The FDA issued a draft guidance document to clarify the administration’s policy on the declaration of small and trace amounts of nutrients on manufacturers’ nutrition labels. Released as a notice in Federal Register, the draft guidance, when finalized, will “...explain to manufacturers of conventional foods and dietary supplements [the FDA’s] policy on determining the amount to declare on the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Issuing the draft guidance was determined necessary by the emergence of a potential conflict of interest between specific stipulations of the Code of Federal Relations (CFR).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The draft guidance document is mostly directed at clarifying the nuances of American labeling laws for food manufacturers and purveyors. In the words of the bureau, “the draft guidance represents the current thinking of FDA on our policy on declaring small amounts of nutrients and dietary ingredients on nutrition labels.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 Furthermore, the FDA is accepting public comments on the draft guidance up until September 28, 2015.
So you have created a barbeque sauce that your family and friends simply can’t live without and you want to share it with the world, while turning a robust profit of course. You want to move forward, take the next steps, make change and be your own boss. But how do you get started?
Well, one of the things you will eventually need to do is to have nutritional analysis performed on your product and will need nutrition labels as well. So you start Googling nutrition labels and you end up on the end of the line with one of our team members.
Welcome, we are so glad that you called, and we are ready to help you with what you will need to prepare for a data based analysis. We will provide you with a recipe template to be filled out in full.
The following Q&A’s will provide you with step by step instructions as to how to fill out our recipe template and expedite the process.
How do I prepare my recipe?
You will need to provide your recipe using amounts in grams, ounces, percentages, or household measurements. Up until now you may have varied the amount of a certain ingredient but will need to maintain consistency moving forward when providing the nutrition facts label on your product to maintain the integrity of the information expressed on that label. In short, you will need to standardize your recipe.
How will I determine the Serving Size for my product?
A Serving Size is the amount of a food or beverage that one would consume in an eating occasion. The FDA has taken the guess work out of it and has provided this information for you to follow. You may use the RACC (Reference Amounts Customarily Consumed) to find the serving size for a particular product. The serving size is made up of two parts: a “household measure term” followed by its metric equivalent.
For example: ¼ c cup (60g).
How will I determine the Servings per Container for my product?
The number of Servings per Container is determined by taking the total Net Weight of your product divided by one Serving Size.
NET WT 8oz (227g)
Serving Size 2 Tbsp (32g)
227g / 32g = 6g
We will utilize rounding rules set forth by the FDA when determining the final number for Servings per Container.
How do I determine the total weight of my product?
You will need to use a scale that provides grams or ounces for foods or mL or liters for beverages. If you need to use a container to hold your product in, like a mixing bowl, then you will need to first weigh the mixing bowl that you will be using. Once you determine the weight, jot that number down. Now add the product in the bowl and weigh again. Then take that weight and deduct the weight of the mixing bowl.
For example: If the weight of the mixing bowl is 1 oz. and the final weight (mixing bowl + product) is 5oz, then the weight of your product before processing will be 4oz (5oz – 1oz).
What information about the ingredients need to be included?
We require a copy of the nutrition facts label, ingredient statement and allergen statement for all processed ingredients used in your recipe, for a couple reasons. To ensure that your analysis is accurate, we load the processed foods used in your recipe into the software. This ensures that your results are specific to your ingredients. We create an ingredient statement for your product and all ingredients and sub ingredients will be listed in descending order by weight.
What is Percent Moisture in final product and why do I need to provide that information when completing my recipe template?
Some foods lose moisture when cooked or baked, and this is called moisture loss. The loss of moisture will affect the nutritional values retained in your final product. Take the weight of your product before cooking then take the weight after cooking.
For example, if you have 758g of dough and the final weight of the baked product is 672g, you know you've lost 11g of moisture.
758g (Initial weight before processing)
672g (Final weight after processing)
86g (moisture loss)
86g /758g = 11% of moisture loss in final product
100% - % = 89% moisture in final product
It’s tough getting started and it can feel a little intimidating. But by reading and understanding what you will need to prepare for a data based analysis it should help ease any uncertainty you may have. You are not alone, we get questions like the ones above every single day. Call us 7 days-a-week at: 877-753-6631. We are here to help you!
Whether you are a food manufacturer, a small startup or a food service provider, you are most likely aware of the FDA's proposed changes to the Nutrition Facts Label, including the proposed changes to serving sizes. The final decision will impact anyone that is required to provide nutrition facts for their product. After the announcement of the proposed changes in February 2014, there was a comment period which enabled the public to comment on the proposed changes. The comment period ended on August 1, 2014. Even with the comment period closing, there is still more to do on the FDA's proposed nutrition label changes.
Very often we receive calls from customers that are either concerned about the FDA's proposed changes or have questions about the changes. We participated in the comment period, ourselves, and voiced a concern about the proposed timeline for the industry to comply with the addition of required nutrients to the label. Like many who have commented, we sometimes wonder: did the FDA hear us and will it make a difference? Is this all we can do?
Just because the comment period ended on August 1st, interest and concern haven't. Instead of feeling helpless and irrelevant, let's start to fill the cup half way full and continue our efforts.
Bruce Silverglade, Principal Attorney at Olsson Frank Weeda (OFW), feels that being proactive is the way to go and offers ways in which we can still engage and impact the final decision. In his recent blog post Mr. Silverglade tells us, "Don't sit back and wait: Be proactive!" He explains, "Filing a comment with FDA is the first, not the last, step in participating in the development of a final regulation."
It can be of interest to know what others have submitted during the comment period. This can help shine a light on who else might share the same stance and who has an opposing perspective.
Mr. Silverglade goes on to encourage anyone in the food industry, who might have concerns, to request a meeting with Members of the House and Senate Committees. They have jurisdiction over FDA's annual appropriations, as well as leading the Members from Congressional committees that have FDA oversight responsibilities. These meetings can serve as a way to share concerns by discussing the impact as it relates to individual areas in the food industry that might be overlooked or aren't being considered merely because of a lack of awareness.
Bottom line, we can still make an impact on the final ruling and there are things that we can be doing to achieve this. Let's continue to work smart, use the available resources, agencies and organizations that are available to be heard, and just remember folks, it's not over...yet.
We are following these propsed changes closely. Check back here for breaking updates.