This article summarizes several key provisions introduced by FDA's new Nutrition and Supplement Facts Labels rule with a specific focus on their effect on the development and marketing of dietary supplements. Potential implications of the new requirements and changes are presented and suggestions are provided for managing various aspects of the new rule.

Introduction

On 27 May 2016, the US Food and Drug Administration (FDA) published in the Federal Register its final rule on Food Labeling: Revision of the Nutrition and Supplement Facts Labels¹ and its final rule on Serving Sizes of Foods That can Reasonably be Consumed at one Eating Occasion; Dual-Column Labeling; and Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed.² These new rules represent the first time FDA has engaged in rulemaking on nutrition labeling in more than 20 years. The impact of the new and revised provisions in these two rules on the food and dietary supplement industries in the US will be significant. While it can be argued that most of the changes introduced by both rules have a greater impact on conventional food products, the changes, especially those in the labeling rule, present a unique set of challenges for dietary supplement products and dietary supplement companies.

For companies with less than $10 million in annual food sales, the compliance dates for the new rule requirements, as published in the Federal Register, are 26 July 2018 and 26 July 2019, respectively. FDA recently proposed an extended compliance timeframe (1 January 2020) with an additional year for smaller businesses.^{3, 4}

Changes to Sugars and Dietary Fiber in Supplements Facts Boxes

Arguably, the most significant change introduced by the Nutrition and Supplements Facts Labels Rule is the requirements related to the declaration of sugars. With this rule, FDA set a Daily Value (DV) for "added sugars" (not for Total Sugars) of 50g per day, which amount to 10 percent of calories based on a caloric intake of 2,000 calories a day. Added sugars must be declared when present at or more than 1g per serving of a product or when claims are made about the product related to sugars, sweeteners, or sugar alcohols. The agency defines added sugars as "Sugars that are either added during the processing of foods or are packaged as such." In addition, "Sugars" must now be declared as "Total Sugars" in the Supplements Facts Box.

This last requirement reflects FDA's effort to inform consumers through food labels about the intrinsic sugar content in a packaged product versus sugar added during manufacturing or processing of a food. While it may be true that this requirement will affect a relatively small number of dietary supplements (relative to conventional food products), including gummies, chews, and powders, it is, nevertheless, a requirement for dietary supplements. The challenge for companies will be in determining in the products affected by this new requirement what is intrinsic versus what is added. There is currently no testing method available to help in making this determination. As such, it will be necessary for companies to work very closely with their suppliers and "dive" into the specifications of the raw materials used in their products to determine sugar content. A further complicating factor is that for added sugars, as well as several other nutrients, FDA will require the records used in determining a product's quantity of added sugars to be maintained by the company.

The new rule increased the Daily Value for dietary fiber from 25 g to 28 g and established a new definition for dietary fiber which, among other things, requires that isolated or synthetic non-digestible carbohydrates provide a beneficial physiological effect to be considered dietary fiber. FDA specifically listed some fiber sources which, according to the agency, fit this definition and laid out the requirements that must be submitted for other fiber sources to be reviewed by FDA for acceptance as dietary fiber. It is a cause for great concern for the industry that excluded from the list published in the final rule are several types of fiber commonly used in dietary supplements, such as inulin. This means that, under the new definition, products making a fiber claim and using fibers not included in FDA's published list of dietary fibers may not continue making a fiber claim.

There also is a problem with the testing method for fiber. There is a test method acceptable, and indeed referenced by FDA in the rule, for determining the content of fiber in a product. The problem lies in the fact that this referenced method does not distinguish between different types of fibers, some of which may not be in the list published by FDA or may not fit the agency's definition for dietary fiber. In cases where both dietary fiber that meets FDA's definition and other non-digestible carbohydrates are present in the finished product, the agency states in the rule that manufacturers must establish and maintain written records to verify the correct amount of dietary fiber as defined by FDA. To further complicate matters, the increase in DV to 28 g may make it necessary for some products making nutrient-content claims to be reformulated to continue meeting the dietary fiber content necessary for making the claim. Thus, the new definition and the increase DV present a variety of issues for manufacturers when determining how to calculate a product's dietary fiber content.

Together, the new requirements in the Nutrition and Supplements Facts Labels Rule related to added sugars and dietary fiber present a new set of challenges for the dietary supplements industry. Companies will be well-advised to work closely with their R&D team and with their raw materials suppliers to not only obtain the information needed for compliance by FDA's deadline, but also dedicate time to developing effective tools and processes to enable effective maintenance of these data to ensure the data will be more easily collected for new products. Some of these tools could include educational and training sessions with internal and external partners; developing tools to gather and maintain data on raw materials and products, e.g., templates; and revising existing or establishing workflows to ensure visibility of these new requirements early in the development process.

While new requirements for sugar and fiber are without a doubt quite significant, the changes contained in the Nutrition and Supplement Facts Labels Rule go well beyond those two nutrients and include other revisions made to the Daily Values (DV) of several macronutrients and the Reference Daily Intakes of most micronutrients. These revisions can be significant for dietary supplement companies.

Revisions to Daily Reference Values and Reference Daily Intakes and Potential Implications: Summary

FDA made a significant number of changes to several Dietary Reference Values (DRV) and many Reference Daily Intakes (RDI). As previously mentioned, the DV for dietary fiber was increased to 28g and a new DV of 50 g for added sugars was established. Other DV's that changed include:

• DRV for fat was increased to 78 g
• DRV for carbohydrates was decreased to 275 g
• DRV for sodium was decreased from 2,400 mg to 2,300 mg

Most vitamins and minerals had their RDI for adults and children age four and older revised. The vitamins and minerals for which the RDI was reduced include:

• Biotin has decreased from 300 mcg to 3 mcg.
• Chloride has decreased from 3,400 mg to 2,30 mg.
• Chromium has decreased from 120 mcg to 35 mcg.
• Copper has decreased from 2 mg to 0.9 mg.
• Molybdenum has decreased from 75 mcg to 45mcg.
• Pantothenic acid has decreased from 10 mg to 5 mg.
• Riboflavin has decreased from 1.7 mg to 1.3 mg.
• Thiamin has decreased from 1.5 mg to 1.2 mg.
• Niacin has decreased from 20 mg to 16 mg.
• vitamin B-6 has decreased from 2 mg to 1.7 mg.
• vitamin B-12 has decreased from 6 mcg to 2.4 mcg.
• Selenium was decreased from 70 mcg to 5 mcg.
• Zinc has decreased from 15 mg to 11 mg.

The following vitamins and minerals had their RDI for adults and children age four and older increased:

• Calcium has increased from 1,000 mg to 1,300 mg.
• Magnesium has increased from 400 mg to 420 mg.
• Manganese has increased from 2 mg to 2.3 mg.
• Phosphorus has increased from 1,000 mg to 1,250 mg.
• Potassium has increased from 3,500 mg to 4,700 mg.
• Vitamin c has increased from 60 mg to 90 mg.
• Vitamin k has increased from 80 mcg to 120 mcg.

Further, several vitamins will now need to be declared using different units of measure. In the case of vitamins A, D and E, International Units (IU) will be replaced by metric units, such as micrograms of Retinol Activity Equivalents (mcg RAE) for vitamin A; micrograms for vitamin D and mg for vitamin E. For vitamin D, however, IU may continue to be used in addition to mcg. Also, folate must now be declared as micrograms of "Dietary Folate Equivalents" (mcg DFE) instead of simply mcg.

The revised RDIs for these four vitamins are:

• vitamin A 900 mcg RAE (from 5000 IU)
• vitamin D 20 mcg (800 IU) (increased from 10mcg or 400 IU)
• vitamin E 15 mg (from 30 IU)
• folate 400 mcg DFE (from 400 mcg)

Because of the change in declaring units of measure, the magnitude of the change in the RDI for vitamins A and E will vary depending on the form of the vitamin being used in a particular product. For folate, the change to DFE is significant because folic acid, commonly used in multivitamins, is considered to be more bioavailable than folate naturally occurring in food. According to the final rule, 1 mcg DFE is equivalent to 1 mcg of naturally-occurring folate, which is equivalent to 0.6 mcg folic acid. This means that a dietary supplement product providing 100 percent of the DV for folate (i.e., 400 mcg DFE folate) will only contain 240 mcg folic acid, which is below the recommended amount (400 mcg folic acid) to prevent neural tube defects.⁵ This is just one sample of the type of issues dietary supplement companies will need to consider when evaluating the implications and impact of the revisions in the rule on various types of products.

In addition, the final rule also:

• determined a single set of RDIs for pregnant and lactating women
• established several DRVs and RDIs for infants seven through 12 months, a group which until now did not have specific RDIs
• introduced a set of specific RDIs for children one through three years
• established a new RDI for Choline for the following groups:
• adults and children four years and older - 550 mg
• infants – 150 mg
• children – one to three years - 200 mg
• pregnant and lactating women - 550 mg

Implications

It is easy to see that the Nutrition and Supplements Facts Labels Rule will affect many dietary supplements in the market, and indeed, products in the development phase. There are several potential implications of the rule especially impacting record keeping and product claims.

Recordkeeping Requirements

Because FDA is requiring manufacturers to establish and maintain written records to support the label declarations of several nutrients, dietary supplement companies and companies supplying raw materials for these products will need to devise effective ways to gather and maintain the records. These records are the basis for determining the label claims for those nutrients for which there is no suitable testing method for distinguishing between different types or forms of nutrients.

Recordkeeping will be required for the following nutrients and scenarios:

• added sugars - where the product contains both naturally occurring and added sugars and where the added sugars are subject to fermentation and/or non-enzymatic browning
• dietary fiber - when a non-digestible carbohydrate that meets the definition of dietary fiber and other non-digestible carbohydrates are both present in the finished product
• vitamin E - when vitamin E is present in a food as a mixture of all rac-alpha-tocopherol acetate and RRR-alpha- tocopherol
• folate and folic acid - when a mixture of folate and folic acid is present in a food or dietary supplement

This recordkeeping requirement is new for dietary supplement companies and one for which FDA did not provide much detail regarding the type of suitable documentation to be kept. However, the agency did state records should be maintained at least two years after introduction or delivery for introduction of the dietary supplement into interstate commerce.

Impacts to Product Claims

Because of the revisions to the DRVs and DRIs one area most likely to be affected in dietary supplements are label claims. When issued, FDA acknowledged how revisions to the labeling regulations would impact other regulations, including several regulations on label claims. The agency subsequently signaled that it intended to address these impacts at the right time. However, as of this writing, there is still no clarity on this topic and companies must figure out a way to move forward without clarification.

Some of the products affected are those bearing nutrient-content claims as they may no longer be eligible to make those claims or some products may become eligible for some claims. Nutrient-content claims characterize the amount of a nutrient in a dietary supplement and must meet, in most cases, a specific amount based on the RDIs or DRVs of the nutrient on which the claim is being made.⁶ Dietary supplement companies must evaluate the impact of the revisions on any nutrient-content claims made for their products. Claims needing to be revisited include:

• 'High,' 'Rich In,' or 'Excellent Source Of' – these claims require 20% of more of DV of the referenced nutrient per Reference Amount Customarily Consumed (RACC).
• 'Good Source,' 'Contains,' or 'Provides' – these require 10-19% of the DV per RACC.
• 'More,' 'Fortified,' 'Enriched,' 'Added,' 'Extra,' or 'Plus' – these claims require 10% or more of the DV per RACC than an appropriate reference food.
• 'High Potency' – this claim describes individual vitamins or minerals that are present at 100% or more of the RDI per RACC or on a multi-ingredient food product that contains 100% or more of the RDI for at least 2/3 of the vitamins and minerals with RDIs and that are present in the product at 2% or more of the RDI.

The potential implications for health claims also can be significant and must be evaluated as well. Several of the authorized health claims are affected by the revisions to RDIs and DRVs in the rule. One of importance for dietary supplements is the claim for osteoporosis and its relationship to calcium and vitamin D.

Health claim on the role of calcium or calcium plus vitamin D in reducing the risk of osteoporosis – the requirements on the product making either of these claims are for calcium and vitamin D to meet the definition of "high" in the product, i.e., 20% or more of the DV per serving.⁷ As discussed above, the RDI for both nutrients was increased; calcium to 1300 mg from 1000 mg and vitamin D to 20 mcg from 10 mcg.

In addition, there are regulatory requirements for disintegration and dissolution that must be met by products bearing either claim. In this example, there is potential for not only a reformulation if the product bearing the claim falls short of meeting the DV requirements, but also for additional testing to be performed to ensure all the requirements to make the claim are met.

Additional Considerations

Other considerations made necessary by changes to the DRVs and RDIs include what a potential reformulation may mean to a product in terms of appearance, taste, size of the capsule/tablet/bar and disintegration issues. These very important issues will need to be wrestled with by manufacturers. Should the decision be made to reformulate, companies also will need to consider the potential for the proliferation of additional formulas of their products. For example, for companies marketing products internationally, the US formula is often the one registered in some other countries, as allowed by local regulations, of course. Making a change to the US formula may mean that additional formulas will need to be maintained by that manufacturer, or that the reformulated product will need to be registered in that market.

It is also important to consider the potential impact on the scientific congruency in a product or product line. The DVs are often used as a scientific benchmark when formulating a product, but they also are relied upon as a marketing tool when developing and marketing a product. Changes to the DVs along with the new DVs established for some populations will likely, at minimum, prompt discussion regarding the need to reevaluate a product or product line which presumably was originally designed to deliver very concrete benefits to the consumer using very specific claims. If the claims need to be modified due to the changes in DVs, the scientific basis for a product also may need to be reevaluated.

For example, a dietary supplement company may have a product or product line consisting of several different types of products which contain various vitamins, minerals or other nutrients affected by the Nutrition and Supplement Facts Labels Rule. This product or product line may have been formulated to deliver specific nutrients at specific levels for specific benefits to a variety of consumers and populations. Changes in the DVs, along with the newly established DVs, present an opportunity to review those products to make sure that, from a scientific, regulatory, and marketing standpoint, they still make good sense and to ensure a company's nutrition or health communication strategy continues to be sound and effective. By the new rule establishing new RDIs for specific population groups also provides some opportunities for product development and consumer communications.

By now, most companies would have already started preparing for the changes and new requirements introduced by the new rules. And, most companies would have already experienced first-hand the myriad issues needing to be addressed. FDA's postponement of the compliance deadline is welcome news, given the enormity of the tasks needing completion. Complying with the requirements for fiber, sugar, and recordkeeping, for example, will require a great amount of work and time, even developing new tools and effective processes to gather and maintain the information and records requested by FDA. Evaluating the impact on claims will require dietary supplement companies to take a careful and holistic look at their product line and adjust or refine their product development and marketing strategies accordingly. By doing so, dietary supplement companies marketing products internationally will do well to consider developments taking place internationally. Regulatory changes, such as the ones introduced by the Nutrition and Supplements Facts Labels Rule, do not usually happen in isolation and often propagate to other markets. The good news is that these changes usually take some time to reach maturity and become actionable regulation.

References                       

1. Food Labeling: Revision of the Nutrition and Supplement Facts Labels Final Rule: 81 Fed. Reg. 33741 (27 May 2016).
2. Final Rule on Serving Sizes of Foods That can Reasonably be Consumed at one Eating Occasion; Dual-Column Labeling; and Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed, 81 Fed. Reg. 34000 (27 May 2016).
3. FDA Proposes to Extend Compliance Dates for Nutrition Facts Label Final Rules. FDA website. https://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm577264.htm. Accessed 16 October 2017.
4. Food Labeling: Revision of the Nutrition and Supplement Facts Labels and Serving Sizes of Foods That can Reasonably be Consumed at one Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments; Proposed Extension of Compliance Dates. Federal Register. October 2017.
5. https://www.federalregister.gov/documents/2017/10/02/2017-21019/food-labeling-nutrition-and-supplement-facts-labels-and-serving-sizes-of-foods-that-can-reasonably. Accessed 16 October 2017.
6. US Department of Health and Human Services and US Department of Agriculture. 2015 – 2020 Dietary Guidelines for Americans. 8th Edition. December 2015. http://health.gov/dietaryguidelines/2015/guidelines/. Accessed 10 October 2017.
7. 21 CFR 101 Subpart D - Specific Requirements for Nutrient Content Claims.
8. 21 CFR 101.72 Subpart E - Specific Requirements for Health Claims.

About the Author

Jesús Muñiz, MS, is co-founder of MBui Consulting LLC providing services in regulatory affairs, regulatory policy and intelligence to the food, dietary supplements, and pharmaceutical industries. He can be contacted at jmuniz@mbuiconsultants.com.

Cite as: Muniz, J. "Preparing for Dietary Supplement Label Changes Under the Final Rule for Nutrition and Supplements Facts Labels." Regulatory Focus. October 2017. Regulatory Affairs Professionals Society.