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FDA Targets Vending Machine Operators

posted by Jennifer Diaz September 1, 2016 0 comments

FDAVending_03.54ef4f5d7ed31Co-Authored by Jennifer Diaz and Kristina Hernandez-Tilson, an attorney in Miami, Florida, practices in state and federal court, litigating matters of civil and administrative law. 

Since April 2008, pursuant to New York City Health Code Section 81.50, all Starbucks (and many other restaurants) in New York City have been required to display the calories of each of the menu items. A subsequent study found that this mandatory calorie posting influenced consumers in NYC, causing average calories per transaction to drop by 6%. The study also found that calorie posting did not cause any significant change in Starbucks’ overall revenue.

Now, owners and operators of vending machines across the U.S. are next. Back in December of 2014, the Food and Drug Administration (FDA) issued a final rule entitled “Food Labeling: Calorie Labeling of Articles of Food in Vending Machines”. This rule is codified at 21 CFR 101.8, and requires vending machine operators who own or operate twenty (20) or more vending machines, or who voluntarily register with FDA to be covered, to declare calories for those vending machine foods for which the Nutrition Facts label cannot be examined before purchase or for which visible nutrition information is not otherwise provided at the point of purchase. According to the December 2014 final rule, covered vending machine operators must comply by December 1, 2016.

However, in the Federal Register of August 1, 2016 (81 FR 50303), FDA issued another final rule entitled “Food Labeling; Calorie Labeling of Articles of Food in Vending Machines; Extension of Compliance Date.” This rule provides that the compliance date for type size front-of-pack labeling requirements and calorie disclosure requirements for certain gums, mints, and roll candy products in glass-front machines in the final rule published December 1, 2014 (79 FR 71259) is extended to July 26, 2018. The compliance date for all other requirements in the final rule (79 FR 71259) remains December 1, 2016.

On August 16, 2016, the FDA announced the availability of a Draft Guidance for the food industry, titled “Calorie Labeling of Articles of Food in Vending Machines.”  This Draft Guidance, like all guidance documents put out by the FDA, represents its current thinking on a topic, but does not create or confer any rights for or on any person and does not operate to bind FDA or the public. Manufactures are free to use alternative approaches, so long as the approach satisfies the requirements of the applicable statutes and regulations. Below are some highlights from the Draft Guidance, however none should be construed as legal advice. Please contact our office regarding any questions specific to your product or situation.

  • I am a food manufacturer, does this rule apply to me? No, final rule “Food Labeling: Calorie Labeling of Articles of Food in Vending Machines,” codified at 21 CFR 101.8 does NOT apply to food manufacturers, rather it applies to certain vending machine operators. Food manufacturers may chose to provide the information that vending machine operators will need to make their own calorie declarations for their products, but food manufacturers are not required to do so.
  • Must a vending machine operator be registered with the FDA to be subject to this rule? NO, voluntary registration is only one of the ways in which you can come under this rule. But regardless of whether or not you are registered with the FDA, you are subject to this rule if you own or operate twenty (20) or more vending machines.
  • Why would a vending machine operator voluntarily register to be covered by this rule? One reason is because once you are registered with the FDA, you are no longer subject to any state or local nutrition labeling requirements for foods sold in vending machines if those rules are not identical to the federal requirements found in section 403(q)(5)(H) of the FD&C Act. (21 CFR 101.8(d)(1)). This could be especially helpful to vending machine operators who own less than twenty (20) vending machines, but whose machines are located in different states or different parts of the same state. Please note however that registration is not automatically renewed, nor does FDA send reminders of the need to renew a registration. This is one of the reasons why it is important to work with an experienced office, such as ours, to help ensure your continued compliance.
  • If you own more than twenty (20) vending machines, or if you are a vending machine owner who is registered with the FDA, but you do not control operations of the machines, are you responsible for posting the calorie information? The short answer is no. Vending machine operators, not owners, are responsible. See 21 CFR 101.8(c)(1)
  • If you own a total of twenty (20) vending machines in two different states, does the rule apply to you? Yes, the location of the vending machines is irrelevant.
  • Do small businesses have to comply with the rule? Yes, it does not exempt “small businesses” from the requirements.
  • Does the rule apply to vending machines in schools? Yes, it does not exempt vending machines in schools from the requirements.
  • Where do I find the calories for a food item? The rule does not prescribe where or how covered vending machine operators must obtain the necessary information to meet the calorie declaration requirements for covered vending machines, but FDA anticipates that for most packaged foods, the package’s Nutrition Facts label will contain the information you need for the calorie declarations. Please note however, that not all packaged foods are required to bear a Nutrition Facts label, this might be the case, for example, with packaged foods that are produced by a local manufacturer and are not sold in other states. If the package does not contain the necessary calorie information, consider one of the following sources to find the information you need, the U.S. Department of Agriculture’s National Nutrient Database for Standard Reference (http://ndb.nal.usda.gov/), or Appendix C of 21 CFR part 101 for raw fruits and vegetables.
  • Are you required to label the calories of fresh foods (such as a freshly prepared sandwich or apple) sold in the vending machine? Yes, and it can me especially tricky to determine an accurate calorie count for some of these foods. For example, fresh fruit may have naturally occurring variations in calorie content, depending on its size or other factors, this is where the guidance of an office experienced in these matters is invaluable. Our office is well equipped to help you navigate these challenging compliance issues. One potential workaround this problem is to provide multiple calorie counts for certain foods, for example, for a small banana, for a medium banana, and for a large banana.
  • If a condiment packet is sold as part of a sandwich, for example a packet of mayonnaise, must you include its calories in the displayed calorie count? Yes, you must declare the total calories for the food as it is vended, which includes the calories for each component (21 CFR 101.8 (c)). You may voluntarily provide additional information about the calories in some of the components of the food, but you must always provide the total calories for the entire package.
  • If a vended food item has multiple servings (such as a package of chips), but its Nutrition Facts label provides calories for only one serving, do you need to display the total calories for the entire package? Yes, this is an important and perhaps counterintuitive point. You may voluntarily provide additional information regarding the calories per individual serving size, but you must always provide the total calories for the entire package. See 21 CFR 101.8(c)(2)(i)(C).
  • How must you display the required calorie information on the vending machine? Here, the FDA has given you flexibility because the rule provides a range of methods. Regardless of the method, you must ensure that the calorie declarations are clear and conspicuous and placed prominently (21 CFR 101.8(c)(2)(ii)) so that customers can read the calories before purchasing the product. If yours is an electronic vending machine (i.e. a machine with a digital or electronic or LCD display, you may present the calorie information electronically, as long as the information is displayed BEFORE the customer buys the product (21 CFR  101.8(c)(2)(ii)(E)), and these electronic displays, like all calorie declarations, must be clear and conspicuous and placed prominently (near the article of food or the selection button) (21 CFR 101.8(c)(2)(ii)). You may also use a sign or sticker in, on, or adjacent to the vending machine to display the calories, provided the other requirements of 21 CFR 101.8(c) are met (see 21 CFR 101.8(c)(2)(ii)).  You may use one sign with calorie declarations for all of the food sold from the machine, or individual signs for each food item.  Alternatively, you may affix stickers with the calorie information to the vending machine.  You must place the sign or sticker near each article of food or selection button (see 21 CFR 101.8(c)(2)(ii)).
  • Is there a particular font size that must be used? If the calorie declaration is on a sign next to the machine, it “must be in a type size large enough to render it likely to be read and understood by the prospective purchaser” (21 CFR 101.8(c)(2)(ii)(C)).  FDA has not prescribed a minimum size, but the customer must be able to read it under “customary conditions of purchase and use” (21 CFR 101.8(c)(2)(ii)(C)).  Additionally, the type must be all black or one color on a white or other neutral background that contrasts with the type color (21 CFR 101.8(c)(2)(ii)(C).  You can use a handwritten sign if it meets these readability criteria. 
If the calorie declaration is in or on the vending machine, the calorie declaration must be in a type size no smaller than the name of the food on the machine (not the label of the food product), selection number, or price of the food as displayed on the vending machine, whichever is smallest, with the same prominence, i.e., the same color, or in a color at least as conspicuous, as the color of the name, if applicable, or price of the food or selection number, and the same contrasting background, or a background at least as contrasting as the background used for the item it is in closest proximity to, i.e., name, selection number, or price of the food item as displayed on the machine (21 CFR 101.8(c)(2)(ii)(B)).  You can use a handwritten sign if it meets the criteria specified in 21 CFR 101.8(c)(2)(ii)(B).
  • Sometimes you might add new items to your machine, how long do you have to list its calories? To be in compliance with the rule, you must declare the calories for all covered vended food items sold from your vending machine (see 21 CFR 101.8(c)(2)(ii)(A)).  If you are using a sign adjacent to the vending machine to declare calories for multiple covered vending machine foods, you may wish to consider leaving empty spaces on such sign and then, when you add new products, list the new product and its calories to your existing sign, rather than preparing a new sign every time you add a product to the vending machine.  Alternatively, you could use individual signs for each item and switch them in or out as you introduce or retire various items.
  • Can you place the calorie information side on the side of the vending machine? No, because such a sign would not be seen by the customer at the same time he or she is selecting the food, and thus would not comply with the criteria in 21 CFR 101.8(c)(2)(ii)(A).   However, a sign on a wall next to the vending machine could be permissible.
  • What are the penalties for not providing accurate calorie information? If the calorie information is not accurate, the foods would be considered misbranded and subject to the same penalties that misbranded packaged foods are subject to under the FD&C Act.

If yours is a small business and you are covered by this final rule, you are not alone. In a study published by the Department of Health and Human Services that is part of the docket for this final rule (docket number FDA-2011-F-0171), it is estimated that 97 percent of vending machine operators that come under this final rule would qualify as small businesses as defined by Small Business Administration.

Above is just a sampling of the many issues that can arise for industry when new regulations are promulgated by the FDA. If any of these comments spark interest or concern, you can voice your opinion to the FDA. While you can comment on any guidance at any time (21 CFR 10.115(g)(5)), to ensure that FDA considers your comment on the draft guidance before it begins work on the final version of the guidance, it is best to submit either electronic or written comments on the draft guidance by September 30, 2016. If you want to submit a formal comment, or have any questions, please contact our office, we are ready to help your business stay in compliance with this, and all regulatory obligations.

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