumer. If you’re trying to make your product look healthier than it is, there are plenty of plaintiffs’ lawyers ready and waiting to challenge you in court.

Jennifer Allen
Food Safety Attorney

Food Labeling Requirements for Natural Flavors

By Jennifer Allen
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Jennifer Allen

Natural flavors are ubiquitous in foods today, and chances are, at least one of the products that your company manufactures contains them. But what are they, and how should they be identified on your packaging?

Natural flavors are defined at 21 CFR 101.22(a)(3) as “the essential oil, oleoresin, essence or extractive, protein hydrolysate, distillate, or any product of roasting, heating or enzymolysis, which contains the flavoring constituents derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf or similar plant material, meat, seafood, poultry, eggs, dairy products, or fermentation products thereof, whose significant function in food is flavoring rather than nutritional.” In short, a natural flavor is a substance the purpose of which is simply to add flavor, which is extracted from a food through one of a certain number of processes.

The astute among you may be asking yourself right now, “Why are so many consumers critical of natural flavors? From this definition, they seem pretty natural to me.” Well, consider that the above regulation applies only to the flavor. But when you take a natural flavor off the shelf to incorporate it into your product, that flavor is contained in some kind of solvent, with certain additives for functionality. The solvent and additives are not required to be in any way “natural.” This may be why some consumers are skeptical about how “natural” natural flavors really are.

Labeling Nuances

As with all ingredients, natural flavors must be identified as such on your product’s ingredients panel. If those flavors don’t make up the primary characterizing flavor of the product, but are included simply to make your product juicier, to enhance mouth-feel or to supplement the flavor imparted by the other food ingredients, then identifying them as “natural flavors” on the ingredients panel is sufficient.

But under certain circumstances, they must also be identified more prominently on the principal display panel. As the regulations explain at 21 CFR 101.22(i), if your product has a certain primary characterizing flavor (the example the regulations use is strawberry shortcake), and most or all of that characterizing flavor comes not from the food itself but from natural flavors derived from that food, then those flavors must be clearly identified. The name of the flavor must be included. It may have the word “natural” in front of it, but it must have the word “flavored” after it. So, to use the strawberry shortcake example, if your shortcake is predominantly flavored with actual strawberries, then your label would read “strawberry shortcake.” But if it is primarily or solely flavored by natural flavor derived from strawberries, then it must be labeled: “natural strawberry flavored shortcake,” or “strawberry flavored shortcake.

What if you are flavoring your product with natural flavors that are not derived from the food that is the characterizing flavor? For example, what if your product is a lemon pie, but you flavor it only with natural flavors derived from limes? In that case, you must either include by the product name the identity of the actual flavor (for example, “with natural lime flavor”), or you must identify it as being artificially flavored. You read that correctly. Even if you are using a natural flavor, if it isn’t from the food that is the characterizing ingredient in your product, then it is considered an artificial flavor. What about a lemon pie flavored with natural lemon flavor but also with natural lime flavor. In that case, your label would include the words “natural lemon flavor, with other natural flavors.”

As a rule of thumb, if your product’s principal display panel contains the name of a food item, or a picture of a piece of fruit or other food item that the consumer would understand to be the primary recognizable flavor in the product, but the product does not in fact contain that fruit or other food item, or is predominantly flavored with natural flavors, then you must comply with the labeling requirements above. But if your product is predominantly flavored by the food item itself, with the natural flavors simply enhancing the flavor or serving a secondary flavoring function, then you need only identify the presence of natural flavors in the ingredients panel.

 

Jennifer Allen
Food Safety Attorney

No Magic Bullets: Making Health Claims that Comply with FDA Regulations

By Jennifer Allen
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Jennifer Allen

With increasing numbers of Americans paying closer attention to the contents of the food they eat, food manufacturers are understandably eager to publicize the health benefits of their products. The FDA allows food manufacturers to make health claims on food labels, but, perhaps not surprisingly, it is strict about how manufacturers make those claims, and all health claims require pre-approval.

First, what qualifies as a health claim? A health claim is any claim on a label or labeling that expressly or impliedly characterizes a relationship between a substance and a disease or health-related condition. The claim may state that increased consumption of a particular substance reduces certain disease risks, or it may state that decreased consumption reduces that risk. The former claim would be associated with a product high in a particular substance, the latter with a product low in a particular substance. A health claim may not state that the substance diagnoses, cures, mitigates, or treats disease. Only pre-approved drugs and medications may carry those claims.

The statement “Adequate calcium throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis,” is an example of the former type of health claim. It connects consumption of a higher amount of a particular substance (calcium) with the reduced risk of a particular disease (osteoporosis). In contrast, the statement “Diets low in saturated fat may reduce the risk of heart disease” is an example of the latter type of health claim. Note that health claims are different from structure/function claims, which don’t reference a specific disease. The statement “Calcium builds strong bones” is a structure/function claim, a type of claim that does not require FDA pre-approval.

You can find the list of currently approved health claims in the regulations at 21 CFR 101, commonly referred to as Subpart E. As an example, if your product contains calcium and vitamin D, you would look to 21 CFR 101.72 for guidance on how to make a claim on your label that consuming more of these substances reduces the risk of osteoporosis. You would look to §101.75 for guidance on making a claim about reduced saturated fat and heart disease.

Disqualifying Substance Levels

But before you make any health claim, you must first ensure that your product doesn’t contain disqualifying levels of certain substances, namely fat, saturated fat, cholesterol, and sodium. You can find those levels in 21 CFR 101.14. The reason for that requirement is, health claims lead the consumer to believe that the product they are consuming is “healthy.” If, for example, your readymade meal product contains 2,500 mg of sodium, the FDA frowns on you marketing it as healthy, even if you’ve manufactured the meal with increased levels of vitamin D.

Key Criteria To Support “Healthy” Labeling

If your product passes the initial test above and meets the following criteria, you can make a health claim:

  • All your statements are consistent with the detailed and specific requirements in Subpart E;
  • Your claim is limited to describing the value of either decreased or increased consumption of the substance as part of a total dietary pattern;
  • Your claim is complete, truthful, and not misleading;
  • All the information is in one place, without intervening material. Note that in place of making a direct claim on the label, you may instead refer the consumer to another location, such as a website, for information about the claim. If you include a graphic image to portray the claim, it must be immediately adjacent to the verbal claim or reference statement;
  • The claim enables the consumer to comprehend the information and understand its relative significance in the context of a total daily diet; and
  • The particular substance is either low enough or high enough to justify the claim.

These six requirements can be summed up in the following statement: Don’t offer false promises to the consumer. Reduction of disease risk is a lifelong process. No single food or group of foods can work miracles. Consuming a low fat dessert product will probably not protect the consumer from heart disease if she routinely consumes it after enjoying a fast-food meal. Your health claim shouldn’t suggest in any way that it will. After all, you’re selling a food product, not a magic bullet.