The FDA has finalized its guidance on menu labeling with the labeling rule being implemented on May 7, 2018 for restaurants and eating establishments. FDA Commissioner, Scott Gottlieb, M.D. states:
Starting today, this information will be required throughout the country as the FDA’s menu labeling rule is implemented. Consumers walking into eating establishments covered under the rule will know how many calories are in the foods they may want to order.
In anticipation of this rule being enacted, many chain restaurants and other retail eating sites (e.g. MacDonald’s, Red Robin) have already implemented the calorie labeling requirement. This is, however, only the beginning of a labeling overhaul that the FDA has undertaken. Its rules regarding changes to the Nutrition Facts Label and Serving Size are also in place and will by fully implemented by January 1, 2021.
From their announcement in September, 2017:
The U.S. Food and Drug Administration is proposing to extend the compliance dates for the Nutrition Facts and Supplement Facts label final rule and the Serving Size final rule from July 26, 2018, to Jan. 1, 2020, for manufacturers with $10 million or more in annual food sales. Manufacturers with less than $10 million in annual food sales would receive an extra year to comply—until Jan. 1, 2021.
Earlier this year, the FDA put forth their Nutrition Innovation Strategy. It aims to provide consumers with science-based and qualified health claims—meaningful claims that are understandable, and ones that they can trust. Commissioner Gottlieb asserts:
FDA’s new policy aims to provide all Americans with easier access to nutritious, affordable foods by arming consumers with information and encouraging the food industry to innovate in producing the healthier foods that today’s informed consumer wants. The Nutrition Innovation Strategy will modernize claims like “healthy” on food packages, modernize how we establish standards of identity for foods, make ingredient information on labels easier to decipher, help streamline the process for establishing qualified health claims on food labels, and encourage companies to reduce sodium intheir products.
By making more substantive links between food and nutrition, key imperatives are emerging to ensure that claims are anchored to the latest nutritional science. An important element in this link is being transparent and rigorous in testing the food being offered to consumers by its providers and manufacturers. RL Testing Laboratory specializes in such testing and can be an effective partner for its clients who are on the forefront of implementing the new FDA guidelines.
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 need to display updated information in nutrition science was a large contributor to the new food labeling ruling. Reporting added sugars, changes in fiber declarations and modifications in what and how nutrients are reported are examples of that.
Historically, the nutrients required or permitted were Vitamin A, Vitamin C, calcium and iron. The new label will now list potassium, calcium, iron and Vitamin D; Vitamin A and Vitamin C will no longer be required but could be included on a voluntary basis. Vitamin A and Vitamin C deficiencies are rare today, while potassium and Vitamin D levels are more likely to be inadequate.
Why Vitamin D?
Of particular interest, the prevalence of Vitamin D deficiency appears to be somewhat sudden and rampant. Over the past decade, the percentage of the American population to test adequate for vitamin D declined from roughly 50% to 25%. This means that 3/4 of the American population are found to be deficient in this essential nutrient. Health professionals have a few theories as to why this sudden decrease.
• Skin-cancer prevention campaigns which encourage sunscreen and long sleeves, blocking vitamin D production from the sun.
• Perhaps less and less people are outside between 10:00 am and 2:00 pm; the ideal window for synthesizing Vitamin D. Most would be inside working, and not outside for at least 15-20 minutes with their head, neck and arms exposed to sunlight.
• They also blame possible faulty testing.
Either way, most agree that it’s a problem that needs to be addressed.
What is Vitamin D?
Vitamin D is a unique nutrient - it functions as a hormone, helping all body cells to communicate properly. As such, the health effects of vitamin D are varied and include:
• The softening and weakening of bones.
• One contributing factor to depression.
• It’s been found to play a role in heart disease, cancer and diabetes.
• It can also effect an individual’s immunity and has been linked to some autoimmune diseases.
It’s quite possible that current research has only scratched the surface of the functions of Vitamin D and possible adverse effects of deficiency.
It’s a fairly easy and routine blood test and levels should be tested prior to supplementation. Proper dosage for deficiencies are based on current levels and are aimed to restore the nutrient to the ideal range without overdoing it, which is quite possible since Vitamin D is a fat soluble vitamin and is stored easily by the body and not eliminated in the urine like water soluble vitamins (such as B vitamins or Vitamin C).
Where does Vitamin D come from?
There are three ways we get vitamin D:
• The body makes Vitamin D through sunlight which is the primary way we keep adequate blood levels. Just 15-20 minutes in the sun will make the equivalent of 20,000 IU taken orally.
• We can also get it through supplementation, but the body will need to convert supplements to the active form called “calcitriol”.
• A small amount may come from food. However, food sources of Vitamin D are limited and include fortified dairy products, fortified breakfast cereals, fortified non-dairy products (fortified almond milk or soy milk, for example), salmon, mackerel, tuna and egg yolks. Again, the type of vitamin D in food or fortified products will need to be converted to the active form.
Food labeling controversy
This has led many to question if Vitamin D really belongs on the nutrition facts label. Many health professionals feel it could lead consumers to believe that food is an adequate source of
Vitamin D when what they really need is more sun. Dr. Marion Nestle, Professor of Nutrition, Food Studies, and Public Health at New York University and author of “Food Politics” has stated: “Vitamin D is not a vitamin; it is a hormone synthesized by the action of sunlight on skin. For this reason alone, it does not belong on the food label.” (1)
However, Vitamin D researcher Michael Holick, MD, PhD at Boston University Medical Center disagrees. While he recognizes the effectiveness of the sun, he also acknowledges the efficacy of Vitamin D supplementation and food fortification without the side effects of UV sun exposure. (1)
The effectiveness of food fortification on Vitamin D status is well documented, the best example being the milk fortification program implemented in the United States in the 1930s to combat rickets (softening and weakening of bones in children), which was then a major public health problem. Since then, almost all of the U.S. milk supply is voluntarily fortified with Vitamin D and fortified prodcuts are the biggest food contributor of the vitamin to the American diet. (2)
The bottom line
While it might be met with controversy, Vitamin D reporting will be required on the new food label. We at RL Foods can help food companies calculate and display the new changes to the nutrition facts label as well as any accompanying nutrient content claims on the front of the package.
Manufacturers should be aware of the limitations of UPC barcodes available. There are basically two categories of UPC barcodes manufacturers can choose. The generic UPC without a company prefix is not registered with GS1. These barcodes are intended for small, local retailers and distributors. If your company’s demand increases for larger sales then you need a GS-1 certified UPC.
If you intend to sell your product to large retailers: Whole Foods, Wal-Mart, Trader Joes, Amazon, etc you will need a GS1 barcode. Contact ALL distributors of your product(s) before you print packaging with the barcode to ensure you meet their requirements.
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.