The compliance date for the new nutrition facts label has been delayed…yet again. The original compliance date was July 26, 2018 for manufacturers with more than $10 million in annual sales, and July 26, 2019 for manufactures with less than $10 million in annual sales. This ruling was announced May 20, 2016 (and filed in federal register on May 26, 2016) which allowed two years for the food industry to make the needed changes.
On October 2, 2017, the FDA issued a proposed rule to extend the compliance date to January 1st, 2020 for manufactures with more than $10 million in annual sales and January 1st, 2021 for manufacturers with less than $10 million in annual sales; a delay of 18 months. The FDA has been clear that the proposed rule ONLY effects the compliance date and not the required changes to the nutrition facts label.
Although the dates have been postponed, it’s important to remember that these nutrition facts changes were consumer driven and they are anxious to have them in their hands. The 2016 Label Insight Food Revolution Study reports 75% of consumers do not trust accuracy of current food labels. The new nutrition facts label changes are aimed to change that. The study also reports “brand loyalty” to be declining, but found that brands who can meet consumer demand for product information will create a new dynamic of trust, while eliminating confusion about their product. (1)
In addition, certain professional groups have expressed concern over the delay, the Academy of Nutrition and Dietetics being one of them. The Academy noted “the final rule provided manufacturers with more than two years to transition to the new format and that the deadline is more than sufficient for companies whose products are already complying.” (2)
The FDA cites the following as reason for the delay: “We are taking this action because, after careful consideration, we have tentatively determined that additional time would help ensure that all manufacturers covered by the rules have guidance from FDA to address, for example, certain technical questions we received after publication of the final rules…Companies and trade associations with members covered by the rules have informed us that they have significant concerns about their ability to update all their labels by the compliance dates due to issues regarding (among other things) the need for upgrades to labeling software, the need to obtain nutrition information from suppliers, the number of products that would need new labels, and a limited time for reformulation of products.” FDA Commissioner Scott Gottlieb, M.D. made specific mention of the food industry needing additional guidance on “added sugars.” (3)
The FDA’s proposal to extend compliance dates was done through a cost/benefit evaluation. While they acknowledge flaws to their method, they report the cost to the food industry to be greater than the reduction of benefits to the consumer by extending the final date ruling. They also report intending to exercise enforcement discretion with respect to the July 26, 2018, and July 26, 2019, compliance dates. (3)
As such, we at RL Foods encourage you to be proactive about attending to the needs of your company in making this switch while putting yourself as a front runner in meeting the needs and demands of your customer.
The California Office of Environmental Health and Human Hazard Administration (OEHHA) has listed cadmium and lead as chemicals known to cause birth defects or other reproductive harm.
Chocolate and confectionary products are among those which are a source of these minerals.
Cadmium and lead may contaminate the chocolate product at many points through the “bean to bar” process; these sources may depend on the cacao growing, fermenting, processing, manufacturing, shipping, and packaging practices.
One significant source is manmade pollution created by industrial processes as described above. Due to the persistence of these heavy metals in soil, they remain present even after the industrial source has been removed. Another source of these heavy metals in chocolate is through direct application of pesticides (lead and cadmium), phosphate fertilizers (cadmium), as well as sewage sludge disposal (lead and cadmium).
A third source of lead and cadmium is contamination through one of the various processing steps a bean undergoes after the harvest. These steps include fermentation, drying of the cacao bean, and manufacturing processes such as grinding, refining, and conching. Other opportunities for contamination are shipping, handling, and finally, packaging. Studies have shown that much of the “lead contamination in (chocolate) products occurs after the beans are harvested and dried, during the shipping of those beans and/or the manufacturing of cocoa and chocolate products.”
How can manufacturers prevent lead and cadmium contamination in their products?
Due to the variances in cocoa production chocolate manufacturers should test every batch of cocoa by an accredited laboratory received from their supply for lead and cadmium before production to ensure it is below or meets the minimum requirements of Proposition 65.
There may not be a single remedy to remove lead and cadmium in chocolate products. Chocolate manufacturers must understand the manufacturing practices and possible manmade sources of contamination and then take steps to identify the source(s) of the contamination. For example, the equipment used to process chocolate could be a primary source of lead or cadmium. Similarly, water used in processing, or shipping containers, may be high in lead. Once the source(s) are identified, suppliers and manufacturers can improve their practices; increase supply chain transparency; and effectively remove lead and cadmium from their final product.
On July 23, 2015, The House of Representatives passed H.R. 1599, or the Safe and Accurate Food Labeling Act of 2015, voting 275-150 in favor of the bill. Among a number of other stipulations, the bill will require federal standards for labeling food products with GMO-based ingredients and preempt any existing state laws to that effect. After facing initial resistance on both sides of the aisle, the bill slowly curried significant bipartisan support, reflected clearly in the margin of victory. Now the legislation travels to the Senate, where resistance is expected to be significantly stronger. Should it pass the top level of the Congress, the government will eschew the presently-active state laws on GMO food labeling for a voluntary labeling program overseen at the Federal level.
The Organic Food Industry and “Right to Know”
Perhaps no singular entity is more in support of tightened state and federal regulation than the organic foods industry, which pins much of its popularity to the growing public stigma towards GMO-derivatives and the processed food industry. Public supporters champion the issue as a “Right to Know” imperative for public health, and voters in Vermont, Connecticut and Maine have already passed laws of their own to that effect, with Massachusetts close behind.
Should the bill pass the Senate, it will render these existing laws null and void.
“Today’s vote to deny Americans the right to know what’s in their food and how it’s grown was a foregone conclusion,” said Scott Faber, senior vice president of government affairs for the Environmental Working Group, a nonprofit advocacy organization. “This House was bought and paid for by corporate interests,” Faber added in his prepared statement.
Skeptics in and out of the Senate
Many in the popular press have already posited doubts to the veracity of GMO-based public health concerns, joining the scientific community in underscoring the lack of a concrete basis for isolating genetic modification as a growing method that warrants specific labeling. H.R. 1599 is specifically focused on preempting a potentially-nightmarish patchwork of state-based GMO-labeling laws, one that would almost certainly prove exceedingly costly and difficult for food manufacturers to effectively navigate. The real question centers upon what, if any, regulations the federal government would enact of its own to replace the state-level legislation. As it stands, if the legislation were to pass, it would simply codify federal policy for GMO labeling, which currently resorts to largely ambiguous language, demanding labeling only for “...genetically-engineered products that are materially different from their conventional counterparts in terms of functional, nutritional, or compositional characteristics.”
The FDA issued a draft guidance document to clarify the administration’s policy on the declaration of small and trace amounts of nutrients on manufacturers’ nutrition labels. Released as a notice in Federal Register, the draft guidance, when finalized, will “...explain to manufacturers of conventional foods and dietary supplements [the FDA’s] policy on determining the amount to declare on the nutrition label for certain nutrients and dietary ingredients that are present in a small amount.”
Issuing the draft guidance was determined necessary by the emergence of a potential conflict of interest between specific stipulations of the Code of Federal Relations (CFR). In the agency’s own words, “...declaring small amounts of nutrients and dietary ingredients in the nutrition labeling may result in a conflict between 21 CFR 101.9(c)(1) through (8) and 21 CFR 101.9(g)(4)(ii) and 21 CFR 101.9(g)(5). In such cases, we are recommending manufacturers declare nutrients and dietary ingredients in accordance with Sec. 101.9(c)(1) through (8).”
The FDA’s announcement will render food labels with declarations of nutritional content “misbranded” should they fall outside a standard deviation of 20% from the suggested amount of a given nutrient or caloric metric. In other words, a nutrition label claiming 8 grams of saturated fat per serving but in fact featuring 10 grams would be “misbranded.” Likewise, a product that claims to feature 50% of one’s daily recommended value (DRV) of Vitamin A that actually offers only 39% of one’s DRV would be subject to departmental recourse.
The draft guidance document is mostly directed at clarifying the nuances of American labeling laws for food manufacturers and purveyors. In the words of the bureau, “the draft guidance represents the current thinking of FDA on our policy on declaring small amounts of nutrients and dietary ingredients on nutrition labels. It does not establish any rights for any person and is not binding on FDA or the public.” Furthermore, the FDA is accepting public comments on the draft guidance up until September 28, 2015.
The FDA announced in June that it will begin mandating American food companies to oversee the removal of partially-hydrogenated oils (PHOs) from their products. Food manufacturers will have 3 years to remove PHO's (Partially Hydrogenated Oils) from their foods. As a major source of artificial trans fats, the presence of PHOs in processed foods has been the source of a decades-long debate regarding whether or not they meet the FDA’s “generally recognized as safe” (GRAS) designation. Food manufacturers have the option to petition the FDA for approval of certain usage of PHO's. Approval must be granted, otherwise all PHO's must be removed by the end of the 3 year period.
The FDA’s 2006 mandate to make national food labels more transparent spurred a national conversation about the outright ban of PHOs and trans fats. The FDA originally announced their plan to ban trans fats in November, 2013. This most recent announcement takes a definitive stance on the issue, and provides American food manufacturers with a three-year grace period to adjust their ingredients and submit any potential alternatives to the FDA for testing and compliance.
LDL: A Smoking Gun
A central component of the FDA’s case rests in the findings of the independent Institute of Medicine (IOM), which connected the consumption of PHOs with elevated levels of low-density lipoprotein (LDL) cholesterol in the bloodstream, which elevates the risk of coronary heart disease. A statement released by the Institute concluded, “transfat provides no known health benefit and that there is no safe level of consumption of artificial trans fat. Additionally, the IOM recommends that consumption of trans fat should be as low as possible while consuming a nutritionally adequate diet.”
From Transparent Food Labeling to an Outright Ban
In the constant battle between government regulators, public policy advocates, and the food manufacturing industry, many advocates speak to the efficacy of the decision, citing the decline of trans fat intake among American consumers from 4.6 daily grams in 2003 to roughly 1 gram per diem in 2012.
A Victory for Public Health, A Setback for the Private Sector
“While consumption of potentially harmful artificial trans fat has declined over the last two decades in the United States, current intake remains a significant public health concern,” said FDA Commissioner Margaret A. Hamburg, M.D. “The FDA’s action today is an important step toward protecting more Americans from the potential dangers of transfat.” Hamburg elaborated that further reduction of trans fats in American diets could reduce heart attacks nationwide by up to 20,000 and preventable deaths from heart disease by up to 7,000 per annum.
While many in the public health sphere view the new regulations as a landmark victory in the public health sector, the American food manufacturing industry will not likely view the measure as kindly. For them, the new requirements mean untold dollars that must be spent in research and development, as well as in marketing and repackaging for certain products.
The FDA announced today a one-year deferment for restaurants and “similar retail food establishments” to adapt to the stipulations of the 2014 menu labeling rules. Originally intended to be in effect and observed nationwide by the end of 2015, the FDA extended the deadline to December 2016, citing the time required to train staff, implement standard operating protocol, develop proper nutrition labeling software, and update menus both online and at brick-and-mortar-based establishments. The new guidelines are intended to apply to everything from professional sports venue concession stands to grocery stores, and in the face of significant industry anticipation the government has struggled to produce a comprehensive draft guidance document.
Corporate Interests vs. Public Policy
The labeling rule only applies to “covered establishments,” or restaurants and retail food companies numbering more than 20 in total locations. Given the size of these organizations, the FDA extended the grace period under significant pressure from the American corporate restaurant and food retail communities via channels in Congress. In response to the announcement, the food retail lobby Food Marketing Institute (FMI) issued a press release celebrating the decision, adding that “...FMI will continue to work with both FDA and Congress to address business challenges with implementing restaurant menu labeling in grocery stores.” The National Restaurant Association also released a statement in response, asserting that the group has “ ...long supported a nationwide, uniform menu-labeling standard for chain restaurants that provides flexibility for restaurants and preempts a patchwork of state and local laws...we continue to work with the agency to address issues of concern for the restaurant industry and ensure a smooth transition for restaurants and consumers alike.”
FDA Promises a Helping Hand
In addition to the extension of the grace period for the new protocols,the FDA pledged to “...provide training and technical assistance to covered businesses and the state, local, and tribal regulatory agencies that will likely take the lead in enforcement.” In the implementation of the new rules, the administration also promised to “work flexibly and collaboratively with individual companies making a good faith effort to comply with the law.” Furthermore,the agency contended within their economic analysis of the regulations’ impact that “...allowing adequate time for covered establishments to fully implement the final rule's requirements, as described in the requests, helps accomplish the primary objective of the final rule and is in the public interest.”
The FDA has issued their final ruling on Menu and Vending Machine labeling requirements. In part 1 of our blogs on this topic, we answer some of your important questions about labeling requirements for menu items in restaurants and similar retail food establishments. In this blog, part 2, we will review the new requirements for calorie labeling on foods in vending machines.
Let’s take a look at some important questions that many vending machine operators might be asking….
What vending machine operators need to comply?
People who own or operate 20 or more vending machines would be “covered” under this ruling and would need to comply.
Some general examples of the definition of “vending machine” could be vending machines that sell prepackaged snacks and beverages, beverage dispensers, prepared foods from a turnstile vending machine, or bulk food machines that dispense a handful of candy or peanuts.
I own less than 20 vending machines and so am not covered, can I still comply?
Yes, vending machine operators who are not covered by this ruling may voluntarily register with the FDA.
What type of vending machine might NOT be covered and are exempt?
Machines that dispense food items as part of a game, are one example of vending machines that are not covered by these requirements.
What other foods may be exempt or NOT covered by these requirements?
If a purchaser can view the nutrition facts panel clearly on the food item, without any obstruction, before they purchase – then additional labeling would not be required for that food item. Also, if there is nutrition information available and able to be viewed on the food item (such as, calories on the front-of-label), then no further calorie labeling would be required. (Further clarificaiton on FOP requirements below.)
I have FOP labeling that shows calories, are these foods exempt?
Perhaps they would be exempt, but there are other requirements for FOP (front-of-package) labeling in order to exempt the food. Ask yourself these questions:
Are the calories that are shown for the entire item? (Not broken up into serving sizes, ie: 2 servings per container.)
Is the type size of the calories at least 50% of the largest type size on the label?
Do the calories have sufficient contrasting compared to the rest of the label, so the purchase can clearly distinguish it?
If you can answer yes to all three questions, then that food item may be exempt from further labeling.
I do NOT have the calories or a nutrition facts label clearly displayed on my food item inside my vending machines. Where do I need to display it?
A sign must be displayed inside, on or just adjacent to the vending machine that shows the total number of calories for the item.
When the sign is inside or on the vending machine, the declaration must be in a type size no smaller than the smallest of either the name of the food on the machine (not the food label), selection number, or price of the food. It must also be:
* Displayed with the same prominence, meaning the same color, or a color at least as conspicuous, as the color of the name or price of the food or selection number; and
* Set against the same contrasting background, or a background at least as contrasting as the background used for the item it is in close proximity to
When the sign is adjacent to the vending machine, the declaration must be:
* in a type size large enough to render it likely to be read and understood by the consumer under customary conditions of purchase and use, and
* in a type that is all black or one color on a white or other neutral background that contrasts with the type color
When do I need to comply by?
Vending machine operators or owners that are covered by this ruling need to comply by December 1st, 2016. The initial proposal by the FDA was a one year deadline; however, this has been extended to two years in their final ruling.
How will the FDA enforce these regulations?
The FDA will use the contact information that is required to show on the vending machine, to contact the owners or operators if they fail to comply.
How do I get the calorie information that is needed?
If a nutrition facts panel is NOT readily available, then you might want to check with the manufacturer of the food item. They may have the analysis already done. Otherwise, there are two methods that can determine a food item’s calories: data-base analysis and laboratory testing.
For more information on these two methods, please give us a call at 877-753—6631.
Last week, the FDA announced their final rulings on the much anticipated Restaurant Menu and Vending Machine Labeling Requirements. The rulings will require calories to be shown on menus and menu boards in chain restaurants and vending machines.
The FDA has issued these rulings in an effort to fight obesity. Nearly two-thirds of adults and one third of children are overweight or obese. Calories are the major contributor to weight gain. The FDA estimates that about a third of the total amount of calories consumed come from outside the home. It is expected that implementing these new food labeling laws will help consumers make better, more informed decisions about what they are eating.
In this article we will be answering your questions on the new Menu labeling requirements for Restaurants and other retail food establishments.
Who does this menu labeling rule apply to?
The FDA refers to the establishments needing to comply as being ‘covered’ by this rule. Here is the criteria that describes the covered establishments:
A restaurant or similar retail food establishment that offers “restaurant-type food” and is part of a chain of 20 or more locations, doing business under the same name and offering for sale substantially the same menu items.
More information on the definitions of “restaurant –type foods and “chain of 20 or more locations” is below…
What are restaurant-type foods?
The FDA defines “restaurant-type foods” as foods that are usually eaten on the premises, while walking away, or soon after arriving at another location. Foods that would NOT be considered “restaurant-type foods” would be grocery type items that would normally be stored to be consumed later.
The FDA provides a helpful table that lists what would generally be defined as “restaurant-type foods.” You may find this table helpful if you are trying to determine whether or not your establishment sells “restaurant-type foods.”
What defines a chain of 20 or more…?
“Locations” means a fixed position or site. This ruling would not apply to airlines, trains or busses because they do not stay in one spot.
“Doing business under the same name” means they would share the same name as other establishments in the chain (regardless of individual franchises).
“Offering for sale substantially the same menu items” means “offering for sale a significant proportion of menu items that use the same general recipe and are prepared in substantially the same way with substantially the same food components, even if the name of the menu item varies.”
Other than restaurants, who else is covered under this ruling and needs to comply?
This ruling also applies to other food services other than restaurants. Here are some examples the FDA gives: bakeries, cafeterias, coffee shops, convenience stores, delicatessens, ice cream shops, mall cookie counters, pizza take-out, grocery stores that sell deli sandwiches from a menu board, retail confectionary stores, superstores, and food services inside amusement parks, bowling alleys, and movie theatres.
When do you need to comply by?
Restaurants or similar retail food establishments that are covered, need to comply by December 1, 2015.
Who does is NOT apply to or is NOT covered?
This ruling does not apply to schools. Other examples of non-covered entities are: transportation carriers (like airplanes), food trucks or ice cream trucks.
If my establishment is NOT covered under this ruling, can I still comply?
Yes, “restaurants and similar retail food establishments” that are not covered, or required to comply because they are not part of a chain of 20 or more – for example, may still voluntarily register under the federal government and comply. These restaurants would still remain subject to local and state nutrition labeling laws; however, registering under this ruling would preempt them from local and state menu labeling laws.
If I am already complying with my local, state menu labeling requirements, do I need to comply to this?
If your establishment is ‘covered’ under this ruling; then YES, you would have to comply with these federal regulations.
Do the menu labeling requirements apply to all of my food items?
Only “standard menu items” are required to comply with the food labeling rules. “Standard menu items” are “restaurant-type foods” that are routinely included on menu and menu boards or routinely offered as a self-service food or food on display.
Some foods that would NOT be considered “standard menu items” are: condiments, daily specials, custom orders, or market test foods. Also, the rule does not include liquor kept behind a bar which is used to make drinks.
Are alcoholic beverages covered under this ruling and need to comply?
Yes, if it is a standard menu item listed in a menu or menu board. Some beers and wines may be clumped together in ranges - in some instances. However, bottles of alcohol kept behind a bar, which are used to make drinks, are not covered under this ruling.
What information MUST be provided for my menu items?
The FDA states, “chain restaurants and similar retail food establishments will provide consumers with clear and consistent nutrition information in a direct and accessible manner for the foods they eat and buy for their families.”
There are three items that must be displayed on menus or menu boards. They are:
Number of Calories per menu item
Succinct statement of daily caloric intake: “2,000 calories a day is used for general nutrition advice, but calorie needs vary”
“Additional nutrition information available upon request” must be stated, as well
For self-service foods, or foods on display that are standard menu items, the calories must be declared on signs adjacent to the foods for sale.
How should the “additional nutrition information” be displayed?
The additional nutrition information must be available on the premises and should include: total calories, calories from fat, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrates, fiber, sugars, and protein.
There are different ways this information can be displayed, as long as it is made available on the premises. (ie: sign, brochure, counter card, electronic device, menu)
What is considered a “menu or menu board?”
The FDA defines “menus and menu boards” as “the primary writing of the covered establishment from which a customer makes an order selection.” Some examples of these are: breakfast, lunch, and dinner menus; dessert menus; beverage menus; children’s menus; take out menus; online menus; drive through window menu board; menu board behind a counter.
Examples of items that would NOT be covered are a billboard, tray liner, or promotional items such as a coupon.
What is the layout for declaring the calories on menu boards?
The number of calories should be stated per menu item or per serving for multiple serving items that are usually offered for sale in discrete units – providing the serving size and number of servings.
The calories should be placed as stated by the FDA:
next to the name or the price of the associated standard menu item
in a type size no smaller than that of the name or the price of the associated standard menu item, whichever is smaller
in the same color, or a color at least as conspicuous as that used for the name of the associated standard menu item
with the same contrasting background or a background at least as contrasting as that used for the name of the associated standard menu item
Self-service foods and foods on display must declare calories “per displayed food item” as it is offered for sale (ie: a muffin, or slice of pizza, a bagel) and not based on a different amount. In other words, a large muffin cannot be put into 2 servings. The calories must be displayed on a sign adjacent to and clearly associated with the food item. For example, on the sneeze guard.
How should the succinct statement be posted?
The succinct statement should say, “2,000 calories a day is used for general nutrition advice, but calorie needs vary” and should be placed as stated by the FDA below:
prominently and in a clear and conspicuous manner
in a type size no smaller than that of any calorie declaration appearing on the same menu or menu board
in the same color or in a color at least as conspicuous as that used for the calorie declarations
with the same contrasting background or a background at least as contrasting as that used for the calorie declarations
For children’s menus, the rule allows for the following succinct statements:
"1,200 to 1,400 calories a day is used for general nutrition advice for children ages 4 to 8 years, but calorie needs vary."
"1,200 to 1,400 calories a day is used for general nutrition advice for children ages 4 to 8 years and 1,400 to 2,000 calories a day for children 9 to 13 years, but calorie needs vary."
How can I get the nutrition information that is required?
First, the menu item’s recipe and serving size should be standardized and the covered establishment must take “reasonable steps to ensure the method of preparation and amount of standard menu item adheres to the factors on which the nutrient values were determined.” This means to not only use the same recipe but also make sure your portions are the same that you used to determine the nutritional information. Be consistent.
If there is not a nutrition facts label available for the finished menu item, then you will need to get the analysis done. There are two methods used to determine the nutritional value of a food:
Data-base software analysis
Data-base software is a less expensive method, compared to lab analysis, and only takes 1 to 2 business days to complete. Whereas, lab analysis can take up to 25 business days.
Not all menu items would need lab analysis. In fact, the majority of food items can be analyzed through the data-base using your detailed recipe.
Wondering if your recipes can use the data-base analysis? It would probably be best if you gave us a call. We would be happy to tell you more. Call us 7 days a week at: 877-753-6631.
Mission accomplished for an estimated three million Americans who are suffering from celiac disease in gluten-free labeling laws. As of August 5th, 2014, any food product stating gluten-free on or after this date must meet the new rule’s requirements.