Andrea Wong, PhD, Vice President, Scientific & Regulatory Affairs, Council for Responsible Nutrition (CRN)04.02.14
FDA’s recent announcement of the long-awaited proposed rule on changes to nutrition and supplement facts labels has sparked a great deal of interest, with focus on major format and content changes proposed for nutrition facts labels, such as the requirement for declaring added sugars and increased prominence of calories and serving sizes.
At first glance, the proposed supplement facts labels do not appear to be substantially altered; however, upon closer inspection there are several parts of the proposed rule that warrant the immediate attention (and action) of the dietary supplement industry. The comment period is currently open for public feedback, providing one last opportunity for the dietary supplement industry to shape this important rule.
RDA-based RDI
First, FDA proposes to continue using the Recommended Dietary Allowance (RDA), when available, as the basis for determining the Reference Daily Intakes (RDIs) for nutrients. The RDIs are used to calculate the percent daily value (DV) for nutrients on nutrition and supplement facts labels. In developing the proposed rule, FDA considered basing the RDI on the Estimated Average Requirement (EAR), which effectively would have diluted the nutrient requirements for Americans since the EAR represents the daily intake level estimated to satisfy the needs of only half of the people in each life stage and sex group.
In contrast, an RDI based on an RDA would meet the daily requirements of nearly all (97.5%) healthy individuals in a given group. Maintaining an RDA-based RDI is important given the significant nutrient shortfalls in the U.S. population, with many Americans not even achieving the EAR for several nutrients.
As an example, recent analysis of nutrient intake data shows that 54.5% of Americans fall short of average magnesium requirements when consumed from food alone. With the addition of magnesium supplements, the percentage of Americans falling short of the EAR drops by nearly 10%.
FDA also put to rest concerns for risk of excessive vitamin and mineral intakes by conducting a thorough analysis of available data and concluding that “total nutrient intakes (from both conventional foods and dietary supplements) … do not exceed the [Tolerable Upper Levels] for most vitamins and minerals.”
Updated RDI Values
Although the approach for determining RDIs will not change, the actual RDI values for a number of nutrients will shift to reflect the updated RDAs (or Adequate Intakes where RDAs are not available) for nutrients established by the Institute of Medicine from 1997 to 2011 (the current RDIs are based on the 1968 National Academy of Sciences RDAs). Of the 27 vitamins and minerals for which RDIs have been set, 23 RDIs will change as a result of the proposed rule. Some notable modifications include a decrease in the RDI of vitamin B12 from 6 mcg to 2.4 mcg, and a 50% increase in vitamin K’s RDI from 80 mcg to 120 mcg.
The proposed changes in RDIs will have a major impact on dietary supplement formulation and/or labeling. Companies seeking to maintain the same percent DV of nutrients in their products will need to reformulate their products, either increasing or decreasing individual nutrient levels depending on their respective new RDIs.
Formulation changes also may be needed for products to continue bearing nutrient content claims (e.g., “good source”) and/or health claims, since eligibility for claims depends on the percent RDI that the product provides. For example, products containing 200 mg calcium and 80 IU vitamin D per serving are currently eligible for the authorized health claim on calcium, vitamin D and osteoporosis risk reduction because they meet the requirement of containing at least 20% of the RDI. However, with the proposed changes in RDIs, products will need to contain 30% more calcium and double the vitamin D to make the claim. At a minimum, if no formulation changes are made, label modifications will be needed to reflect the new percent DVs based on the updated RDIs.
Declaring Vitamin D & Potassium
It was reassuring to see FDA recognized vitamin D and potassium as nutrients of “public health significance” based on their beneficial effects on bone health and blood pressure, respectively, the high prevalence of osteoporosis, osteopenia and hypertension among the general population, and the lack of adequate vitamin D and potassium intakes.
As a result, the agency is proposing to require mandatory declaration of these important nutrients, if present, on nutrition and supplement facts labels to help consumers make informed choices on how to achieve adequacy. The current mandatory requirement for declaring calcium and iron will not change, while declaration of vitamins A and C will no longer be required but may be made voluntarily.
Folate vs. Folic Acid
Nearly hidden in the 109-page document is a statement that FDA proposes “to only allow the use of the term ‘folic acid’ for the labeling of dietary supplements.” This is based on the agency’s rationale that folate is a nutrient occurring in conventional foods, whereas folic acid is the synthetic form of folate that is added to fortified foods and supplements.
However, several dietary supplements on the market contain folate from natural sources. Since these folate ingredients do not meet the definition of folic acid, the proposed rule would prevent companies from communicating the folate content of their products to consumers, and its contribution to the percent DV for this nutrient.
Dietary Fiber Concerns
Another part of the proposed rule that represents a major change is related to dietary fiber. FDA has proposed a formal definition of dietary fiber that is very restrictive. Isolated and synthetic non-digestible carbohydrates (with three or more monomeric units) will only meet the proposed definition if: a) FDA grants their inclusion in the definition in response to a petition demonstrating that such carbohydrates have a physiological effect(s) that is beneficial to human health; or b) they are the subject of an authorized health claim.
Currently, only two isolated fibers, beta-glucan soluble fiber and barley beta-fiber, are the subject of authorized health claims. The proposed definition will put a significant burden on manufacturers and marketers of innovative fiber products to conduct human studies showing a beneficial physiological effect, and to submit a petition to FDA for review. If these investments are not made, companies may find themselves unable to continue marketing their products as dietary fiber, along with the associated claimed health benefits.
These are only a few aspects of the proposed rule that may affect your business if implemented. It is essential to review the document carefully and express your concerns (and/or support) by submitting comments to the agency by the June 2nd deadline.
Working with your trade association to submit comments will provide a stronger voice to FDA. CRN will prepare comments on behalf of our members and has already requested an extension of the comment period to allow more time for our members to digest the proposed rule and its far-reaching implications. Also, start planning now; while we don’t know when the rule will be finalized, FDA has indicated that compliance will be expected within two years after the final rule becomes effective.
At first glance, the proposed supplement facts labels do not appear to be substantially altered; however, upon closer inspection there are several parts of the proposed rule that warrant the immediate attention (and action) of the dietary supplement industry. The comment period is currently open for public feedback, providing one last opportunity for the dietary supplement industry to shape this important rule.
RDA-based RDI
First, FDA proposes to continue using the Recommended Dietary Allowance (RDA), when available, as the basis for determining the Reference Daily Intakes (RDIs) for nutrients. The RDIs are used to calculate the percent daily value (DV) for nutrients on nutrition and supplement facts labels. In developing the proposed rule, FDA considered basing the RDI on the Estimated Average Requirement (EAR), which effectively would have diluted the nutrient requirements for Americans since the EAR represents the daily intake level estimated to satisfy the needs of only half of the people in each life stage and sex group.
In contrast, an RDI based on an RDA would meet the daily requirements of nearly all (97.5%) healthy individuals in a given group. Maintaining an RDA-based RDI is important given the significant nutrient shortfalls in the U.S. population, with many Americans not even achieving the EAR for several nutrients.
As an example, recent analysis of nutrient intake data shows that 54.5% of Americans fall short of average magnesium requirements when consumed from food alone. With the addition of magnesium supplements, the percentage of Americans falling short of the EAR drops by nearly 10%.
FDA also put to rest concerns for risk of excessive vitamin and mineral intakes by conducting a thorough analysis of available data and concluding that “total nutrient intakes (from both conventional foods and dietary supplements) … do not exceed the [Tolerable Upper Levels] for most vitamins and minerals.”
Updated RDI Values
Although the approach for determining RDIs will not change, the actual RDI values for a number of nutrients will shift to reflect the updated RDAs (or Adequate Intakes where RDAs are not available) for nutrients established by the Institute of Medicine from 1997 to 2011 (the current RDIs are based on the 1968 National Academy of Sciences RDAs). Of the 27 vitamins and minerals for which RDIs have been set, 23 RDIs will change as a result of the proposed rule. Some notable modifications include a decrease in the RDI of vitamin B12 from 6 mcg to 2.4 mcg, and a 50% increase in vitamin K’s RDI from 80 mcg to 120 mcg.
The proposed changes in RDIs will have a major impact on dietary supplement formulation and/or labeling. Companies seeking to maintain the same percent DV of nutrients in their products will need to reformulate their products, either increasing or decreasing individual nutrient levels depending on their respective new RDIs.
Formulation changes also may be needed for products to continue bearing nutrient content claims (e.g., “good source”) and/or health claims, since eligibility for claims depends on the percent RDI that the product provides. For example, products containing 200 mg calcium and 80 IU vitamin D per serving are currently eligible for the authorized health claim on calcium, vitamin D and osteoporosis risk reduction because they meet the requirement of containing at least 20% of the RDI. However, with the proposed changes in RDIs, products will need to contain 30% more calcium and double the vitamin D to make the claim. At a minimum, if no formulation changes are made, label modifications will be needed to reflect the new percent DVs based on the updated RDIs.
Declaring Vitamin D & Potassium
It was reassuring to see FDA recognized vitamin D and potassium as nutrients of “public health significance” based on their beneficial effects on bone health and blood pressure, respectively, the high prevalence of osteoporosis, osteopenia and hypertension among the general population, and the lack of adequate vitamin D and potassium intakes.
As a result, the agency is proposing to require mandatory declaration of these important nutrients, if present, on nutrition and supplement facts labels to help consumers make informed choices on how to achieve adequacy. The current mandatory requirement for declaring calcium and iron will not change, while declaration of vitamins A and C will no longer be required but may be made voluntarily.
Folate vs. Folic Acid
Nearly hidden in the 109-page document is a statement that FDA proposes “to only allow the use of the term ‘folic acid’ for the labeling of dietary supplements.” This is based on the agency’s rationale that folate is a nutrient occurring in conventional foods, whereas folic acid is the synthetic form of folate that is added to fortified foods and supplements.
However, several dietary supplements on the market contain folate from natural sources. Since these folate ingredients do not meet the definition of folic acid, the proposed rule would prevent companies from communicating the folate content of their products to consumers, and its contribution to the percent DV for this nutrient.
Dietary Fiber Concerns
Another part of the proposed rule that represents a major change is related to dietary fiber. FDA has proposed a formal definition of dietary fiber that is very restrictive. Isolated and synthetic non-digestible carbohydrates (with three or more monomeric units) will only meet the proposed definition if: a) FDA grants their inclusion in the definition in response to a petition demonstrating that such carbohydrates have a physiological effect(s) that is beneficial to human health; or b) they are the subject of an authorized health claim.
Currently, only two isolated fibers, beta-glucan soluble fiber and barley beta-fiber, are the subject of authorized health claims. The proposed definition will put a significant burden on manufacturers and marketers of innovative fiber products to conduct human studies showing a beneficial physiological effect, and to submit a petition to FDA for review. If these investments are not made, companies may find themselves unable to continue marketing their products as dietary fiber, along with the associated claimed health benefits.
These are only a few aspects of the proposed rule that may affect your business if implemented. It is essential to review the document carefully and express your concerns (and/or support) by submitting comments to the agency by the June 2nd deadline.
Working with your trade association to submit comments will provide a stronger voice to FDA. CRN will prepare comments on behalf of our members and has already requested an extension of the comment period to allow more time for our members to digest the proposed rule and its far-reaching implications. Also, start planning now; while we don’t know when the rule will be finalized, FDA has indicated that compliance will be expected within two years after the final rule becomes effective.