Dietary supplements: recent regulations and related activities

Donna V. Porter

DSHEA REGULATIONS

On December 31, 1995, the Food and Drug Administration (FDA) published several documents that would revise the regulations for the labeling of dietary supplements. These rules are primarily promulgated based on the provisions of DSHEA, but also address several unresolved issues that resulted from the Nutrition Labeling and Education Act of 1990 (NLEA). The following discussion is a brief overview of those regulations.

Reference Daily Intakes (RDIs). The first document was actually a final rule on RDIs. FDA has amended the existing regulation to establish RDIs for vitamin K, selenium, manganese, chromium, molybdenum, and chloride, but not for fluoride.[1] Before passage of NLEA, FDA proposed to amend food label reference values to replace the US Recommended Daily Allowances with RDIs for protein and 26 vitamins and minerals. The nutrients that were required to be labeled on conventional foods under NLEA were incorporated into the RDIs regulation and appeared on food labels as DVs (daily values). However, passage of DSHEA required the agency to create RDIs for additional nutrients that would appear on supplement labels; hence, the additions made for vitamin K, selenium, manganese, chromium, molybdenum, and chloride in this rule. The exclusion of fluoride from the list of nutrients with RDIs is based on the agency’s determination that there is no consensus on its essentiality and its declaration would be of little value to consumers. The effective date for this rule is January 1, 1997.

Claims. To implement part of DSHEA, FDA has proposed to amend the nutrient and health claims regulation.[2] The proposed regulations change the terminology used to describe the conditions which a dietary supplement must retain, ie, contribute taste, aroma, or nutritive value, or any other technical effect when consumed, to justify a nutrient content or health claim. A nutrient content claim is a claim that expressly or implicitly characterizes the level of a nutrient in a product and uses descriptive terms that have been authorized by FDA through regulation. In addition, the proposed rules allow for the use of statements that characterize the percentage level of dietary ingredients, where RDIs or Daily Reference Values (DRVs) have not yet been established by scientific consensus, compared with a clearly identified reference food with the amount of the dietary ingredient in both products. The use of defined terms such as “good source” and high,” has been limited to only those nutrients for which there are RDIs and DRVs, although such terms as “contains” and “provides” can be used with the actual amount of the dietary ingredient per serving. Nutrient content claims would be required to be accompanied by a referral statement when fat/saturated fat/ cholesterol/sodium were present. The new rules withdraw the current provisions that a supplement of vitamins and minerals may not give prominence to a dietary ingredient that is not a nutrient on its label.

Manufacturers will be allowed to make truthful, nonmisleading statements of nutritional support (describe the role of the nutrient or dietary ingredient intended to affect the structure or function in humans) as long as the DSHEA-mandated disclaimer is present. FDA has proposed that the disclaimer be prominently displayed in boldface type, immediately adjacent to the statement of nutritional support, and in one-sixth-inch type in a box, stating that: This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. A modified format is provided for cases in which multiple statements of nutritional support appear on the product. FDA has proposed to make this regulation effective on January 1, 1997.

Other Claims. In a separate notice, FDA has proposed to amend its regulations on several additional issues that concern nutrient content claims.[3] The agency has proposed to amend its nutrient content claim rule on the calorie content of foods or dietary supplements to allow sugar-free and no-sugar claims on supplements that meet the standards to make these claims. The agency has also proposed to define the term “high potency” as a product that contains 100% or more of the RDI for vitamins or minerals (or DRV in the case of protein or fiber) for at least two thirds of the nutrients present and may be used only on supplements. Products that contain nutrients for which RDIs or DRVs have not been established will not be able to use the term “high potency.” The proposed rules would also provide a definition of the term “antioxidant” for use in nutrient content claims on labels or in labeling of supplements and conventional foods as an expressed claim that is a collective term inclusive of vitamin C, vitamin E, and beta-carotene when used as part of a nutrient content claim with the terms “good source,” “high,” or “more” that describes products. It also requires that the food must contain requisite amounts of each nutrient to qualify to bear the claim, eg, a product “high in antioxidants” must contain 20% or more of the RDI for vitamins C and E and 20% or more for vitamin A present as beta-carotene per reference amount customarily consumed. The proposed rule includes a requirement that vitamin A as beta-carotene must be present at a sufficient level to qualify for the claims: “high in antioxidants” (20% of the DV for vitamin A) or “high-potency antioxidant” (100% or more of the DV for vitamin A). In cases where all three antioxidant vitamins are not present, FDA proposes to allow the nutrient content claim for antioxidant content to be made with the label disclosing the antioxidants present in sufficient amounts to quality for the claim. The terms “complete antioxidant complex” or “antioxidant formula” are also proposed to be allowed if the product contains at least 10% of the RDI for vitamins C and E, and vitamin A (present as beta-carotene). The effective date of this regulation was January 1, 1996.

Labeling. The largest of the proposed regulations published by FDA concerns the labeling of dietary supplements.[4] The statutory language required that a dietary supplement be labeled as such on the principle display panel, and the agency has proposed that where a food is marketed as a dietary supplement that the label should bear this term as part of its statement of identity. Under the new regulations, most dietary supplements, regardless of their form, would be required to bear nutrition labeling that conforms to the general requirements and appears under the heading of “Supplement Facts.” FDA has proposed that the supplement facts panel first list the dietary ingredients for which RDIs and DRVs have been established, followed by a separate listing for those for which no such standards currently exist. In addition, the regulations also propose: to require that calories from the subcomponents of nutrients may be declared and are required when a claim is made; to require the listing of nonrequired vitamins and minerals only when they are added for supplementation or a claim is made; and not to require the listing of amounts of less than 2% of the RDI for vitamins and minerals. Protein listing would not be required where only individual amino acids are contained in the product. Figure 1 is an example of a proposed label format for a product with both nutrient and nonnutrient ingredients; other formats for other combinations of supplement ingredients are provided in the Federal Register notice. The heading of “Amount per Serving” will be used, except where the serving size of the product is one unit, and will appear over the column of amounts. Dietary ingredients are to be listed on the left-hand column of the label, with calories being listed first in the column of names and synonyms allowed after ingredient names. The term “folic acid” is proposed as an allowable synonym for folate, and the percentage of vitamin A present as beta-carotene may be declared immediately adjacent to the listing of vitamin A. The proposed rules would require the listing in per-serving amounts for the number of calories and the listing of actual amounts present by weight of the 14 nutrient ingredients (required in the nutrition facts label) in the column to the right of the names column. The quantitative amount by weight for any dietary ingredient is to be the weight of that dietary ingredient rather than the weight of its source, ie, the weight of the calcium in the calcium carbonate. The declaration of the percent daily value for each nutrient ingredient is to be listed, with the exception of several nutrient ingredients that are provided. The amount per serving and the percent daily value are to appear on the same line. The agency has proposed to require footnote symbols referring to “Percent Daily Values are based on a 2000-calorie diet,” on products intended for the use of those over 4 years of age, and “Daily Value not established,” for dietary ingredients for which a percent DV cannot be calculated.

COMMISSION ON DIETARY SUPPLEMENTS LABELS

The Commission on Dietary Supplements was established under the provisions of DSHEA as an independent entity of the Government. Section 12 of the law authorizes the establishment of a seven-member, Presidentially appointed panel of which three have expertise on the use of dietary supplements. Panel members and staff are to be without bias on the use of dietary supplements.

The Commission’s charge is to study and provide recommendations for regulation of label claims and statements for dietary supplements and procedures for evaluation of labeling claims. Consideration of the use of third-party literature in connection with the sale of supplements is to be included in the deliberations. The Commission is expected to evaluate how best to provide truthful, scientifically valid, and nonmisleading information to consumers so that they can make informed health care choices for themselves and their families. It has 2 years from the date of enactment to study and report to the President and Congress on recommendations, including the need for legislative changes, if necessary and appropriate.

The Commission held its first meeting in Washington, DC, in February 1996, during which oral comments from interested parties were heard. Field hearings will be held in Salt Lake City, Utah; San Francisco, California; and Orlando, Florida, this spring to seek the views of all interested parties on the standards and procedures for making health claims for supplements. The Commission has requested all comments by the end of June 1996. The Commission expects to consider all comments received and report its recommendations by the end of 1996.

OFFICE OF DIETARY SUPPLEMENTS RESEARCH

DSHEA also established an Office of Dietary Supplements at the National Institutes of Health (NIH) to explore the potential role of supplements to improve health care and promote scientific study of their benefits in maintaining health and preventing disease. The Office Director is to:

1. Conduct and coordinate supplement-related scientific research within NIH on the extent to which supplement use can limit or reduce the risk of disease;

2. Collect and compile the results of scientific research relating to supplements, including scientific data from foreign sources or the Office of Alternative Medicine;

3. Serve as principal scientific advisor to officials in Department of Health and Human Services (DHHS) and FDA on issues related to supplement regulation, safety, disease prevention claims, and scientific issues in connection with labeling and composition;

4. Compile a database of scientific research on supplements and individual nutrients;

5. Coordinate research funding related to supplements.

The substances to be addressed by this Office include vitamins, minerals, amino acids, herbs and botanicals, any dietary substances used to increase total dietary intake, any concentrate, metabolite, constituent, extract, or combination of these substances.

The Office was opened under the Office of the Director of NIH in January 1996. The mission of the Office is to increase the research on dietary supplements. It will sponsor its first conference in June 1996 on Dietary Supplements and the Physically Active. The Office is currently funded at $5 million annually.

INTERNATIONAL ISSUES

In 1995 the Codex Alimentarious Commission proposed guidelines or dietary supplements of vitamins and minerals. The Codex is an international intergovernmental body responsible for the implementation of the Joint Food and Agriculture Organization/ World Health Organization Food Standards Program. The aim of the program is to simplify and integrate national food standards by enhancing consumer protection and fair practices in food trade. Subordinate committees of the Commission meet on a regular basis to discuss and work on standards and guidelines that affect various aspects of food trade, eg, food labeling and commodity standards. One such committee is the Codex Alimentarious Commission Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU), which is responsible for the need for standards and guidelines on nutritional quality of foods in general, and specific products such as infant formula, cereal-based supplemental foods for infants and children, dietary supplements, and foods for special dietary uses.

At the 1995 CCNFSDU meeting, the German delegation proposed that the Committee consider the development of guidelines for dietary supplements of vitamins and minerals. The proposed guidelines would establish recommendations for minimum and maximum dosages, approved and prohibited ingredients, and guidelines for claims that could be used on the labels. The US delegation opposed undertaking this work, but the majority voted for the proposed guideline to be considered. The US FDA circulated the draft Codex document to interested parties in this country for comment to prepare its response in accordance with applicable US law and regulations promulgated under the authority of The Federal Food, Drug, and Cosmetics Act and related statutes.

The Codex is one organization that will be developing standards that can be used by nations participating in the General Agreement on Tariffs and Trade (GATT) which was signed by the United States and ratified by the US Senate. Under the requirements of the Agreement on the Application of Sanitary and Phytosanitary Measures, he United States retains its rights to enact and enforce laws to ensure he health and safety of its population.

This draft document represents he concern of a number of governments about the level of regulation to which dietary supplements are currently subjected. If finalized, the document would represent a consensus of the signatory countries that there should be some baseline Level of regulation of these products. The document is not binding on any member country, unless it is adopted into the laws of that country. In many cases, the member countries already have adopted statutes that are more strict than the Codex provisions. Therefore, this document will not prescribe how and what supplements are sold in the United States. The document may serve as a guideline for member countries that do not yet have, but may wish to develop, their own standards for the regulation of these products within their own borders. The development of a Codex guideline is a multistep process, and this draft guideline is currently at level 3 of 7 steps.

Comment. Nutrition professionals will undoubtedly be interested in following the developments for each issue outlined in this report.

Figure 1 [ILLUSTRATION OMITTED]

REFERENCES

[1.] US Dept. of Health and Human Services. FDA. Food labeling: Reference daily intakes Final rule. Fed Register 1995,60:67164-75.

[2.] US Dept. of Health and Human Services. FDA. Food labeling: Requirements for nutrient content claims, health claims, and statements of nutritional support for dietary supplements. Fed Register 1995,60:67176-84.

[3.] US Dept. of Health and Human Services. FDA. Food labeling: Nutrient content claims Definition of “high potency” claim for dietary supplements and definition of “antioxidant” for use in nutrient content claims for dietary supplements and conventional foods. Proposed rule. Fed Register 1995,60:67184-94.

[4.] US Dept. of Health and Human Services. FDA. Food labeling: Statement of identity, nutrition labeling, and ingredient labeling of dietary supplements. Proposed rule. Fed Register 1995; 60:67194-224.

The views expressed in this column are those of the author and do not reflect the position of the Library of Congress.

Dr. Donna Porter, Specialist in Life Sciences at the Library of Congress since 1980, served previously as a Fellow at the National Nutrition Consortium and a Congressional Science Fellow in the Science Policy Research Division of the Congressional Research Service. She holds a Ph.D. in human nutrition with a minor in political science from Ohio State University. Comments can be addressed to Dr. Porter at the Congressional Research Service, Library of Congress, Washington, DC 20540.

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