Dietary Supplement Health and Education Act of 1994: P.L. 103-417
Donna V. Porter
DEFINITION OF SUPPLEMENT
The Dietary Supplement Health and Education Act defines a dietary supplement as a product added to the total diet that contains at least one of the following: a vitamin, mineral, herb, botanical, amino acid, another dietary substance for use to supplement the diet, or a concentrate, metabolite, constituent, extract, or combination of ingredients. A product can be in any form such as a capsule, softgel, powder, concentrate, or extract but must be labeled as a supplement and cannot be represented for use as a conventional food or sole meal item. Supplements are excluded from food additive status. A supplement may also be defined and regulated as a drug, which does not change its previous status as a supplement.
Comment. The Act allows the ingredient in a supplement, regardless of its form or composition, to be excluded from regulation as a food additive or drug, both of which require premarket approval. The inclusion of the phrase “another dietary substance for use to supplement the diet” would seem to suggest that there is no limit on the substances that could be considered to be supplementing the diet and therefore exempted from regulation as food additives or drugs. Given the agency’s resource constraints, the exemption from the food additives provisions of the Federal Food Drug and Cosmetics Act (FDCA) may make it more difficult for FDA to challenge products for which there is a health or safety question. The burden of proof will be placed on the agency, not on the manufacturer as in the premarket approval required for food additives. Furthermore, FDA will have to use the general food safety provision, which requires it to show that an ingredient is “ordinarily injurious to health,” meaning it would be expected to harm most individuals who consume it. This is a standard that is much more difficult to meet than the “may be injurious to health” standard for food additives. The definition also establishes that, should a supplement ingredient at some later date be approved for marketing as a prescription drug, that decision will in no way affect its continuing regulatory status as a dietary supplement. There is some concern that manufacturers may choose to market their products as supplements in order to avoid needing to meet the requirements for drug approval. The provisions also prevent any restrictions based on the form of a product, so that if a product contains a higher dose of a substance with increased potency, the agency would be unable to regulate it on that basis alone. FDA and the health professional in general have long held the view that many substances, although not hazardous at low doses, may become a health problem at higherconcentration levels.
SAFETY BURDEN ON FDA
The Act considers a supplement to be adulterated if it presents a significant or unreasonable risk of illness or injury under conditions of use stated on label or understood under ordinary use. It can also be declared unsafe if it contains an ingredient for which there is inadequate information to provide reasonable assurance that is does not present a significant or unreasonable risk to illness or injury or if the Secretary determines that it poses an imminent hazard to public health or safety. The burden of proof is placed on the U.S. Government to make the determination that a supplement or its ingredient is unsafe. The courts would be charged with deciding any issue of safety of a supplement or its ingredient on a de novo basis.
Comment. This provision shifts the burden of proof for demonstrating that a supplement or its ingredient is unsafe to FDA. This change represents a significant policy change from the present procedures applied to food additives and drugs, where the burden of proof is on manufacturers to demonstrate that their products are safe prior to marketing. There will be increased demands on FDA resources to address perceived safety problems of a supplement or its ingredients when they arise. The difficulty of demonstrating a potential safety problem might be mitigated if regulations clearly define the terms “substantial and unreasonable risk” of illness or injury. Although these two terms might seem to clarify the anticipated level of safety desired for a supplement if challenged, those terms arguably may be viewed as synonyms for the standard “ordinarily injurious to health.” There has never been a comprehensive safety review of supplement products and their ingredients. Although such a review would, no doubt, demonstrate that most products are relatively safe, there may be some products whose long-term use might lead to toxic effects. Such products might warrant the need for public notification and/or limiting access. As demonstrated in the L-tryptophan contamination case, consumers seem to believe that any product that appears in pill form has been reviewed for safety by FDA, which is not true for supplements.
The Act seems to suggest that a supplement label would be required to state the conditions for use, unless the ordinary conditions of use would be understood by consumers. However, it is unclear where consumers would obtain this information if it is not on the label. Nor is it clear whether conditions of use on the label include the type of information that appears on an over-the-counter drug which, by regulation, must provide consumers with information such as warnings, precautions, and adequate directions for use. Although this type of information exists for vitamins and minerals, no comparable objective information is available for amino acids and herbal products.
The courts are charged with being the final arbitrator in determining the safety of supplements as if they had not been previously reviewed by the agency. This provision puts the final decision on a scientific matter in the hands of the legal system.
DIETARY SUPPLEMENT CLAIMS
The Act exempts, from the definition of labeling, information in the form of an article, book chapter, or official abstract of a peer-reviewed scientific publication used in connection with the sale of supplements. Such materials cannot be false or misleading or promote a particular brand. In addition, this information must be displayed with other materials that present a balanced view of the available scientific information and displayed physically separate from the products and cannot be appended from product packages. The burden of proof is on the U.S. Government to establish that this information is false or misleading.
Comment. This provision allows for the availability of nonmisleading informational materials that promote the therapeutic use of various substances for certain diseases. Exempting this information from the definition of labeling means that these materials will not be subject to the preclearance provisions and scientific standards that other health claims must meet. The term “misleading” is not defined in the Act, but may be clarified in the regulations. There is concern among some health professionals that these informational materials may play on the fears and desperation of individuals with serious health conditions if the information promoting the use of certain substances is not balanced. Although there are undoubtably supplement ingredients that have beneficial health effects for certain conditions, few, if any, of these ingredients have been subjected to systematic randomized clinical trials in the United States.
The provision requires that the materials be placed with information that presents a balanced view of the state of knowledge on the subject, but there is no provision to enforce this requirement. This provision assumes that information that can provide a balanced view is publicly available, when such information may not exist. It also places the burden of proof on FDA to demonstrate that the materials are false and misleading, a responsibility the agency may find difficult to implement due to limited enforcement resources.
STATEMENTS OF NUTRITIONAL SUPPORT
The Act allows manufacturers to make nutritional benefit claims that are not disease-related claims, if they do not profess to diagnose, prevent, mitigate, treat, or cure a specific disease. It specifically allows statements to address classical nutrient deficiency diseases as long as they describe the prevalence of the disease in the United States, the role or documented mechanism that the nutrient is intended to affect, or the general well-being from consumption of the nutrient, without being considered a disease-prevention claim. A manufacturer must have substantiation that any such statement is truthful and nonmisleading. Use of such a statement must be accompanied by the following statement in a prominent place and in bold type: “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.” Any manufacturer making such a statement must notify FDA within 30 days of its use.
Comment. This provision allows statements of nutrient function to be made. Although these claims may have been allowed in the past, the situation needed to be clarified. These statements are not considered to be health claims as long as they do not profess to diagnose, prevent, mitigate, treat, or cure a disease or condition. Such statements need to be made in a very factual and straightforward manner to prevent them from being misleading to consumers. Such statements may need to be characterized or defined in regulations and then monitored to assure that manufacturers limit their claims to either structure or functional roles.
FDCA defines a drug to be “… an article intended to affect the structure and function of the body of man….” Delineation between dietary supplement and drug-related structure and function statements may become problematic for FDA. The materials that will be used to document the function of non-nutrient ingredients in the body may be controversial. The requirement for the FDA disclaimer will inform consumers that the agency has not evaluated the validity of such statements. Although the manufacturer is required to have substantiation, there is no indication in the law as to what this constitutes, leaving it open to the same type of debate that has faced policymakers over what constitutes “significant scientific agreement.” Manufacturers need only notify FDA within 30 days after the appearance of such statements, without requiring that they provide substantiation to the agency, which does not allow adequate time for FDA oversight and enforcement before they appear on product labels. Even if a statement is challenged by the agency, it will likely have been read by consumers and used to sell products before either voluntarily or involuntarily removal by the manufacturer.
NEW LABELING REQUIREMENTS
The Act requires dietary supplements to state the name and quantity of each ingredient or the total quantity of ingredients in proprietary blends. The products must be identified as a supplement. Herbal products must identify the part of the plant used. Supplements must be covered by and conform to an official compendium or list the same type of specifications contained in such a standard. Nutrition information must first list the dietary ingredients present in significant amounts for which there are established daily consumption levels. Supplement ingredients that are present in insignificant amounts are not required to be listed. Nonessential dietary ingredients are required to be listed on the nutrition label and identified as not having an established daily consumption recommendation.
The product label is required to list the amount of each ingredient per serving and identify its source, and the nutrition information is to precede the ingredient listing. An ingredient is not required to be listed twice. The Act allows a statement of the percentage level of an ingredient in a product for which there is not a recommended daily intake value. The term “dietary supplement” is substituted for “vitamins and minerals” in the Proxmire amendment to FDCA (sec. 411).
Comment. This language is a step forward in the labeling of these products. Tying products to the specifications in an official compendium or its equivalent would require that standards of identity, strength, quantity, purity, or compositional specifications be met for the first time for many of these products that contain vitamins and minerals. Because there is no existing official compendium on herbals, botanicals, or amino acids, it is unclear how the standards will be established for these substances. There is no requirement to verify that the portion of the herbal product stated to be present in the supplement is that portion which is actually present. The lack of verification arguably creates the potential for fraud, abuse, and health problems, as there are certain portions of some herbs that are hazardous to health.
Although the listing of the product’s nonessential substances on the nutrition labeling may be desirable, it may detract from the recent attempt in food labeling reform to attain consistency among all food labels for the sake of clarity. Listing nonessential dietary ingredients on the nutrition facts panel may suggest to consumers that these ingredients have some nutritional role, which they do not. If supplements are allowed to list any ingredient on the nutrition panel, it may be contrary to other labeling reform which focused nutrition panel information to those nutrients for which there is public health significance. Furthermore, there is no requirement that the Secretary promulgate regulations for this section of the Act. In the absence of such rules, manufacturers can adopt the language of the provisions into their labeling according to their own interpretations as soon as they choose.
NEW DIETARY INGREDIENTS
The Act allows ingredients in supplements only if they have been present in the food supply in a form that is not chemically altered, or have a history of use or other evidence of safety. Seventy-five days before a new dietary ingredient is introduced into interstate commerce, a manufacturer must provide to FDA the scientific basis on which it has been concluded that the ingredient is safe. This information is kept confidential for 90 days before it is placed on display, except for proprietary information, which remains confidential. Anyone may file a petition proposing the issuance of an order prescribing the conditions under which a dietary ingredient is expected to be safe, and the Secretary has 180 days in which to make a decision. A “new dietary ingredient” is a substance marketed after October 15, 1994.
Comment. New dietary ingredients are allowed to be used in supplements, as long as they are unaltered from their natural form in the food supply or there is other evidence of their safety. The Act allows a history of use or other evidence of safety to be the basis for judging whether a new ingredient is considered safe. A “history of safe use” is not defined, and it is not clear what documentation is required to demonstrate evidence of long-term effects.
In the case of some supplements already used for decades, the “history of use” standard has been shown to be a flawed premise on which to base safety alone. The Act grandfathers many substances that have previously been on the market without ever having undergone any thorough safety review. Use of some dietary ingredients (e.g., the herbal ingredients comfrey and chaparral) have recently raised safety concerns. Laboratory analysis of some imported Chinese herbs–used for centuries–has identified the presence of steroids. Manufacturers are required to provide citations to published articles that demonstrate evidence that a new dietary ingredient is safe. However, there is no requirement that the articles be from scientific peer-reviewed journals. Furthermore, the term “dietary ingredient” is not defined in the Act, leaving open the question of whether there is any limit on the type of products that can be marketed under this provision.
GOOD MANUFACTURING PRACTICES
The Act requires that supplements be prepared, packed, or held under good manufacturing practices (GMPs), including expiration dates. GMPs are established by modeling them after those practices for conventional food and may not impose standards for which there is not current and generally available analytical methodology. No standard of current GMP is to be imposed, unless it is included in a regulation promulgated after notice and comment.
Comment. Currently, there are no GMP regulations specifically for supplements, although they have been subject to the same GMPs used for foods. Manufacturers of supplements who also produce drugs generally follow the GMPs for drug products which, by comparison, are relatively strict standards. However, the nature of supplements would suggest that there needs to be a separate set of these standards established for their unique composition, which is food ingredients compounded in pill form. Current U.S. Pharmacopeia (USP) monograph standards developed for vitamin and mineral supplements could be adopted into supplement GMPs after proper regulatory review. Similar USP standards have not been established for herbals and botanicals. These standards are arguably needed to assure product consistency and provide some degree of consumer protection.
WITHDRAWAL OF THE ADVANCED NOTICE OF PROPOSED RULEMAKING
The Act declares that the advanced notice of proposed rulemaking (ANPR) on supplement safety published in the June 18, 1993 Federal Register is null and void and has no force or effect on these products. The Secretary is directed to publish a Federal Register notice to revoke this document.
Comment. The ANPR published in June 1993 outlined issues that FDA believed warranted further discussion before it decided whether to propose new regulation on supplement safety. The language in the ANPR suggested that the agency was considering a stricter approach to future regulation of these products, particularly for safety testing following the contaminated L-tryptophan incident. An ANPR is an exploratory document designed to elicit comment to assist an agency in determining whether and what to do concerning an issue. Given the controversy created by the publication of the supplement ANPR, FDA had shown no intention of proceeding with rulemaking on this issue. (The notice revoking the ANPR was published in December 1994.)
COMMISSION ON DIETARY SUPPLEMENT LABELS
The Act establishes a Commission on Dietary Supplement Labels as an independent executive branch agency. The Commission is to be appointed by the President and consist of seven members with experience in the manufacture, regulation, distribution, and use of supplements. At least three members are to be qualified by scientific training and experience to evaluate the benefits of supplements with one member experienced in pharmacognosy, medical botany, traditional herbal medicine, or other related science. Members and staff of the Commission are to be without bias on the use of supplements.
The Commission is to study and provide recommendations for the regulation of label claims and statements for supplements, including use of literature in connection with the sale of these products and procedures for the evaluation of such claims. It is to evaluate how best to provide truthful, scientifically valid, and nonmisleading information to consumers so that they can make informed and appropriate health care choices. The Commission may obtain information through hearings and receive any evidence it considers necessary, including that from Federal agencies.
Funding is authorized to be appropriated as needed to carry out the Commission’s work. The final report is to be prepared and submitted to the President and Congress within 24 months containing recommendations, including any legislation deemed necessary. Within 90 days, FDA is directed to publish a notice of the Commission’s recommendations for regulatory change for supplements and include a notice of proposed rulemaking on such changes to provide an opportunity for comment. Rulemaking is to be completed within 2 years after the date of the issuance of the Commission’s report. If rulemaking is not completed in 2 years, the final regulations on supplement health claims published January 4, 1994, are no longer in effect.
Comment. The 2-year commission created by the Act is to recommend the procedures and standards to be used in authorizing health claims for supplement products. It appears from the debate on this issue that the supplement industry anticipates that the Commission will be composed of individuals who favor supplement use and the unlimited use of health claims. The supplement industry favors a weaker standard than significant scientific agreement (or its current interpretation in the existing regulation under NLEA) for the authorization of health claims for their products. Balanced representation on the Commission will be important to the weight given its recommendations by policymakers.
Among health professionals and the conventional food industry, there is concern that the Commission might recommend a different procedure and interpretation of the significant scientific agreement standard than that currently applied to conventional foods for health claims. With a separate standard for supplement claims, manufacturers of a nutrient or other ingredient contained in their products might be able to make a claim that others using the same ingredient in a conventional food or over-the-counter drug would not be allowed to make. They fear a separate standard might result in unfair marketing advantage between different segments of the market, conventional foods versus supplements.
The recommendations of the Commission are advisory in nature and do not carry a requirement for implementation by the Administration. The 90-day time frame to propose new regulations for supplement health claims is short and may impose a difficulty for a policy issue of this complexity and scope. Until 2 years after the Commission reports, supplement health claims will be subject to and must be authorized under the significant scientific agreement standard for conventional foods. If the Commission’s recommendations are not adopted, it is unclear how supplement health claims will be regulated after the 4-year period, because these products will no longer be subject to the health claims regulations for conventional foods.
OFFICE OF DIETARY SUPPLEMENTS
The Act requires that an Office of Dietary Supplements be established at NIH to explore the potential role of supplements to improve health care and promote scientific study of their benefits in maintaining health and preventing chronic diseases. The Director of this Office is to
1. Conduct and coordinate scientific research within NIH related to the extent to which their use can limit or reduce disease risk
2. Collect and compile the results of scientific research relating to supplements, including from foreign sources and the Office of Alternative Medicine
3. Serve as principal scientific advisor to officials in DHHS and FDA on issues related to supplement regulation, safety claims, 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 funding related to supplements.
The substances to be addressed include vitamins, minerals, amino acids, herbs, and botanicals; any dietary substance used to increase total dietary intake; and any concentrate, metabolite, constituent, extract, or combination of these substances. The law authorizes $5 million to be appropriated for fiscal year 1994 and such funds thereafter as are needed in future years to be added to the NIH budget.
Comment. An Office of Dietary Supplements is to be created at NIH to coordinate and conduct research on supplements and serve as primary advisor on the regulation and promotion of these products to other governmental agencies. This Office appears to be primarily designed to advise FDA on the regulation of these products on such issues as their intake, safety, claims, labeling, and composition, while at the same time overseeing Federal research on the benefits of these products. To some observers, the separation of research and regulation might be desirable for the sake of independence and credibility. The amount of money authorized for research appears to be small in terms of supporting a comprehensive program to undertake the numerous tasks anticipated by the Act.
In addition, no language in the Act suggests the location of this Office within NIH or the relationship between this Office and (a) the Division of Nutrition Research Coordination or the Office of Alternative Medicine (OAM) both at NIH and responsible, in part, for research on certain dietary substances, or (b) the Office of Special Nutritionals at FDA created to address these issues in the 1992 agency reorganization.
Recently, proponents of alternative medical therapies have criticized what they perceive to be the slow rate of output from the OAM in supporting such practices. However, receiving results from any NIH-funded research program is a time-consuming process. Grantproposal review and funding takes at least a year, followed by an average 4-year period during which the research is conducted, and then additional months are needed to prepare the research results for publication. The pursuit of objective science proceeds at a relatively slow pace, sometimes taking decades to generate the evidence to support a particular therapy.
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